Sacituzumab govitecan | C12656 | | | Unresectable locally advanced or metastatic triple‑negative breast cancer
Initial treatment
Patient must have progressive disease following two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting; AND
The condition must be inoperable; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
The treatment must be the sole PBS‑subsidised therapy for this PBS indication. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12656 |
| C12669 | | | Unresectable locally advanced or metastatic triple‑negative breast cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this PBS indication. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12669 |
Sacubitril with valsartan | C11680 | P11680 | | Chronic heart failure
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta‑blocker, unless at least one of the following is present in relation to the beta‑blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta‑blocker; AND
Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA‑approved Product Information or cannot be tolerated; AND
The treatment must not be co‑administered with an ACE inhibitor or an angiotensin II antagonist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11680 |
C14254 | P14254 | | Chronic heart failure
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND
Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta‑blocker, unless at least one of the following is present in relation to the beta‑blocker: (i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta‑blocker; AND
Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA‑approved Product Information or cannot be tolerated; AND
The treatment must not be co‑administered with an ACE inhibitor or an angiotensin II antagonist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14254 |
Safinamide | C8624 | | | Parkinson disease The treatment must be as adjunctive therapy to a levodopa‑decarboxylase inhibitor combination. | |
Salbutamol | C6367 | | | Bronchospasm
Patient must be unable to achieve co‑ordinated use of other metered dose inhalers containing this drug. | |
C6815 | | | Asthma
Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer. | |
C6825 | | | Chronic obstructive pulmonary disease (COPD)
Patient must be unable to use this drug delivered from an oral pressurised inhalation device via a spacer. | |
Salmeterol | C6355 | | | Asthma
Patient must experience frequent episodes of the condition; AND
Patient must be currently receiving treatment with oral corticosteroids; OR
Patient must be currently receiving treatment with optimal doses of inhaled corticosteroids. | |
Sapropterin | C10076 | P10076 | | Hyperphenylalaninaemia
Initial treatment
Must be treated by a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured. | Compliance with Authority Required procedures |
| C10355 | P10355 | | Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency
Continuing treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured. | Compliance with Authority Required procedures |
| C10390 | P10390 | | Hyperphenylalaninaemia
Continuing treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured. | Compliance with Authority Required procedures |
| C10391 | P10391 | | Hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency
Initial treatment
Must be treated by a metabolic physician.
Patient must have hyperphenylalaninaemia (HPA) due to tetrahydrobiopterin (BH4) deficiency.
Patient must have documented tetrahydrobiopterin (BH4) deficiency using tests for BH4 loading and/or urine pterin metabolites, blood spot dihydropteridine reductase (DHPR) and have cerebrospinal fluid neurotransmitter metabolites measured. | Compliance with Authority Required procedures |
| C11836 | P11836 | | Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Pre‑conception through to when pregnancy first becomes known
Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%.
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
Patient must not be undergoing treatment with this drug under this Treatment phase, following completion of this authority application, for more than 13 cumulative months (assuming 1 month consists of 30 days); AND
Patient must not be undergoing simultaneous treatment with this drug under another non‑maternal PBS‑listing (apply under either listing type, but not both simultaneously).
Patient must be actively trying to conceive. | Compliance with Authority Required procedures |
| C11960 | P11960 | | Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Existing pregnancy to birth
Patient must be pregnant.
Patient must have demonstrated an adequate response to treatment with this drug at least once in a lifetime, with an adequate response defined as a reduction in phenylalanine levels from baseline during initial responsiveness testing of no less than 30%.
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND
Patient must not be undergoing further treatment with this drug as a PBS benefit, post‑partum in the absence of actively trying to conceive a subsequent child/a known subsequent pregnancy; AND
Patient must not be undergoing simultaneous treatment with this drug under another non‑maternal PBS‑listing (apply under either listing type, but not both simultaneously). | Compliance with Authority Required procedures |
| C13868 | P13868 | | Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Initial treatment ‑ responsiveness testing
The treatment must be for the purpose of ascertaining the patient's response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase: First continuing treatment, Indication: Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU); AND
Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels.
Must be treated by a metabolic physician; AND
Patient must be undergoing treatment with this drug for the first time; AND
Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND
Patient must not be undergoing simultaneous treatment with this drug under another PBS‑listing (apply under either listing type, but not both simultaneously).
Patient must be one of: (i) planning conception, (ii) pregnant. | Compliance with Authority Required procedures |
| C13880 | P13880 | | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
First continuing treatment
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have previously received PBS‑subsidised treatment under the Initial treatment ‑ responsiveness testing restriction with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing.
Blood phenylalanine levels must be based on measurements taken during stable periods of the condition.
Dietary phenylalanine intake must be maintained at a constant level. | Compliance with Authority Required procedures |
| C13885 | P13885 | | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Initial treatment ‑ responsiveness testing
Must be treated by a metabolic physician.
Patient must be untreated with this drug; OR
Patient must have completed prior responsiveness testing on only 1 occasion ‑ this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND
Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; OR
Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND
The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age; OR
The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month.
Dietary phenylalanine intake must be maintained at a constant level.
Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing. | Compliance with Authority Required procedures |
| C13912 | P13912 | | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Subsequent continuing
Must be treated by a metabolic physician; OR
Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications. | Compliance with Authority Required procedures |
Saxagliptin | C6346 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6346 |
C6363 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6363 |
C7505 | | | Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS‑subsidised regimen of oral diabetic medicines which included a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7505 |
C7541 | | | Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and an SGLT2 inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7541 |
Saxagliptin with dapagliflozin | C7524 | | | Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with metformin; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and a dipeptidyl peptidase 4 inhibitor (gliptin) or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7524 |
C7556 | | | Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with metformin; AND
Patient must have previously received a PBS‑subsidised regimen of oral diabetic medicines which included a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7556 |
Saxagliptin with metformin | C6333 | | | Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this fixed dose combination. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6333 |
C6335 | | | Diabetes mellitus type 2
Continuing
Patient must have previously received and been stabilised on a PBS‑subsidised regimen of oral diabetic medicines which includes metformin and saxagliptin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6335 |
C6344 | | | Diabetes mellitus type 2
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this fixed dose combination. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6344 |
C7507 | | | Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS‑subsidised regimen of oral diabetic medicines which includes metformin and an SGLT2 inhibitor for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7507 |
C7530 | | | Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS‑subsidised regimen of oral diabetic medicines which included a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7530 |
Secukinumab | C6696 | P6696 | | Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot ‑ balance of supply
Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C8830 | P8830 | | Severe chronic plaque psoriasis
Continuing treatment, Whole body
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C8831 | P8831 | | Severe chronic plaque psoriasis
Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C8892 | P8892 | | Severe chronic plaque psoriasis
Continuing treatment, Face, hand, foot
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9063 | P9063 | | Severe psoriatic arthritis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9064 | P9064 | | Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9069 | P9069 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9078 | P9078 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9105 | P9105 | | Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9155 | P9155 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9429 | P9429 | | Ankylosing spondylitis
Initial treatment ‑ Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C9431 | P9431 | | Ankylosing spondylitis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C10431 | P10431 | | Non‑radiographic axial spondyloarthritis
Continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND
The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0‑10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment. | Compliance with Authority Required procedures |
| C11089 | P11089 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C11096 | P11096 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Whole body (change or re‑commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11138 | P11138 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Face, hand, foot (change or re‑commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11154 | P11154 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Whole body (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C11389 | P11389 | | Non‑radiographic axial spondyloarthritis
Initial treatment ‑ Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA‑B27); AND
The condition must not be radiographically evidenced on plain x‑ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND
The condition must be non‑radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND
The condition must be sacroiliitis with active inflammation and/or oedema on non‑contrast Magnetic Resonance Imaging (MRI); AND
The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND
The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
The following must be provided at the time of application and documented in the patient's medical records:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale; and
(b) C‑reactive protein (CRP) level greater than 10 mg per L.
The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.
If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.
State in the application whether a loading dose regimen is intended or not.
Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.
Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1. | Compliance with Authority Required procedures |
| C11390 | P11390 | | Non‑radiographic axial spondyloarthritis
Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patients) restriction to complete 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 20 weeks treatment.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
| C11502 | P11502 | | Non‑radiographic axial spondyloarthritis
Initial treatment ‑ Initial 1 (New patient)
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA‑B27); AND
The condition must not be radiographically evidenced on plain x‑ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND
The condition must be non‑radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND
The condition must be sacroiliitis with active inflammation and/or oedema on non‑contrast Magnetic Resonance Imaging (MRI); AND
The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND
The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.
State in the application whether a loading dose regimen is intended or not.
Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.
Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale; and
(b) C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and CRP level must be determined at the completion of the 3‑month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The baseline BASDAI score and CRP level must also be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C12392 | P12392 | | Non‑radiographic axial spondyloarthritis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
| C14220 | P14220 | | Non‑radiographic axial spondyloarthritis
Initial treatment ‑ Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND
Patient must not receive more than 20 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C‑reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0‑10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C‑reactive protein (CRP) level.
The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.
State in the application whether a loading dose regimen is intended or not.
Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.
Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1. | Compliance with Authority Required procedures |
| C14430 | P14430 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C14462 | P14462 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C14655 | P14655 | | Ankylosing spondylitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a patient is changing from PBS‑subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14662 | P14662 | | Ankylosing spondylitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of at least 5 years from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C‑reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a baseline ESR and/or CRP level.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14670 | P14670 | | Ankylosing spondylitis
Initial treatment ‑ Initial 1 (new patient)
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14692 | P14692 | | Ankylosing spondylitis
Continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Selegiline | C5338 | | | Late stage Parkinson disease
The treatment must be as adjunctive therapy to a levodopa‑decarboxylase inhibitor combination. | |
Selexipag | C11193 | P11193 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
(i) Hospitalisation due to worsening PAH;
(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6‑Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6‑Minute Walk Distance from baseline, combined with the need for additional PAH‑specific therapy;
(iv) Initiation of parenteral prostanoid therapy or long‑term oxygen therapy for worsening of PAH;
(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH. | Compliance with Authority Required procedures |
| C11195 | P11195 | | Pulmonary arterial hypertension (PAH)
Initial treatment following dose titration
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
Patient must have completed the dose titration phase; AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS‑subsidised PAH agent prior to this authority application.
Select one appropriate strength (determined under the 'Initial treatment ‑ dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. | Compliance with Authority Required procedures |
| C11261 | P11261 | | Pulmonary arterial hypertension (PAH)
Initial treatment ‑ dose titration
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS‑subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. | Compliance with Authority Required procedures |
Selinexor | C13161 | P13161 | | Relapsed and/or refractory multiple myeloma
Grandfather treatment ‑ Transitioning from non‑PBS to PBS‑subsidised supply ‑ Dose requirement of 160 mg per week
Patient must have received non‑PBS‑subsidised treatment with this drug for this PBS indication prior to 1 September 2022; AND
The treatment must be in combination with dexamethasone; AND
Patient must have progressive disease after at least four prior lines of therapy, prior to initiating non‑PBS‑subsidised therapy with this drug for this condition; AND
Patient must have demonstrated refractory disease to prior treatments, prior to initiating non‑PBS‑subsidised therapy with this drug for this condition, which must include: (i) a minimum of two proteasome inhibitors; and (ii) a minimum of two immunomodulators; and (iii) an anti‑CD38 monoclonal antibody; AND
Patient must not be receiving concomitant PBS‑subsidised treatment with any of the following: (i) proteasome inhibitors, (ii) Immunomodulators, (iii) anti‑CD38 monoclonal antibody.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C14021 | P14021 | | Relapsed and/or refractory multiple myeloma
Initial treatment ‑ Dose requirement of 80 mg, 60 mg or 40 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
| C14022 | P14022 | | Relapsed and/or refractory multiple myeloma
Grandfather treatment ‑ Transitioning from non‑PBS to PBS‑subsidised supply ‑ Dose requirement of 80 mg, 60 mg or 40 mg per week
Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 June 2023; AND
Patient must have met all initial treatment PBS eligibility criteria applying to a non‑grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C14023 | P14023 | | Relapsed and/or refractory multiple myeloma
Continuing treatment ‑ Dose requirement of 100 mg per week
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C14024 | P14024 | | Relapsed and/or refractory multiple myeloma
Initial treatment ‑ Dose requirement of 100 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
| C14031 | P14031 | | Relapsed and/or refractory multiple myeloma
Continuing treatment ‑ Dose requirement of 160 mg per week
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C14037 | P14037 | | Relapsed and/or refractory multiple myeloma
Grandfather treatment ‑ Transitioning from non‑PBS to PBS‑subsidised supply ‑ Dose requirement of 100 mg per week
Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 June 2023; AND
Patient must have met all initial treatment PBS eligibility criteria applying to a non‑grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C14039 | P14039 | | Relapsed and/or refractory multiple myeloma
Initial treatment ‑ Dose requirement of 160 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
| C14045 | P14045 | | Relapsed and/or refractory multiple myeloma
Continuing treatment ‑ Dose requirement of 80 mg, 60 mg or 40 mg per week
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
Semaglutide | C5469 | | | Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
The treatment must be in combination with metformin unless contraindicated or not tolerated; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5469 |
| C5478 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5478 |
| C5500 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5500 |
Sertraline | C4755 | | | Major depressive disorders | |
C6277 | | | Obsessive‑compulsive disorder | |
C6289 | | | Panic disorder
The treatment must be for use when other treatments have failed; OR
The treatment must be for use when other treatments are inappropriate. | |
Sevelamer | C5491 | | | Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5491 |
C5530 | | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530 |
| C9762 | | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762 |
Siltuximab | C12585 | | | Idiopathic multicentric Castleman disease (iMCD)
Initial treatment
Patient must have a diagnosis of iMCD consistent with the latest international, evidence‑based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient's medical records; AND
The condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus‑8 infection, (ii) an Epstein‑Barr virus‑lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist; AND
Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; OR
Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum. | Compliance with Authority Required procedures |
| C12594 | | | Idiopathic multicentric Castleman disease (iMCD)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum. | Compliance with Authority Required procedures |
Silver sulfadiazine | C6345 | | | Stasis ulcers | |
C6362 | | | Infection
Prevention and treatment
The condition must be in partial or full skin thickness loss due to burns; OR
The condition must be in partial or full skin thickness loss due to epidermolysis bullosa. | |
Simvastatin | | P14238 | | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
Siponimod | C10953 | | | Multiple sclerosis
Continuing treatment (including recommencement of treatment)
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must be ambulatory, with/without assistance/support; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10953 |
| C10955 | | | Multiple sclerosis
Initial treatment
The condition must be/have previously been diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; OR
The condition must be/have previously been diagnosed as clinically definite relapsing‑remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory, with/without assistance/support; AND
Patient must have mild disability in at least 3 functional systems; OR
Patient must have moderate disability in at least 1 functional system.
Functional systems referred to in this restriction are the: visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.
Select a dose and pack size appropriate for the patient's CYP2C9 metabolising enzyme status. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10955 |
Sirolimus | | P5795 | CN5795 | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5795 |
| | P9914 | CN9914 | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9914 |
Sitagliptin | C6346 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6346 |
C6363 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6363 |
C6376 | | | Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6376 |
| C7505 | | | Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS‑subsidised regimen of oral diabetic medicines which included a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7505 |
| C7541 | | | Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and an SGLT2 inhibitor; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7541 |
Sitagliptin with metformin | C6333 | | | Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this fixed dose combination. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6333 |
C6334 | | | Diabetes mellitus type 2
Continuing
Patient must have previously received and been stabilised on a PBS‑subsidised regimen of oral diabetic medicines which includes metformin and sitagliptin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6334 |
C6344 | | | Diabetes mellitus type 2
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this fixed dose combination. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6344 |
C6443 | | | Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6443 |
| C7507 | | | Diabetes mellitus type 2
Initial treatment
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have an HbA1c measurement greater than 7% despite treatment with a PBS‑subsidised regimen of oral diabetic medicines which includes metformin and an SGLT2 inhibitor for this condition; OR
Patient must have, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin.
The date and level of the qualifying HbA1c measurement must be documented in the patient's medical records at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
The HbA1c must be no more than 4 months old at the time triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin is initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a gliptin, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7507 |
| C7530 | | | Diabetes mellitus type 2
Continuing treatment
The treatment must be in combination with a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor; AND
Patient must have previously received a PBS‑subsidised regimen of oral diabetic medicines which included a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor, metformin and a gliptin for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7530 |
Sodium acid phosphate | C5089 | | | Hypophosphataemic rickets | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5089 |
C5095 | | | Familial hypophosphataemia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5095 |
C5114 | | | Vitamin D‑resistant rickets | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5114 |
C5123 | | | Hypercalcaemia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5123 |
Sodium phenylbutyrate | C9919 | | | Urea cycle disorders
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m2/day in patients weighing more than 20 kg. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9919 |
| C9993 | | | Urea cycle disorders
Initial treatment
Patient must have elevated ammonia levels that are not controlled with diet alone and other adjunct care alone.
An increase in the maximum quantity will be authorised to provide for up to one month's supply at a dose of up to 600 mg/kg/day in patients weighing less than 20 kg and up to 13 g/m2/day in patients weighing more than 20 kg. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9993 |
Sofosbuvir with velpatasvir | C5969 | | | Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks. | Compliance with Authority Required procedures |
Sofosbuvir with velpatasvir and voxilaprevir | C10248 | | | Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
The application must include details of the prior treatment regimen containing an NS5A inhibitor. | Compliance with Authority Required procedures |
Somatrogon | C13282 | | | Short stature and slow growth
Recommencement of treatment as a reclassified patient
Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of continuing treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height no higher than the 1 st percentile for age plus sex at the time treatment first commenced; AND
Patient must have had a growth velocity below the 25 th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; OR
Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.
