C13001

P13001

CN13001

Midostaurin

Acute Myeloid Leukaemia

Induction / Consolidation therapy

Patient must not have received prior chemotherapy as induction therapy for this condition; or

The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; AND

The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; AND

The condition must not be acute promyelocytic leukaemia; AND

The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.

A maximum of 6 cycles will be authorised under this restriction in a lifetime.

Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.

The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.

This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.

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.

Progressive disease is defined as the presence of any of the following:

Leukaemic cells in the CSF;

Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;

Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;

Extramedullary leukaemia.

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

C13004

P13004

CN13004

Trastuzumab emtansine

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

C13006

P13006

CN13006

Ponatinib

Chronic Myeloid Leukaemia (CML)

Subsequent continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals.  or

Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals.

A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13007

P13007

CN13007

Lapatinib

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 treatment must be in combination with capecitabine; AND

Patient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or

Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or

Patient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; or

Patient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; AND

The treatment must be the sole PBS-subsidised anti-HER2 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.

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 

(i) 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); and

(ii) date of last treatment with a taxane and total number of cycles; or

(iii) dates of treatment with trastuzumab and pertuzumab; or

(iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab; or

(v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab

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.

If the application is submitted through HPOS upload or mail, it must include 

(a) a completed authority prescription form; and

(b) a completed authority 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

C13008

P13008

CN13008

Zanubrutinib

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

C13010

P13010

CN13010

Azacitidine

Acute Myeloid Leukaemia

Initial treatment

The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND

The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.

The following reports must be documented in the patient's medical records 

(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and

(b) full blood examination report.

Compliance with Authority Required procedures

C13011

P13011

CN13011

Azacitidine

Myelodysplastic syndrome

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have progressive disease.

Up to 6 cycles will be authorised.

Compliance with Authority Required procedures

C13012

P13012

CN13012

Azacitidine

Acute Myeloid Leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have progressive disease.

Compliance with Authority Required procedures - Streamlined Authority Code 13012

C13013

P13013

CN13013

Midostaurin

Acute Myeloid Leukaemia

Maintenance therapy - Initial 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

Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND

Patient must not be undergoing or have undergone a stem cell transplant; AND

The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority.

A maximum of 3 cycles will be authorised under this restriction in a lifetime.

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.

Progressive disease is defined as the presence of any of the following:

Leukaemic cells in the CSF;

Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;

Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;

Extramedullary leukaemia.

A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.

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 that the patient is not undergoing or has not undergone a stem cell transplant; and

(b) confirmation that the patient does not have progressive disease; and

(c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and

(d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin.

All reports must be documented in the patient's medical records.

If the application is submitted through HPOS upload or mail, it must include 

(a) a completed authority prescription form; and

(b) a completed authority 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

C13015

P13015

CN13015

Azacitidine

Chronic Myelomonocytic Leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have progressive disease.

Up to 6 cycles will be authorised.

Compliance with Authority Required procedures

C13017

P13017

CN13017

Trastuzumab emtansine

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

C13018

P13018

CN13018

Pertuzumab

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

Patient must have a WHO performance status of 0 or 1; AND

Patient must not have received prior anti-HER2 therapy for this condition; AND

Patient must not have received prior chemotherapy for this condition; AND

The treatment must be in combination with trastuzumab and a taxane; 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.

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) must be provided at the time of application.

The pathology report 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

C13022

P13022

CN13022

Ponatinib

Chronic Myeloid Leukaemia (CML)

First continuing treatment

Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals.  or

Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals.

The first continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include 

(i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or

(ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].

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

C13025

P13025

CN13025

Ponatinib

Chronic Myeloid Leukaemia (CML)

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or

Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND

Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority.  or

Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal.  or

Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis.

Failure of an adequate trial of dasatinib or nilotinib is defined as 

1. Lack of response to dasatinib or nilotinib therapy, defined as either 

(i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or

(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR

2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR

3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR

4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR

5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.

Accelerated phase is defined by the presence of 1 or more of the following 

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or

3. Peripheral basophils greater than or equal to 20%; or

4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).

Blast crisis is defined as either 

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

2. Extramedullary involvement other than spleen and liver.

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 

(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or

(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and

(iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.

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).

Up to a maximum of 18 months of treatment may be authorised under this initial restriction.

Compliance with Written Authority Required procedures

C13029

P13029

CN13029

Azacitidine

Chronic Myelomonocytic Leukaemia

Initial treatment

The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND

The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.

The first 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 bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and

(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority

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).

The following reports must be documented in the patient's medical records 

(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and

(b) full blood examination report

No more than 3 cycles will be authorised under this restriction in a patient's lifetime.

Compliance with Written Authority Required procedures

C13030

P13030

CN13030

Ponatinib

Chronic Myeloid Leukaemia (CML)

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND

Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority.  or

Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority.  or

Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority.

Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as 

1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either 

(i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or

(ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or

(iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR

2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR

3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR

4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR

5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia.

Accelerated phase is defined by the presence of 1 or more of the following 

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or

2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or

3. Peripheral basophils greater than or equal to 20%; or

4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or

5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome).

Blast crisis is defined as either 

1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or

2. Extramedullary involvement other than spleen and liver.

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 

(i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or

(ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and

(iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and

(iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement.

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).

Up to a maximum of 18 months of treatment may be authorised under this initial restriction.

