C13927 | P13927 | CN13927 | Ustekinumab | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must not exceed a single dose to be administered at week 8 under this restriction; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats. Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Authority Required procedures |
C13936 | P13936 | CN13936 | Memantine | Moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. A patient who is unable to register a score of 10 to 14 for reasons other than their Alzheimer disease, as specified below. Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. Patients who qualify under this criterion are from 1 or more of the following groups (1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; (2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; (3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test; (4) Intellectual (developmental or acquired) disability, eg Down's syndrome; (5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test; (6) Prominent dysphasia, out of proportion to other cognitive and functional impairment. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C13938 | P13938 | CN13938 | Donepezil Galantamine Rivastigmine | Mild to moderately severe Alzheimer disease Continuing Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND Patient must demonstrate a clinically meaningful response to the initial treatment; AND The treatment must be the sole PBS-subsidised therapy for this condition. Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit. Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use. Re-assessments for a clinically meaningful response are to be undertaken and documented every six months. Clinically meaningful response to treatment is demonstrated in the following areas Patient's quality of life including but not limited to level of independence and happiness; Patient's cognitive function including but not limited to memory, recognition and interest in environment; Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 13938 |
C13940 | P13940 | CN13940 | Donepezil Galantamine Rivastigmine | Mild to moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. A patient who is unable to register a score of 10 or more for reasons other than their Alzheimer disease, as specified below. Such patients will need to be assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale. The authority application must include the result of the baseline (S)MMSE and specify to which group(s) (see below) the patient belongs. Patients who qualify under this criterion are from 1 or more of the following groups (1) Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background; (2) Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate; (3) Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an (S)MMSE test; (4) Intellectual (developmental or acquired) disability, eg Down's syndrome; (5) Significant sensory impairment despite best correction, which precludes completion of an (S)MMSE test; (6) Prominent dysphasia, out of proportion to other cognitive and functional impairment. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C13941 | P13941 | CN13941 | Donepezil Galantamine Rivastigmine | Mild to moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. The authority application must include the result of the baseline MMSE or SMMSE. If this score is 25 - 30 points, the result of a baseline Alzheimer Disease Assessment Scale, cognitive sub-scale (ADAS-Cog) may also be specified. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C13945 | P13945 | CN13945 | Abiraterone | Castration resistant metastatic carcinoma of the prostate The treatment must be used in combination with a corticosteroid; AND The treatment must not be used in combination with chemotherapy; AND Patient must have a WHO performance status of 2 or less; AND The treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of:
(i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits; AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). or Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. | Compliance with Authority Required procedures |
C13946 | P13946 | CN13946 | Ozanimod | Moderate to severe ulcerative colitis Continuing treatment - balance of supply Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
C13948 | P13948 | CN13948 | Pembrolizumab | Stage IV clear cell variant renal cell carcinoma (RCC) Initial treatment Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either:
(i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records; AND The condition must be untreated; AND Patient must have a WHO performance status of 2 or less; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib; or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 13948 |
C13949 | P13949 | CN13949 | Pembrolizumab | Stage IV clear cell variant renal cell carcinoma (RCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib; or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 13949 |
C13950 | P13950 | CN13950 | Asciminib | Chronic Myeloid Leukaemia (CML) Initial PBS-subsidised treatment for patients without T315I mutation The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must not be in the blast phase; AND The treatment must not exceed a total maximum of 18 months of therapy with PBS-subsidised treatment with a tyrosine kinase inhibitor for this condition under this restriction; AND The condition must be expressing the Philadelphia chromosome confirmed through cytogenetic analysis; or The condition must have the transcript BCR-ABL tyrosine kinase confirmed through quantitative polymerase chain reaction (PCR); AND Patient must have failed an adequate trial of at least two tyrosine kinase inhibitors. or Patient must have experienced intolerance, not failure to respond, to at least two tyrosine kinase inhibitors. or Patient must have failed an adequate trial of at least one tyrosine kinase inhibitor with intolerance to at least another tyrosine kinase inhibitor. Failure of an adequate trial of a tyrosine kinase inhibitor is defined as 1. Lack of response defined as either (i) failure to achieve a haematological response after a minimum of 3 months therapy; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive (Ph+) cells; or (iii) failure to achieve or maintain a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph+ cells on bone marrow biopsy), during ongoing tyrosine kinase inhibitor (TKI) 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 tyrosine kinase inhibitor (TKI) therapy; OR 4. Development of accelerated phase in a patient previously prescribed a TKI inhibitor 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 TKI therapy in patients with accelerated phase 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). | Compliance with Authority Required procedures |
C13952 | P13952 | CN13952 | Ustekinumab | Moderate to severe ulcerative colitis Continuing treatment - balance of supply Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
C13955 | P13955 | CN13955 | Ustekinumab | Moderate to severe ulcerative colitis Initial treatment - initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND The treatment must not exceed a single dose to be administered at week 8 under this restriction; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats. Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Authority Required procedures |
C13958 | P13958 | CN13958 | Upadacitinib | Moderate to severe ulcerative colitis Continuing treatment - balance of supply Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND The treatment must have been prescribed most recently through the Continuing treatment phase in a quantity which did not seek the full number available in regards to any of:
(i) the quantity per dispensing, (ii) repeat prescriptions; AND The treatment must provide no more than the balance of 24 weeks treatment. | Compliance with Authority Required procedures |
C13959 | P13959 | CN13959 | Upadacitinib | Moderate to severe ulcerative colitis Dose modification Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must be undergoing existing PBS-subsidised treatment with this therapy. | Compliance with Authority Required procedures |
C13966 | P13966 | CN13966 | Memantine | Moderately severe Alzheimer disease Continuing Patient must have received six months of sole PBS-subsidised initial therapy with this drug; AND Patient must demonstrate a clinically meaningful response to the initial treatment; AND The treatment must be the sole PBS-subsidised therapy for this condition. Prior to continuing treatment, a comprehensive assessment must be undertaken and documented, involving the patient, the patient's family or carer and the treating physician to establish agreement that treatment is continuing to produce worthwhile benefit. Treatment should cease if there is no agreement of benefit as there is always the possibility of harm from unnecessary use. Re-assessments for a clinically meaningful response are to be undertaken and documented every six months. Clinically meaningful response to treatment is demonstrated in the following areas Patient's quality of life including but not limited to level of independence and happiness; Patient's cognitive function including but not limited to memory, recognition and interest in environment; Patient's behavioural symptoms, including but not limited to hallucination, delusions, anxiety, marked agitation or associated aggressive behaviour. | Compliance with Authority Required procedures - Streamlined Authority Code 13966 |
C13967 | P13967 | CN13967 | Naltrexone | Alcohol dependence The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence/controlled consumption. | Compliance with Authority Required procedures - Streamlined Authority Code 13967 |
C13972 | P13972 | CN13972 | Lenvatinib | Stage IV clear cell variant renal cell carcinoma (RCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib. or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records. or Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose. In a patient who has experienced an intolerance to pembrolizumab, details of intolerance must be documented in the patient's medical record. | Compliance with Authority Required procedures - Streamlined Authority Code 13972 |
C13977 | P13977 | CN13977 | Vosoritide | Achondroplasia Initial treatment Patient must have a diagnosis of achondroplasia, confirmed by appropriate genetic testing; AND Patient must not have evidence of growth plate closure demonstrated by at least one of the following:
i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND Must be treated by a medical specialist, experienced in the management of achondroplasia. or Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Appropriate genetic testing constitutes testing for FGFR3 gene mutation. In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient's medical records. Additional radiographic evidence is not required until patient has begun puberty. In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C13988 | P13988 | CN13988 | Ustekinumab | Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND The treatment must not exceed a single dose to be administered at week 8 under this restriction; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre-filled syringe of 90 mg and no repeats. | Compliance with Authority Required procedures |
C13990 | P13990 | CN13990 | Upadacitinib | Moderate to severe ulcerative colitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C13992 | P13992 | CN13992 | Abiraterone and methylprednisolone | Castration resistant metastatic carcinoma of the prostate The treatment must not be used in combination with chemotherapy; AND Patient must have a WHO performance status of 2 or less; AND The treatment must not be a PBS benefit where disease progression occurs whilst being treated with any of:
(i) a combination treatment containing the individual drugs in one pharmaceutical benefit, (ii) the individual drugs obtained as separate pharmaceutical benefits; AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). or Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. | Compliance with Authority Required procedures |
C13995 | P13995 | CN13995 | Ozanimod | Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C13998 | P13998 | CN13998 | Vosoritide | Achondroplasia Continuing treatment Patient must have received PBS subsidised vosoritide treatment for this condition; AND Patient must not have evidence of growth plate closure demonstrated by at least one of the following:
i) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 6 months of this application if puberty has commenced; ii) bilateral lower extremity X-rays (proximal tibia, distal femur) taken within 2 years of commencing treatment if puberty has not commenced; iii) an annual growth velocity of greater than 1.5 cm/year as assessed over a period of at least 6 months; AND Must be treated by a medical specialist, experienced in the management of achondroplasia. or Must be treated by a paediatrician in consultation with a medical specialist experienced in the management of achondroplasia. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. In patients where puberty has not commenced, radiographic evidence that epiphyses have not closed must be obtained within 2 years of commencing treatment with vosoritide. X-rays and dates (date commenced treatment and date of X-ray) must be documented in the patient's medical records. Additional radiographic evidence is not required until patient has begun puberty. In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C13999 | P13999 | CN13999 | Upadacitinib | Moderate to severe ulcerative colitis Initial treatment - Initial 1 (new patient - untreated with biological medicine) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14000 | P14000 | CN14000 | Memantine | Moderately severe Alzheimer disease Initial Patient must have a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14; AND The condition must be confirmed by, or in consultation with, a specialist/consultant physician (including a psychiatrist); AND The treatment must be the sole PBS-subsidised therapy for this condition. The authority application must include the result of the baseline MMSE or SMMSE of 10 to 14. Up to a maximum of 6 months' initial therapy will be authorised for this drug, for this strength under this treatment restriction. | Compliance with Authority Required procedures |
C14001 | P14001 | CN14001 | Nivolumab | Stage IV clear cell variant renal cell carcinoma (RCC) Induction treatment The condition must not have previously been treated; AND Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either:
(i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records; AND Patient must have a WHO performance status of 2 or less; AND The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition. Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. | Compliance with Authority Required procedures - Streamlined Authority Code 14001 |
C14002 | P14002 | CN14002 | Ozanimod | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; Patient must be at least 18 years of age. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
C14003 | P14003 | CN14003 | Ozanimod | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An assessment of a patient's response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14004 | P14004 | CN14004 | Ozanimod | Moderate to severe ulcerative colitis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; or Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 9 and 17 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14005 | P14005 | CN14005 | Ozanimod | Moderate to severe ulcerative colitis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
C14008 | P14008 | CN14008 | Asciminib | Chronic Myeloid Leukaemia (CML) Continuing Treatment for patients with T315I mutation 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 be undergoing first continuing treatment with this drug, demonstrating either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%. or Patient must be undergoing subsequent continuing treatment with this drug, demonstrating a 12-month response of either (i) a major cytogenetic response (ii) a peripheral blood level of BCR-ABL of less than 1%. A major cytogenetic response [see Note explaining requirements] or a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining requirements] must be documented in the patient's medical records. The 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). Patients are eligible for PBS-subsidised treatment with only one of imatinib, dasatinib, nilotinib, ponatinib or asciminib at any one time and must not be receiving concomitant interferon alfa therapy | Compliance with Authority Required procedures |
C14011 | P14011 | CN14011 | Upadacitinib | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; Patient must be at least 18 years of age. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
C14014 | P14014 | CN14014 | Upadacitinib | Moderate to severe ulcerative colitis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. | Compliance with Written Authority Required procedures |
C14015 | P14015 | CN14015 | Daratumumab | Newly diagnosed systemic light chain amyloidosis Initial treatment from week 0 to week 24 The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation; AND Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND Patient must be undergoing concomitant treatment limited to each of:
(i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information. 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 Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to (i) the name of pathologist/pathology provider, (ii) the site of biopsy 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 |
C14017 | P14017 | CN14017 | Ozanimod | Moderate to severe ulcerative colitis Dose escalation occurring at initial treatment or re-initiation of treatment Must be treated by a gastroenterologist (code 87). or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]. or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. | Compliance with Authority Required procedures - Streamlined Authority Code 14017 |
C14018 | P14018 | CN14018 | Ustekinumab | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
C14021 | P14021 | CN14021 | Selinexor | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week The condition must be confirmed by a histological diagnosis; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Details of the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records. Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records (a) the level of serum monoclonal protein; or (b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or (c) the serum level of free kappa and lambda light chains; or (d) bone marrow aspirate or trephine; or (e) if present, the size and location of lytic bone lesions (not including compression fractures); or (f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or (g) if present, the level of hypercalcaemia, corrected for albumin concentration. As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
C14022 | P14022 | CN14022 | Selinexor | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 80 mg, 60 mg or 40 mg per week Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are:
(a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14023 | P14023 | CN14023 | Selinexor | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 100 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14024 | P14024 | CN14024 | Selinexor | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 100 mg per week The condition must be confirmed by a histological diagnosis; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
C14026 | P14026 | CN14026 | Ciclosporin | Chronic severe dry eye disease with keratitis Initial treatment for up to the first 180 days of treatment Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of:
(i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment; Patient must be at least 18 years of age. Prescribing instruction State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23). | Compliance with Authority Required procedures |
C14027 | P14027 | CN14027 | Pembrolizumab | Advanced, metastatic or recurrent endometrial carcinoma Initial treatment Patient must have received prior treatment with platinum-based chemotherapy; AND The condition must be untreated with each of:
(i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib; or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14027 |
C14031 | P14031 | CN14031 | Selinexor | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 160 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14032 | P14032 | CN14032 | Ciclosporin | Chronic severe dry eye disease with keratitis Continuing treatment Patient must have received PBS-subsidised treatment with this drug for this condition; AND The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND The condition must have improved to an extent that the patient's ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist. or Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines. Prescribing instructions State in the first continuing treatment authority application for this drug (i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application). (ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application). State in all continuing treatment authority applications (ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application). | Compliance with Authority Required procedures |
C14034 | P14034 | CN14034 | Abiraterone and methylprednisolone Apalutamide Darolutamide Enzalutamide | Metastatic castration sensitive carcinoma of the prostate The treatment must be/have been initiated within 6 months of treatment initiation with androgen deprivation therapy; AND Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication); or Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND Patient must be undergoing concurrent androgen deprivation therapy. | Compliance with Authority Required procedures |
C14037 | P14037 | CN14037 | Selinexor | Relapsed and/or refractory multiple myeloma Grandfather treatment - Transitioning from non-PBS to PBS-subsidised supply - Dose requirement of 100 mg per week Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 June 2023; AND Patient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are:
(a) the condition was confirmed by histological diagnosis, (b) the treatment is/was being used as part of combination therapy limited to this drug in combination with either: (i) dexamethasone, (ii) dexamethasone plus bortezomib, (c) the condition progressed (see definition of progressive disease below) after at least one prior therapy, (d) the patient had never been treated with this drug; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14039 | P14039 | CN14039 | Selinexor | Relapsed and/or refractory multiple myeloma Initial treatment - Dose requirement of 160 mg per week The condition must be confirmed by a histological diagnosis; AND Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
C14040 | P14040 | CN14040 | Nicotine | Nicotine dependence The treatment must be as an aid to achieving abstinence from smoking; AND The treatment must not be a PBS-benefit with other non-nicotine drugs that are PBS indicated for smoking cessation; AND Patient must have indicated they are ready to cease smoking; AND Patient must not receive more than 2 x 12-week PBS-subsidised treatment courses per 12 month period; AND Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated. Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated. | |
C14041 | P14041 | CN14041 | Lenvatinib | Advanced, metastatic or recurrent endometrial carcinoma 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 Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib. or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records. or Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose. | Compliance with Authority Required procedures - Streamlined Authority Code 14041 |
C14042 | P14042 | CN14042 | Lenvatinib | Advanced, metastatic or recurrent endometrial carcinoma Initial treatment Patient must have received prior treatment with platinum-based chemotherapy; AND The condition must be untreated with each of:
(i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib. or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14042 |
C14044 | P14044 | CN14044 | Pembrolizumab | Advanced, metastatic or recurrent endometrial carcinoma 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 Patient must be undergoing combination therapy consisting of:
(i) pembrolizumab, (ii) lenvatinib; or Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures - Streamlined Authority Code 14044 |
C14045 | P14045 | CN14045 | Selinexor | Relapsed and/or refractory multiple myeloma Continuing treatment - Dose requirement of 80 mg, 60 mg or 40 mg per week Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must be undergoing triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; or Patient must be undergoing dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