2. Recent growth data (height and weight, not older than three months).
3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13284 | | | Short stature and slow growth
Initial treatment
Patient must have a current height at or below the 1 st percentile for age and sex; AND
Patient must have a growth velocity below the 25 th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; OR
Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. Confirmation of the patient's maturational or constitutional delay status.
4. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1 st adult height percentile.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13287 | | | Short stature associated with biochemical growth hormone deficiency
Continuing treatment as a reclassified patient
Patient must be undergoing continuing PBS‑subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously.
The treatment must not be for the purposes of continuing treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height at or below the 1 st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25 th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13288 | | | Short stature associated with biochemical growth hormone deficiency
Change of drug
Patient must be undergoing existing PBS‑subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.
Patient must have been treated with PBS‑subsidised growth hormone for less than 32 weeks; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance to treatment arising from social/family problems, (v) sub‑optimal dosing (i.e. the dose was less than the permitted upper dose range); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Definition:
An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:
(a) the 50thpercentile growth velocity for bone age;
(b) an increase in height standard deviation score for chronological age;
(c) a minimum growth velocity of 4 cm per year;
(d) a mid‑parental height standard deviation score.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
Where growth data has been supplied within 3 months of this authority application, do not resupply this data.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13292 | | | Short stature associated with biochemical growth hormone deficiency
Initial treatment
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have a current height at or below the 1 st percentile for age and sex; OR
Patient must have a current height above the 1 st and at or below the 25 th percentiles for age and sex and a growth velocity below the 25 th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1 st and at or below the 25 th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1 st and at or below the 25 th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; or
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1 st percentile for age and sex.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13294 | | | Short stature associated with biochemical growth hormone deficiency
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements
Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application ‑ subsidy through this treatment phase must only occur once per lifetime.
The treatment must not be for the purposes of continuing treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height at or below the 1 st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25 th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13297 | | | Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment
Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of resuming treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Recent growth data (height and weight, not older than three months).
2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13298 | | | Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment as a reclassified patient
Patient must be undergoing treatment that is simultaneously: (a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of continuing treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height at or below the 1 st percentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25 th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1 st and at or below the 25 th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations.
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13304 | | | Short stature and slow growth
Recommencement of treatment
Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication.
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not be for the purposes of resuming treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Recent growth data (height and weight, not older than three months).
2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13308 | | | Short stature and slow growth
Continuing treatment
Patient must be undergoing continuing PBS‑subsidised therapy with this drug ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication.
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must have achieved the 50 th percentile growth velocity for bone age plus sex following the most recent supply; OR
Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; OR
Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; OR
Patient must have achieved a mid‑parental height standard deviation score following the most recent supply; OR
The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. The final adult height (in cm) of the patient's mother and father (where available).
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13309 | | | Short stature and slow growth
Change of drug
Patient must be undergoing existing PBS‑subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.
Patient must have been treated with PBS‑subsidised growth hormone for less than 32 weeks; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance to treatment arising from social/family problems, (v) sub‑optimal dosing (i.e. the dose was less than the permitted upper dose range); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Definition:
An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:
(a) the 50thpercentile growth velocity for bone age;
(b) an increase in height standard deviation score for chronological age;
(c) a minimum growth velocity of 4 cm per year;
(d) a mid‑parental height standard deviation score.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
Where growth data has been supplied within 3 months of this authority application, do not resupply this data.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13311 | | | Short stature associated with biochemical growth hormone deficiency
Continuing treatment
Patient must be undergoing continuing PBS‑subsidised therapy with this drug ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication.
Patient must have achieved the 50 th percentile growth velocity for bone age plus sex following the most recent supply; OR
Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; OR
Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; OR
Patient must have achieved a mid‑parental height standard deviation score following the most recent supply; OR
The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
3. The final adult height (in cm) of the patient's mother and father (where available).
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13312 | | | Short stature and slow growth
Continuing treatment as a reclassified patient
Patient must be undergoing continuing PBS‑subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously.
The treatment must not be for the purposes of continuing treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height no higher than the 1 st percentile for age plus sex at the time treatment first commenced; AND
Patient must have had a growth velocity below the 25 th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; OR
Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment.
2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13318 | | | Short stature and slow growth
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements
Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application ‑ subsidy through this treatment phase must only occur once per lifetime.
The treatment must not be for the purposes of continuing treatment that is known to be non‑efficacious for the patient ‑ where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND
Patient must have had a height no higher than the 1 st percentile for age plus sex at the time treatment first commenced; AND
Patient must have had a growth velocity below the 25 th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; OR
Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment; OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1 st percentile for age plus sex immediately prior to commencing treatment.
2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
3. A bone age result performed within the last 12 months where the patient has chronological age greater than 2.5 years.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
Somatropin | C12588 | | | Severe growth hormone deficiency
Initial treatment of late onset growth hormone deficiency
Must be treated by an endocrinologist.
Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; OR
Patient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years; AND
Patient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender. | Compliance with Written Authority Required procedures |
| C12703 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12704 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Initial treatment
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have a current height at or below the 1stpercentile for age and sex; AND
Patient must have a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
6. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12705 | | | Short stature and poor body composition due to Prader‑Willi syndrome
Initial treatment
Patient must have diagnostic results consistent with Prader‑Willi syndrome (the condition must be genetically proven); OR
Patient must have a clinical diagnosis of Prader‑Willi syndrome, confirmed by a clinical geneticist; AND
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND
Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a chronological age of 18 years or greater.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 6 months of recent growth data (height, weight and waist circumference). The most recent data must not be older than three months; AND
4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
5. (a) Confirmation that the patient has diagnostic results consistent with Prader‑Willi syndrome; OR
(b) Confirmation that the patient has a clinical diagnosis of Prader‑Willi syndrome, confirmed by a clinical geneticist
6. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months and any sleep disorders identified via polysomnography that required treatment have been addressed; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with 1 repeat allowed)
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12711 | | | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12712 | | | Short stature associated with Turner syndrome
Recommencement of treatment as a reclassified patient
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring‑chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a height greater than or equal to 155.0 cm; AND
Patient must not have a bone age of 13.5 years or greater.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12713 | | | Biochemical growth hormone deficiency and precocious puberty
Initial treatment
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Confirmation that the patient has precocious puberty; AND
7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12721 | | | Short stature associated with chronic renal insufficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12722 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Initial treatment
Patient must have had an intracranial lesion which is under appropriate observation and management; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stpercentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stpercentile for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stpercentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR
(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12723 | | | Biochemical growth hormone deficiency and precocious puberty
Initial treatment
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (males chronological age 12 and over or bone age 10 and over, females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Confirmation that the patient has precocious puberty; AND
7. Confirmation that the patient is undergoing Gonadotropin Releasing Hormone agonist therapy, for pubertal suppression; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12725 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12726 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had an intracranial lesion which is under appropriate observation and management; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR
(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12731 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12738 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12749 | | | Short stature associated with chronic renal insufficiency
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months; AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12752 | | | Short stature associated with chronic renal insufficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post‑transplant has an eGFR of equal to or greater than 30mL/min/1.73m2prescribers should seek reclassification to the indication short stature and slow growth.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12755 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Initial treatment
Patient must have had an intracranial lesion which is under appropriate observation and management; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stpercentile for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stpercentile for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex; AND
4. A bone age result performed within the last 12 months; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR
(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12758 | | | Short stature associated with Turner syndrome
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring‑chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12760 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12765 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Initial treatment
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have a growth velocity above the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of greater than 14 cm per year if the patient has a chronological age of 2 years or less; OR
Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
8. Confirmation that the patient has hypothalamic obesity; AND
9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12768 | | | Short stature and poor body composition due to Prader‑Willi syndrome
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader‑Willi syndrome category; AND
Patient must have been re‑evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved height percentile for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist circumference while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and must have achieved an increase in height percentile with reference to the untreated Prader‑Willi syndrome standards for age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must not have been on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved body mass index SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist circumference while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies; OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved waist/height ratio (waist circumference in centimetres divided by height in centimetres) while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and must have maintained or improved weight SDS for age and sex while on the maximum dose of 0.04mg/kg/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have developed uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height.
Patient must not have a chronological age of equal to or greater than 18 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height, weight and waist circumference) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
5. Confirmation that during the initial 32 week treatment period, the patient was re‑evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Maintenance is defined as a value within a 5% tolerance (this allows for seasonal and other measurement variations).
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12769 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had an intracranial lesion which is under appropriate observation and management; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR
(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
| C12770 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have had a growth velocity above the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
7. Confirmation that the patient has hypothalamic obesity; AND
8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12771 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12774 | | | Short stature associated with Turner syndrome
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12775 | | | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have a chronological age of less than 2 years; AND
Patient must have a documented clinical risk of hypoglycaemia; AND
Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND
4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
5. Recent growth data (height and weight, not older than three months); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12779 | | | Biochemical growth hormone deficiency and precocious puberty
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12780 | | | Short stature associated with Turner syndrome
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome ‑ Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12784 | | | Biochemical growth hormone deficiency and precocious puberty
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12785 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have had a growth velocity above the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
7. Confirmation that the patient has hypothalamic obesity; AND
8. Recent growth data (height and weight, not older than three months); AND
9. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12789 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have had a growth velocity above the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
7. Confirmation that the patient has hypothalamic obesity; AND
8. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
9. A bone age result performed within the last 12 months; AND
10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12790 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12791 | | | Short stature associated with chronic renal insufficiency
Initial treatment
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12793 | | | Short stature and poor body composition due to Prader‑Willi syndrome
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and poor body composition due to Prader Willi syndrome category; AND
Patient must have had a lapse in growth hormone treatment; AND
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
Patient must have had a bone age below skeletal maturity (15.5 years for males and 13.5 years for females) (except where the patient had a chronological age of 2.5 years or less) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies); OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by a significant medical illness; OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
Patient must have had a bone age at or above skeletal maturity (15.5 years for males and 13.5 years for females) at the last application and treatment must not have lapsed due to failure to respond to growth hormone at a dose of 0.04mg/kg/wk or greater for the most recent treatment period (32 weeks for the initial treatment period or 26 weeks for subsequent treatment periods, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have been re‑evaluated via polysomnography for airway obstruction and apnoea during the initial 32 week treatment period and any sleep disorders identified that required treatment must have been addressed; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have developed uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height.
Patient must not have a chronological age of equal to or greater than 18 years.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height, weight, and waist circumference, not older than three months); AND
4. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity.]; AND
5. Confirmation that during the initial 32 week treatment period, the patient was re‑evaluated via polysomnography for airway obstruction and apnoea, and any sleep disorders that were identified have been addressed; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12798 | | | Short stature associated with chronic renal insufficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12803 | | | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have a chronological age of less than 2 years; AND
Patient must have a documented clinical risk of hypoglycaemia; AND
Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND
5. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12805 | | | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication 'short stature due to biochemical growth hormone deficiency'.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12806 | | | Short stature associated with chronic renal insufficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12809 | | | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12810 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had an intracranial lesion which is under appropriate observation and management; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1st percentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR
(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12812 | | | Short stature associated with chronic renal insufficiency
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with chronic renal insufficiency; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
4. Confirmation that the patient has an estimated glomerular filtration rate less than 30ml/minute/1.73m2; AND
5. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12817 | | | Short stature associated with Turner syndrome
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature associated with Turner syndrome; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring‑chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12820 | | | Short stature associated with Turner syndrome
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12821 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have had a growth velocity above the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of greater than 14 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of greater than 8 cm per year in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
6. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
7. Confirmation that the patient has hypothalamic obesity; AND
8. Recent growth data (height and weight, not older than three months); AND
9. A bone age result performed within the last 12 months; AND
10. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
| C12824 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12826 | | | Short stature associated with Turner syndrome
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring‑chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a height greater than or equal to 155.0 cm; AND
Patient must not have a bone age of 13.5 years or greater.
Patient must be aged 3 years or older.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12829 | | | Short stature associated with chronic renal insufficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
If a patient receiving treatment under the indication 'short stature associated with chronic renal insufficiency' undergoes a renal transplant and 12 months post‑transplant has an eGFR of equal to or greater than 30mL/min/1.73m2prescribers should seek reclassification to the indication short stature and slow growth.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12831 | | | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 5 years or greater.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
When a patient receiving treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants reaches or surpasses 5 years of age (chronological), prescribers should seek reclassification to the indication 'short stature due to biochemical growth hormone deficiency'.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12832 | | | Risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have a chronological age of less than 2 years; AND
Patient must have a documented clinical risk of hypoglycaemia; AND
Patient must have documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. Confirmation that the patient has a documented clinical risk of hypoglycaemia; AND
4. Confirmation that the patient has documented evidence that the risk of hypoglycaemia is secondary to biochemical growth hormone deficiency; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12834 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12855 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Initial treatment
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have a current height at or below the 1stpercentile for age and sex; AND
Patient must have a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
6. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12857 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature due to short stature homeobox (SHOX) gene disorders; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; OR
Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
Patient must have had a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); AND
4. Confirmation that the patient has diagnostic results consistent with a short stature homeobox (SHOX) gene disorder; AND
5. If the patient's condition is secondary to mixed gonadal dysgenesis, confirmation that an appropriate plan of management for the patient's increased risk of gonadoblastoma is in place; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12858 | | | Biochemical growth hormone deficiency and precocious puberty
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. Confirmation that the patient has precocious puberty; AND
4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12860 | | | Short stature associated with Turner syndrome
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring‑chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must not have a height greater than or equal to 155.0cm; AND
Patient must not have a bone age of 13.5 years or greater.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight) at intervals no greater than six months. The most recent data must not be older than three months; OR
(b) A minimum of 6 months of recent growth data (height and weight) for older children (females chronological age 10 and over or bone age 8 and over). The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12861 | | | Short stature associated with chronic renal insufficiency
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months; AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12866 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12867 | | | Short stature associated with chronic renal insufficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with chronic renal insufficiency category; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have undergone a renal transplant within the 12 month period immediately prior to the date of application; AND
Patient must not have an eGFR equal to or greater than 30mL/min/1.73m2; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12869 | | | Short stature and poor body composition due to Prader‑Willi syndrome
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature and poor body composition due to Prader‑Willi syndrome; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Prader‑Willi syndrome (the condition must be genetically proven); OR
Patient must have a clinical diagnosis of Prader‑Willi syndrome, confirmed by a clinical geneticist; AND
Patient must have been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with no sleep disorders identified; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified which are not of sufficient severity to require treatment; OR
Patient must have been evaluated via polysomnography for airway obstruction and apnoea within the last 12 months with sleep disorders identified for which the patient is currently receiving ameliorative treatment; AND
Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 18 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) Confirmation that the patient has diagnostic results consistent with Prader‑Willi syndrome, OR
(b) Confirmation that the patient has a clinical diagnosis of Prader‑Willi syndrome, confirmed by a clinical geneticist; AND
4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment or within the last 12 months, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND
5. Recent growth data (height and weight, not older than three months); AND
6. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12871 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12872 | | | Short stature due to short stature homeobox (SHOX) gene disorders
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature due to short stature homeobox (SHOX) gene disorders category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12876 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the growth retardation secondary to an intracranial lesion, or cranial irradiation category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12877 | | | Biochemical growth hormone deficiency and precocious puberty
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. Confirmation that the patient has precocious puberty; AND
4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12880 | | | Short stature associated with Turner syndrome
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with Turner syndrome category; AND
Patient must not have been on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an annualised growth velocity for bone age at or above the mean growth velocity for untreated Turner Syndrome girls (using the Turner Syndrome ‑ Ranke growth velocity chart) while on the maximum dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a bone age of 13.5 years or greater; AND
Patient must not have a height greater than or equal to 155.0 cm.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12882 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12884 | | | Biochemical growth hormone deficiency and precocious puberty
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. Confirmation that the patient has precocious puberty; AND
4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Recent growth data (height and weight, not older than three months); AND
7. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12886 | | | Biochemical growth hormone deficiency and precocious puberty
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than biochemical growth hormone deficiency and precocious puberty; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must be male and have commenced puberty (demonstrated by Tanner stage 2 genital or pubic hair development or testicular volumes greater than or equal to 4 mL) before the chronological age of 9 years; OR
Patient must be female and have commenced puberty (demonstrated by Tanner stage 2 breast or pubic hair development) before the chronological age of 8 years; OR
Patient must be female and menarche occurred before the chronological age of 10 years; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. Confirmation that the patient has precocious puberty; AND
4. Confirmation that the patient is undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12887 | | | Short stature and poor body composition due to Prader‑Willi syndrome
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature and poor body composition due to Prader‑Willi syndrome; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Prader‑Willi syndrome (the condition must be genetically proven); OR
Patient must have a clinical diagnosis of Prader‑Willi syndrome, confirmed by a clinical geneticist; AND
Patient must have been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment and any sleep disorders identified that required treatment must have been addressed; AND
Patient must not have uncontrolled morbid obesity, defined as a body weight greater than 200% of ideal body weight for height and sex, with ideal body weight derived by calculating the 50th percentile weight for the patient's current height; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a chronological age of 18 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) Confirmation that the patient has diagnostic results consistent with Prader‑Willi syndrome, OR
(b) Confirmation that the patient has a clinical diagnosis of Prader‑Willi syndrome, confirmed by a clinical geneticist; AND
4. Confirmation that the patient has been evaluated via polysomnography for airway obstruction and apnoea whilst on growth hormone treatment, and any sleep disorders identified via the polysomnography that required treatment have been addressed; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. The date at which skeletal maturity was achieved (if applicable) [Note: In patients whose chronological age is greater than 2.5 years, a bone age reading should be performed at least once every 12 months prior to attainment of skeletal maturity]; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12899 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12901 | | | Biochemical growth hormone deficiency and precocious puberty
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must be undergoing Gonadotrophin Releasing Hormone agonist therapy for pubertal suppression; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12916 | | | Short stature associated with Turner syndrome
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under a category other than short stature assciated with Turner syndrome; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 9.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in all cells (45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as a loss of a whole X chromosome in some cells (mosaic 46XX/45X), and gender of rearing is female; OR
Patient must have diagnostic results consistent with Turner syndrome (the condition must be genetically proven), defined as genetic loss or rearrangement of an X chromosome (such as isochromosome X, ring‑chromosome, or partial deletion of an X chromosome), and gender of rearing is female; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have a height greater than or equal to 155.0 cm; AND
Patient must not have a bone age of 13.5 years or greater.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
Patient must be aged 3 years or older.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. A height measurement from immediately prior to commencement of growth hormone treatment; AND
4. Confirmation that the patient has diagnostic results consistent with Turner syndrome; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12918 | | | Biochemical growth hormone deficiency and precocious puberty
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the biochemical growth hormone deficiency and precocious puberty category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12926 | | | Hypothalamic‑pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth
Initial treatment
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
Patient must have a structural lesion that is not neoplastic; OR
Patient must have had a structural lesion that was neoplastic and have undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
Patient must have a structural lesion that is neoplastic, have received medical advice that it is unsafe to treat the structural lesion, and have undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have other hypothalamic/pituitary hormone deficits (includes ACTH, TSH, GnRH and/or vasopressin/ADH deficiencies); AND
Patient must have hypothalamic obesity; AND
Patient must have a growth velocity above the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of greater than 8 cm per year if the patient has a bone age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. (a) Confirmation that the patient has a structural lesion that is not neoplastic; OR
(b) Confirmation that the patient had a structural lesion that was neoplastic and has undergone a 12 month period of observation following completion of treatment for the structural lesion (all treatment); OR
(c) Confirmation that the patient has a structural lesion that is neoplastic, has received medical advice that it is unsafe to treat the structural lesion, and has undergone a 12 month period of observation since initial diagnosis of the structural lesion; AND
7. Confirmation that the patient has other hypothalamic/pituitary hormone deficits; AND
8. Confirmation that the patient has hypothalamic obesity; AND
9. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Testing for biochemical growth hormone deficiency must have been performed at a time when all other pituitary hormone deficits were being adequately replaced.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12928 | | | Growth retardation secondary to an intracranial lesion, or cranial irradiation
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than growth retardation secondary to an intracranial lesion, or cranial irradiation; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have had an intracranial lesion which is under appropriate observation and management; OR
Patient must have received cranial irradiation without having had an intracranial lesion, and is under appropriate observation and management; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stpercentile for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be aged 3 years or older.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. (a) Confirmation that the patient has had an intracranial lesion which is under appropriate observation and management; OR
(b) Confirmation that the patient has received cranial irradiation without having had an intracranial lesion and is under appropriate observation and management; AND
6. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
7. A bone age result performed within the last 12 months; AND
8. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C12929 | | | Short stature associated with chronic renal insufficiency
Initial treatment
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, and not have undergone a renal transplant; OR
Patient must have an estimated glomerular filtration rate less than 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula, have undergone a renal transplant, and have undergone a 12 month period of observation following the transplant; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity less than or equal to the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation that the patient has an estimated glomerular filtration rate less than 30mL/minute/1.73m2; AND
6. If a renal transplant has taken place, confirmation that the patient has undergone a 12 month period of observation following transplantation; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13288 | | | Short stature associated with biochemical growth hormone deficiency
Change of drug
Patient must be undergoing existing PBS‑subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.