Compliance with Written Authority Required procedures

C13034

P13034

CN13034

Diroximel fumarate

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 13034

C13035

P13035

CN13035

Abemaciclib

Locally advanced or metastatic breast cancer

Initial treatment

Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or

Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND

The condition must be hormone receptor positive; AND

The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND

The condition must be inoperable; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND

The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or

The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13036

P13036

CN13036

Abemaciclib

Locally advanced or metastatic 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 in combination with one of:
 (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13037

P13037

CN13037

Ribociclib

Locally advanced or metastatic 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 in combination with one of:
 (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND

Patient must require dosage reduction requiring a pack of 42 tablets;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13039

P13039

CN13039

Infliximab

Complex refractory Fistulising Crohn disease

Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made

Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND

Patient must be undergoing treatment with this benefit where:
 (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;

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).

The PBS administrator will confirm that 

(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;

(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Authority Required procedures

C13040

P13040

CN13040

Infliximab

Severe psoriatic arthritis

Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND

Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or

Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions;

Patient must be at least 18 years of age.

Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

C13043

P13043

CN13043

Infliximab

Severe psoriatic arthritis

Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

The treatment must have both:
 (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; 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).

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.

Compliance with Authority Required procedures

C13045

P13045

CN13045

Infliximab

Moderate to severe ulcerative colitis

Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made

Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND

Patient must be undergoing treatment with this benefit where:
 (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;

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).

The PBS administrator will confirm that 

(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;

(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Authority Required procedures

C13049

P13049

CN13049

Paliperidone

Schizophrenia

Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months.  or

Patient must have previously received and be stabilised on PBS-subsidised paliperidone six-monthly injection for at least one cycle.

Compliance with Authority Required procedures - Streamlined Authority Code 13049

C13055

P13055

CN13055

Palbociclib

Locally advanced or metastatic breast cancer

Initial treatment

Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or

Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND

The condition must be hormone receptor positive; AND

The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND

The condition must be inoperable; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND

The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with a non-steroidal aromatase inhibitor; or

The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13056

P13056

CN13056

Infliximab

Complex refractory Fistulising Crohn disease

Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form

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

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).

An adequate response is defined as 

(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or

(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.

The most recent fistula assessment must be no more than 1 month old at the time of application.

Compliance with Authority Required procedures

C13058

P13058

CN13058

Infliximab

Severe chronic plaque psoriasis

Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription

Must be treated by a dermatologist; AND

Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or

Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions;

Patient must be at least 18 years of age.

Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

C13061

P13061

CN13061

Infliximab

Moderate to severe ulcerative colitis

Balance of supply for Initial treatment, Continuing treatment - 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)]; AND

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 for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks 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 treatment available under the Continuing treatment - subcutaneous form;

Patient must be at least 18 years of age.

Compliance with Authority Required procedures

C13066

P13066

CN13066

Palbociclib

Locally advanced or metastatic 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 in combination with one of:
 (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy;

Patient must not be premenopausal.

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

C13068

P13068

CN13068

Infliximab

Severe Crohn disease

Balance of supply for Initial treatment, Continuing treatment - 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)]; AND

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 for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks 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 treatment available under the Continuing treatment - subcutaneous form;

Patient must be at least 18 years of age.

Compliance with Authority Required procedures

C13069

P13069

CN13069

Infliximab

Severe active rheumatoid arthritis

Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made

Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND

Patient must be undergoing treatment with this benefit where:
 (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;

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).

The PBS administrator will confirm that 

(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;

(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Authority Required procedures

C13070

P13070

CN13070

Bimekizumab

Severe chronic plaque psoriasis

Grandfathered patient - Face, hand, foot or Whole body - Balance of Supply

Must be treated by a dermatologist; AND

The treatment must be as systemic monotherapy (other than methotrexate); AND

Patient must have received insufficient therapy with this drug for this condition under the Grandfathered patient - Whole body restriction to complete 24 weeks treatment; or

Patient must have received insufficient therapy with this drug for this condition under the Grandfathered patient - 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.

Compliance with Authority Required procedures

C13072

P13072

CN13072

Diroximel fumarate

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 13072

C13074

P13074

CN13074

Ribociclib

Locally advanced or metastatic breast cancer

Initial treatment

Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or

Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND

The condition must be hormone receptor positive; AND

The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND

The condition must be inoperable; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND

The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or

The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND

Patient must require dosage reduction requiring a pack of 42 tablets;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13077

P13077

CN13077

Infliximab

Ankylosing spondylitis

Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made

Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND

Patient must be undergoing treatment with this benefit where:
 (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;

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).

The PBS administrator will confirm that 

(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;

(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Authority Required procedures

C13078

P13078

CN13078

Infliximab

Severe chronic plaque psoriasis

Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made

Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND

Patient must be undergoing treatment with this benefit where:
 (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;

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).

The PBS administrator will confirm that 

(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;

(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Authority Required procedures

C13079

P13079

CN13079

Infliximab

Severe chronic plaque psoriasis

Continuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous form

Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND

The treatment must have both:
 (i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; 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 at least 18 years of age;

Must be treated by a dermatologist.

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 condition is affecting the whole body, an adequate response to treatment is defined as 

A Psoriasis Area and Severity Index (PASI) score which is reduced by at least 75%, or, is sustained at this level, when compared with the baseline value for this treatment cycle. State the qualifying PASI score in the authority application.