C14047 | P14047 | CN14047 | Cannabidiol | Seizures of the Lennox-Gastaut syndrome Patient must have a diagnosis of Lennox-Gastaut syndrome confirmed by an electroencephalogram (EEG) that showed a pattern of slow (less than 3.0 hertz) spike-and-wave discharges with generalised paroxysmal fast activity (sleep recording should be obtained where it is possible); AND Patient must have (as an initiating patient)/have had (as a continuing patient) more than one type of generalised seizures; AND Patient must have had at least two drop seizures (atonic, tonic or tonic-clonic) per week that are not adequately controlled with at least two other anti-epileptic drugs prior to initiating treatment with this medicine; AND The treatment must be as adjunctive therapy to at least two other anti-epileptic drugs; AND Must be treated by a neurologist if treatment is being initiated. or Must be treated by a neurologist if treatment is being continued or re-initiated. or Must be treated by a paediatrician in consultation with a neurologist if treatment is being continued. or Must be treated by a general practitioner in consultation with a neurologist if treatment is being continued. Tonic seizures must have been recorded on video-EEG or have been clearly observed and reported by a witness. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C14061 | P14061 | CN14061 | Adalimumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
C14063 | P14063 | CN14063 | Adalimumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Active joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints. At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active juvenile idiopathic; and (b) the date of the last continuing prescription. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14064 | P14064 | CN14064 | Adalimumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens:
(i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application (a) an active joint count of at least 20 active (swollen and tender) joints; OR (b) at least 4 active joints from the following list (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active juvenile idiopathic arthritis; and (b) details of prior treatment including dose and duration of treatment. At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14068 | P14068 | CN14068 | Etanercept | Severe active juvenile idiopathic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
C14070 | P14070 | CN14070 | Etanercept | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens:
(i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application (a) an active joint count of at least 20 active (swollen and tender) joints; OR (b) at least 4 active joints from the following list (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active juvenile idiopathic arthritis; and (b) details of prior treatment including dose and duration of treatment. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14071 | P14071 | CN14071 | Etanercept | Severe active juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction. Active joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active juvenile idiopathic arthritis; and (b) the date of the last continuing prescription. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14080 | P14080 | CN14080 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient weighing at least 30 kg) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN). The assessment of response to prior treatment must be documented in the patient's medical records. The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and (b) details of prior treatment including dose and duration of treatment. The following reports must be documented in the patient's medical records where appropriate (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; (b) details of prior treatment including dose and duration of treatment; and (c) the pathology reports detailing CRP and platelet count where appropriate. | Compliance with Authority Required procedures |
C14084 | P14084 | CN14084 | Tocilizumab | Systemic juvenile idiopathic arthritis Continuing treatment in a patient weighing less than 30 kg Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 14084 |
C14088 | P14088 | CN14088 | Tocilizumab | Systemic juvenile idiopathic arthritis Continuing treatment in a patient weighing at least 30 kg Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application. The following reports must be documented in the patient's medical records where appropriate (a) baseline and current pathology reports detailing C-reactive protein (CRP) levels; and (b) baseline and current pathology reports detailing platelet count. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 14088 |
C14094 | P14094 | CN14094 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient weighing less than 30 kg) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; or Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN). The assessment of response to prior treatment must be documented in the patient's medical records. The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and (b) the details of prior treatment including dose and duration of treatment. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
C14096 | P14096 | CN14096 | Choriogonadotropin alfa | Infertility indications other than that of Assisted Reproductive Technology Patient must not be undergoing treatment with medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing; AND Must be treated by an obstetrician/gynaecologist. or Must be treated by a specialist in reproductive endocrinology/infertility. or Must be treated by a urogynaecologist. or Must be treated by an endocrinologist. or Must be treated by a urologist. The PBS prescription, whether it is to initiate or continue treatment, must be made out under the specialist's prescriber number. | |
C14097 | P14097 | CN14097 | Finerenone | Chronic kidney disease with Type 2 diabetes 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 not have known significant non-diabetic renal disease, prior to initiating treatment with this drug; AND Patient must have an estimated glomerular filtration rate of 25 mL/min/1.73 m2 or greater, prior to initiating treatment with this drug; AND Patient must have a urinary albumin-to-creatinine ratio of 200 mg/g (22.6 mg/mmol) or greater, 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 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; AND The treatment must be in combination with an SGLT2i unless medically contraindicated or intolerant; AND Patient must not be receiving treatment with another selective nonsteroidal mineralocorticoid receptor antagonist, a renin inhibitor or a potassium-sparing diuretic; AND Patient must not have established heart failure with reduced ejection fraction with an indication for treatment with a mineralocorticoid receptor antagonist. | Compliance with Authority Required procedures - Streamlined Authority Code 14097 |
C14103 | P14103 | CN14103 | Tocilizumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; or Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens:
(i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti-rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; Patient must be under 18 years of age. Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non-steroidal anti-inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours. Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis. If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA-approved Product Information, details must be documented in the patient's medical records. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application (a) an active joint count of at least 20 active (swollen and tender) joints; OR (b) at least 4 active joints from the following list (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active juvenile idiopathic arthritis; and (b) details of prior treatment including dose and duration of treatment. Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14104 | P14104 | CN14104 | Tocilizumab | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must be under 30kg; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 14104 |
C14107 | P14107 | CN14107 | Adalimumab | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 14107 |
C14121 | P14121 | CN14121 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of a new treatment cycle after a break of more than 12 months in a patient weighing less than 30 kg) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND Patient must have polyarticular course disease and the condition must have at least one of:
(a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND Patient must not receive more than 16 weeks of treatment under this restriction; AND Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; Patient must be under 18 years of age. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14124 | P14124 | CN14124 | Choriogonadotropin alfa | Assisted Reproductive Technology Patient must be receiving medical services as described in items 13200, 13201, 13202 or 13203 of the Medicare Benefits Schedule; AND Patient must not be undergoing simultaneous treatment with this drug through another PBS program listing. | Compliance with Authority Required procedures - Streamlined Authority Code 14124 |
C14136 | P14136 | CN14136 | Adalimumab | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 14136 |
C14147 | P14147 | CN14147 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break of more than 12 months in a patient weighing at least 30 kg) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND Patient must have polyarticular course disease and the condition must have at least one of:
(a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); or Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C-reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND Patient must not receive more than 16 weeks of treatment under this restriction; AND Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; Patient must be under 18 years of age. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active systemic juvenile idiopathic arthritis. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14150 | P14150 | CN14150 | Tocilizumab | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must be 30kg or over; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 14150 |
C14153 | P14153 | CN14153 | Tocilizumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 12 months or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints. Active joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints. Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the date of assessment of severe active juvenile idiopathic arthritis; and (b) the date of the last continuing prescription. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
C14154 | P14154 | CN14154 | Etanercept | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 14154 |
C14155 | P14155 | CN14155 | Etanercept | Severe active juvenile idiopathic arthritis Continuing treatment Must be treated by a rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application. At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 14155 |
C14166 | P14166 | CN14166 | Tocilizumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) Must be treated by a paediatric rheumatologist; or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle. An adequate response to treatment is defined as (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records. Patients under 30 kg may receive up to 24 weeks of treatment under this restriction. Patients 30 kg and over may receive up to 16 weeks of treatment under this restriction. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS-subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
C14175 | P14175 | CN14175 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing at least 30 kg) Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
C14180 | P14180 | CN14180 | Fluticasone propionate | Asthma The treatment must not be a PBS benefit where this 50 microgram strength is being initiated in a patient over the age of 6.00 years. | Compliance with Authority Required procedures - Streamlined Authority Code 14180 |
C14182 | P14182 | CN14182 | Tocilizumab | Systemic juvenile idiopathic arthritis Initial treatment - Initial 2 (retrial or recommencement of treatment after a break of less than 12 months in a patient weighing less than 30 kg) Patient must have received prior PBS-subsidised treatment with this drug for this condition in the previous 12 months; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be under 18 years of age; Must be treated by a rheumatologist. or Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. An adequate response to treatment is defined as (a) in a patient with polyarticular course disease (i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (ii) a reduction in the number of the following major active joints, from at least 4, by at least 50% (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. - elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or - shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). (b) in a patient with refractory systemic symptoms (i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or (ii) a reduction in the C-reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or (iii) a reduction in the dose of corticosteroid by at least 30% from baseline. The assessment of response to treatment must be documented in the patient's medical records. The following reports must be documented in the patient's medical records where appropriate (a) pathology reports detailing C-reactive protein (CRP) level and platelet count. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle. If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS-subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