Patient must have been treated with PBS‑subsidised growth hormone for less than 32 weeks; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance to treatment arising from social/family problems, (v) sub‑optimal dosing (i.e. the dose was less than the permitted upper dose range); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Definition:
An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:
(a) the 50thpercentile growth velocity for bone age;
(b) an increase in height standard deviation score for chronological age;
(c) a minimum growth velocity of 4 cm per year;
(d) a mid‑parental height standard deviation score.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
Where growth data has been supplied within 3 months of this authority application, do not resupply this data.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13309 | | | Short stature and slow growth
Change of drug
Patient must be undergoing existing PBS‑subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication ‑ subsidy through this treatment phase must not: (i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication.
Patient must have been treated with PBS‑subsidised growth hormone for less than 32 weeks; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; OR
Patient must have been treated with PBS‑subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of: (i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non‑compliance to treatment arising from social/family problems, (v) sub‑optimal dosing (i.e. the dose was less than the permitted upper dose range); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
Definition:
An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of:
(a) the 50thpercentile growth velocity for bone age;
(b) an increase in height standard deviation score for chronological age;
(c) a minimum growth velocity of 4 cm per year;
(d) a mid‑parental height standard deviation score.
Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months.
2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years.
Where growth data has been supplied within 3 months of this authority application, do not resupply this data.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13346 | | | Short stature associated with biochemical growth hormone deficiency
Initial treatment
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13350 | | | Short stature and slow growth
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13352 | | | Short stature and slow growth
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13353 | | | Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13355 | | | Short stature and slow growth
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both: (i) a height no higher than the 1stpercentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient's chronological age was higher than 2.5 years); OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Recent growth data (height and weight, not older than three months); AND
5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
6. The proprietary name (brand), form and strength of the growth hormone requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13356 | | | Short stature and slow growth
Initial treatment
Patient must have a current height at or below the 1stpercentile for age and sex; AND
Patient must have a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7 cm; OR
Patient must be female and must not have a height greater than or equal to 155.0 cm; AND
Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; OR
Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. Confirmation of the patient's maturational or constitutional delay status; AND
6. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1stadult height percentile; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13359 | | | Short stature and slow growth
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both: (i) a height no higher than the 1stpercentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more; AND
Patient must be male and must not have a height greater than or equal to 167.7cm; OR
Patient must be female and must not have a height greater than or equal to 155.0cm.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient's chronological age was higher than 2.5 years); OR
(b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND
4. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13360 | | | Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13363 | | | Short stature associated with biochemical growth hormone deficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13364 | | | Short stature associated with biochemical growth hormone deficiency
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13367 | | | Short stature associated with biochemical growth hormone deficiency
Initial treatment
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must have a current height at or below the 1stpercentile for age and sex; OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and a growth velocity below the 25thpercentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); OR
Patient must have a current height above the 1stand at or below the 25thpercentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND
3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR
(b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1stpercentile for age and sex; AND
4. A bone age result performed within the last 12 months; AND
5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13368 | | | Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must have had a lapse in growth hormone treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND
3. Recent growth data (height and weight, not older than three months); AND
4. A bone age result performed within the last 12 months; AND
5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13393 | | | Short stature associated with biochemical growth hormone deficiency
Continuing treatment
Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND
Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND
3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
4. A bone age result performed within the last 12 months; AND
5. The final adult height (in cm) of the patient's mother and father (where available); AND
6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13417 | | | Short stature associated with biochemical growth hormone deficiency
Continuing treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND
6. A bone age result performed within the last 12 months; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Written Authority Required procedures |
| C13418 | | | Short stature associated with biochemical growth hormone deficiency
Recommencement of treatment as a reclassified patient
Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND
Patient must have had a lapse in treatment; AND
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; OR
The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non‑compliance due to social/family problems; AND
Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); OR
Patient must have had a height at or below the 1stpercentile for age and sex immediately prior to commencing treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25thpercentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; OR
Patient must have had both a height above the 1stand at or below the 25thpercentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo‑optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF‑1 levels; OR
Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP‑3 levels; AND
Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
Patient must not have an active tumour or evidence of tumour growth or activity; AND
Patient must be male and must not have a bone age of 15.5 years or more; OR
Patient must be female and must not have a bone age of 13.5 years or more.
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; OR
Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND
Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time.
An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years.
The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
The authority application must be in writing and must include:
1. A completed authority prescription form; AND
2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND
3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR
(b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR
(c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND
4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND
5. Recent growth data (height and weight, not older than three months); AND
6. A bone age result performed within the last 12 months; AND
7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category.
In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
| C14366 | | | Severe growth hormone deficiency
Continuing treatment in a person with a mature skeleton or aged 18 years or older
Must be treated by an endocrinologist.
Patient must have previously received PBS‑subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton; OR
Patient must have previously received PBS‑subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older; OR
Patient must have previously received PBS‑subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years. | Compliance with Authority Required procedures |
| C14390 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received non‑PBS subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received non‑PBS subsidised treatment with this drug for this condition as a child; AND
Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
Patient must have a mature skeleton.
Somatropin is not PBS‑subsidised for patients with Prader‑Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form; AND
Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender. | Compliance with Written Authority Required procedures |
| C14431 | | | Severe growth hormone deficiency
Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS‑subsidised treatment as a child
Must be treated by an endocrinologist.
Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition as a child.
Patient must have a mature skeleton.
Somatropin is not PBS‑subsidised for patients with Prader‑Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.
The authority application must be in writing and must include:
A completed authority prescription form; AND
A completed Severe Growth Hormone Deficiency supporting information form. | Compliance with Written Authority Required procedures |
Sonidegib | C7491 | | | Metastatic or locally advanced basal cell carcinoma (BCC)
Initial treatment or Continuing treatment – balance of supply
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C13175 | | | Metastatic or locally advanced basal cell carcinoma (BCC)
Initial treatment
The condition must be inappropriate for surgery; AND
The condition must be inappropriate for curative radiotherapy; AND
Patient must not have received previous PBS‑subsidised treatment with another hedgehog (Hh) inhibitor for this condition; OR
Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and
(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and
(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.
The assessment of the patient's response to this PBS‑subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Inappropriate for surgery is defined as:
(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
(iii) Medical contraindication to surgery.
Inappropriate for curative radiotherapy is defined as:
(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
(ii) Limitations due to location of tumour; or
(iii) Limitations due to cumulative prior radiotherapy dose; or
(iv) Progressive disease despite prior irradiation of locally advanced BCC.
For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
| C13260 | | | Metastatic or locally advanced basal cell carcinoma (BCC)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The condition must remain inappropriate for surgery; AND
The condition must remain inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) Confirmation from the treating doctor that the disease has not progressed; and
(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.
The assessment of the patient's response to this PBS‑subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Inappropriate for surgery is defined as:
(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
(iii) Medical contraindication to surgery.
Inappropriate for curative radiotherapy is defined as:
(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
(ii) Limitations due to location of tumour; or
(iii) Limitations due to cumulative prior radiotherapy dose; or
(iv) Progressive disease despite prior irradiation of locally advanced BCC.
For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
Sorafenib | C7487 | P7487 | | Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment beyond 3 months
Patient must have received an initial authority prescription for this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7487 |
| C8617 | P8617 | | Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma Continuing treatment
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8617 |
| C8621 | P8621 | | Stage IV clear cell variant renal cell carcinoma (RCC) Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised treatment with this drug.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures |
| C11160 | P11160 | | Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma
Initial treatment
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have Child Pugh class A; AND
The condition must be untreated with systemic therapy; OR
Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following: (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11160 |
Sorbitol with sodium citrate dihydrate and sodium lauryl sulfoacetate | C5613 | P5613 | | Constipation
Patient must be receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. | |
| C5640 | P5640 | | Constipation
Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function. | |
| C5685 | P5685 | | Anorectal congenital abnormalities | |
| C5720 | P5720 | | Constipation
Patient must be receiving long‑term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. | |
| C5775 | P5775 | | Constipation
Patient must be receiving palliative care. | |
| C5776 | P5776 | | Terminal malignant neoplasia | |
| C5804 | P5804 | | Megacolon | |
| C6139 | P6139 | | Constipation
Patient must be receiving palliative care. | |
Sotalol | C5664 | | | Severe cardiac arrhythmias | |
Soy lecithin | C6172 | | | Severe dry eye syndrome
Patient must be sensitive to preservatives in multi‑dose eye drops. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6172 |
Soy protein and fat formula with vitamins and minerals ‑‑ carbohydrate free | C6658 | | | Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency; OR
Patient must be an infant or young child with glucose‑galactose intolerance and multiple monosaccharide intolerance. | |
Spironolactone | | P14238 | | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
Sterculia with frangula bark | C5613 | P5613 | | Constipation
Patient must be receiving long‑term nursing care and in respect of whom a Carer Allowance is payable as a disabled adult. | |
C5640 | P5640 | | Constipation
Patient must be paraplegic or quadriplegic or have severe neurogenic impairment of bowel function. | |
P5685 | P5685 | | Anorectal congenital abnormalities | |
C5720 | P5720 | | Constipation
Patient must be receiving long‑term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility. | |
C5775 | P5775 | | Constipation
Patient must be receiving palliative care. | |
C5776 | P5776 | | Terminal malignant neoplasia | |
C5804 | P5804 | | Megacolon | |
C6139 | P6139 | | Constipation
Patient must be receiving palliative care. | |
Stiripentol | C11642 | | | Severe myoclonic epilepsy in infancy (Dravet syndrome)
Patient must have (as an initiating patient)/have had (as a continuing patient), generalised tonic‑clonic seizures or generalised clonic seizures that are not adequately controlled with at least two other anti‑epileptic drugs; AND
The treatment must be as adjunctive therapy to at least two other anti‑epileptic drugs.
Must be treated by a neurologist if treatment is being initiated; OR
Must be treated by a neurologist if treatment is being continued or re‑initiated; OR
Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued; OR
Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11642 |
Sucroferric oxyhydroxide | C5491 | | | Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5491 |
C5530 | | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530 |
| C9762 | | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762 |
Sulfasalazine | | P14238 | | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
Sumatriptan | C5259 | | | Migraine attack
The condition must have usually failed to respond to analgesics in the past. | |
Sunitinib | C4862 | P4862 | | Metastatic or unresectable, well‑differentiated malignant pancreatic neuroendocrine tumour (pNET)
Initial treatment
Patient must be symptomatic (despite somatostatin analogues); OR
Patient must have disease progression; AND
The treatment must be as monotherapy.
Disease progression must be documented in the patient's medical records.
Patients who have developed progressive disease on everolimus are not eligible to receive PBS‑subsidised sunitinib for this condition.
Patients who have developed intolerance to everolimus of a severity necessitating permanent treatment withdrawal are eligible to receive PBS‑subsidised sunitinib. | Compliance with Authority Required procedures |
C7471 | P7471 | | Metastatic or unresectable, well‑differentiated malignant pancreatic neuroendocrine tumour (pNET)
Continuing treatment
Patient must have received an initial authority prescription for this drug for this condition; AND
Patient must not have disease progression; AND
The treatment must be as monotherapy.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7471 |
| C11875 | P11875 | | Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment beyond 3 months
Patient must have received an initial authority prescription for this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS‑subsidised tyrosine kinase inhibitor therapy for this condition.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
PBS‑subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11875 |
| C11878 | P11878 | | Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
The condition must be classified as favourable to intermediate risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS‑subsidised tyrosine kinase inhibitor therapy for this condition.
PBS‑subsidy does not apply to a patient who has progressive disease whilst on, or, who has recurrent disease following treatment with any of: (i) cabozantinib, (ii) pazopanib, (iii) sunitinib. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11878 |
| C13152 | P13152 | | Metastatic or unresectable malignant gastrointestinal stromal tumour
Initial treatment
The condition must not be resectable; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have previously failed or be intolerant to imatinib mesilate.
Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) A completed authority prescription form; and
(b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS‑subsidised imatinib. | Compliance with Written Authority Required procedures |
| C13153 | P13153 | | Metastatic or unresectable malignant gastrointestinal stromal tumour
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The condition must not be resectable; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13153 |
Tacrolimus | | P5569 | CN5569 | Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5569 |
| | P9697 | CN9697 | Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9697 |
Tamoxifen | C6381 | P6381 | | Breast cancer
The condition must be hormone receptor positive. | |
C6421 | P6421 | | Reduction of breast cancer risk
Patient must have a moderate or high risk of developing breast cancer; AND
The treatment must not exceed a dose of 20 mg per day; AND
The treatment must not exceed a lifetime maximum of 5 years for this condition. | |
C6449 | P6449 | | Breast cancer
The condition must be hormone receptor positive. | |
Tapentadol | C10748 | | | Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid or other opioid analgesics; OR
Patient must be unable to use non‑opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment:
(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10748 |
| C10752 | | | Chronic severe pain
Continuing PBS treatment after 1 June 2020
Patient must have previously received PBS‑subsidised treatment with this form of this drug for this condition after 1 June 2020.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non‑PBS and PBS opioid analgesic treatment:
(i) is less than 12 months; or
(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10752 |
| C10755 | | | Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid or other opioid analgesics; OR
Patient must be unable to use non‑opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment is less than 12 months.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10755 |
Telmisartan | | P14238 | | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
Telmisartan with amlodipine | C4373 | P4373 | | Hypertension
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker. | |
C14257 | P14257 | | Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker. | |
Telmisartan with hydrochlorothiazide | C4374 | P4374 | | Hypertension
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic. | |
C14255 | P14255 | | Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic. | |
Temazepam | | P5661 | CN5661 | Malignant neoplasia (late stage) | Compliance with Authority Required procedures |
| P5941 | CN5941 | Insomnia
Patient must be receiving this drug for the management of insomnia; AND
Patient must be receiving long‑term nursing care; AND
Patient must be one in respect of whom a Carer Allowance is payable as a disabled adult; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal. | Compliance with Authority Required procedures |
| P5950 | CN5950 | Insomnia
Patient must be receiving this drug for the management of insomnia; AND
Patient must be receiving long‑term nursing care on account of age, infirmity or other condition in a hospital, nursing home or residential facility; AND
Patient must have demonstrated, within the past 6 months, benzodiazepine dependence by an unsuccessful attempt at gradual withdrawal. | Compliance with Authority Required procedures |
| P6175 | CN6175 | Insomnia
Patient must be receiving palliative care. | Compliance with Authority Required procedures |
Temozolomide | | P4897 | | Glioblastoma multiforme
Patient must be undergoing concomitant radiotherapy. | |
Tenecteplase | C5783 | | | Acute myocardial infarction
The treatment must be administrated within 12 hours of onset of attack. | |
Tenofovir | C6980 | P6980 | | Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must be nucleoside analogue naive; AND
Patient must have detectable HBV DNA; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6980 |
C6982 | P6982 | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6982 |
C6983 | P6983 | | Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA.
Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6983 |
C6984 | P6984 | | Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6984 |
C6992 | P6992 | | Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must be nucleoside analogue naive; AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND
Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6992 |
C6998 | P6998 | | HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6998 |
| C10362 | P10362 | | Chronic hepatitis B infection
Patient must be in the third trimester of pregnancy; AND
Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10362 |
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat | C4470 | | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470 |
C4522 | | | HIV infection
Initial
Patient must be antiretroviral treatment naive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522 |
Tenofovir with emtricitabine | C6985 | | | HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6985 |
C6986 | | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6986 |
C11143 | | | Pre‑exposure prophylaxis (PrEP) against human immunodeficiency virus (HIV) infection
Patient must have at least one of the following prior to having the latest PBS‑subsidised prescription issued: (i) a negative HIV test result no older than 4 weeks, (ii) evidence that an HIV test has been conducted, but the result is still forthcoming. | |
Tenofovir with emtricitabine and efavirenz | C4470 | | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470 |
C4522 | | | HIV infection
Initial
Patient must be antiretroviral treatment naive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522 |
Tepotinib | C13434 | | | Stage IIIB (locally advanced) or Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Initial treatment
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have evidence of MET exon 14 skipping alterations in tumour material. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13434 |
| C13435 | | | Stage IIIB (locally advanced) or Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements
Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 November 2022; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have had a WHO performance status of 2 or less prior to initiating non‑PBS‑subsidised treatment with this drug for this condition; AND
Patient must have evidence of MET exon 14 skipping alterations in tumour material. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13435 |
| C13441 | | | Stage IIIB (locally advanced) or Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13441 |
Terbinafine | C6395 | P6395 | | Onychomycosis
The condition must be proximal or extensive (greater than 80% nail involvement); AND
Patient must have failed to respond to topical treatment; AND
The condition must be due to dermatophyte infection proven by microscopy and confirmed by an Approved Pathology Provider; OR
The condition must be due to dermatophyte infection proven by culture and confirmed by an Approved Pathology Provider.
The date of the pathology report must be provided at the time of application and must not be more than 12 months old | Compliance with Authority Required procedures |
C6404 | P6404 | | Dermatophyte infection
Patient must have failed to respond to topical treatment.
Patient must be an Aboriginal or a Torres Strait Islander person. | Compliance with Authority Required procedures |
C6412 | | | Fungal or yeast infection
The condition must be fungal; OR
The condition must be due to yeast.
Patient must be 18 years of age or less. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6412 |
C6434 | | | Fungal or yeast infection
Patient must be an Aboriginal or a Torres Strait Islander person. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6434 |
C6453 | P6453 | | Dermatophyte infection
Patient must have failed to respond to topical treatment; AND
Patient must have failed to respond to griseofulvin.
Patient must be 18 years of age or less. | Compliance with Authority Required procedures |
Terbutaline | C9828 | | | Bronchospasm
Patient must be unable to achieve co‑ordinated use of a metered dose inhaler containing a short‑acting beta‑2 agonist; OR
Patient must have developed a clinically important product‑related adverse event during treatment with another short‑acting beta‑2 agonist.
Device (inhaler) technique should be reviewed at each clinical visit and before initiating treatment with this medicine. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9828 |
Teriflunomide | C10150 | | | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10150 |
| C10199 | | | Multiple sclerosis
Continuing treatment
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10199 |
Teriparatide | C12270 | | | Severe established osteoporosis
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
The treatment must not exceed a lifetime maximum of 18 months therapy.
Must be treated by a specialist; OR
Must be treated by a consultant physician. | Compliance with Authority Required procedures |
| C12492 | | | Severe established osteoporosis
Initial treatment
Must be treated by a specialist; OR
Must be treated by a consultant physician.
Patient must be at very high risk of fracture; AND
Patient must have a bone mineral density (BMD) T‑score of ‑3.0 or less; AND
Patient must have had 2 or more fractures due to minimal trauma; AND
Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti‑resorptive agent at adequate doses; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The treatment must not exceed a lifetime maximum of 18 months therapy; AND
Patient must not have received treatment with PBS‑subsidised romosozumab; OR
Patient must have developed intolerance to romosozumab of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
If treatment with anti‑resorptive therapy is contraindicated according to the relevant TGA‑approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti‑resorptive agent, alternate anti‑resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with teriparatide is initiated.
Anti‑resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
Details of prior anti‑resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti‑resorptive therapy and the score of the qualifying BMD measurement must be documented in the patient's medical record. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12492 |
Testosterone | C6324 | | | Androgen deficiency
Patient must not have an established pituitary or testicular disorder; AND
The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs.
Patient must be aged 40 years or older.
Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
Androgen deficiency is defined as:
(i) testosterone level of less than 6 nmol per litre; OR
(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).
Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.
The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C6910 | | | Androgen deficiency
Patient must have an established pituitary or testicular disorder.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C6919 | | | Pubertal induction
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C6933 | | | Micropenis
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
C6934 | | | Constitutional delay of growth or puberty
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
| C11838 | | | Constitutional delay of growth or puberty
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The treatment must be applied to the scrotum area.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
| C11891 | | | Androgen deficiency
Patient must not have an established pituitary or testicular disorder; AND
The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs.
Patient must be aged 40 years or older.
Must be treated by a specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The treatment must be applied to the scrotum area.
Androgen deficiency is defined as:
(i) testosterone level of less than 6 nmol per litre; OR
(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher).
Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings.
The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
| C11947 | | | Micropenis
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The treatment must be applied to the scrotum area.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
| C11962 | | | Androgen deficiency
Patient must have an established pituitary or testicular disorder.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The treatment must be applied to the scrotum area.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
| C11963 | | | Pubertal induction
Patient must be under 18 years of age.
Must be treated by a specialist general paediatrician, specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a Fellow of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists.
The treatment must be applied to the scrotum area.
The name of the specialist must be included in the authority application. | Compliance with Authority Required procedures |
Tetrabenazine | C5340 | | | Hyperkinetic extrapyramidal disorders | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5340 |
Tetracosactide | C7484 | | | Hypsarrhythmia and/or infantile spasms | |
Thalidomide | C5914 | | | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5914 |
C9290 | | | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9290 |
Thiamine | C5139 | P5139 | | Thiamine deficiency
The treatment must be for prophylaxis.
Patient must be an Aboriginal or a Torres Strait Islander person. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5139 |
C14319 | P14319 | | Thiamine deficiency
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be for prophylaxis.
Patient must be an Aboriginal or a Torres Strait Islander person. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14319 |
Thyrotropin alfa | C5296 | | | Ablation of thyroid remnant tissue
Patient must have undergone a thyroidectomy; AND
The treatment must be in combination with radioactive iodine; AND
Patient must not have a known metastatic disease. | |
Tiagabine | C4928 | | | Partial epileptic seizures
The condition must have failed to be controlled satisfactorily by other anti‑epileptic drugs. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4928 |
Ticagrelor | C5746 | P5746 | | Acute coronary syndrome (myocardial infarction or unstable angina)
The treatment must be in combination with aspirin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5746 |
C14240 | P14240 | | Acute coronary syndrome (myocardial infarction or unstable angina)
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must be in combination with aspirin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14240 |
Tildrakizumab | C10802 | P10802 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Whole body (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C10806 | P10806 | | Severe chronic plaque psoriasis
Continuing treatment, Whole body
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C10807 | P10807 | | Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot ‑ balance of supply
Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions.
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C10853 | P10853 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C10889 | P10889 | | Severe chronic plaque psoriasis
Continuing treatment, Face, hand, foot
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11090 | P11090 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Whole body (change or re‑commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
| C11120 | P11120 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re‑commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C11123 | P11123 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Face, hand, foot (change or re‑commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
| C14464 | P14464 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
| C14465 | P14465 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
Tiotropium | C5509 | | | Bronchospasm and dyspnoea associated with chronic obstructive pulmonary disease
Long‑term maintenance treatment | |
C6352 | | | Chronic obstructive pulmonary disease (COPD) | |
C8606 | | | Severe asthma Must be treated by a respiratory physician, paediatric respiratory physician, clinical immunologist, allergist, paediatrician or general physician experienced in the management of patients with severe asthma; or in consultation with one of these specialists.
Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented; AND
Patient must have experienced at least one severe exacerbation prior to receiving PBS‑subsidised treatment with this drug for this condition, which has required documented use of systemic corticosteroids in the previous 12 months while receiving optimised asthma therapy; OR
Patient must have experienced frequent episodes of moderate asthma exacerbations prior to receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta‑2 agonist (LABA) unless a LABA is contraindicated.
Patient must be aged 6 to 17 years inclusive.
Optimised asthma therapy includes adherence to the maintenance combination of a medium to high dose ICS and a LABA. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8606 |
C12599 | | | Severe asthma
Patient must have experienced at least one severe asthma exacerbation in the 12 months prior to having first commenced treatment for severe asthma, which required systemic corticosteroid treatment despite each of: (i) receiving optimised asthma therapy, (ii) being assessed for adherence to therapy, (iii) being assessed for correct inhaler technique; AND
The treatment must be used in combination with a maintenance combination of an inhaled corticosteroid (ICS) and a long acting beta‑2 agonist (LABA) unless a LABA is contraindicated.
Patient must be at least 18 years of age.
Optimised asthma therapy includes adherence to the maintenance combination of an inhaled corticosteroid (at least 800 micrograms budesonide per day or equivalent) and a long acting beta‑2 agonist. | |
Tiotropium with olodaterol | C7798 | | | Chronic obstructive pulmonary disease (COPD) Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); OR Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); OR Patient must have been stabilised on a combination of a LAMA and a LABA. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7798 |
Tirofiban | C5691 | | | Non‑Q‑wave myocardial infarction | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5691 |
C5782 | | | High risk of unstable angina
Patient must have new transient or persistent ST‑T ischaemic changes; AND
Patient must have pain lasting longer than 20 minutes. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5782 |
C5809 | | | High risk of unstable angina
Patient must have new transient or persistent ST‑T ischaemic changes; AND
Patient must have repetitive episodes of angina at rest or during minimal exercise in the previous 12 hours. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5809 |
Tobramycin | C4456 | P4456 | | Proven Pseudomonas aeruginosa infection
Initial treatment
Patient must have cystic fibrosis; AND
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA‑approved Product Information, with a negative test result; AND
Patient must be participating in a four week trial of tobramycin inhalation powder and will be assessed for ability to tolerate the dry powder formulation in order to qualify for continued PBS‑subsidised therapy. The trial commencement date must be documented in the patient's medical records.
Patient must be 6 years of age or older. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4456 |
C4513 | P4513 | | Proven Pseudomonas aeruginosa infection
Continuing treatment
Patient must have cystic fibrosis; AND
Patient must have previously been issued with an authority prescription for tobramycin inhalation capsules; AND
Patient must have demonstrated ability to tolerate the dry powder formulation following the initial 4‑week treatment period, as agreed by the patient, the patient's family (in the case of paediatric patients) and the treating physician(s).
Patient must be 6 years of age or older. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4513 |
C5446 | | | Septicaemia, suspected | |
C5451 | | | Perioperative use in ophthalmic surgery | |
C5476 | | | Perioperative use in ophthalmic surgery | |
C5477 | | | Suspected Pseudomonal eye infection | |
C5483 | | | Invasive ocular infection | |
C5490 | | | Septicaemia, proven | |
C5498 | | | Pseudomonas aeruginosa infection
Patient must have cystic fibrosis; AND
The treatment must be systemic. | |
C5499 | | | Suspected Pseudomonal eye infection | |
C5519 | | | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent | |
C5520 | | | Proven Pseudomonas aeruginosa infection
Patient must have cystic fibrosis; AND
The treatment must be for management. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5520 |
Tocilizumab | C9180 | P9180 | | Active giant cell arteritis
Continuing treatment
Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not exceed 52 weeks in total including initial and continuing applications. | Compliance with Authority Required procedures |
| C9380 | P9380 | | Severe active juvenile idiopathic arthritis
Continuing Treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
| C9386 | P9386 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9391 | P9391 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; OR
Patient must not have received PBS‑subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS‑subsidised biological medicine treatment 3 times in their last treatment cycle; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count must be no more than 4 weeks old at the time of this application.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9477 | P9477 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) ‑ balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 16 or 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 or 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 or 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions for patients 30 kg or over; OR
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions for patients under 30 kg. | Compliance with Authority Required procedures |
| C9478 | P9478 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9553 | P9553 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C10560 | P10560 | | Systemic juvenile idiopathic arthritis
Balance of supply for Initial treatment ‑ Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months) ‑ in a patient of any weight being administered a subcutaneous form of this biological medicine
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. | Compliance with Authority Required procedures |
| C12193 | P12193 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C12399 | P12399 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 4 (Temporary listing ‑ change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have been receiving PBS‑subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
Patient must have been receiving PBS‑subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C12404 | P12404 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 4 (Temporary listing ‑ change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have been receiving PBS‑subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
Patient must have been receiving PBS‑subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C12405 | P12405 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 4 (Temporary listing ‑ change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have been receiving PBS‑subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
Patient must have been receiving PBS‑subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14080 | P14080 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient weighing at least 30 kg)
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; OR
Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 2 active joints; and
(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
(c) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
The assessment of response to prior treatment must be documented in the patient's medical records.
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
The following reports must be documented in the patient's medical records where appropriate:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis;
(b) details of prior treatment including dose and duration of treatment; and
(c) the pathology reports detailing CRP and platelet count where appropriate. | Compliance with Authority Required procedures |
| C14082 | P14082 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14082 |
| C14084 | P14084 | | Systemic juvenile idiopathic arthritis
Continuing treatment in a patient weighing less than 30 kg
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14084 |
| C14088 | P14088 | | Systemic juvenile idiopathic arthritis
Continuing treatment in a patient weighing at least 30 kg
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The following reports must be documented in the patient's medical records where appropriate:
(a) baseline and current pathology reports detailing C‑reactive protein (CRP) levels; and
(b) baseline and current pathology reports detailing platelet count.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14088 |
| C14093 | P14093 | | Systemic juvenile idiopathic arthritis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14093 |
| C14094 | P14094 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient weighing less than 30 kg)
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; OR
Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 2 active joints; and
(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
(c) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
The assessment of response to prior treatment must be documented in the patient's medical records.
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and
(b) the details of prior treatment including dose and duration of treatment.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
| C14103 | P14103 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14104 | P14104 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must be under 30kg; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14104 |
| C14121 | P14121 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND
Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); OR
Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must be under 18 years of age.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14147 | P14147 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND
Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); OR
Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must be under 18 years of age.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14150 | P14150 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must be 30kg or over; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14150 |
| C14153 | P14153 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14164 | P14164 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14164 |
| C14166 | P14166 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
| C14175 | P14175 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg)
Patient must have received prior PBS‑subsidised treatment with this drug for this condition in the previous 12 months; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C14179 | P14179 | | Systemic juvenile idiopathic arthritis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14179 |
| C14182 | P14182 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg)
Patient must have received prior PBS‑subsidised treatment with this drug for this condition in the previous 12 months; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C14195 | P14195 | | Active giant cell arteritis
Initial treatment
Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis.
Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND
Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; OR
Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; OR
Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND
Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND
Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; OR
Patient must have had evidence of large‑vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; OR
Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND
The treatment must be in combination with a tapering course of corticosteroids; AND
The treatment must not exceed 52 weeks in total including initial and continuing applications.
Patient must be aged 50 years or older.
Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include:
(a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and
(b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C14483 | P14483 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
| C14485 | P14485 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14485 |
| C14486 | P14486 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14488 | P14488 | | Severe active rheumatoid arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14493 | P14493 | | Severe active rheumatoid arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14498 | P14498 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA‑approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14499 | P14499 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14499 |
| C14507 | P14507 | | Severe active rheumatoid arthritis
First continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
| C14621 | P14621 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14621 |
Tofacitinib | C9064 | P9064 | | Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9417 | P9417 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) ‑ balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9431 | P9431 | | Ankylosing spondylitis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C11883 | P11883 | | Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C11886 | P11886 | | Severe psoriatic arthritis
Continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
| C11915 | P11915 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 2 (change or re‑commencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle.