Where the condition is affecting the face/hand/foot, 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. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or

(ii) A reduction by at least 75% in the skin area affected, or, sustained at this level, as compared to the baseline value for this treatment cycle. State the qualifying numerical percentage figure in the authority application for each affected area.

All assessment findings must be no more than 1 month old at the time of application. Response assessments must be performed on the same affected area assessed at baseline.

Compliance with Authority Required procedures

C13080

P13080

CN13080

Infliximab

Severe Crohn disease

Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made

Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND

Patient must be undergoing treatment with this benefit where:
 (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;

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).

The PBS administrator will confirm that 

(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;

(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Authority Required procedures

C13082

P13082

CN13082

Paliperidone

Schizophrenia

Patient must have previously received and be stabilised on PBS-subsidised paliperidone three-monthly injection for at least one cycle.  or

Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months.

Compliance with Authority Required procedures - Streamlined Authority Code 13082

C13084

P13084

CN13084

Ribociclib

Locally advanced or metastatic breast cancer

Initial treatment

Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or

Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND

The condition must be hormone receptor positive; AND

The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND

The condition must be inoperable; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND

The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or

The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13093

P13093

CN13093

Ribociclib

Locally advanced or metastatic 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 in combination with one of:
 (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13094

P13094

CN13094

Infliximab

Complex refractory Fistulising Crohn disease

Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription

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 continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or

Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions;

Patient must be at least 18 years of age.

Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

C13096

P13096

CN13096

Infliximab

Ankylosing spondylitis

Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis; AND

Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or

Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
 (i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions;

Patient must be at least 18 years of age.

Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'.

Compliance with Authority Required procedures

C13097

P13097

CN13097

Infliximab

Severe psoriatic arthritis

Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made

Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND

Patient must be undergoing treatment with this benefit where:
 (i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved;

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).

The PBS administrator will confirm that 

(i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient;

(ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application.

Compliance with Authority Required procedures

C13099

P13099

CN13099

Ribociclib

Locally advanced or metastatic 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 in combination with one of:
 (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND

Patient must require dosage reduction requiring a pack of 21 tablets; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13104

P13104

CN13104

Infliximab

Severe active rheumatoid arthritis

Balance of supply for Initial treatment, Continuing treatment - subcutaneous form

Must be treated by a rheumatologist; or

Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND

Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); or

Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND

The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND

The treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form; or

The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form;

Patient must be at least 18 years of age.

Compliance with Authority Required procedures

C13105

P13105

CN13105

Ribociclib

Locally advanced or metastatic breast cancer

Initial treatment

Patient must be untreated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; or

Patient must have developed an intolerance to another CDK4/6 inhibitor therapy (other than this drug) of a severity necessitating permanent treatment withdrawal; AND

The condition must be hormone receptor positive; AND

The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND

The condition must be inoperable; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND

The treatment must be in combination, where the patient has never been treated with endocrine therapy for advanced/metastatic disease, with one of (i) a non-steroidal aromatase inhibitor, (ii) fulvestrant; or

The treatment must be in combination, where the patient has recurrence/progressive disease despite being treated with endocrine therapy for advanced/metastatic disease, with fulvestrant only; AND

The treatment must not be in combination with another cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy; AND

Patient must require dosage reduction requiring a pack of 21 tablets;

Patient must not be premenopausal.

Compliance with Authority Required procedures

C13122

P13122

CN13122

Ciclosporin

Severe psoriasis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; or

The condition must be inappropriate for other systemic therapies; AND

The condition must have caused significant interference with quality of life; AND

Must be treated by a medical practitioner who is either:
 (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist.

Compliance with Authority Required procedures - Streamlined Authority Code 13122

C13127

P13127

CN13127

Ruxolitinib

High risk and intermediate-2 risk myelofibrosis

Initial treatment

The condition must be either:
 (i) primary myelofibrosis, (ii) post-polycythemia vera myelofibrosis, (iii) post-essential thrombocythemia myelofibrosis, confirmed through a bone marrow biopsy report.

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 bone marrow biopsy report confirming diagnosis of myelofibrosis; and

(b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS.

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 Authority Required procedures

C13128

P13128

CN13128

Ruxolitinib

High risk and intermediate-2 risk myelofibrosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

C13130

P13130

CN13130

Ruxolitinib

Intermediate-1 risk myelofibrosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

C13132

P13132

CN13132

Imatinib

Malignant gastrointestinal stromal tumour

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be given at a dose not exceeding 600 mg per day.

Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib

Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.

A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347 472-80.)

Compliance with Authority Required procedures - Streamlined Authority Code 13132

C13134

P13134

CN13134

Brentuximab vedotin

CD30 positive peripheral T-cell lymphoma, non-cutaneous type

Initial treatment

Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND

The treatment must be for first line therapy for this condition; AND

The treatment must be for curative intent; AND

The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND

The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.

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 and must include 

(a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and

(b) The date of initial diagnosis of Peripheral T-cell lymphoma.

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 Authority Required procedures

C13152

P13152

CN13152

Sunitinib

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

CN13153

Sunitinib

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

C13165

P13165

CN13165

Decitabine with cedazuridine

Chronic Myelomonocytic Leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have progressive disease.

Up to 6 cycles will be authorised.

Compliance with Authority Required procedures

C13166

P13166

CN13166

Gilteritinib

Relapsed or refractory Acute Myeloid Leukaemia

Initial treatment

The treatment must be the sole PBS-subsidised therapy for this condition; AND

The condition must not be acute promyelocytic leukaemia; AND

The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND

Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation.