C14188 | P14188 | CN14188 | Trabectedin | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements Patient must have been receiving treatment with this drug for this condition prior to 1 August 2023; AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated; AND Patient must have received chemotherapy treatment including an anthracycline, prior to initiating non-PBS-subsidised treatment; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be one of the following subtypes for patients with liposarcoma:
(i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 14188 |
C14189 | P14189 | CN14189 | Eptinezumab | Chronic migraine Initial treatment Must be treated by a neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits:
(i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND Patient must have experienced an average of 15 or more headache days per month, with at least 8 days of migraine, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; Patient must be at least 18 years of age. Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate. Patient must have the number of migraine days per month documented in their medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14189 |
C14195 | P14195 | CN14195 | Tocilizumab | Active giant cell arteritis Initial treatment Must be treated by a rheumatologist, clinical immunologist or neurologist experienced in the management of giant cell arteritis; AND Patient must have clinical symptoms of active giant cell arteritis in the absence of any other identifiable cause; AND Patient must have an ESR equal to or greater than 30 mm/hour within the past 6 weeks; or Patient must have a CRP equal to or greater than 10 mg/L within the past 6 weeks; or Patient must have active giant cell arteritis confirmed by positive temporal artery biopsy or imaging; AND Patient must have had a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis; AND Patient must have had temporal artery biopsy revealing features of giant cell arteritis at diagnosis; or Patient must have had evidence of large-vessel vasculitis by magnetic resonance (MR) or computed tomography (CT) angiography or PET/CT at diagnosis; or Patient must have had evidence of positive temporal artery halo sign by ultrasound (US) at diagnosis; AND The treatment must be in combination with a tapering course of corticosteroids; AND The treatment must not exceed 52 weeks in total including initial and continuing applications; Patient must be aged 50 years or older. Clinical symptoms of giant cell arteritis at diagnosis include unequivocal cranial symptoms of giant cell arteritis (new onset localized headache, scalp tenderness, temporal artery tenderness or decreased pulsation, ischemia related vision loss, or otherwise unexplained mouth or jaw pain upon mastication); or symptoms of polymyalgia rheumatica, defined as shoulder and/or hip girdle pain associated with inflammatory morning stiffness. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS and must include (a) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has active giant cell arteritis including pathology reports outlining the patient's ESR or CRP levels within the last 6 weeks, or positive temporal artery biopsy or imaging; and (b) details (dates, results, and unique identifying number/code or provider number) of evidence that the patient has been diagnosed with giant cell arteritis with a history of an ESR equal to or greater than 50 mm/hour or a CRP equal to or greater than 24.5 mg/L at diagnosis. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C14196 | P14196 | CN14196 | Trabectedin | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Initial treatment Patient must have an ECOG performance status of 2 or less; AND Patient must have received prior chemotherapy treatment including an anthracycline; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be one of the following subtypes for patients with liposarcoma:
(i) dedifferentiated, (ii) myxoid, (iii) round-cell, (iv) pleomorphic. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 14196 |
C14197 | P14197 | CN14197 | Trabectedin | Advanced (unresectable and/or metastatic) leiomyosarcoma or liposarcoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 14197 |
C14202 | P14202 | CN14202 | Mifepristone and misoprostol | Termination of an intra-uterine pregnancy The condition must be an intra-uterine pregnancy of up to 63 days of gestation. | Compliance with Authority Required procedures - Streamlined Authority Code 14202 |
C14217 | P14217 | CN14217 | Upadacitinib | Non-radiographic axial spondyloarthritis Initial 1 (New patient), Initial 2 (Change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (Recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 weeks treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment; AND Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis. | Compliance with Authority Required procedures |
C14228 | P14228 | CN14228 | Calcium | Hyperphosphataemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be associated with chronic renal failure. | Compliance with Authority Required procedures - Streamlined Authority Code 14228 |
C14229 | P14229 | CN14229 | Mesalazine | Crohn disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14231 | P14231 | CN14231 | Calcitriol | Hypophosphataemic rickets The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14231 |
C14234 | P14234 | CN14234 | Risedronic acid | Corticosteroid-induced osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14235 | P14235 | CN14235 | Risedronic acid | Osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be aged 70 years or older; Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14236 | P14236 | CN14236 | Calcipotriol with betamethasone | Chronic stable plaque type psoriasis vulgaris The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be inadequately controlled by potent topical corticosteroid monotherapy. | |
C14238 | P14238 | CN14238 | Acarbose Allopurinol Amlodipine Amlodipine with atorvastatin Atenolol Atorvastatin Baclofen Candesartan Carbamazepine Carbimazole Chlortalidone Ciclosporin Clonidine Clopidogrel Clopidogrel with aspirin Cortisone Cyproterone Dexamethasone Enalapril Eprosartan Estradiol Estradiol and estradiol with dydrogesterone Estradiol and estradiol with norethisterone Estradiol with norethisterone Estriol Ethosuximide Everolimus Felodipine Fenofibrate Fluvastatin Furosemide Gemfibrozil Glibenclamide Gliclazide Glimepiride Glipizide Glyceryl trinitrate Hydrochlorothiazide Hydrochlorothiazide with amiloride Hydrocortisone Indapamide Irbesartan Isosorbide dinitrate Isosorbide mononitrate Labetalol Lercanidipine Lisinopril Medroxyprogesterone Metformin Methenamine Methotrexate Metoprolol Mycophenolic acid Nicorandil Nifedipine Norethisterone Olmesartan Pancreatic extract Penicillamine Perindopril Perindopril with indapamide Phenytoin Pizotifen Potassium chloride Potassium chloride with potassium bicarbonate Pravastatin Prazosin Prednisolone Prednisone Probenecid Propranolol Propylthiouracil Ramipril Rosuvastatin Simvastatin Sirolimus Sodium bicarbonate Spironolactone Sulfasalazine Sulthiame Tacrolimus Telmisartan Toremifene Trandolapril Valproic acid Valsartan Verapamil | The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14240 | P14240 | CN14240 | Ticagrelor | Acute coronary syndrome (myocardial infarction or unstable angina) The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in combination with aspirin. | Compliance with Authority Required procedures - Streamlined Authority Code 14240 |
C14242 | P14242 | CN14242 | Alendronic acid | Osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; Patient must be aged 70 years or older; Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14244 | P14244 | CN14244 | Trandolapril with verapamil | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with an ACE inhibitor. or The condition must be inadequately controlled with verapamil. | |
C14245 | P14245 | CN14245 | Lercanidipine with enalapril Perindopril with amlodipine Ramipril with felodipine | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with an ACE inhibitor. or The condition must be inadequately controlled with a dihydropyridine calcium channel blocker. | |
C14246 | P14246 | CN14246 | Perindopril with amlodipine | Stable coronary heart disease The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of therapy for coronary heart disease; AND The condition must be stabilised by treatment with perindopril and amlodipine at the same doses. | |
C14249 | P14249 | CN14249 | Ezetimibe | Hypercholesterolaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in conjunction with dietary therapy and exercise; AND The treatment must be co-administered with an HMG CoA reductase inhibitor (statin); AND Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND Patient must have coronary heart disease. or Patient must have cerebrovascular disease. or Patient must have peripheral vascular disease. or Patient must have diabetes mellitus with microalbuminuria. or Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus. or Patient must have diabetes mellitus and be aged 60 years or more. or Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years. or Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years. or Patient must have heterozygous familial hypercholesterolaemia. Patient must have homozygous familial hypercholesterolaemia. or Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on 1 April 2018. or Inadequate control with a statin is defined as a LDL cholesterol concentration in excess of current target lipid levels for primary and secondary prevention after at least 3 months of treatment at a maximum tolerated dose of a statin. The dose and duration of statin treatment and the cholesterol concentration which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol concentration which shows inadequate control must be no more than 2 months old when ezetimibe is initiated. Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. | Compliance with Authority Required procedures - Streamlined Authority Code 14249 |
C14251 | P14251 | CN14251 | Bisoprolol Carvedilol Metoprolol succinate Nebivolol | Moderate to severe heart failure The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be stabilised on conventional therapy, which must include an ACE inhibitor or Angiotensin II antagonist, if tolerated. | |
C14254 | P14254 | CN14254 | Sacubitril with valsartan | Chronic heart failure The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be symptomatic with NYHA classes II, III or IV; AND Patient must have a documented left ventricular ejection fraction (LVEF) of less than or equal to 40%; AND Patient must receive concomitant optimal standard chronic heart failure treatment, which must include a beta-blocker, unless at least one of the following is present in relation to the beta-blocker:
(i) a contraindication listed in the Product Information, (ii) an existing/expected intolerance, (iii) local treatment guidelines recommend initiation of this drug product prior to a beta-blocker; AND Patient must have been stabilised on an ACE inhibitor at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; or Patient must have been stabilised on an angiotensin II antagonist at the time of initiation with this drug, unless such treatment is contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must not be co-administered with an ACE inhibitor or an angiotensin II antagonist. | Compliance with Authority Required procedures - Streamlined Authority Code 14254 |
C14255 | P14255 | CN14255 | Candesartan with hydrochlorothiazide Irbesartan with hydrochlorothiazide Olmesartan with hydrochlorothiazide Telmisartan with hydrochlorothiazide Valsartan with hydrochlorothiazide | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with an angiotensin II antagonist. or The condition must be inadequately controlled with a thiazide diuretic. | |
C14257 | P14257 | CN14257 | Amlodipine with valsartan Olmesartan with amlodipine Telmisartan with amlodipine | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with an angiotensin II antagonist. or The condition must be inadequately controlled with a dihydropyridine calcium channel blocker. | |