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
| C11940 | P11940 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
| C11944 | P11944 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C11945 | P11945 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11956 | P11956 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C11975 | P11975 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be aged 18 years or older.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
| C11976 | P11976 | | Moderate to severe ulcerative colitis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C11978 | P11978 | | Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C12174 | P12174 | | Ankylosing spondylitis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C12976 | P12976 | | Moderate to severe ulcerative colitis
Continuing treatment ‑ balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
| C14483 | P14483 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
| C14486 | P14486 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14488 | P14488 | | Severe active rheumatoid arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14493 | P14493 | | Severe active rheumatoid arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14498 | P14498 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA‑approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14499 | P14499 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14499 |
| C14507 | P14507 | | Severe active rheumatoid arthritis
First continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
| C14647 | P14647 | | Severe active juvenile idiopathic arthritis
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received non‑PBS‑subsidised treatment with this drug for this PBS indication prior to 1 December 2023; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate prior to initiating treatment with this drug for this condition; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens prior to initiating treatment with this drug for this condition: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14649 | P14649 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
| C14650 | P14650 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14652 | P14652 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14655 | P14655 | | Ankylosing spondylitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a patient is changing from PBS‑subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14662 | P14662 | | Ankylosing spondylitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of at least 5 years from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C‑reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a baseline ESR and/or CRP level.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14670 | P14670 | | Ankylosing spondylitis
Initial treatment ‑ Initial 1 (new patient)
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14692 | P14692 | | Ankylosing spondylitis
Continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14697 | P14697 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14697 |
| C14720 | P14720 | | Ankylosing spondylitis
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must have received non‑PBS‑subsidised treatment with this drug for this PBS indication prior to 1 August 2023; AND
Patient must have had at least 2 of the following prior to commencing non‑PBS‑subsidised treatment: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months prior to commencing non‑PBS‑subsidised treatment; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response to NSAIDs and must have been demonstrated prior to initiation of non‑PBS subsidised treatment with this biological medicine for this condition:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must have been determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. If the above requirement to demonstrate an elevated ESR or CRP could not be met, the application must state the reason this criterion could not be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
Tolvaptan | C8288 | | | Autosomal dominant polycystic kidney disease (ADPKD)
Continuing treatment
Must be treated by a nephrologist or in consultation with a nephrologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have end‑stage renal disease defined as an estimated glomerular filtration rate (eGFR) of less than 15 mL/min/1.73m2; AND
Patient must not have had a kidney transplant. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8288 |
| C10250 | | | Autosomal dominant polycystic kidney disease (ADPKD)
Initial treatment
Must be treated by a nephrologist.
Patient must have an estimated glomerular filtration rate (eGFR) between 30 and 89 mL/min 1.73 m2at the initiation of treatment with this drug for this condition; AND
Patient must have or have had rapidly progressing disease at the time of initiation of this drug for this condition.
Rapidly progressing disease is defined as either of the following:
A decline in eGFR of greater than or equal to 5 mL/min/1.73 m2within one year;
OR
An average decline in eGFR of greater than or equal to 2.5 mL/min/1.73 m2per year over a five year period. | Compliance with Authority Required procedures |
Topiramate | C5173 | | | Seizures
Patient must have partial epileptic seizures; OR
Patient must have primary generalised tonic‑clonic seizures; OR
Patient must have seizures of the Lennox‑Gastaut syndrome; AND
The condition must have failed to be controlled satisfactorily by other anti‑epileptic drugs; AND
Patient must be unable to take a solid dose form of topiramate. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5173 |
C5325 | | | Migraine
The treatment must be for prophylaxis; AND
Patient must have experienced an average of 3 or more migraines per month over a period of at least 6 months; AND
Patient must have a contraindication to beta‑blockers, as described in the relevant TGA‑approved Product Information; OR
Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with a beta‑blocker; AND
Patient must have a contraindication to pizotifen because the weight gain associated with this drug poses an unacceptable risk; OR
Patient must have experienced intolerance of a severity necessitating permanent withdrawal during treatment with pizotifen.
Details of the contraindication and/or intolerance(s) must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5325 |
C5516 | | | Seizures
Patient must have partial epileptic seizures; OR
Patient must have primary generalised tonic‑clonic seizures; OR
Patient must have seizures of the Lennox‑Gastaut syndrome; AND
The condition must have failed to be controlled satisfactorily by other anti‑epileptic drugs. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5516 |
Trabectedin | C14188 | | | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma
Transitioning from non‑PBS to PBS‑subsidised treatment ‑ Grandfather arrangements
Patient must have been receiving treatment with this drug for this condition prior to 1 August 2023; AND
Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non‑PBS supply was initiated; AND
Patient must have received chemotherapy treatment including an anthracycline, prior to initiating non‑PBS‑subsidised treatment; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
The condition must be one of the following subtypes for patients with liposarcoma: (i) dedifferentiated, (ii) myxoid, (iii) round‑cell, (iv) pleomorphic.
This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14188 |
| C14196 | | | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma
Initial treatment
Patient must have an ECOG performance status of 2 or less; AND
Patient must have received prior chemotherapy treatment including an anthracycline; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
The condition must be one of the following subtypes for patients with liposarcoma: (i) dedifferentiated, (ii) myxoid, (iii) round‑cell, (iv) pleomorphic.
This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14196 |
| C14197 | | | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition.
This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14197 |
Tramadol | C10748 | | | Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid or other opioid analgesics; OR
Patient must be unable to use non‑opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment:
(i) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(ii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iii) has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10748 |
| C10752 | | | Chronic severe pain
Continuing PBS treatment after 1 June 2020
Patient must have previously received PBS‑subsidised treatment with this form of this drug for this condition after 1 June 2020.
Authorities for increased maximum quantities and/or repeats must only be considered for chronic severe disabling pain where the patient has received initial authority approval and the total duration of non‑PBS and PBS opioid analgesic treatment:
(i) is less than 12 months; or
(ii) exceeds 12 months and the palliative care patient is unable to have annual pain management review due to their clinical condition; or
(iii) exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iv) has exceeded 12 months prior to 1 June 2020 and the patient's pain management and clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10752 |
| C10755 | | | Chronic severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
The condition must require daily, continuous, long term opioid treatment; AND
Patient must have cancer pain; OR
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid or other opioid analgesics; OR
Patient must be unable to use non‑opioid or other opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment is less than 12 months.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10755 |
| C10764 | P10764 | | Severe pain
Continuing PBS treatment after 1 June 2020
Patient must have previously received PBS‑subsidised treatment with this form of this drug for this condition after 1 June 2020.
Authorities for increased maximum quantities and/or repeats must only be considered where the patient has received initial authority approval for:
(i) severe disabling pain associated with malignant neoplasia; or
(ii) chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment is less than 12 months; or
(iii) palliative care patients with chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or
(iv) chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(v) chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | |
| C10766 | P10766 | | Severe pain
The treatment must be for short term therapy of acute severe pain; AND
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid analgesics; OR
Patient must be unable to use non‑opioid analgesics due to contraindications or intolerance. | |
| C10768 | P10768 | | Severe pain
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid analgesics; OR
Patient must be unable to use non‑opioid analgesics due to contraindications or intolerance. | |
| C10771 | P10771 | | Severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid analgesics; OR
Patient must be unable to use non‑opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats under this restriction must only be considered for severe disabling pain associated with malignant neoplasia or chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment is less than 12 months.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | |
| C10772 | P10772 | | Severe pain
Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for more than 12 months
Patient must have had or would have inadequate pain management with maximum tolerated doses of non‑opioid analgesics; OR
Patient must be unable to use non‑opioid analgesics due to contraindications or intolerance.
Authorities for increased maximum quantities and/or repeats must only be considered for:
(i) severe disabling pain associated with proven malignant neoplasia; or
(ii) palliative care patients with chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment exceeds 12 months and the patient is unable to have annual pain management review due to their clinical condition; or
(iii) chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment exceeds 12 months and the patient's clinical need for continuing opioid treatment has been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months; or
(iv) chronic severe disabling pain where the total duration of non‑PBS and PBS opioid analgesic treatment has exceeded 12 months prior to 1 June 2020 and the patient's clinical need for continuing opioid treatment has not been confirmed through consultation with the patient by another medical practitioner or a palliative care nurse practitioner in the past 12 months, but is planned in the next 3 months.
Palliative care nurses may conduct annual review under this item for the treatment of palliative care patients only.
Authority requests extending treatment duration up to 1 month may be requested through the Online PBS Authorities system or by calling Services Australia.
Authority requests extending treatment duration beyond 1 month may be requested through the Online PBS Authorities system or in writing and must not provide a treatment duration exceeding 3 months (quantity sufficient for up to 1 month treatment and sufficient repeats). | |
Trametinib | C6752 | P6752 | | Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must be receiving PBS‑subsidised dabrafenib concomitantly for this condition; AND
Patient must have stable or responding disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6752 |
| C10051 | P10051 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must be receiving PBS‑subsidised dabrafenib concomitantly for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10051 |
| C10130 | P10130 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for trametinib and dabrafenib concomitantly for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy. | Compliance with Authority Required procedures |
| C10148 | P10148 | | Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment
The treatment must be adjuvant to complete surgical resection; AND
The condition must be positive for a BRAF V600 mutation; AND
Patient must have a WHO performance status of 1 or less; AND
Patient must be receiving PBS‑subsidised trametinib and dabrafenib concomitantly for this condition; AND
Patient must not have received prior PBS‑subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy. | Compliance with Authority Required procedures |
Trandolapril | | P14238 | | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
Trandolapril with verapamil | C4390 | P4390 | | Hypertension
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with verapamil. | |
C14244 | P14244 | | Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an ACE inhibitor; OR
The condition must be inadequately controlled with verapamil. | |
Trastuzumab | C9349 | | | Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Where a patient has a break in trastuzumab therapy of more than 1 week from when the last dose was due, a new loading dose may be required. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9349 |
| C9353 | P9353 | | Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion; AND
The treatment must not be in combination with nab‑paclitaxel; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9353 |
| C9462 | P9462 | | Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9462 |
| C9571 | | | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro‑oesophageal junction
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9571 |
| C9573 | | | Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro‑oesophageal junction
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND
Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND
Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND
Patient must commence treatment in combination with platinum based chemotherapy and capecitabine; OR
Patient must commence treatment in combination with platinum based chemotherapy and 5 fluorouracil; AND
Patient must not have previously received this drug for this condition; AND
Patient must not have received prior chemotherapy for this condition; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9573 |
| C10212 | P10212 | | Early HER2 positive breast cancer
3 weekly treatment regimen
Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy; OR
Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10212 |
| C10213 | | | Early HER2 positive breast cancer
Continuing treatment (weekly regimen)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy; OR
Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10213 |
| C10293 | | | Early HER2 positive breast cancer
Initial treatment (3 weekly regimen)
Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy; OR
Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10293 |
| C10294 | | | Early HER2 positive breast cancer
Continuing treatment (3 weekly regimen)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy; OR
Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10294 |
| C10296 | | | Early HER2 positive breast cancer
Initial treatment (weekly regimen)
Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
Patient must not receive more than 52 weeks of combined PBS‑subsidised and non‑PBS‑subsidised therapy; OR
Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.
HER2 positivity must be demonstrated by in situ hybridisation (ISH).
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10296 |
Trastuzumab deruxtecan | C14470 | | | Metastatic (Stage IV) HER2 positive breast cancer
Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion ‑ establish this finding once only with the first PBS prescription; AND
The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; OR
The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND
Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; AND
The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only.
Patient must be undergoing initial treatment with this drug ‑ the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR
Patient must be undergoing continuing treatment with drug ‑ the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re‑treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.
Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:
1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable).
2) Details of prior HER2 directed drug regimens prescribed for the patient.
3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable). | Compliance with Authority Required procedures |
Trastuzumab emtansine | C10295 | | | Early HER2 positive breast cancer
Continuing adjuvant treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. | Compliance with Authority Required procedures |
| C12989 | | | Metastatic (Stage IV) HER2 positive breast cancer
Initial treatment
Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND
The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
The following information must be provided by the prescriber at the time of application:
(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH).
(b) dates of treatment with trastuzumab and pertuzumab;
(c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or
(d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.
All reports must be documented in the patient's medical records.
Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Authority Required procedures |
| C13004 | | | Early HER2 positive breast cancer
Initial adjuvant treatment
The treatment must be prescribed within 12 weeks after surgery; AND
Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND
Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane‑based chemotherapy prior to surgery; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND
The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.
Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.
The pathology report must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13017 | | | Metastatic (Stage IV) HER2 positive breast cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND
Patient must not receive PBS‑subsidised treatment with this drug if progressive disease develops while on this drug; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
The treatment must not exceed a lifetime total of one continuous course for this PBS indication. | Compliance with Authority Required procedures |
Travoprost with timolol | C4343 | | | Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension. | |
C5038 | | | Elevated intra‑ocular pressure
The condition must have been inadequately controlled with monotherapy; AND
Patient must have open‑angle glaucoma; OR
Patient must have ocular hypertension. | |
Triamcinolone | C4924 | | | Corticosteroid‑responsive dermatoses | |
C6209 | | | Local intra‑articular or peri‑articular infiltration | |
C6210 | | | Keloid | |
C6211 | | | Chronic discoid lupus erythematosus | |
C6237 | | | Keloid | |
C6253 | | | Alopecia areata | |
C6254 | | | Granulomata
The condition must be dermal. | |
C6255 | | | Lichen simplex chronicus | |
C6268 | | | Local intra‑articular or peri‑articular infiltration | |
C6269 | | | Necrobiosis lipoidica | |
C6281 | | | Lichen planus hypertrophic | |
C6287 | | | Psoriasis | |
C6291 | | | Lichen planus hypertrophic | |
Trientine | C13321 | | | Chelation of elevated copper levels
Patient must have a diagnosis of Wilson disease; AND
Patient must be intolerant to penicillamine.
Must be treated by a specialist medical practitioner, where this authority application is to initiate treatment with this drug, of the following type: (i) gastroenterologist, (ii) hepatologist, (iii) neurologist; the authority prescription must be completed by the specialist prescriber; OR
Must be treated by a medical practitioner (of any type), where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types; OR
Must be treated by a nurse practitioner where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types.
Prior to seeking the initial authority approval, establish evidence of excess copper levels based on at least one of: (i) clinical symptoms, (ii) measured serum copper levels, (iii) measured urinary copper levels.
Document what these findings were in the patient's medical records. Do not supply them in this authority application.
Refer to the following definitions if in doubt over what constitutes an acceptable intolerance to penicillamine:
Side effects of penicillamine occurring soon after initiation (within first few weeks/months):
(i) fever, (ii) rash, (iii) enlarged lymph nodes, (iv) neutropenia, (v) thrombocytopenia, (vi) proteinuria, (vii) severe, persistent nausea.
Side effects of penicillamine developing later:
(i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1‑2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus‑like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia.