The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.

Compliance with Authority Required procedures

C13168

P13168

CN13168

Ciclosporin

Severe psoriasis

Management (initiation, stabilisation and review of therapy)

The condition must be ineffective to other systemic therapies; or

The condition must be inappropriate for other systemic therapies; AND

The condition must have caused significant interference with quality of life; AND

Must be treated by a medical practitioner who is either:
 (i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist.

Compliance with Authority Required procedures - Streamlined Authority Code 13168

C13173

P13173

CN13173

Ruxolitinib

Intermediate-1 risk myelofibrosis

Initial treatment

The condition must be either:
 (i) primary myelofibrosis, (ii) post-polycythemia vera myelofibrosis, (iii) post-essential thrombocythemia myelofibrosis, confirmed through a bone marrow biopsy report; AND

Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy.

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 bone marrow biopsy report confirming diagnosis of myelofibrosis; and

b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS; and

c) A confirmation that the patient's disease related symptoms are resistant, refractory or intolerant to available therapy.

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 Authority Required procedures

C13175

P13175

CN13175

Sonidegib

Vismodegib

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.

(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.

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

C13177

P13177

CN13177

Vorinostat

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

C13179

P13179

CN13179

Brentuximab vedotin

CD30 positive cutaneous T-cell lymphoma

Initial treatment

Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; AND

Patient must have CD30 positivity of at least 3% of malignant cells; AND

Patient must have a diagnosis of mycosis fungoides; or

Patient must have a diagnosis of Sezary syndrome; or

Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND

Patient must have received prior systemic treatment for this condition; AND

The condition must be relapsed or refractory; AND

The treatment must not exceed 4 cycles under this restriction in a lifetime; AND

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition.

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 histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and

(b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and

(c) Date of commencement and completion of the most recent prior systemic treatment.

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

C13181

P13181

CN13181

Brentuximab vedotin

CD30 positive cutaneous T-cell lymphoma

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have achieved an objective response with this drug; 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 systemic anti-cancer therapy for this condition; AND

The treatment must not exceed 12 cycles under this restriction in a lifetime.

An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria.

Compliance with Authority Required procedures

C13182

P13182

CN13182

Brentuximab vedotin

CD30 positive systemic anaplastic large cell lymphoma

Initial treatment

The treatment must be for curative intent; AND

Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND

Patient must demonstrate relapsed or chemotherapy-refractory disease; AND

Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; AND

The treatment must not exceed 4 cycles under this restriction.

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 and must include 

(a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and

(b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and

(c) Dates of commencement and completion of front-line curative intent chemotherapy; and

(d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory.

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 Authority Required procedures

C13184

P13184

CN13184

Entrectinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; or

Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND

Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.

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).

The following must be documented in the patient's medical records 

(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.

Compliance with Authority Required procedures

C13186

P13186

CN13186

Crizotinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer 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 receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

C13205

P13205

CN13205

Decitabine with cedazuridine

Chronic Myelomonocytic Leukaemia

Initial treatment

The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND

The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.

No more than 3 cycles will be authorised under this restriction in a patient's lifetime.

The first 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 bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and

(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority

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).

The following reports must be documented in the patient's medical records 

(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and

(b) full blood examination report

Compliance with Authority Required procedures

C13207

P13207

CN13207

Cabazitaxel

Castration resistant metastatic carcinoma of the prostate

The treatment must be in combination with prednisone or prednisolone; AND

The condition must be resistant to treatment with docetaxel; or

Patient must have a documented intolerance necessitating permanent treatment withdrawal or a contraindication to docetaxel; AND

The treatment must not be used in combination with a novel hormonal drug; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel.

Compliance with Authority Required procedures - Streamlined Authority Code 13207

C13208

P13208

CN13208

Brentuximab vedotin

Relapsed or Refractory Hodgkin lymphoma

Continuing treatment

Patient must have undergone a primary autologous stem cell transplant (ASCT) 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 receiving PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 12 cycles of treatment under this restriction.

The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime.

Compliance with Authority Required procedures

C13209

P13209

CN13209

Brentuximab vedotin

Relapsed or Refractory Hodgkin lymphoma

Initial treatment

Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND

Patient must not be suitable for ASCT for this condition; or

Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND

Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; or

Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND

Patient must not receive more than 4 cycles of treatment under this restriction.

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 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

C13212

P13212

CN13212

Brentuximab vedotin

CD30 positive peripheral T-cell lymphoma, non-cutaneous type

Continuing treatment

The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND

Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND

Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND

Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND

The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.

Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as 

(a) Positron emission tomography-based response lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR

(b) Computed tomography-based response lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable.

Compliance with Authority Required procedures

C13222

P13222

CN13222

Nusinersen

Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)

Initial PBS-subsidised treatment in a child

The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or

The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND

Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug;

Patient must be of an age that is prior to their 19th birthday at the time of this authority application;

Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC);

Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND

Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days:
 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or

Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND

Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.

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).

Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are 

(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,

(ii) Proximal weakness,

(iii) Hypotonia,

(iv) Absence of deep tendon reflexes,

(v) Any active denervation or chronic neurogenic changes found on electromyography,

(vi) A compound muscle action potential below normative values for an age-matched child.