C14259 | P14259 | CN14259 | Calcitriol | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | Compliance with Authority Required procedures - Streamlined Authority Code 14259 |
C14260 | P14260 | CN14260 | Mesalazine | Ulcerative colitis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14263 | P14263 | CN14263 | Risedronic acid | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | |
C14264 | P14264 | CN14264 | Apixaban Rivaroxaban | Deep vein thrombosis Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have confirmed acute symptomatic deep vein thrombosis; AND Patient must not have symptomatic pulmonary embolism. | Compliance with Authority Required procedures - Streamlined Authority Code 14264 |
C14266 | P14266 | CN14266 | Eplerenone | Heart failure with a left ventricular ejection fraction of 40% or less The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must occur within 3 to 14 days following an acute myocardial infarction; AND The treatment must be commenced within 14 days of an acute myocardial infarction. The date of the acute myocardial infarction and the date of initiation of treatment with this drug must be documented in the patient's medical records when PBS-subsidised treatment is initiated | Compliance with Authority Required procedures - Streamlined Authority Code 14266 |
C14267 | P14267 | CN14267 | Perindopril with indapamide | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with an ACE inhibitor. or The condition must be inadequately controlled with a thiazide-like diuretic. | |
C14269 | P14269 | CN14269 | Ezetimibe with atorvastatin Ezetimibe with simvastatin | Hypercholesterolaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; AND Patient must have coronary heart disease. or Patient must have cerebrovascular disease. or Patient must have peripheral vascular disease. or Patient must have diabetes mellitus with microalbuminuria. or Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus. or Patient must have diabetes mellitus and be aged 60 years or more. or Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years. or Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years. or Patient must have heterozygous familial hypercholesterolaemia. Patient must have homozygous familial hypercholesterolaemia. or Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on 1 April 2018. or A clinically important product-related adverse event is defined as follows (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. The type and severity of the adverse event or contraindication must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14269 |
C14270 | P14270 | CN14270 | Carvedilol | Patients receiving this drug as a pharmaceutical benefit prior to 1 August 2002 The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14272 | P14272 | CN14272 | Amlodipine with valsartan and hydrochlorothiazide Olmesartan with amlodipine and hydrochlorothiazide | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with concomitant treatment with two of the following:
an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic. | |
C14274 | P14274 | CN14274 | Raloxifene | Established post-menopausal osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | Compliance with Authority Required procedures - Streamlined Authority Code 14274 |
C14275 | P14275 | CN14275 | Adapalene with benzoyl peroxide | Severe acne vulgaris The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be maintenance therapy. | |
C14280 | P14280 | CN14280 | Enalapril with hydrochlorothiazide | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with an ACE inhibitor. or The condition must be inadequately controlled with a thiazide diuretic. | |
C14283 | P14283 | CN14283 | Ezetimibe | Hypercholesterolaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; or Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a withdrawal of the statin treatment; or Patient must be one in whom treatment with an HMG CoA reductase inhibitor (statin) is contraindicated; AND Patient must have coronary heart disease. or Patient must have cerebrovascular disease. or Patient must have peripheral vascular disease. or Patient must have diabetes mellitus with microalbuminuria. or Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus. or Patient must have diabetes mellitus and be aged 60 years or more. or Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years. or Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years. or Patient must have heterozygous familial hypercholesterolaemia. Patient must have homozygous familial hypercholesterolaemia. or Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on 1 April 2018. or A clinically important product-related adverse event is defined as follows (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. The type and severity of the adverse event or contraindication must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14283 |
C14284 | P14284 | CN14284 | Ezetimibe and rosuvastatin Ezetimibe with atorvastatin Ezetimibe with simvastatin | Hypercholesterolaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND Patient must have coronary heart disease. or Patient must have cerebrovascular disease. or Patient must have peripheral vascular disease. or Patient must have diabetes mellitus with microalbuminuria. or Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus. or Patient must have diabetes mellitus and be aged 60 years or more. or Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years. or Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years. or Patient must have heterozygous familial hypercholesterolaemia. Patient must have homozygous familial hypercholesterolaemia. or Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on 1 April 2018. or Inadequate control with a statin is defined as a LDL cholesterol concentration in excess of current target lipid levels for primary and secondary prevention after at least 3 months of treatment at a maximum tolerated dose of a statin. The dose and duration of statin treatment and the cholesterol concentration which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol concentration which shows inadequate control must be no more than 2 months old when ezetimibe is initiated. Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. | Compliance with Authority Required procedures - Streamlined Authority Code 14284 |
C14287 | P14287 | CN14287 | Calcitriol | Hypoparathyroidism The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14287 |
C14289 | P14289 | CN14289 | Moxonidine | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must be receiving concurrent antihypertensive therapy. | |
C14291 | P14291 | CN14291 | Alendronic acid | Established osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have fracture due to minimal trauma; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. | |
C14296 | P14296 | CN14296 | Calcitriol | Vitamin D-resistant rickets The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | Compliance with Authority Required procedures - Streamlined Authority Code 14296 |
C14298 | P14298 | CN14298 | Rivaroxaban | Chronic stable atherosclerotic disease Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with aspirin, but not with any other anti-platelet therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 14298 |
C14300 | P14300 | CN14300 | Apixaban Rivaroxaban | Prevention of recurrent venous thromboembolism Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have a history of venous thromboembolism. | Compliance with Authority Required procedures - Streamlined Authority Code 14300 |
C14301 | P14301 | CN14301 | Rivaroxaban | Prevention of stroke or systemic embolism The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have non-valvular atrial fibrillation; AND Patient must have one or more risk factors for developing stroke or systemic embolism. Risk factors for developing stroke or systemic ischaemic embolism are (i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism; (ii) age 75 years or older; (iii) hypertension; (iv) diabetes mellitus; (v) heart failure and/or left ventricular ejection fraction 35% or less. | Compliance with Authority Required procedures - Streamlined Authority Code 14301 |
C14302 | P14302 | CN14302 | Apixaban | Pulmonary embolism Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have confirmed acute symptomatic pulmonary embolism. | Compliance with Authority Required procedures - Streamlined Authority Code 14302 |
C14305 | P14305 | CN14305 | Atenolol | For a patient who is unable to take a solid dose form of atenolol. The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient. | |
C14306 | P14306 | CN14306 | Balsalazide | Ulcerative colitis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have had a documented hypersensitivity reaction to a sulphonamide. or Patient must be intolerant to sulfasalazine. | Compliance with Authority Required procedures - Streamlined Authority Code 14306 |
C14308 | P14308 | CN14308 | Apixaban Dabigatran etexilate | Prevention of stroke or systemic embolism The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have non-valvular atrial fibrillation; AND Patient must have one or more risk factors for developing stroke or systemic embolism. Risk factors for developing stroke or systemic ischaemic embolism are (i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism; (ii) age 75 years or older; (iii) hypertension; (iv) diabetes mellitus; (v) heart failure and/or left ventricular ejection fraction 35% or less. | Compliance with Authority Required procedures - Streamlined Authority Code 14308 |
C14309 | P14309 | CN14309 | Alendronic acid | Corticosteroid-induced osteoporosis The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition. The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated. | |
C14310 | P14310 | CN14310 | Ezetimibe | Hypercholesterolaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have homozygous sitosterolaemia. | Compliance with Authority Required procedures - Streamlined Authority Code 14310 |
C14311 | P14311 | CN14311 | Valsartan with hydrochlorothiazide | Hypertension The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must not be for the initiation of anti-hypertensive therapy; AND The condition must be inadequately controlled with an angiotensin II antagonist. or The condition must be inadequately controlled with a thiazide diuretic. | |
C14313 | P14313 | CN14313 | Febuxostat | Chronic gout The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be either chronic gouty arthritis or chronic tophaceous gout; AND Patient must have a medical contraindication to allopurinol. or Patient must have a documented history of allopurinol hypersensitivity syndrome. or Patient must have an intolerance to allopurinol necessitating permanent treatment discontinuation. | Compliance with Authority Required procedures - Streamlined Authority Code 14313 |
C14318 | P14318 | CN14318 | Rivaroxaban | Pulmonary embolism Continuing treatment The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND Patient must have confirmed acute symptomatic pulmonary embolism. | Compliance with Authority Required procedures - Streamlined Authority Code 14318 |
C14319 | P14319 | CN14319 | Thiamine | Thiamine deficiency The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be for prophylaxis; Patient must be an Aboriginal or a Torres Strait Islander person. | Compliance with Authority Required procedures - Streamlined Authority Code 14319 |
C14322 | P14322 | CN14322 | Calcitriol | Hypocalcaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The condition must be due to renal disease. | Compliance with Authority Required procedures - Streamlined Authority Code 14322 |
C14323 | P14323 | CN14323 | Azacitidine | Acute Myeloid Leukaemia Dose escalation therapy - Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have, in order to extend the dose schedule as per the TGA-approved Product Information, between 5% to 15% blasts in either the:
(i) bone marrow, (ii) peripheral blood, in conjunction with clinical assessment; AND Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin. 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) (c) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating the blast percentage. All reports must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C14324 | P14324 | CN14324 | Pembrolizumab | Recurrent, unresectable or metastatic triple negative breast cancer The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage; AND The condition must have been (up until this drug therapy) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy in breast cancer; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND The treatment must be in combination with chemotherapy; AND The condition must have both:
(i) programmed cell death ligand 1 (PD-L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation; AND Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or Patient must be undergoing continuing treatment with this drug - both the following are true:
(i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14324 |
C14326 | P14326 | CN14326 | Obinutuzumab | Chronic lymphocytic leukaemia (CLL) Combination use with chlorambucil only The condition must be CD20 positive; AND The condition must be previously untreated; AND The treatment must be in combination with chlorambucil; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition. Treatment must be discontinued in patients who experience disease progression whilst on this treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 14326 |
C14327 | P14327 | CN14327 | Patiromer | Chronic hyperkalaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not be in place of emergency treatment of hyperkalaemia; AND Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; AND Patient must not be undergoing dialysis. | Compliance with Authority Required procedures - Streamlined Authority Code 14327 |
C14332 | P14332 | CN14332 | Azacitidine | Acute Myeloid Leukaemia Treatment following intensive induction chemotherapy - Initial treatment Patient must have demonstrated either:
(i) first complete remission, (ii) complete remission with incomplete blood count recovery following intensive induction chemotherapy; AND Patient must not be a candidate for, including those who choose not to proceed to, haematopoietic stem cell transplantation; AND Patient must have, at the time of induction therapy, a cytogenetic risk classified as either:
(i) intermediate-risk, (ii) poor-risk; AND Patient must not have undergone a stem cell transplant; AND Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin. A complete remission is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count greater than 1.0 x 109/L and platelet count greater than or equal to 100 x 109/L. A complete remission with incomplete blood count recovery is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count less than 1.0 x 109/L or platelet count less than 100 x 109/L. | Compliance with Authority Required procedures |
C14337 | P14337 | CN14337 | Zanubrutinib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) First line drug treatment of this indication The condition must be untreated with drug treatment at the time of the first dose of this drug; or Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug. or Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug. | Compliance with Authority Required procedures |
C14338 | P14338 | CN14338 | Azacitidine | Acute Myeloid Leukaemia Treatment following intensive induction chemotherapy - Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have, for reasons not attributable to any cause other than AML, no more than 15% blasts in either the:
(i) bone marrow, (ii) peripheral blood; AND Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin. | Compliance with Authority Required procedures |
C14340 | P14340 | CN14340 | Venetoclax | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule) The condition must be untreated with drug treatment at the time of the first dose of this drug; or Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition; AND The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses). | Compliance with Authority Required procedures |
C14342 | P14342 | CN14342 | Patiromer | Chronic hyperkalaemia Initial PBS-subsidised treatment (including grandfathered patients) Patient must have stage 3 to stage 4 chronic kidney disease; The condition must be inadequately controlled by a low potassium diet.; AND Patient must have experienced at least 2 episodes of hyperkalaemia (defined as serum potassium levels of at least 6.0 mmol/L) within the 12 months prior to commencing this drug; AND The treatment must not be in place of emergency treatment of hyperkalaemia; AND Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; or Patient must be indicated for treatment with a renin angiotensin aldosterone system inhibitor, but unable to tolerate this due to prior occurrence of hyperkalaemia; AND Must be treated by a specialist medical practitioner with experience in the diagnosis and management of chronic kidney disease. | Compliance with Authority Required procedures |
C14346 | P14346 | CN14346 | Idelalisib | Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Initial treatment The condition must be confirmed Chronic lymphocytic leukaemia (CLL) prior to initiation of treatment; or The condition must be confirmed Small lymphocytic lymphoma (SLL) prior to initiation of treatment; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with rituximab for up to a maximum of 8 doses under this restriction, followed by monotherapy for this condition; AND The condition must have relapsed or be refractory to at least one prior therapy; AND The condition must be CD20 positive; AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition. | Compliance with Authority Required procedures |
C14348 | P14348 | CN14348 | Ezetimibe with atorvastatin | Hypercholesterolaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND Patient must have coronary heart disease. or Patient must have cerebrovascular disease. or Patient must have peripheral vascular disease. or Patient must have diabetes mellitus with microalbuminuria. or Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus. or Patient must have diabetes mellitus and be aged 60 years or more. or Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years. or Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years. or Patient must have heterozygous familial hypercholesterolaemia. Patient must have homozygous familial hypercholesterolaemia. or Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on 1 April 2018. or Inadequate control with a statin is defined as a LDL cholesterol concentration in excess of current target lipid levels for primary and secondary prevention after at least 3 months of treatment at a maximum tolerated dose of a statin. The dose and duration of statin treatment and the cholesterol concentration which shows inadequate control must be documented in the patient's medical records when ezetimibe is initiated. The cholesterol concentration which shows inadequate control must be no more than 2 months old when ezetimibe is initiated. Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. | Compliance with Authority Required procedures - Streamlined Authority Code 14348 |
C14350 | P14350 | CN14350 | Ezetimibe and rosuvastatin | Hypercholesterolaemia The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND The treatment must be in conjunction with dietary therapy and exercise; AND Patient must have cholesterol concentrations that are inadequately controlled with an HMG CoA reductase inhibitor (statin); AND Patient must have developed a clinically important product-related adverse event during treatment with an HMG CoA reductase inhibitor (statin) necessitating a reduction in the statin dose; AND Patient must have coronary heart disease. or Patient must have cerebrovascular disease. or Patient must have peripheral vascular disease. or Patient must have diabetes mellitus with microalbuminuria. or Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus. or Patient must have diabetes mellitus and be aged 60 years or more. or Patient must have a family history of coronary heart disease in two or more first degree relatives before the age of 55 years. or Patient must have a family history of coronary heart disease in one or more first degree relatives before the age of 45 years. or Patient must have heterozygous familial hypercholesterolaemia. Patient must have homozygous familial hypercholesterolaemia. or Patient must have a level of absolute risk of a cardiovascular event greater than 15% over 5 years as calculated using the Australian Absolute Cardiovascular Disease Risk Calculator (National Vascular Disease Prevention Alliance), as in force on 1 April 2018. or A clinically important product-related adverse event is defined as follows (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or (ii) Myositis (clinically important creatine kinase elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a rising pattern on consecutive measurements and which is unexplained by other causes; or (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin. Microalbuminuria is defined as urinary albumin excretion rate of greater than 20mcg/min or urinary albumin to creatinine ratio of greater than 2.5 for males, or greater than 3.5 for females. The type and severity of the adverse event or contraindication must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14350 |
C14363 | P14363 | CN14363 | Carfilzomib | Relapsed and/or refractory multiple myeloma Continuing treatment for Cycles 3 to 12 Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with lenalidomide and dexamethasone; AND Patient must not have progressive disease while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 14363 |
C14364 | P14364 | CN14364 | Carfilzomib | Relapsed and/or refractory multiple myeloma Continuing treatment for Cycles 13 onwards Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be in combination with lenalidomide and dexamethasone; AND Patient must not have progressive disease while receiving treatment with this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures - Streamlined Authority Code 14364 |
C14366 | P14366 | CN14366 | Somatropin | Severe growth hormone deficiency Continuing treatment in a person with a mature skeleton or aged 18 years or older Must be treated by an endocrinologist; AND Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause in a patient with a mature skeleton. or Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease in a patient with chronological age of 18 years or older. or Patient must have previously received PBS-subsidised therapy with this drug for this condition under an initial treatment restriction applying to late onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males or 13.5 years in females) and before chronological age of 18 years. | Compliance with Authority Required procedures |
C14374 | P14374 | CN14374 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14375 | P14375 | CN14375 | Bimekizumab | Severe chronic plaque psoriasis Continuing treatment, Whole body Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. An adequate response to treatment is defined as A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 4 weeks old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C14376 | P14376 | CN14376 | Bimekizumab | Severe chronic plaque psoriasis Continuing treatment, Face, hand, foot Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition. The most recent PASI assessment must be no more than 4 weeks old at the time of application. Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C14377 | P14377 | CN14377 | Adalimumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14378 | P14378 | CN14378 | Adalimumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14382 | P14382 | CN14382 | Etanercept | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14387 | P14387 | CN14387 | Fosnetupitant with palonosetron | Nausea and vomiting The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy; AND The treatment must be in combination with dexamethasone, unless contraindicated; AND Patient must be unable to swallow. or Patient must be contraindicated to oral anti-emetics. | Compliance with Authority Required procedures |
C14389 | P14389 | CN14389 | Carfilzomib | Relapsed and/or refractory multiple myeloma Initial treatment for Cycles 1 to 3 The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with lenalidomide and dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must not have previously received this drug for this condition. Progressive disease is defined as at least 1 of the following (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. Provide details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of the most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response once only through the Authority application for lenalidomide. | Compliance with Authority Required procedures - Streamlined Authority Code 14389 |
C14390 | P14390 | CN14390 | Somatropin | Severe growth hormone deficiency Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child Must be treated by an endocrinologist; AND Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND Patient must have current or historical evidence of an insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; or Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; or Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre; Patient must have a mature skeleton. Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form; AND Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender. | Compliance with Written Authority Required procedures |