At the time of the first authority application for this drug, document the details (date of reaction, severity of reaction, dose of penicillamine, etc) of the penicillamine intolerance, if not already done, in the patient's medical records. Do not supply these details in this authority application. | Compliance with Authority Required procedures |
Trifluridine with tipiracil | C8183 | | | Metastatic colorectal cancer
Continuing treatment
Patient must have previously been treated with PBS‑subsidised treatment with this drug for this condition; AND
Patient must not develop progressive disease whilst receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8183 |
| C10252 | | | Metastatic (Stage IV) adenocarcinoma of the stomach or gastro‑oesophageal junction
Initial treatment
Patient must have a WHO performance status of 1 or less; AND
Patient must have previously received at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum and either a taxane or irinotecan; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10252 |
| C10309 | | | Metastatic colorectal cancer
Initial treatment
Patient must have a WHO performance status of 1 or less; AND
Patient must have previously received treatment with fluoropyrimidine, oxaliplatin, irinotecan‑based chemotherapies, an anti‑vascular endothelial growth factor (anti‑VEGF) agent and an anti‑epidermal growth factor receptor (anti‑EGFR) agent for this condition; OR
Patient must not be a suitable candidate for treatment with fluoropyrimidine, oxaliplatin, irinotecan‑based chemotherapies, an anti‑VEGF agent and an anti‑EGFR agent for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
The patient's WHO performance status and body weight must be documented in the patient's medical records at the time the treatment cycle is initiated. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10309 |
| C10310 | | | Metastatic (Stage IV) adenocarcinoma of the stomach or gastro‑oesophageal junction
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not develop progressive disease whilst receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10310 |
Triglycerides, long chain with glucose polymer | C4438 | | | Proven inborn errors of protein metabolism
Patient must be unable to meet their energy requirements with permitted food and formulae. | |
Triglycerides, medium chain | C6134 | | | Chylothorax | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6134 |
C6135 | | | Cerebrospinal fluid glucose transporter defect
Patient must require a ketogenic diet. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6135 |
C6146 | | | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6146 |
C6147 | | | Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6147 |
C6155 | | | Intractable childhood epilepsy
Patient must require a ketogenic diet. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6155 |
C6164 | | | Fat malabsorption
The condition must be due to liver disease; OR
The condition must be due to short gut syndrome; OR
The condition must be due to cystic fibrosis; OR
The condition must be due to gastrointestinal disorders. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6164 |
C6181 | | | Chylous ascites | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6181 |
C6191 | | | Dietary management of conditions requiring a source of medium chain triglycerides
Patient must have chylous ascites; OR
Patient must have chylothorax; OR
Patient must have hyperlipoproteinaemia type 1; OR
Patient must have long chain fatty acid oxidation disorders; OR
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6191 |
C6203 | | | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6203 |
Triglycerides, medium chain and long chain with glucose polymer | C4438 | | | Proven inborn errors of protein metabolism
Patient must be unable to meet their energy requirements with permitted food and formulae. | |
Triglycerides ‑ medium chain, formula | C4651 | | | Hyperlipoproteinaemia type 1 | |
C4652 | | | Chylous ascites | |
C4653 | | | Chylothorax | |
C4659 | | | Long chain fatty acid oxidation disorders | |
C4660 | | | Dietary management of conditions requiring a source of medium chain triglycerides
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders. | |
C5541 | | | Dietary management of conditions requiring a source of medium chain triglycerides
Patient must have fat malabsorption due to liver disease; OR
Patient must have fat malabsorption due to short gut syndrome; OR
Patient must have fat malabsorption due to cystic fibrosis; OR
Patient must have fat malabsorption due to gastrointestinal disorders. | |
C6136 | | | Long chain fatty acid oxidation disorders | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6136 |
C6156 | | | Hyperlipoproteinaemia type 1 | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6156 |
C6165 | | | Chylous ascites | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6165 |
C6173 | | | Fat malabsorption
The condition must be due to liver disease; OR
The condition must be due to short gut syndrome; OR
The condition must be due to cystic fibrosis; OR
The condition must be due to gastrointestinal disorders. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6173 |
C6192 | | | Chylothorax | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6192 |
Trimethoprim | | P4243 | CN4243 | Prophylaxis of urinary tract infection | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4243 |
| P6163 | | Prostatitis | |
Trimethoprim with sulfamethoxazole | | P6201 | CN6201 | Prophylaxis of Pneumocystis jiroveci pneumonia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6201 |
Triptorelin | C5046 | | | Assisted Reproductive Technology
The treatment must be for prevention of premature luteinisation and ovulation; AND
Patient must be undergoing controlled ovarian stimulation; AND
Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5046 |
C6409 | | | Locally advanced (stage C) or metastatic (stage D) carcinoma of the prostate | |
C12351 | | | Central precocious puberty
Continuing treatment with this drug, or, switching gonadotropin releasing hormone analogue therapy
Must be treated by a medical practitioner identifying as one of: (i) a paediatric endocrinologist, (ii) an endocrinologist specialising in paediatrics; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing continuing treatment with a gonadotropin releasing hormone analogue initiated through the PBS for this PBS indication. | |
C12387 | | | Central precocious puberty
Initial treatment
Must be treated by a paediatric endocrinologist; OR
Must be treated by an endocrinologist specialising in paediatrics.
Patient must be of an age that is prior to their 12thbirthday if female; OR
Patient must be of an age that is prior to their 13thbirthday if male; AND
Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9thbirthday if female; OR
Patient must have had onset of signs/symptoms of central precocious puberty prior to their 10thbirthday if male. | |
Tropisetron | C4077 | | | Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle. | |
C5749 | | | Nausea and vomiting
The condition must be associated with cytotoxic chemotherapy being used to treat malignancy which occurs within 48 hours of chemotherapy administration.
Increased maximum quantities will be limited to a maximum of 7 days per chemotherapy cycle. | |
Tyrosine with carbohydrate | C4295 | | | Phenylketonuria | |
Umeclidinium | C4516 | | | Chronic obstructive pulmonary disease (COPD) | |
Umeclidinium with vilanterol | C7798 | | | Chronic obstructive pulmonary disease (COPD) Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); OR Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); OR Patient must have been stabilised on a combination of a LAMA and a LABA. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7798 |
Upadacitinib | C9064 | P9064 | | Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9431 | P9431 | | Ankylosing spondylitis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C10434 | P10434 | | Non‑radiographic axial spondyloarthritis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
| C11886 | P11886 | | Severe psoriatic arthritis
Continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
| C11944 | P11944 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C11945 | P11945 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11956 | P11956 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C11976 | P11976 | | Moderate to severe ulcerative colitis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C11978 | P11978 | | Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C12174 | P12174 | | Ankylosing spondylitis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C12493 | P12493 | | Chronic severe atopic dermatitis
Continuing or resuming treatment with this drug of the whole body
Patient must have received PBS‑subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the whole body; AND
Patient must have achieved an adequate response prior to this first continuing treatment authority application; OR
Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; OR
Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse‑effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application.
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist; AND
Patient must be undergoing treatment with this drug as the sole PBS‑subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).
For the purposes of this restriction, an adequate response to treatment is defined as:
(a) An improvement/maintenance in the Eczema Area and Severity Index (EASI) score of at least 50% compared to baseline; and
(b) An improvement/maintenance in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline
Where an initial baseline (post‑topical corticosteroid, pre‑biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non‑PBS‑subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.
State each of the current EASI and DLQI scores for this authority application. | Compliance with Authority Required procedures |
| C12494 | P12494 | | Chronic severe atopic dermatitis
Continuing or resuming treatment with this drug of the face and/or hands
Patient must have received PBS‑subsidised treatment with this therapy for the treatment of chronic severe atopic dermatitis affecting the face/hands; AND
Patient must have achieved an adequate response prior to this first continuing treatment authority application; OR
Patient must have maintained an adequate response to their most recent supply of this therapy for this PBS indication if this is any Continuing treatment authority application other than the first; OR
Patient must have temporarily ceased treatment for reasons other than lack of response (e.g. family planning, vaccination with live vaccines, adverse‑effect investigation), thereby being unable to achieve/maintain an adequate response immediately prior to this authority application.
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist; AND
Patient must be undergoing treatment with this drug as the sole PBS‑subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).
For the purposes of this restriction, an adequate response to treatment of the face/hands is defined as:
(a) (i) A rating of either mild (1) to none (0) on at least 3 of the assessments of erythema, oedema/papulation, excoriation and lichenification mentioned in the Eczema Area and Severity Index (EASI); or
(ii) At least a 75% reduction in the skin area affected by this condition compared to baseline; and
(b) An improvement in Dermatology Life Quality Index (DLQI) score of at least 4 points compared to baseline
Where an initial baseline (post‑topical corticosteroid, pre‑biological medicine) DLQI score was not measured for a patient who had commenced treatment through a clinical trial, early access program or through private, non‑PBS‑subsidised supply, an absence of worsening in the current DLQI score compared to that measured at the time of the 'Grandfather listing' authority application will suffice as an adequate response for requirement (b) above.
Document each qualifying response measure in the patient's medical records for PBS compliance auditing purposes | Compliance with Authority Required procedures |
| C12499 | P12499 | | Chronic severe atopic dermatitis
Initial treatment with this drug of the whole body
Patient must have a Physicians Global Assessment (PGA) (5‑point scale) baseline score of at least 4 as evidence of severe disease despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
Patient must have an Eczema Area and Severity Index (EASI) baseline score of at least 20 despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND
Patient must not have experienced an inadequate response to this therapy.
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist; AND
Patient must be undergoing treatment with this drug as the sole PBS‑subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).
Patient must be 12 years of age or older.
State each of the qualifying (i) PGA, (ii) EASI and (iii) DLQI scores in the authority application.
Acceptable scores can be:
(a) current scores; or
(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.
The EASI and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient's medical records.
Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled in the patient's medical records. | Compliance with Written Authority Required procedures |
| C12504 | P12504 | | Chronic severe atopic dermatitis
Dose change (increasing up to the 30 mg dose, or, decreasing back down to the 15 mg dose) ‑ whole body, or, face/hands
Patient must not be undergoing each of: (i) commencing treatment through this treatment phase listing, (ii) treatment accessed through this treatment phase on more than 2 consecutive occasions; AND
Patient must be undergoing existing PBS‑subsidised treatment with this therapy where each of the following is true: (i) there is a change in daily dose, (ii) any remaining PBS repeat prescriptions for the strength that the patient is changing from, is marked as 'cancelled'; AND
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist; AND
Patient must be undergoing treatment with this drug as the sole PBS‑subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis). | Compliance with Authority Required procedures |
| C12508 | P12508 | | Chronic severe atopic dermatitis
Initial treatment with this drug of the face and/or hands
The condition must have at least 2 of the following Eczema Area and Severity Index (EASI) symptom sub‑scores for erythema, oedema/papulation, excoriation, lichenification rated as severe despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; OR
The condition must have affected at least 30% of the face/hands surface area despite treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
Patient must have an age appropriate Dermatology Life Quality Index (DLQI) baseline score (of any value) measured following treatment with daily topical therapy (corticosteroid of medium to high potency/calcineurin inhibitor), for at least 28 days; AND
The condition must have had lesions for at least 6 months from the time of the initial diagnosis of chronic severe atopic dermatitis affecting either of: (i) the whole body, (ii) face/hands; AND
Patient must not have experienced an inadequate response to this therapy.
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist; AND
Patient must be undergoing treatment with this drug as the sole PBS‑subsidised therapy with this PBS indication (combination with oral corticosteroids is permitted as these are not listed with the PBS indication: chronic severe atopic dermatitis).
Patient must be 12 years of age or older.
State each of the 4 Eczema Area and Severity Index (EASI) symptom sub‑score ratings (0 = none, 1 = mild, 2 = moderate, 3 = severe) for:
(i) erythema,
(ii) oedema/papulation,
(iii) excoriation,
(iv) lichenification
Acceptable scores can be:
(a) current scores; or
(b) past scores, including those previously quoted in a PBS authority application for another drug listed for this indication.
State the percentage face/hand surface area affected by the condition (must be at least 30%) where EASI symptom sub‑scores are not provided. This percentage surface area can also be stated in addition to the EASI symptom sub‑scores.
The EASI/percentage surface area and DLQI baseline measurements are to form the basis of determining if an adequate response to treatment has been achieved under the Continuing treatment restriction. In addition to stating them in this authority application, document them in the patient's medical records.
Document the details of the medium to high potency topical corticosteroids (or calcineurin inhibitors) initially trialled are in the patient's medical records. | Compliance with Written Authority Required procedures |
| C13930 | P13930 | | Moderate to severe ulcerative colitis
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangementsr
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 May 2023; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
The condition must have responded inadequately to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for at least 3 consecutive months prior to treatment initiation with this drug; OR
Patient must have experienced a severe intolerance to the above therapy leading to permanent treatment discontinuation; AND
The condition must have responded inadequately to azathioprine at a dose of at least 2 mg per kg daily for at least 3 consecutive months prior to treatment initiation with this drug; OR
The condition must have responded inadequately to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for at least 3 consecutive months prior to treatment initiation with this drug; OR
The condition must have responded inadequately to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period, followed by an inadequate response to at least 3 consecutive months of treatment with an appropriately dosed thiopurine agent, prior to treatment initiation with this drug; OR
Patient must have experienced a severe intolerance to each of the above 3 therapies leading to permanent treatment discontinuation; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing non‑PBS‑subsidised treatment with this drug for this condition; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing non‑PBS‑subsidised treatment with this drug for this condition; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced non‑PBS‑subsidised treatment with this drug for this condition where a Mayo clinic or partial Mayo clinic baseline assessment is not available.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) including the date of assessment;
(ii) the date of commencement of this drug.
A patient may qualify for PBS‑subsidised treatment under this restriction once only.
For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The assessment of the patient's response to this PBS‑subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. | Compliance with Written Authority Required procedures |
| C13958 | P13958 | | Moderate to severe ulcerative colitis
Continuing treatment ‑ balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
The treatment must have been prescribed most recently through the Continuing treatment phase in a quantity which did not seek the full number available in regards to any of: (i) the quantity per dispensing, (ii) repeat prescriptions; AND
The treatment must provide no more than the balance of 24 weeks treatment. | Compliance with Authority Required procedures |
| C13959 | P13959 | | Moderate to severe ulcerative colitis
Dose modification
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
Patient must be undergoing existing PBS‑subsidised treatment with this therapy. | Compliance with Authority Required procedures |
| C13990 | P13990 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
| C13999 | P13999 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 1 (new patient ‑ untreated with biological medicine)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score).
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
| C14011 | P14011 | | Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug.
Patient must be at least 18 years of age.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C14014 | P14014 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
| C14198 | P14198 | | Non‑radiographic axial spondyloarthritis
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements
Patient must have commenced treatment with this biological medicine for this condition prior to 1 August 2023; AND
The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA‑B27); AND
The condition must not be radiographically evidenced on plain x‑ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND
The condition must be non‑radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND
The condition must be sacroiliitis with active inflammation and/or oedema on non‑contrast Magnetic Resonance Imaging (MRI); AND
The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND
The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND
The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale; and
(b) C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and CRP level must be determined at the completion of the 3‑month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The baseline BASDAI score and CRP level must also be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14199 | P14199 | | Non‑radiographic axial spondyloarthritis
Continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND
The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0‑10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment. | Compliance with Authority Required procedures |
| C14208 | P14208 | | Non‑radiographic axial spondyloarthritis
Initial treatment ‑ Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND
The treatment must not exceed a maximum of 16 weeks with this drug under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C‑reactive protein (CRP) level may be provided at the time of this application.
An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0‑10) and 1 of the following:
(a) a CRP measurement no greater than 10 mg per L; or
(b) a CRP measurement reduced by at least 20% from baseline.
The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
BASDAI scores and CRP levels must be documented in the patient's medical records.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The following must be provided at the time of application and documented in the patient's medical records:
(a) the BASDAI score; and
(b) the C‑reactive protein (CRP) level. | Compliance with Authority Required procedures |
| C14213 | P14213 | | Non‑radiographic axial spondyloarthritis
Initial treatment ‑ Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA‑B27); AND
The condition must not be radiographically evidenced on plain x‑ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND
The condition must be non‑radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND
The condition must be sacroiliitis with active inflammation and/or oedema on non‑contrast Magnetic Resonance Imaging (MRI); AND
The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND
The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND
The treatment must not exceed a maximum of 16 weeks with this drug under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
The following must be provided at the time of application and documented in the patient's medical records:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale; and
(b) C‑reactive protein (CRP) level greater than 10 mg per L.
The BASDAI score and CRP level must be no more than 4 weeks old at the time of this application.
If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
| C14216 | P14216 | | Non‑radiographic axial spondyloarthritis
Initial treatment ‑ Initial 1 (New patient)
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had chronic lower back pain and stiffness for 3 or more months that is relieved by exercise but not rest; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must have one or more of the following: (a) enthesitis (heel); (b) uveitis; (c) dactylitis; (d) psoriasis; (e) inflammatory bowel disease; or (f) positive for Human Leukocyte Antigen B27 (HLA‑B27); AND
The condition must not be radiographically evidenced on plain x‑ray of Grade II bilateral sacroiliitis or Grade III or IV unilateral sacroiliitis; AND
The condition must be non‑radiographic axial spondyloarthritis, as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria; AND
The condition must be sacroiliitis with active inflammation and/or oedema on non‑contrast Magnetic Resonance Imaging (MRI); AND
The condition must have presence of Bone Marrow Oedema (BMO) depicted as a hyperintense signal on a Short Tau Inversion Recovery (STIR) image (or equivalent); AND
The condition must have BMO depicted as a hypointense signal on a T1 weighted image (without gadolinium); AND
The treatment must not exceed a maximum of 16 weeks with this drug under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response to NSAIDs and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of at least 4 on a 0‑10 scale; and
(b) C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and CRP level must be determined at the completion of the 3‑month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The baseline BASDAI score and CRP level must also be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14217 | P14217 | | Non‑radiographic axial spondyloarthritis
Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of non‑radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
| C14483 | P14483 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
| C14486 | P14486 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14488 | P14488 | | Severe active rheumatoid arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14498 | P14498 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA‑approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14613 | P14613 | | Severe active rheumatoid arthritis
Continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
| C14633 | P14633 | | Severe active rheumatoid arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14653 | P14653 | | Severe Crohn disease
Balance of supply for Initial (induction) treatment phases
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
The treatment must have been prescribed in a quantity in the most recent prescription which did not seek the full quantity available in regards to any of: (i) the quantity per dispensing, (ii) repeat prescriptions; AND
The treatment must provide no more than the balance available under the treatment phase from which the immediately preceding supply was obtained under. | Compliance with Authority Required procedures |
| C14655 | P14655 | | Ankylosing spondylitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a patient is changing from PBS‑subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14662 | P14662 | | Ankylosing spondylitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of at least 5 years from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C‑reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a baseline ESR and/or CRP level.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14670 | P14670 | | Ankylosing spondylitis
Initial treatment ‑ Initial 1 (new patient)
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14692 | P14692 | | Ankylosing spondylitis
Continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14696 | P14696 | | Severe Crohn disease
Transitioning from non‑PBS to PBS‑subsidised supply ‑ 'grandfather' arrangements
Patient must have received non‑PBS‑subsidised treatment with this drug for this PBS indication prior to 1 December 2023; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
Patient must have had a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 prior to commencing treatment with this drug; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies were to have been within 4 weeks leading up to commencing the non‑PBS subsidised supply of this drug and should have been performed preferably whilst still on conventional treatment, but no longer than 4 weeks following the last dose of conventional treatment.