In this authority application, confirm 

(1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,

(2) which of the above (i to vi) (at least 1) were present after their 3rd birthday, but before their 19th birthday,

(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.

Compliance with Written Authority Required procedures

C13230

P13230

CN13230

Dapagliflozin

Empagliflozin

Chronic kidney disease

Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of:
 (i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND

Patient must have an estimated glomerular filtration rate of between 25 to 75 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND

Patient must have a urinary albumin to creatinine ratio of between 200 to 5000 mg/g (22.6-565 mg/mmol) inclusive prior to initiating treatment with this drug; AND

Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND

Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND

Patient must be stabilised, for at least 4 weeks, on either:
 (i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug.

Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug.

Compliance with Authority Required procedures - Streamlined Authority Code 13230

C13231

P13231

CN13231

Brentuximab vedotin

Relapsed or Refractory Hodgkin lymphoma

Continuing treatment

Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND

Patient must not be suitable for ASCT for this condition; or

Patient must not be suitable for treatment with multi-agent chemotherapy 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 receiving PBS-subsidised treatment with this drug for this condition; AND

Patient must not receive more than 12 cycles of treatment under this restriction.

The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime.

Compliance with Authority Required procedures

C13233

P13233

CN13233

Crizotinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less;

Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.

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).

The following must be documented in the patient's medical records 

(a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material.

Compliance with Authority Required procedures

C13236

P13236

CN13236

Vedolizumab

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)]; AND

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

CN13237

Vedolizumab

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)]; AND

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

C13241

P13241

CN13241

Decitabine with cedazuridine

Acute Myeloid Leukaemia

Initial treatment

The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND

The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification.

The following reports must be documented in the patient's medical records 

(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and

(b) full blood examination report.

Compliance with Authority Required procedures

C13242

P13242

CN13242

Gilteritinib

Relapsed or refractory Acute Myeloid Leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not have developed disease progression while being treated with this drug for this condition; AND

Patient must not be undergoing or have undergone a stem cell transplant.

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, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.

Progressive disease is defined as the presence of any of the following 

(a) Leukaemic cells in the CSF; or

(b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or

(c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or

(d) Extramedullary leukaemia.

Compliance with Authority Required procedures

C13246

P13246

CN13246

Vorinostat

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

C13250

P13250

CN13250

Crizotinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Initial treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND

The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND

Patient must have a WHO performance status of 2 or less; AND

Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND

Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition.  or

Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.

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).

The following must be documented in the patient's medical records 

(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.

Compliance with Authority Required procedures

C13251

P13251

CN13251

Crizotinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer 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 receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

C13257

P13257

CN13257

Decitabine with cedazuridine

Myelodysplastic syndrome

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have progressive disease.

Up to 6 cycles will be authorised.

Compliance with Authority Required procedures

C13258

P13258

CN13258

Decitabine with cedazuridine

Acute Myeloid Leukaemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must not have progressive disease.

Compliance with Authority Required procedures - Streamlined Authority Code 13258

C13259

P13259

CN13259

Brentuximab vedotin

Relapsed or Refractory Hodgkin lymphoma

Initial treatment

Patient must have undergone a primary autologous stem cell transplant (ASCT); AND

Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; or

Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND

Patient must not receive more than 4 cycles of treatment under this restriction.

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 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

C13260

P13260

CN13260

Sonidegib

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.

(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.

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

C13261

P13261

CN13261

Brentuximab vedotin

CD30 positive systemic anaplastic large cell lymphoma

Continuing treatment

Patient must not have developed disease progression 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; AND

The treatment must not exceed 12 cycles under this restriction in a lifetime.

Compliance with Authority Required procedures

C13267

P13267

CN13267

Decitabine with cedazuridine

Myelodysplastic syndrome

Initial treatment

The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND

The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or

The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND

The condition must have up to 20% marrow blasts according to World Health Organisation (WHO) Classification.

Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations 

(a) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR

(b) 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR

(c) 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR

(d) 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR

(e) Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.

Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations 

(a) 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR

(b) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.

The following information must be provided by the prescriber at the time of application 

(a) The patient's International Prognostic Scoring System (IPSS) score.

The following reports must be documented in the patient's medical records 

(a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and

(b) full blood examination report; and

(c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS).

No more than 3 cycles will be authorised under this restriction in a patient's lifetime.

Compliance with Authority Required procedures

C13268

P13268

CN13268

Vismodegib

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.

(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.

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

C13270

P13270

CN13270

Nusinersen

Spinal muscular atrophy (SMA)

Initial PBS-subsidised treatment in an adult who did not initiate PBS subsidy during childhood

The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or

The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND

Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug;

Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood;

Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised);

Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or

Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND

Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days:
 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or

Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND

Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment.

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).

Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are 

(i) Failure to meet or regression in ability to perform age-appropriate motor milestones,

(ii) Proximal weakness,

(iii) Hypotonia,

(iv) Absence of deep tendon reflexes,

(v) Failure to gain weight appropriate for age,

(vi) Any active denervation or chronic neurogenic changes found on electromyography,

(vii) A compound muscle action potential below normative values for an age-matched child.

In this authority application, confirm 

(1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,

(2) which of the above (i to vii) (at least 1) were present during childhood,

(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.