C14396 | P14396 | CN14396 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C14398 | P14398 | CN14398 | Adalimumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14399 | P14399 | CN14399 | Adalimumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14400 | P14400 | CN14400 | Guselkumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14403 | P14403 | CN14403 | Pembrolizumab | Advanced carcinoma of the cervix Initial treatment The condition must be at least one of (i) persistent carcinoma, (ii) recurrent carcinoma, (iii) metastatic carcinoma of the cervix; AND The condition must be unsuitable for curative treatment with either of (i) surgical resection, (ii) radiation; AND Patient must have WHO performance status no higher than 1; AND Patient must not have received prior treatment for this PBS indication; AND Patient must be undergoing concomitant treatment with chemotherapy, containing a minimum of:
(i) a platinum-based chemotherapy agent, plus (ii) paclitaxel; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14403 |
C14404 | P14404 | CN14404 | Pembrolizumab | Advanced carcinoma of the cervix Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14404 |
C14405 | P14405 | CN14405 | Pembrolizumab | Advanced carcinoma of the cervix Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must be currently receiving non-PBS-subsidised treatment with this drug for this condition, with treatment having commenced prior to 1 October 2023; AND Patient must have met all other PBS eligibility criteria that a non-Grandfather patient would ordinarily be required to meet, meaning that at the time non-PBS supply was commenced, the patient:
(i) had either one of (1) persistent carcinoma, (2) recurrent carcinoma, (3) metastatic carcinoma of the cervix; (ii) had a WHO performance status no higher than 1; (iii) was unsuitable for curative treatment with either of (1) surgical resection, (2) radiation; (iv) had not received prior treatment for this PBS indication; (v) was treated concomitantly with platinum-based chemotherapy agent, plus paclitaxel; AND The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions. or Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14405 |
C14412 | P14412 | CN14412 | Bimekizumab | Severe chronic plaque psoriasis Grandfathered patient - Whole body (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) Patient must have a documented severe chronic plaque psoriasis where lesions have been present for at least 6 months prior to commencing non-PBS-subsidised treatment with this drug for this condition; AND Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2023; AND Patient must have a documented failure to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 5 treatments prior to commencing non-PBS-subsidised treatment with this drug for this condition:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; AND Patient must have a documented Psoriasis Area and Severity Index (PASI) score of greater than 15 prior to commencing non-PBS-subsidised treatment with this drug for this condition; 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. An adequate response to treatment is defined as A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The authority application must be made in writing and must include (a) a completed authority prescription form; and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheets including the date of the assessment of the patient's condition at baseline (prior to initiation of therapy with this drug); and (c) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. The most recent PASI assessment must be no more than 4 weeks old at the time of application. An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. | Compliance with Written Authority Required procedures |
C14415 | P14415 | CN14415 | Ustekinumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14416 | P14416 | CN14416 | Enfortumab vedotin | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer The condition must have progressed on/following both:
(i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or The condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation; AND Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND Patient must be undergoing treatment with this drug for the first time. or Patient must be undergoing continuing treatment with this drug, with each of the following being true:
(i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent. | Compliance with Authority Required procedures - Streamlined Authority Code 14416 |
C14425 | P14425 | CN14425 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14427 | P14427 | CN14427 | Etanercept | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 1 month following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 1 month old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment. To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an application for the continuing treatment is submitted to Services Australia no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should be provided within this timeframe. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14428 | P14428 | CN14428 | Guselkumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 20 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14430 | P14430 | CN14430 | Secukinumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14431 | P14431 | CN14431 | Somatropin | Severe growth hormone deficiency Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child Must be treated by an endocrinologist; AND Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child; Patient must have a mature skeleton. Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency. The authority application must be in writing and must include: A completed authority prescription form; AND A completed Severe Growth Hormone Deficiency supporting information form. | Compliance with Written Authority Required procedures |
C14437 | P14437 | CN14437 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. An adequate response to treatment is defined as A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C14442 | P14442 | CN14442 | Ustekinumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 2 repeats will be authorised. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14443 | P14443 | CN14443 | Netupitant with Palonosetron | Nausea and vomiting The treatment must be in combination with dexamethasone, unless contraindicated; AND The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapy. | Compliance with Authority Required procedures - Streamlined Authority Code 14443 |
C14448 | P14448 | CN14448 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. The most recent PASI assessment must be no more than 4 weeks old at the time of application. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14449 | P14449 | CN14449 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; AND The treatment must be as systemic monotherapy (other than methotrexate); AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND Must be treated by a dermatologist. | Compliance with Authority Required procedures |
C14453 | P14453 | CN14453 | Ixekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14460 | P14460 | CN14460 | Bimekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14461 | P14461 | CN14461 | Ixekizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14462 | P14462 | CN14462 | Secukinumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C14464 | P14464 | CN14464 | Tildrakizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Whole body (new patient) Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
C14465 | P14465 | CN14465 | Tildrakizumab | Severe chronic plaque psoriasis Initial treatment - Initial 1, Face, hand, foot (new patient) Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 28 weeks of treatment under this restriction; Patient must be aged 18 years or older; Must be treated by a dermatologist. Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application. Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met. The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application (a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment. (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application. The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy]. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 100 mg for weeks 0 and 4, then 100 mg every 12 weeks thereafter. | Compliance with Written Authority Required procedures |
C14470 | P14470 | CN14470 | Trastuzumab deruxtecan | Metastatic (Stage IV) HER2 positive breast cancer Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; or The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; AND Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND The treatment must not be prescribed where any of the following is present:
(i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only; AND Patient must be undergoing initial treatment with this drug - the following are true:
(i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions. or Patient must be undergoing continuing treatment with drug - the following are true:
(i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions. Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription 1) Evidence of HER2 gene amplification (evidence obtained in relation to past PBS treatment is acceptable). 2) Details of prior HER2 directed drug regimens prescribed for the patient. 3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable). | Compliance with Authority Required procedures |
C14471 | P14471 | CN14471 | Dapagliflozin Empagliflozin | Chronic heart failure Patient must be symptomatic with NYHA classes II, III or IV prior to initiating treatment with this drug; AND Patient must have a documented left ventricular ejection fraction (LVEF) of greater than 40%; AND Patient must have documented evidence of structural changes in the heart on echocardiography that would be expected to cause diastolic dysfunction (e.g. left ventricular hypertrophy); AND Patient must have documented evidence of at least one of the following:
(i) diastolic dysfunction with high filling pressure on echocardiography, stress echocardiography or cardiac catheterisation; (ii) hospitalisation for heart failure in the 12 months prior to initiating treatment with this drug; (iii) requirement for intravenous diuretic therapy in the 12 months prior to initiating treatment with this drug; (iv) elevated N-terminal pro brain natriuretic peptide (NT-proBNP) levels in the absence of another cause; AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor. | Compliance with Authority Required procedures - Streamlined Authority Code 14471 |
C14472 | P14472 | CN14472 | Fremanezumab | Treatment-resistant migraine Initial treatment Must be treated by a neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits:
(i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND Patient must have experienced at least 8 migraine headache days per month, over a period of at least 6 months, prior to commencement of treatment with this medicine for this condition; AND Patient must have experienced an inadequate response, intolerance or a contraindication to at least three prophylactic migraine medications prior to commencement of treatment with this drug for this condition; AND Patient must be appropriately managed by their practitioner for medication overuse headache, prior to initiation of treatment with this drug; Patient must be at least 18 years of age. Prophylactic migraine medications are propranolol, amitriptyline, pizotifen, candesartan, verapamil, nortriptyline, sodium valproate or topiramate. Patient must have the number of migraine headache days per month documented in their medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14472 |
C14483 | P14483 | CN14483 | Adalimumab Baricitinib Etanercept Tocilizumab Tofacitinib Upadacitinib | Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores. Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
C14486 | P14486 | CN14486 | Adalimumab Baricitinib Etanercept Tocilizumab Tofacitinib Upadacitinib | Severe active rheumatoid arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
C14488 | P14488 | CN14488 | Abatacept Adalimumab Baricitinib Etanercept Golimumab Tocilizumab Tofacitinib Upadacitinib | Severe active rheumatoid arthritis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
C14493 | P14493 | CN14493 | Adalimumab Baricitinib Certolizumab pegol Etanercept Tocilizumab Tofacitinib | Severe active rheumatoid arthritis First continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
C14496 | P14496 | CN14496 | Adalimumab | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of:
(i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or Patient must have a contraindication/severe intolerance to each of:
(i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to prior treatment must be documented in the patient's medical records. The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The following information must be provided by the prescriber at the time of application and documented in the patient's medical records (a) the active joint count, ESR and/or CRP result and date of results; (b) details of prior treatment, including dose and date/duration of treatment. (c) If applicable, details of any contraindications/intolerances. (d) If applicable, the maximum tolerated dose of methotrexate. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C14498 | P14498 | CN14498 | Adalimumab Baricitinib Etanercept Tocilizumab Tofacitinib Upadacitinib | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of:
(i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or Patient must have a contraindication/severe intolerance to each of:
(i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
C14499 | P14499 | CN14499 | Adalimumab Baricitinib Certolizumab pegol Etanercept Tocilizumab Tofacitinib Upadacitinib | Severe active rheumatoid arthritis Subsequent continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition under the First continuing treatment restriction; or Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 14499 |
C14507 | P14507 | CN14507 | Abatacept Adalimumab Baricitinib Certolizumab pegol Etanercept Golimumab Infliximab Tocilizumab Tofacitinib | Severe active rheumatoid arthritis First continuing treatment - balance of supply Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
C14508 | P14508 | CN14508 | Etanercept | Severe chronic plaque psoriasis Completion of course - treatment covering weeks 16 to 24 (Face, hand, foot) Must be treated by a dermatologist; AND Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 8 weeks of treatment with etanercept under this restriction. An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle. The assessment of response to treatment must be documented in the patient's medical records. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 14508 |
C14509 | P14509 | CN14509 | Etanercept | Severe chronic plaque psoriasis Completion of course - treatment covering weeks 16 to 24 (Whole body) Must be treated by a dermatologist; AND Patient must be undergoing current PBS-subsidised treatment with this biological medicine, with the intention to complete the remainder of a 24-week treatment course with this biological medicine; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 8 weeks of treatment with etanercept under this restriction. An adequate response to treatment is defined as A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The assessment of response to treatment must be documented in the patient's medical records. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Authority Required procedures - Streamlined Authority Code 14509 |
C14513 | P14513 | CN14513 | Etanercept | Severe chronic plaque psoriasis Initial 1 treatment (Whole body) - biological medicine-naive patient Must be treated by a dermatologist; AND Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient's medical records. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient's medical records. Details of the accepted toxicities including severity can be found on the Services Australia website. The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy. (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined. A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient's medical records, each of (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined. Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine. | Compliance with Authority Required procedures |
C14515 | P14515 | CN14515 | Infliximab | Severe active rheumatoid 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 rheumatoid arthritis; AND Patient must have received this drug (in any form) as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; or Patient must have demonstrated an adequate response to treatment with this drug in the intravenous form; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction. | Compliance with Written Authority Required procedures |
C14519 | P14519 | CN14519 | Abatacept Golimumab | Severe active rheumatoid arthritis First continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
C14522 | P14522 | CN14522 | Abatacept | Severe active rheumatoid arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs:
(i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of:
(i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA-approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or Patient must have a contraindication/severe intolerance to each of:
(i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; Patient must be at least 18 years of age. If methotrexate is contraindicated according to the TGA-approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion. 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). Initial treatment with an I.V. loading dose Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
C14542 | P14542 | CN14542 | Certolizumab pegol | Severe active rheumatoid arthritis Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) - balance of supply Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; or Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; or Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) restriction to complete 18 to 20 weeks treatment, depending on the dosage regimen; AND The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
C14543 | P14543 | CN14543 | Ustekinumab | Severe chronic plaque psoriasis Initial 1 treatment (Whole body) - biological medicine-naive patient Must be treated by a dermatologist; AND Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have lesions present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 28 weeks of treatment under this restriction; Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be provided at the time of application. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy (a) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of the last pre-requisite therapy. (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined. A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. Provide in this authority application, and document in the patient's medical records, each of (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) the PASI score that followed each prior therapy trialled; (iv) the date the PASI scores were determined. Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine. | Compliance with Written Authority Required procedures |
C14552 | P14552 | CN14552 | Etanercept | Severe chronic plaque psoriasis Initial 2 treatment (Face, hand, foot) - Change of treatment Must be treated by a dermatologist; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction; Patient must be under 18 years of age. 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 pre-biological treatment baseline values; or (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value. (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above. In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because (i) there is an absence of an adequate response to that treatment; or (ii) there was an intolerance to that treatment; or (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above. The assessment of response to treatment and the reason for changing therapy must be provided in this application and documented in the patient's medical records. | Compliance with Authority Required procedures |
C14553 | P14553 | CN14553 | Etanercept | Severe chronic plaque psoriasis Initial 4 - Re-treatment (Whole body) Must be treated by a dermatologist; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following:
(i) a disease flare where the PASI score has worsened (increased) by at least 50%, (ii) the current PASI score has returned above 15; AND Patient must not have failed more than once to achieve an adequate response with etanercept; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; Patient must be under 18 years of age. Where a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment. | Compliance with Authority Required procedures |
C14554 | P14554 | CN14554 | Etanercept | Severe chronic plaque psoriasis Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient Must be treated by a dermatologist; AND Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND The treatment must be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments:
(i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND Patient must not receive more than 16 weeks of treatment with etanercept under this restriction; Patient must be under 18 years of age. Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient's medical records. Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient's medical records. Details of the accepted toxicities including severity can be found on the Services Australia website. The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy (a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or (b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined. (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. Provide in this authority application, and document in the patient's medical records, each of (i) the name of each prior therapy trialled that meets the above requirements - state at least 2; (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies); (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled; (iv) the dates that response assessments were determined. (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe); (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine. Where a patient has had a 12 month treatment break, the length of the break is measured from the date the most recent treatment was stopped to the date of the application to re-commence treatment. | Compliance with Authority Required procedures |
C14556 | P14556 | CN14556 | Golimumab | Severe active rheumatoid arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; or Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; Patient must be at least 18 years of age. Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores. Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
C14557 | P14557 | CN14557 | Golimumab | Severe active rheumatoid arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
C14558 | P14558 | CN14558 | Ustekinumab | Severe chronic plaque psoriasis Continuing treatment (Whole body) - treatment covering week 28 and onwards Must be treated by a dermatologist; 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 be as systemic monotherapy; or The treatment must be in combination with methotrexate; AND Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND Patient must have demonstrated an adequate response to treatment; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle. The assessment of response to treatment must be provided in this application and documented in the patient's medical records. The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment. | Compliance with Authority Required procedures |
C14560 | P14560 | CN14560 | Abatacept | Severe active rheumatoid arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either:
(a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; Patient must be at least 18 years of age. Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application. If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Initial treatment with an I.V. loading dose Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats. Initial treatment with no loading dose One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
C14563 | P14563 | CN14563 | Fremanezumab | Treatment-resistant migraine Continuing treatment Must be treated by a neurologist; or Must be treated by a general practitioner in consultation with a neurologist; AND Patient must not be undergoing concurrent treatment with the following PBS benefits:
(i) botulinum toxin type A listed for this PBS indication, (ii) another drug in the same pharmacological class as this drug listed for this PBS indication; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved and maintained at least 50% reduction from baseline in the number of migraine headache days per month; AND Patient must continue to be appropriately managed for medication overuse headache. Patient must have the number of migraine headache days per month documented in their medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 14563 |
C14567 | P14567 | CN14567 | Adalimumab | Severe active rheumatoid arthritis First continuing treatment Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response. If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 14567 |
