C13001 | P13001 | CN13001 | Midostaurin | Acute Myeloid Leukaemia Induction / Consolidation therapy Patient must not have received prior chemotherapy as induction therapy for this condition; or The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; AND The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; AND The condition must not be acute promyelocytic leukaemia; AND The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition. A maximum of 6 cycles will be authorised under this restriction in a lifetime. Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline. The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. Progressive disease monitoring via a complete blood count must be taken at the end of each cycle. If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles. Progressive disease is defined as the presence of any of the following: Leukaemic cells in the CSF; Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; Extramedullary leukaemia. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. | Compliance with Authority Required procedures |
C13004 | P13004 | CN13004 | Trastuzumab emtansine | Early HER2 positive breast cancer Initial adjuvant treatment The treatment must be prescribed within 12 weeks after surgery; AND Patient must have, prior to commencing treatment with this drug, evidence of residual invasive cancer in the breast and/or axillary lymph nodes following completion of surgery, as demonstrated by a pathology report; AND Patient must have completed systemic neoadjuvant therapy that included trastuzumab and taxane-based chemotherapy prior to surgery; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure; AND The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined. Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery. The pathology report must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13006 | P13006 | CN13006 | Ponatinib | Chronic Myeloid Leukaemia (CML) Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have maintained a major cytogenic response of less than 35% Philadelphia positive bone marrow cells at 12 month intervals. or Patient must have maintained a peripheral blood level of BCR-ABL of less than 1% on the international scale at 12 month intervals. A pathology report demonstrating the patient's cytogenetic response or a peripheral blood level of BCR-ABL must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C13007 | P13007 | CN13007 | Lapatinib | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND The treatment must be in combination with capecitabine; AND Patient must have received prior therapy with a taxane for at least 3 cycles; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or Patient must have developed intolerance to treatment with a taxane of a severity necessitating permanent treatment withdrawal; and experienced disease progression during or within 6 months of completing treatment with pertuzumab and trastuzumab in combination; or Patient must have experienced disease progression following treatment with trastuzumab emtansine in whom disease had relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; or Patient must have experienced disease relapsed during or within 6 months of completing prior adjuvant therapy with trastuzumab; AND The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Authority applications for initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (i) details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH); and (ii) date of last treatment with a taxane and total number of cycles; or (iii) dates of treatment with trastuzumab and pertuzumab; or (iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab; or (v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application. All reports must be documented in the patient's medical records. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. If the application is submitted through HPOS upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13008 | P13008 | CN13008 | Zanubrutinib | Waldenstrom macroglobulinaemia Initial treatment The condition must have relapsed or be refractory to at least one prior chemo-immunotherapy; or Patient must be unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND Patient must be untreated with a Bruton's tyrosine kinase inhibitor for this condition. or Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this condition. | Compliance with Authority Required procedures |
C13013 | P13013 | CN13013 | Midostaurin | Acute Myeloid Leukaemia Maintenance therapy - Initial treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND Patient must not be undergoing or have undergone a stem cell transplant; AND The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority. A maximum of 3 cycles will be authorised under this restriction in a lifetime. Progressive disease monitoring via a complete blood count must be taken at the end of each cycle. If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles. Progressive disease is defined as the presence of any of the following: Leukaemic cells in the CSF; Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; Extramedullary leukaemia. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) confirmation that the patient is not undergoing or has not undergone a stem cell transplant; and (b) confirmation that the patient does not have progressive disease; and (c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and (d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin. All reports must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13017 | P13017 | CN13017 | Trastuzumab emtansine | Metastatic (Stage IV) HER2 positive breast cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. The treatment must not exceed a lifetime total of one continuous course for this PBS indication. | Compliance with Authority Required procedures |