Compliance with Written Authority Required procedures

C13276

P13276

CN13276

Entrectinib

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)

Continuing treatment

The treatment must be the sole PBS-subsidised systemic anti-cancer 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 receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

C13282

P13282

CN13282

Somatrogon

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; AND

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 1st percentile for age plus sex at the time treatment first commenced; AND

Patient must have had a growth velocity below the 25th 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; AND

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 Authority Required procedures

C13284

P13284

CN13284

Somatrogon

Short stature and slow growth

Initial treatment

Patient must have a current height at or below the 1st percentile for age and sex; AND

Patient must have 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 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; AND

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 1st 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 Authority Required procedures

C13287

P13287

CN13287

Somatrogon

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; 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 1st percentile for age and sex immediately prior to commencing treatment; or

Patient must have had both a height above the 1st and at or below the 25th percentiles 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 and at or below the 25th 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 1st and at or below the 25th 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; AND

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 1st 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 Authority Required procedures

C13288

P13288

CN13288

Somatrogon

Somatropin

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; AND

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

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 50th percentile 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 Authority Required procedures

C13290

P13290

CN13290

Avelumab

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer

Maintenance therapy - 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 condition.

Compliance with Authority Required procedures - Streamlined Authority Code 13290

C13292

P13292

CN13292

Somatrogon

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 1st percentile for age and sex; or

Patient must have a current height above the 1st and at or below the 25th percentiles 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 1st and at or below the 25th 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 1st and at or below the 25th 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; AND

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 1st 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 Authority Required procedures

C13293

P13293

CN13293

Mecasermin

Severe growth failure with primary insulin-like growth factor-1 deficiency

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have a bone age of less than 13.5 years (females); or

Patient must have a bone age of less than 15.5 years (males); AND

The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND

The condition must be responsive to this drug treatment as evidenced by each of:
 (i) patient is showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (ii) patient has a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this continuing authority application; or

The condition must be yet to respond to this drug treatment only for the reason of sub-optimal dosing; AND

Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or

Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician;

Patient must be aged from 2 years up until their 18th birthday.

The continuing treatment 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 

(1) The patient's height (cm);

(2) Where this authority application seeks to continue treatment where there has been an inadequate response to treatment due to sub-optimal dosing, state each of 

(i) the most recently prescribed dose (mg/kg) that resulted in an inadequate response;

(ii) the dose (mg/kg) (between 0.04 to 0.12) that was/will be subsequently prescribed to address the inadequate response;

(3) The patient's weight (kg);

(4) The patient's growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment);

(5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.

Height, growth velocity and weight measurements must not be more than three months old at the time of application.

Document growth improvements 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 Authority Required procedures

C13294

P13294

CN13294

Somatrogon

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; 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 1st percentile for age and sex immediately prior to commencing treatment; or

Patient must have had both a height above the 1st and at or below the 25th percentiles 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 and at or below the 25th 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 1st and at or below the 25th 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; AND

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 1st 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 Authority Required procedures

C13297

P13297

CN13297

Somatrogon

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; AND

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

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 Authority Required procedures

C13298

P13298

CN13298

Somatrogon

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; AND

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 1st percentile for age and sex immediately prior to commencing treatment; or

Patient must have had both a height above the 1st and at or below the 25th percentiles 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 and at or below the 25th 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 1st and at or below the 25th 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; AND

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 1st 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 Authority Required procedures

C13304

P13304

CN13304

Somatrogon

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; AND

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; AND

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 Authority Required procedures

C13308

P13308

CN13308

Somatrogon

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; AND

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 50th 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; 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. 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 Authority Required procedures

C13309

P13309

CN13309

Somatrogon

Somatropin

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; AND

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; AND

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 50th percentile 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 Authority Required procedures

C13311

P13311

CN13311

Somatrogon

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; AND

Patient must have achieved the 50th 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 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 Authority Required procedures

C13312

P13312

CN13312

Somatrogon

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; 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 1st percentile for age plus sex at the time treatment first commenced; AND

Patient must have had a growth velocity below the 25th 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; AND

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 Authority Required procedures

C13313

P13313

CN13313

Avelumab

Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer

Maintenance therapy - Initial treatment

Patient must have received first-line platinum-based chemotherapy; AND

Patient must not have progressive disease following first-line platinum-based chemotherapy; 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.

Compliance with Authority Required procedures - Streamlined Authority Code 13313

C13318

P13318

CN13318

Somatrogon

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; 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 1st percentile for age plus sex at the time treatment first commenced; AND

Patient must have had a growth velocity below the 25th 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; AND

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 1st 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 Authority Required procedures

C13320

P13320

CN13320

Mecasermin

Severe growth failure with primary insulin-like growth factor-1 deficiency

Initial treatment

The condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5th percentile adjusted for each of:
 (i) age, (ii) gender; AND

The condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient's height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of:
 (i) age, (ii) gender; AND

Patient must have 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); AND

The condition must not be caused by growth hormone deficiency; AND

Patient must have a bone age of less than 13.5 years (females); or

Patient must have a bone age of less than 15.5 years (males); AND

The condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following:
 (i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; AND

The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND

Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or

Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician;

Patient must be aged from 2 years up until their 18th birthday.

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 initial treatment 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 the following 

(1) Insulin-like growth factor-1 deficiency 

(2) Short stature 

(3) Normal growth hormone levels 

(4) Bone age (where the patient has a chronological age of at least 2.5 years):

(5) The patient's weight (kg);

(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);

(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.