Where extensive small intestinal disease affecting more than 50 cm of the small intestine applies, the CDAI must have been at least 220 prior to commencing the non‑PBS subsidised supply of this drug.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy. | Compliance with Written Authority Required procedures |
| C14698 | P14698 | | Severe Crohn disease
Balance of supply for the Continuing (maintenance) treatment phase
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
The treatment must have been prescribed in a quantity in the most recent prescription which did not seek the full quantity available in regards to any of: (i) the quantity per dispensing, (ii) repeat prescriptions; AND
The treatment must provide no more than the balance available under the treatment phase from which the immediately preceding supply was obtained under. | Compliance with Authority Required procedures |
| C14709 | P14709 | | Severe Crohn disease
Continuing (maintenance) treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
In relation to the immediately preceding supply of this biological medicine, provide at least one of the following which is not more than 4 weeks from the last administered dose:
(i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or
(ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant. | Compliance with Written Authority Required procedures |
| C14710 | P14710 | | Severe Crohn disease
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Provide at least one of the following:
(i) the current Crohn Disease Activity Index (CDAI) score, including the date this score was calculated on;
(ii) confirmation that there is a documented history of intestinal inflammation plus diagnostic imaging/surgical evidence of at least one of: (a) short gut syndrome, (b) ileostomy, (c) colostomy;
(iii) confirmation that there is a documented history and radiological evidence of intestinal inflammation from extensive small intestinal disease affecting more than 50 cm of the small intestine where the CDAI score is at least 220, but below 300.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy. | Compliance with Written Authority Required procedures |
| C14711 | P14711 | | Severe Crohn disease
Extended induction period (optional) from weeks 12 to 24
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have experienced an inadequate therapeutic benefit following at least one of: (i) dosing with 45 mg daily in the initial 12‑week induction period, (ii) dosing with 15 mg daily.
Patient must be at least 18 years of age. | Compliance with Authority Required procedures |
| C14721 | P14721 | | Severe Crohn disease
Initial 1 (induction treatment covering the first 12 weeks in a patient untreated with biological medicine)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be at least 18 years of age.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy. | Compliance with Written Authority Required procedures |
| C14728 | P14728 | | Severe Crohn disease
Continuing (maintenance) treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; OR
The condition must have not met the improvements specified above due to the prescribed dose being too low ‑ this authority application seeks higher dosing.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
In relation to the immediately preceding supply of this biological medicine, provide at least one of the following which is not more than 4 weeks from the last administered dose:
(i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or
(ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant. | Compliance with Written Authority Required procedures |
| C14734 | P14734 | | Severe Crohn disease
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
The treatment must not have on a previous occasion failed to provide the patient with an adequate response during the current treatment cycle.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
In relation to the biological medicine prescribed immediately before this one, provide at least one of the following which is not more than 4 weeks from the last administered dose:
(i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or
(ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; or
(iii) confirmation that a severe intolerance occurred that resulted in the cessation of treatment. | Compliance with Written Authority Required procedures |
Ursodeoxycholic acid | C9032 | | | Primary biliary cholangitis (previously known as Primary biliary cirrhosis) | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9032 |
Ustekinumab | C6696 | P6696 | | Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot ‑ balance of supply
Patient must have received insufficient therapy with this drug under the continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C8891 | P8891 | | Severe chronic plaque psoriasis
Continuing treatment, Whole body
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C8987 | P8987 | | Severe chronic plaque psoriasis
Continuing treatment, Face, hand, foot
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area assessed at baseline.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9063 | P9063 | | Severe psoriatic arthritis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. | Compliance with Authority Required procedures |
| C9116 | P9116 | | Severe psoriatic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9122 | P9122 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9160 | P9160 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9175 | P9175 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9176 | P9176 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9655 | P9655 | | Severe Crohn disease
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9656 | P9656 | | Severe Crohn disease
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9657 | P9657 | | Severe Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
An application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS‑subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats; up to 1 repeat will be authorised for patients whose dosing frequency is every 12 weeks. Up to a maximum of 2 repeats will be authorised for patients whose dosing frequency is every 8 weeks.
Where an inadequate number of repeats are requested at the time of the application to complete a course of 24 weeks treatment, authority approvals for sufficient repeats to complete 24 weeks of treatment may be requested by telephone by contacting the Department of Human Services and applying through the Balance of Supply restriction. Under no circumstances will telephone approvals be granted for treatment that would otherwise extend continuing treatment beyond 24 months. | Compliance with Written Authority Required procedures |
| C9710 | P9710 | | Severe Crohn disease
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9711 | P9711 | | Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment. | Compliance with Authority Required procedures |
| C11119 | P11119 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Face, hand, foot (change or re‑commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11120 | P11120 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re‑commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C11145 | P11145 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C11153 | P11153 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 2, Whole body (change or re‑commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS‑subsidised treatment with this drug and who wishes to re‑commence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C11161 | P11161 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Whole body (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C12285 | P12285 | | Severe chronic plaque psoriasis
Balance of supply ‑ Continuing treatment (Whole body, or, face/hand/foot)
Must be treated by a dermatologist; AND
Patient must be undergoing current PBS‑subsidised treatment with this biological medicine, but the full number of repeats available under the continuing treatment phase was not prescribed. | Compliance with Authority Required procedures |
| C12334 | P12334 | | Severe chronic plaque psoriasis
Balance of supply ‑ Initial 1, 2 or 3 treatment (Whole body, or, face/hand/foot)
Must be treated by a dermatologist; AND
Patient must be undergoing current PBS‑subsidised treatment with this biological medicine, but has received insufficient therapy with this biological medicine to complete 3 doses available under any of the initial treatment phases (regardless of the affected body area): (i) Initial 1, (ii) Initial 2, (iii) Initial 3.
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
The treatment must provide no more than the balance of 3 doses available under any of the initial treatment phases. | Compliance with Authority Required procedures |
| C13927 | P13927 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a single dose to be administered at week 8 under this restriction.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre‑filled syringe of 90 mg and no repeats.
Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Written Authority Required procedures |
| C13952 | P13952 | | Moderate to severe ulcerative colitis
Continuing treatment ‑ balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
| C13955 | P13955 | | Moderate to severe ulcerative colitis
Initial treatment ‑ initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
The treatment must not exceed a single dose to be administered at week 8 under this restriction.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre‑filled syringe of 90 mg and no repeats.
Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Written Authority Required procedures |
| C13988 | P13988 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
The treatment must not exceed a single dose to be administered at week 8 under this restriction.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre‑filled syringe of 90 mg and no repeats. | Compliance with Written Authority Required procedures |
| C14009 | P14009 | | Moderate to severe ulcerative colitis
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 May 2023; AND
Patient must be receiving treatment with this drug for this condition at the time of application; AND
The condition must have responded inadequately to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for at least 3 consecutive months prior to treatment initiation with this drug; OR
Patient must have experienced a severe intolerance to the above therapy leading to permanent treatment discontinuation; AND
The condition must have responded inadequately to azathioprine at a dose of at least 2 mg per kg daily for at least 3 consecutive months prior to treatment initiation with this drug; OR
The condition must have responded inadequately to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for at least 3 consecutive months prior to treatment initiation with this drug; OR
The condition must have responded inadequately to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period, followed by an inadequate response to at least 3 consecutive months of treatment with an appropriately dosed thiopurine agent, prior to treatment initiation with this drug; OR
Patient must have experienced a severe intolerance to each of the above 3 therapies leading to permanent treatment discontinuation; AND
Patient must have had a Mayo clinic score greater than or equal to 6 prior to commencing non‑PBS‑subsidised treatment with this drug for this condition; OR
Patient must have had a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores were both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo score) prior to commencing non‑PBS‑subsidised treatment with this drug for this condition; OR
Patient must have a documented history of moderate to severe refractory ulcerative colitis prior to having commenced non‑PBS‑subsidised treatment with this drug for this condition where a Mayo clinic or partial Mayo clinic baseline assessment is not available; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes:
(i) the completed baseline Mayo clinic or partial Mayo clinic calculation sheet prior to initiating treatment (if available) including the date of assessment;
(ii) the date of commencement of this drug.
A patient may qualify for PBS‑subsidised treatment under this restriction once only.
For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
The assessment of the patient's response to this PBS‑subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. | Compliance with Written Authority Required procedures |
| C14018 | P14018 | | Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C14415 | P14415 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C14442 | P14442 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C14543 | P14543 | | Severe chronic plaque psoriasis
Initial 1 treatment (Whole body) ‑ biological medicine‑naive patient
Must be treated by a dermatologist.
Patient must be undergoing treatment for the first time with PBS‑subsidised biological medicine for this PBS indication; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND
Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Where treatment with any of the above‑mentioned drugs was contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.
Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:
(a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre‑requisite therapy.
A PASI assessment must have been completed for each pre‑requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre‑requisite treatment. Provide in this authority application, and document in the patient's medical records, each of:
(i) the name of each prior therapy trialled that meets the above requirements ‑ state at least 2;
(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
(iii) the PASI score that followed each prior therapy trialled;
(iv) the date the PASI scores were determined.
Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of: (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre‑requisite non‑biological medicine. | Compliance with Written Authority Required procedures |
| C14558 | P14558 | | Severe chronic plaque psoriasis
Continuing treatment (Whole body) ‑ treatment covering week 28 and onwards
Must be treated by a dermatologist.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND
Patient must have demonstrated an adequate response to treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The assessment of response to treatment must be provided in this application and documented in the patient's medical records.
The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Written Authority Required procedures |
| C14572 | P14572 | | Severe chronic plaque psoriasis
Initial 3 treatment (Whole body, or, face/hand/foot) ‑ Recommencement of treatment after a break in biological medicine of more than 5 years
Must be treated by a dermatologist.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS‑subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND
The condition must be affecting the whole body ‑ all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; OR
The condition must be limited to the face/hand/foot ‑ all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND
Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; OR
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be under 18 years of age.
The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C14573 | P14573 | | Severe chronic plaque psoriasis
Initial 2 treatment (Face, hand, foot) ‑ Change or recommencement of treatment after a break in biological medicine of less than 5 years
Must be treated by a dermatologist.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment 3 times for this condition within this treatment cycle; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.
Response to preceding supply:
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
Change in therapy:
If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:
(i) there is an absence of an adequate response to that treatment; or
(ii) there was an intolerance to that treatment; or
(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above
Recommencing therapy:
If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:
(i) an absence of an adequate response; or
(ii) an intolerance to that treatment; or
(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.
The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14628 | P14628 | | Severe chronic plaque psoriasis
Continuing treatment (Face, hand, foot) ‑ treatment covering week 28 and onwards
Must be treated by a dermatologist.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND
Patient must have demonstrated an adequate response to treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The assessment of response to treatment must be provided in this application and documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14636 | P14636 | | Severe chronic plaque psoriasis
Initial 1 treatment (Face, hand, foot) ‑ biological medicine‑naive patient
Must be treated by a dermatologist.
Patient must be undergoing treatment for the first time with PBS‑subsidised biological medicine for this PBS indication; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND
Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Where treatment with any of the above‑mentioned drugs was contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application.
Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy:
(a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre‑requisite therapy; or
(b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre‑requisite therapy
Provide in this authority application, and document in the patient's medical records, each of:
(i) the name of each prior therapy trialled that meets the above requirements ‑ state at least 2;
(ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
(iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;
(iv) the dates that response assessments were determined.
Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment:
(v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);
(vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. | Compliance with Written Authority Required procedures |
| C14643 | P14643 | | Severe chronic plaque psoriasis
Initial 2 treatment (Whole body) ‑ Change of treatment, or, recommencement of treatment after a break in biological medicine of less than 5 years
Must be treated by a dermatologist.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment 3 times for this condition within this treatment cycle; AND
The treatment must be as systemic monotherapy; OR
The treatment must be in combination with methotrexate; AND
Patient must not receive more than 28 weeks of treatment under this restriction.
Patient must be under 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Where the patient is changing from treatment with etanercept a baseline PASI measurement must be provided with this authority application.
Response to preceding supply:
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
Change in therapy:
If the patient is changing therapy, in relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because:
(i) there is an absence of an adequate response to that treatment; or
(ii) there was an intolerance to that treatment; or
(iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above
Recommencing therapy:
If the patient is recommencing therapy, in relation to the last administered dose, state whether there was:
(i) an absence of an adequate response; or
(ii) an intolerance to that treatment; or
(iii) an adequate response, but a break in therapy was necessary for reasons other than the 2 mentioned above.
The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records. | Compliance with Written Authority Required procedures |
Valaciclovir | C5940 | P5940 | | Recurrent moderate to severe genital herpes
Suppressive therapy
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5940 |
C5960 | P5960 | | Initial moderate to severe genital herpes
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5960 |
C5961 | P5961 | | Recurrent moderate to severe genital herpes
Episodic treatment
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5961 |
C5962 | P5962 | | Herpes zoster
The treatment must be administered within 72 hours of the onset of the rash. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5962 |
C5968 | P5968 | | Herpes zoster ophthalmicus | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5968 |
C5975 | | | Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5975 |
C9267 | | | Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9267 |
Valganciclovir | C4980 | | | Cytomegalovirus retinitis
Patient must have HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4980 |
C4989 | | | Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4989 |
C9316 | | | Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9316 |
Valine with carbohydrate | C5571 | | | Maple syrup urine disease | |
Valsartan | | P14238 | | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
Valsartan with hydrochlorothiazide | C4361 | P4361 | | Hypertension
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic. | |
C4374 | P4374 | | Hypertension
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic. | |
C14255 | P14255 | | Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic. | |
C14311 | P14311 | | Hypertension
The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
The treatment must not be for the initiation of anti‑hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a thiazide diuretic. | |
Vancomycin | C5636 | | | Antibiotic associated pseudomembranous colitis
The condition must be due to Clostridium difficile; AND
Patient must have an intolerance to metronidazole. | Compliance with Authority Required procedures |
C5660 | | | Antibiotic associated pseudomembranous colitis
The condition must be due to Clostridium difficile; AND
The condition must be unresponsive to metronidazole. | Compliance with Authority Required procedures |
C5716 | P5716 | | Endophthalmitis | |
C5717 | P5717 | | Endocarditis
The treatment must be for prophylaxis; AND
Patient must be hypersensitive to penicillin. | |
C5769 | P5769 | | Infection
The treatment must be initiated in a hospital; AND
The condition must be one in which vancomycin is an appropriate antibiotic. | |
C5801 | | | Endocarditis
The treatment must be for prophylaxis; AND
Patient must be hypersensitive to penicillin. | |
Varenicline | C6871 | | | Nicotine dependence
Commencement of a short‑term (12 weeks or 24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have indicated they are ready to cease smoking; AND
Patient must not receive more than 24 weeks of PBS‑subsidised treatment with this drug per 12‑month period.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS‑subsidised treatment is initiated.
Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated.
Clinical review is recommended within 2 to 3 weeks of the initial prescription being requested. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6871 |
C6885 | P6885 | | Nicotine dependence
Completion of a short‑term (24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug during this current course of treatment; AND
Patient must have ceased smoking in the process of completing an initial 12‑weeks or ceased smoking following an initial 12‑weeks of PBS‑subsidised treatment with this drug in the current course of treatment.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6885 |
C7483 | P7483 | | Nicotine dependence
Continuation of a short‑term (12 weeks or 24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have previously received treatment with this drug during this current course of treatment.
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7483 |
Vedolizumab | C12078 | P12078 | | Moderate to severe ulcerative colitis
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the intravenous form as their most recent course of PBS‑subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
Up to a maximum of 5 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C12178 | P12178 | | Severe Crohn disease
Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the intravenous form as their most recent course of PBS‑subsidised biological medicine for this condition under the vedolizumab intravenous form continuing treatment restriction; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; OR
Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
Up to a maximum of 5 repeats will be authorised.
If fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone or electronically via the Online PBS Authorities system and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will immediate assessment approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C12242 | P12242 | | Moderate to severe ulcerative colitis
Initial treatment with subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR
Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16.
Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C12576 | P12576 | | Severe Crohn disease
Initial treatment with subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 1 (new patient); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years); OR
Patient must have received at least 2 of the 3 initial intravenous infusions with this drug for this condition at weeks 0, 2 and 6 under Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); OR
Patient must have a concurrent authority application for the intravenous infusion for this condition under either Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Where two initial doses of vedolizumab (at weeks 0 and 2) are administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 6. The maximum listed quantity and 2 repeats should be requested to provide for weeks 6, 8, 10, 12, 14 and 16.