State each of (a) the patient's most recent basal IGF-1 level measured (ng/mL), (b) the measurement date (dd/mm/yy), (c) the name of the pathology result provider;

(2) Short stature 

(3) Normal growth hormone levels 

(4) Bone age (where the patient has a chronological age of at least 2.5 years):

(5) The patient's weight (kg);

(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);

(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.

State the patient's height (cm);

(3) Normal growth hormone levels 

(4) Bone age (where the patient has a chronological age of at least 2.5 years):

(5) The patient's weight (kg);

(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);

(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.

State the patient's most recent growth hormone level measurement (mcg/L) - this figure must be greater than 6.6 mcg/L;

(4) Bone age (where the patient has a chronological age of at least 2.5 years):

(5) The patient's weight (kg);

(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);

(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.

State each of (a) the patient's bone age in numerical figures at the time when it was most recently determined, (b) the date (dd/mm/yy) of this determination that is within 12 months of this authority application;

(5) The patient's weight (kg);

(6) The prescribed dose (mg/kg) (between 0.04 to 0.12);

(7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance.

Height, growth velocity and weight measurements must not be more than three months old at the time of application.

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 Authority Required procedures

C13321

P13321

CN13321

Trientine

Chelation of elevated copper levels

Patient must have a diagnosis of Wilson disease; AND

Patient must be intolerant to penicillamine; AND

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.

(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.

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

C13322

P13322

CN13322

Cemiplimab

Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)

Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements

Patient must have received non-PBS-subsidised therapy with this drug for this condition prior to 1 November 2022; AND

The condition must be unsuitable for each of:
 (i) curative surgical resection, (ii) curative radiotherapy; AND

Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first:
 (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.

Compliance with Authority Required procedures

C13327

P13327

CN13327

Eltrombopag

Severe thrombocytopenia

Second or Subsequent Continuing treatment

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND

Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13330

P13330

CN13330

Burosumab

X-linked hypophosphataemia

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

Patient must have achieved normalisation in serum phosphate levels; AND

Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion; AND

Must be treated by a medical practitioner identifying as at least one of the following specialists:
 (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.

Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.

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.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13336

P13336

CN13336

Aflibercept

Dexamethasone

Ranibizumab

Central retinal vein occlusion with macular oedema

Continuing treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 13336

C13337

P13337

CN13337

Aflibercept

Ranibizumab

Subfoveal choroidal neovascularisation (CNV)

Initial treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

The condition must be due to pathologic myopia (PM); AND

The condition must be diagnosed by optical coherence tomography; or

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye 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) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.

(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).

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).

All reports must be documented in the patient's medical records.

Compliance with Written Authority Required procedures

C13340

P13340

CN13340

Ranibizumab

Subfoveal choroidal neovascularisation (CNV)

Continuing treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

The condition must not be due to pathologic myopia; AND

The condition must not be due to age-related macular degeneration; 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 for this condition for the same eye.

Compliance with Authority Required procedures - Streamlined Authority Code 13340

C13341

P13341

CN13341

Dexamethasone

Diabetic macular oedema (DMO)

Initial treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

Patient must have visual impairment due to diabetic macular oedema; AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; or

The condition must be diagnosed by fluorescein angiography; AND

Patient must have had a cataract removed in the treated eye; or

Patient must be scheduled for cataract surgery in the treated eye; AND

Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or

Patient must be unsuitable for treatment with VEGF inhibitors; or

Patient must have failed prior treatment with VEGF inhibitors; AND

The treatment must be as monotherapy; or

The treatment must be in combination with laser photocoagulation; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye 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) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.

(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).

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).

All reports must be documented in the patient's medical records.

Compliance with Written Authority Required procedures

C13346

P13346

CN13346

Somatropin

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 1st percentile for age and sex; or

Patient must have a current height above the 1st and at or below the 25th percentiles 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 1st and at or below the 25th 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 1st and at or below the 25th 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; AND

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 1st percentile 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 Authority Required procedures

C13350

P13350

CN13350

Somatropin

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; AND

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 Authority Required procedures

C13352

P13352

CN13352

Somatropin

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; AND

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 Authority Required procedures

C13353

P13353

CN13353

Somatropin

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 1st percentile for age and sex immediately prior to commencing treatment; or

Patient must have had both a height above the 1st and at or below the 25th percentiles 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 and at or below the 25th 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 1st and at or below the 25th 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; AND

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 Authority Required procedures

C13355

P13355

CN13355

Somatropin

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/1.73m2 measured 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 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:
 (i) a height no higher than the 1st percentile 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; AND

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/1.73m2 measured 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 Authority Required procedures

C13356

P13356

CN13356

Somatropin

Short stature and slow growth

Initial treatment

Patient must have a current height at or below the 1st percentile for age and sex; AND

Patient must have 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 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; AND

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 1st adult 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 Authority Required procedures

C13359

P13359

CN13359

Somatropin

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/1.73m2 measured 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 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:
 (i) a height no higher than the 1st percentile 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; AND

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/1.73m2 measured 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 Authority Required procedures

C13360

P13360

CN13360

Somatropin

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; AND

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 Authority Required procedures

C13363

P13363

CN13363

Somatropin

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; AND

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 Authority Required procedures

C13364

P13364

CN13364

Somatropin

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 1st percentile for age and sex immediately prior to commencing treatment; or

Patient must have had both a height above the 1st and at or below the 25th percentiles 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 and at or below the 25th 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 1st and at or below the 25th 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; AND

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 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. 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 Authority Required procedures

C13367

P13367

CN13367

Somatropin

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 1st percentile for age and sex; or

Patient must have a current height above the 1st and at or below the 25th percentiles 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 1st and at or below the 25th percentiles 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; AND

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 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. 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

C13368

P13368

CN13368

Somatropin

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; AND

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 Authority Required procedures

C13377

P13377

CN13377

Burosumab

X-linked hypophosphataemia

Initial treatment - New patient

Patient must have a documented confirmation of PHEX pathogenic variant; or

Patient must have a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following:
 (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic X-ray evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND

Must be treated by a medical practitioner identifying as at least one of the following specialists:
 (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.

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.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13378

P13378

CN13378

Nintedanib

Pirfenidone

Idiopathic pulmonary fibrosis

Initial treatment 1 - new patient

The condition must be diagnosed through a multidisciplinary team; AND

Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND

Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND

Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND

Patient must not have had an acute respiratory infection at the time of FVC measurement; AND

Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND

Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Must be treated by a medical practitioner who is either:
 (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND

Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following:
 (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.

A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.

Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.

Authority applications 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 Written Authority Required procedures

C13380

P13380

CN13380

Nintedanib

Pirfenidone

Idiopathic pulmonary fibrosis

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Must be treated by a medical practitioner who is either:
 (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND

Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.

Compliance with Authority Required procedures

C13381

P13381

CN13381

Nintedanib

Pirfenidone

Idiopathic pulmonary fibrosis

Initial treatment 2 - change or recommencement of treatment

Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND

The treatment must be the sole PBS-subsidised therapy for this condition; AND

Must be treated by a medical practitioner who is either:
 (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND

Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.

Compliance with Authority Required procedures

C13384

P13384

CN13384

Aflibercept

Ranibizumab

Branch retinal vein occlusion with macular oedema

Initial treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; or

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye 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) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.

(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).

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).

All reports must be documented in the patient's medical records.

Compliance with Written Authority Required procedures

C13387

P13387

CN13387

Aflibercept

Dexamethasone

Ranibizumab

Branch retinal vein occlusion with macular oedema

Continuing treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Compliance with Authority Required procedures - Streamlined Authority Code 13387

C13388

P13388

CN13388

Aflibercept

Faricimab

Ranibizumab

Diabetic macular oedema (DMO)

Initial treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

Patient must have visual impairment due to diabetic macular oedema; AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; or

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be as monotherapy; or

The treatment must be in combination with laser photocoagulation; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye 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) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.

(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).

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).

All reports must be documented in the patient's medical records.

Compliance with Written Authority Required procedures

C13390

P13390

CN13390

Aflibercept

Ranibizumab

Central retinal vein occlusion with macular oedema

Initial treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND

Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND

The condition must be diagnosed by optical coherence tomography; or

The condition must be diagnosed by fluorescein angiography; AND

The treatment must be the sole PBS-subsidised therapy for this condition.

Authority approval for initial treatment of each eye must be sought.

The first authority application for each eye 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) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.

(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).

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).

All reports must be documented in the patient's medical records.

Compliance with Written Authority Required procedures

C13392

P13392

CN13392

Aflibercept

Ranibizumab

Subfoveal choroidal neovascularisation (CNV)

Continuing treatment

Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND

The condition must be due to pathologic myopia (PM); 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 for this condition for the same eye.

Compliance with Authority Required procedures - Streamlined Authority Code 13392

C13393

P13393

CN13393

Somatropin

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; AND

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 Authority Required procedures

C13396

P13396

CN13396

Romiplostim

Severe thrombocytopenia

Second or Subsequent Continuing treatment

The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND

Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND

Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND

The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.

The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.

The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.

Authority approval will not be given for doses higher than 10 micrograms/kg/week

Compliance with Authority Required procedures

C13400

P13400

CN13400

Burosumab

X-linked hypophosphataemia

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

Patient must have a documented confirmation of PHEX pathogenic variant; or

Patient must have, prior to commencing non-PBS-subsidised supply, a confirmed diagnosis of X-linked hypophosphataemia demonstrated by the presence of all of the following:
 (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF-23 levels of above the mean of the assay-specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine; AND

Patient must have achieved normalisation in serum phosphate levels; AND

Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion; AND

Must be treated by a medical practitioner identifying as at least one of the following specialists:
 (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.

Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia.

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.

Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records.

Compliance with Authority Required procedures

C13401

P13401

CN13401

Nintedanib

Progressive fibrosing Interstitial lung disease

Initial treatment

The condition must be diagnosed through a multidisciplinary team; AND

The condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication; AND

The condition must display, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5); AND

Patient must have a current (no older than 2 years) forced vital capacity (FVC) measurement of no less than 45% predicted, adjusted for each of:
 (i) age, (ii) gender, (iii) height; AND

The condition must be of a progressive nature, observed by, in the 2 years leading up to this authority application, any of:
 (i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient's medical records; AND

Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND

Patient must not have had an acute respiratory infection at the time of FVC measurement; AND

Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin that is both:
 (i) at least 30% predicted, (ii) no greater than 80% predicted; AND

The condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is); AND

The condition must not be due to reversible causes (e.g. drug toxicity); AND

Must be treated by a medical practitioner who is either:
 (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND

Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
 (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND

Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following:
 (i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.