Where three initial doses of vedolizumab (at weeks 0, 2 and 6) is administered via intravenous infusion, initial treatment with subcutaneous form will commence at week 14 (8 weeks after the third dose). A maximum quantity with no repeats should be requested to provide for weeks 14 and 16.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C13236 | P13236 | | Severe Crohn disease
Balance of supply ‑ subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment ‑ subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment ‑ subcutaneous form. | Compliance with Authority Required procedures |
| C13237 | P13237 | | Moderate to severe ulcerative colitis
Balance of supply ‑ subcutaneous form
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); OR
Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment ‑ subcutaneous form; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment ‑ subcutaneous form. | Compliance with Authority Required procedures |
Vemurafenib | C6013 | P6013 | | Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must have stable or responding disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6013 |
| C10157 | P10157 | | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
The condition must be positive for a BRAF V600 mutation; AND
The condition must not have been treated previously with PBS‑subsidised BRAF inhibitor therapy for unresectable Stage III or Stage IV disease; OR
Patient must have developed intolerance to other BRAF inhibitors of a severity necessitating permanent treatment withdrawal; AND
Patient must not have experienced disease progression whilst on adjuvant BRAF inhibitor treatment or disease recurrence within 6 months of completion of adjuvant BRAF inhibitor with MEK inhibitor treatment if previously treated for resected Stage IIIB, IIIC or IIID melanoma; AND
Patient must have a WHO performance status of 2 or less. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10157 |
Venetoclax | C10995 | P10995 | | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Dose modification
The treatment must be for dose titration purposes. | Compliance with Authority Required procedures |
| C11017 | P11017 | | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
First continuing treatment (treatment cycles 2 to 6 inclusive) of first‑line therapy
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses); AND
The treatment must cease upon disease progression. | Compliance with Authority Required procedures |
| C11069 | P11069 | | Chronic lymphocytic leukaemia (CLL)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be in combination with rituximab for up to a maximum of 6 cycles, followed by monotherapy; AND
The treatment must be ceased on disease progression or on completion of 24 months of PBS‑subsidised treatment under this restriction with this drug for this condition, whichever comes first. | Compliance with Authority Required procedures |
| C11073 | P11073 | | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Second and final continuing treatment prescription (treatment cycles 7 to 12 inclusive) of first‑line therapy
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must cease upon disease progression; OR
The treatment must cease upon completion of 12 cycles of treatment with this drug for this condition, whichever comes first. | Compliance with Authority Required procedures |
| C12462 | P12462 | | Acute Myeloid Leukaemia
The condition must be previously untreated at the time of initiation with this drug (except for essential treatment with hydroxyurea or leukapheresis); AND
Patient must not be considered eligible for standard intensive remission induction chemotherapy at the time of initiation with this drug; AND
The treatment must be used in combination with azacitidine (refer to Product Information for timing of azacitidine and venetoclax doses); AND
Patient must not have progressive disease while receiving PBS‑subsidised treatment with this drug for this condition; AND
The condition must not be acute promyelocytic leukaemia.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles. | Compliance with Authority Required procedures |
| C14325 | | | Chronic lymphocytic leukaemia (CLL)
Dose titration occurring at the start of treatment for relapsed/refractory disease
The condition must have relapsed or be refractory to at least one prior therapy; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.
Patient must not be undergoing retreatment with this drug where prior, active treatment of CLL/SLL with this same drug was unable to prevent disease progression. | Compliance with Authority Required procedures |
| C14340 | | | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Initial treatment in first‑line therapy ‑ Dose titration (weeks 1 to 4 of a 5‑week ramp‑up schedule)
The condition must be untreated with drug treatment at the time of the first dose of this drug; OR
Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first‑line drug treatment of CLL/SLL; AND
The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND
The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses). | Compliance with Authority Required procedures |
Venlafaxine | C5650 | | | Major depressive disorders | |
Verapamil | | P14238 | | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
Vericiguat | C13561 | | | Chronic heart failure
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include a beta‑blocker, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; AND
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13561 |
| C13562 | | | Chronic heart failure
Initial treatment
Must be treated by a cardiologist; OR
Must be treated by a medical practitioner who has been directed to prescribe this medicine by a cardiologist.
Patient must be symptomatic with NYHA classes II, III or IV; AND
Patient must have a documented left ventricular ejection fraction (LVEF) of less than 45%; AND
The condition must be stabilised following a decompensation event that required at least one of: (i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND
Patient must not have clinical signs of fluid overload; AND
Patient must not have received intravenous treatment for fluid overload in the previous 24 hours; AND
Patient must not have a systolic blood pressure less than 100 mmHg; AND
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include a beta‑blocker, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; AND
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated. | Compliance with Authority Required procedures |
| C13621 | | | Chronic heart failure
Grandfather treatment
Must be treated by a cardiologist; OR
Must be treated by a medical practitioner who has been directed to prescribe this medicine by a cardiologist.
Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 December 2022; AND
Patient must have been symptomatic with NYHA classes II, III or IV prior to initiating non‑PBS‑subsidised treatment with this drug for this condition; AND
Patient must have had a documented left ventricular ejection fraction (LVEF) of less than 45% prior to initiating non‑PBS‑subsidised treatment with this drug for this condition; AND
The condition must have been, at the time of initiating non‑PBS‑subsidised treatment with this drug, stabilised following a decompensation event that required at least one of: (i) hospitalisation in the 6 months prior to initiating non‑PBS‑subsidised drug for this PBS indication, (ii) intravenous diuretic therapy in the three months prior to initiating non‑PBS‑subsidised drug for this PBS indication; AND
Patient must not have had clinical signs of fluid overload at the time of initiating non‑PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have received intravenous treatment in the 24 hours prior to initiating non‑PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have a systolic blood pressure less than 100 mmHg; AND
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include a beta‑blocker, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; AND
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated; OR
The treatment must be an add‑on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA‑approved Product Information or cannot be tolerated. | Compliance with Authority Required procedures |
Vigabatrin | C4929 | | | Epileptic seizures
The condition must have failed to be controlled satisfactorily by other anti‑epileptic drugs. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4929 |
Vildagliptin | C6346 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6346 |
C6363 | | | Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6363 |
C6376 | | | Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6376 |
Vildagliptin with metformin | C6333 | | | Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this fixed dose combination. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6333 |
C6344 | | | Diabetes mellitus type 2
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with optimal doses of dual oral therapy; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with optimal doses of dual oral therapy.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS‑subsidised treatment with this fixed dose combination. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6344 |
C6357 | | | Diabetes mellitus type 2
Continuing
Patient must have previously received and been stabilised on a PBS‑subsidised regimen of oral diabetic medicines which includes metformin and vildagliptin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6357 |
C6443 | | | Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon‑like peptide‑1 or a sodium‑glucose co‑transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon‑like peptide‑1 or an SGLT2 inhibitor, must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6443 |
Vinorelbine | C4242 | | | Locally advanced or metastatic non‑small cell lung cancer | Compliance with Authority Required procedures |
C4272 | | | Advanced breast cancer
Patient must have failed standard prior therapy, which includes an anthracycline. | Compliance with Authority Required procedures |
Vismodegib | C7491 | | | Metastatic or locally advanced basal cell carcinoma (BCC)
Initial treatment or Continuing treatment – balance of supply
Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete maximum of 16 weeks of treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete maximum of 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C13175 | | | Metastatic or locally advanced basal cell carcinoma (BCC)
Initial treatment
The condition must be inappropriate for surgery; AND
The condition must be inappropriate for curative radiotherapy; AND
Patient must not have received previous PBS‑subsidised treatment with another hedgehog (Hh) inhibitor for this condition; OR
Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and
(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and
(c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate.
The assessment of the patient's response to this PBS‑subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Inappropriate for surgery is defined as:
(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
(iii) Medical contraindication to surgery.
Inappropriate for curative radiotherapy is defined as:
(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
(ii) Limitations due to location of tumour; or
(iii) Limitations due to cumulative prior radiotherapy dose; or
(iv) Progressive disease despite prior irradiation of locally advanced BCC.
For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
| C13268 | | | Metastatic or locally advanced basal cell carcinoma (BCC)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The condition must remain inappropriate for surgery; AND
The condition must remain inappropriate for curative radiotherapy; AND
Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) Confirmation from the treating doctor that the disease has not progressed; and
(b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy.
The assessment of the patient's response to this PBS‑subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Inappropriate for surgery is defined as:
(i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or
(ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or
(iii) Medical contraindication to surgery.
Inappropriate for curative radiotherapy is defined as:
(i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or
(ii) Limitations due to location of tumour; or
(iii) Limitations due to cumulative prior radiotherapy dose; or
(iv) Progressive disease despite prior irradiation of locally advanced BCC.
For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
Vitamins, minerals and trace elements formula | C7275 | | | Dietary management of conditions requiring a highly restrictive therapeutic diet
Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations.
Patient must be aged 3 years or older. | |
Vitamins, minerals and trace elements with carbohydrate | C6152 | | | Dietary management of conditions requiring a highly restrictive therapeutic diet
Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations.
Patient must be an infant or a child. | |
C6159 | | | Dietary management of conditions requiring a highly restrictive therapeutic diet
Patient must have insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet; AND
Patient must be unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations.
Patient must be aged 3 years or older. | |
Voriconazole | C4683 | P4683 | | Serious invasive mycosis infections
Treatment and maintenance therapy
The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis. | Compliance with Authority Required procedures |
C4685 | P4685 | | Prophylaxis of invasive fungal infections including both yeasts and moulds
Patient must be considered at high risk of developing an invasive fungal infection due to anticipated neutropenia (an absolute neutrophil count less than 500 cells per cubic millimetre) for at least 10 days whilst receiving chemotherapy for acute myeloid leukaemia or myelodysplastic syndrome; OR
Patient must be considered at high risk of developing an invasive fungal infection due to having acute graft versus host disease (GVHD) grade II, III or IV, or, extensive chronic GVHD, whilst receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; OR
Patient must be undergoing allogeneic haematopoietic stem cell transplant using either bone marrow from an unrelated donor or umbilical cord blood (related or unrelated), and, be considered to be at high risk of developing an invasive fungal infection during the neutropenic phase prior to engraftment. | Compliance with Authority Required procedures |
C5624 | | | Serious fungal infections
Treatment and maintenance therapy
The condition must be caused by Scedosporium species; OR
The condition must caused by Fusarium species. | Compliance with Authority Required procedures |
C5692 | P5692 | | Serious Candida infections
Treatment and maintenance therapy
The condition must be caused by species not susceptible to fluconazole; OR
The condition must be resistant to fluconazole; OR
Patient must be unable to tolerate fluconazole. | Compliance with Authority Required procedures |
C5725 | P5725 | | Definite or probable invasive aspergillosis
Treatment and maintenance therapy
Patient must be immunocompromised. | Compliance with Authority Required procedures |
C5734 | | | Serious invasive mycosis infections
Treatment and maintenance therapy
The treatment must be for invasive mycosis infections other than definite or probable invasive aspergillosis. | Compliance with Authority Required procedures |
C5748 | P5748 | | Serious fungal infections
Treatment and maintenance therapy
The condition must be caused by Scedosporium species; OR
The condition must caused by Fusarium species. | Compliance with Authority Required procedures |
C5813 | | | Definite or probable invasive aspergillosis
Treatment and maintenance therapy
Patient must be immunocompromised. | Compliance with Authority Required procedures |
C5814 | | | Serious Candida infections
Treatment and maintenance therapy
The condition must be caused by species not susceptible to fluconazole; OR
The condition must be resistant to fluconazole; OR
Patient must be unable to tolerate fluconazole. | Compliance with Authority Required procedures |
Vorinostat | C13177 | P13177 | | Cutaneous T‑cell lymphoma
Initial treatment
Patient must have received systemic treatment with chemotherapy; AND
Patient must demonstrate relapsed or chemotherapy‑refractory disease; AND
Patient must be ineligible for stem cell transplant; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
| C13246 | P13246 | | Cutaneous T‑cell lymphoma
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures |
Vosoritide | C13929 | | | achondroplasia
Grandfather treatment (transition from non‑PBS subsidised treatment)
Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing; AND
Patient must have received non‑PBS subsidised vosoritide treatment for this condition prior to 1 May 2023; AND
Patient must not have evidence of growth plate closure demonstrated by at least one of the following: i) bilateral lower extremity X‑rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X‑rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months.
Must be treated by a medical specialist, experienced in the management of achondroplasia; OR
Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Appropriate genetic testing constitutes testing for FGFR3 gene mutation.
In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X‑rays and dates (date commenced treatment and date of X‑ray) must be documented in the patient's medical records.
Additional radiographic evidence is not required until patient has begun puberty.
In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X‑ray and date taken must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C13977 | | | achondroplasia
Initial treatment
Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing; AND
Patient must not have evidence of growth plate closure demonstrated by at least one of the following: i) bilateral lower extremity X‑rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X‑rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months.
Must be treated by a medical specialist, experienced in the management of achondroplasia; OR
Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Appropriate genetic testing constitutes testing for FGFR3 gene mutation.
In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X‑rays and dates (date commenced treatment and date of X‑ray) must be documented in the patient's medical records.
Additional radiographic evidence is not required until patient has begun puberty.
In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X‑ray and date taken must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C13998 | | | achondroplasia
Continuing treatment
Patient must have received PBS subsidised vosoritide treatment for this condition; AND
Patient must not have evidence of growth plate closure demonstrated by at least one of the following: i) bilateral lower extremity X‑rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X‑rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months.
Must be treated by a medical specialist, experienced in the management of achondroplasia; OR
Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X‑rays and dates (date commenced treatment and date of X‑ray) must be documented in the patient's medical records.
Additional radiographic evidence is not required until patient has begun puberty.
In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X‑ray and date taken must be documented in the patient's medical records. | Compliance with Authority Required procedures |
Whey protein formula supplemented with amino acids, long chain polyunsaturated fatty acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | C6190 | | | Chronic renal failure
Patient must be an infant or a young child.
Patient must require treatment with a low protein and a low phosphorus diet; OR
Patient must require treatment with a low protein, low phosphorus and low potassium diet. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6190 |
Whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose | C6190 | | | Chronic renal failure
Patient must be an infant or a young child.
Patient must require treatment with a low protein and a low phosphorus diet; OR
Patient must require treatment with a low protein, low phosphorus and low potassium diet. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6190 |
Zanubrutinib | C12495 | | | Mantle cell lymphoma
Initial treatment
The condition must have relapsed or be refractory to at least one prior therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must be untreated with Bruton’s tyrosine kinase inhibitor therapy; OR
Patient must have developed intolerance to another Bruton’s tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this PBS indication. | Compliance with Authority Required procedures |
| C12500 | | | Mantle cell lymphoma
Continuing treatment
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition. | Compliance with Authority Required procedures |
| C12999 | | | Waldenstrom macroglobulinaemia
Continuing treatment
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
The condition must not have progressed while receiving PBS‑subsidised treatment with this drug for this condition; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
| C13008 | | | Waldenstrom macroglobulinaemia
Initial treatment
The condition must have relapsed or be refractory to at least one prior chemo‑immunotherapy; OR
Patient must be unsuitable for treatment with chemo‑immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment‑naive) for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
Patient must be untreated with a Bruton's tyrosine kinase inhibitor for this condition; OR
Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this condition. | Compliance with Authority Required procedures |
| C14337 | | | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
First line drug treatment of this indication
The condition must be untreated with drug treatment at the time of the first dose of this drug; OR
Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first‑line drug treatment of CLL/SLL; AND
The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication.
Patient must be undergoing initial treatment with this drug ‑ this is the first prescription for this drug; OR
Patient must be undergoing continuing treatment with this drug ‑ the condition has not progressed whilst the patient has actively been on this drug. | Compliance with Authority Required procedures |
| C14344 | | | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
Treatment of relapsed/refractory disease
The condition must have relapsed or be refractory to at least one prior therapy; AND
The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication.
Patient must not be undergoing retreatment with this drug where prior, active treatment of CLL/SLL with this same drug was unable to prevent disease progression; AND
Patient must be undergoing treatment through this treatment phase listing for the first time; OR
Patient must be undergoing treatment through this treatment phase listing on a subsequent occasion, with disease progression being absent. | Compliance with Authority Required procedures |
Zidovudine | C4454 | | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
C4512 | | | HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Ziprasidone | C4246 | | | Schizophrenia | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4246 |
C5742 | | | Acute mania or mixed episodes
The condition must be associated with bipolar I disorder; AND
The treatment must be as monotherapy; AND
The treatment must be limited to up to 6 months per episode. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5742 |
Zoledronic acid | C5605 | P5605 | | Bone metastases
The condition must be due to breast cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5605 |
C5703 | P5703 | | Bone metastases
The condition must be due to castration‑resistant prostate cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5703 |
C5704 | P5704 | | Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5704 |
C5710 | | | Symptomatic Paget disease of bone
Only 1 treatment each year per patient will be PBS‑subsidised | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5710 |
C5735 | P5735 | | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5735 |
C6308 | | | Corticosteroid‑induced osteoporosis
Patient must currently be on long‑term (at least 3 months), high‑dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T‑score of ‑1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition; AND
Patient must not receive more than one PBS‑subsidised treatment per year.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6308 |
C6313 | | | Osteoporosis
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T‑score of ‑3.0 or less; AND
Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition; AND
Patient must not receive more than one PBS‑subsidised treatment per year.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6313 |
C6318 | | | Established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS‑subsidised anti‑resorptive agent for this condition; AND
Patient must not receive more than one PBS‑subsidised treatment per year.
The fracture must have been demonstrated radiologically and the year of plain x‑ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6318 |
| C9268 | P9268 | | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9268 |
| C9304 | P9304 | | Bone metastases
The condition must be due to castration‑resistant prostate cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9304 |
| C9317 | P9317 | | Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9317 |
| C9328 | P9328 | | Bone metastases
The condition must be due to breast cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9328 |
| C14729 | P14729 | | Adjuvant management of breast cancer
Patient must be post‑menopausal.
Patient must not be undergoing PBS‑subsidised treatment with this drug for this indication for more than 36 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14729 |
| C14735 | P14735 | | Adjuvant management of breast cancer
Patient must be post‑menopausal.
Patient must not be undergoing PBS‑subsidised treatment with this drug for this indication for more than 36 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14735 |
Zolmitriptan | C5489 | | | Migraine attack
The condition must have usually failed to respond to analgesics in the past. | |
Zonisamide | C4928 | | | Partial epileptic seizures
The condition must have failed to be controlled satisfactorily by other anti‑epileptic drugs. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4928 |