C13018 | P13018 | CN13018 | Pertuzumab | Metastatic (Stage IV) HER2 positive breast cancer Initial treatment Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND Patient must have a WHO performance status of 0 or 1; AND Patient must not have received prior anti-HER2 therapy for this condition; AND Patient must not have received prior chemotherapy for this condition; AND The treatment must be in combination with trastuzumab and a taxane; AND The treatment must not be in combination with nab-paclitaxel; AND The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure. Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) must be provided at the time of application. The pathology report must be documented in the patient's medical records. Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval. | Compliance with Authority Required procedures |
C13022 | P13022 | CN13022 | Ponatinib | Chronic Myeloid Leukaemia (CML) First continuing treatment Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals. or Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals. The first continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or (ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response]. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13025 | P13025 | CN13025 | Ponatinib | Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; or Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal; AND Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority. or Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal. or Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis. Failure of an adequate trial of dasatinib or nilotinib is defined as 1. Lack of response to dasatinib or nilotinib therapy, defined as either (i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. All reports must be documented in the patient's medical records If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
C13030 | P13030 | CN13030 | Ponatinib | Chronic Myeloid Leukaemia (CML) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND Patient must have failed an adequate trial of imatinib confirmed through a pathology report from an Approved Pathology Authority. or Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority. or Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority. Failure of an adequate trial of imatinib or dasatinib or nilotinib is defined as 1. Lack of response to imatinib or dasatinib or nilotinib therapy, defined as either (i) failure to achieve a haematological response after a minimum of 3 months therapy with imatinib or dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with imatinib or dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with imatinib or dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing imatinib or dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing imatinib or dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed imatinib or dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during imatinib or dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and (iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
C13034 | P13034 | CN13034 | Diroximel fumarate | Multiple sclerosis Continuing treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 13034 |
C13039 | P13039 | CN13039 | Infliximab | Complex refractory Fistulising Crohn disease Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13040 | P13040 | CN13040 | Infliximab | Severe psoriatic arthritis Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13043 | P13043 | CN13043 | Infliximab | Severe psoriatic arthritis Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; AND Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must have both:
(i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response to treatment is defined as an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments. | Compliance with Authority Required procedures |
C13045 | P13045 | CN13045 | Infliximab | Moderate to severe ulcerative colitis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13049 | P13049 | CN13049 | Paliperidone | Schizophrenia Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months. or Patient must have previously received and be stabilised on PBS-subsidised paliperidone six-monthly injection for at least one cycle. | Compliance with Authority Required procedures - Streamlined Authority Code 13049 |
C13056 | P13056 | CN13056 | Infliximab | Complex refractory Fistulising Crohn disease Continuing treatment with subcutaneous form or switching from intravenous form to subcutaneous form Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug; AND Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An adequate response is defined as (a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or (b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient. The most recent fistula assessment must be no more than 1 month old at the time of application. | Compliance with Authority Required procedures |
C13058 | P13058 | CN13058 | Infliximab | Severe chronic plaque psoriasis Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a dermatologist; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13061 | P13061 | CN13061 | Infliximab | Moderate to severe ulcerative colitis Balance of supply for Initial treatment, Continuing treatment - subcutaneous form Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); or Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; or The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form; Patient must be at least 18 years of age. | Compliance with Authority Required procedures |
C13068 | P13068 | CN13068 | Infliximab | Severe Crohn disease Balance of supply for Initial treatment, Continuing treatment - subcutaneous form Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks initial treatment (intravenous and subcutaneous inclusive); or Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form; or The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form; Patient must be at least 18 years of age. | Compliance with Authority Required procedures |
C13069 | P13069 | CN13069 | Infliximab | Severe active rheumatoid arthritis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13070 | P13070 | CN13070 | Bimekizumab | Severe chronic plaque psoriasis Grandfathered patient - Face, hand, foot or Whole body - Balance of Supply Must be treated by a dermatologist; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must have received insufficient therapy with this drug for this condition under the Grandfathered patient - Whole body restriction to complete 24 weeks treatment; or Patient must have received insufficient therapy with this drug for this condition under the Grandfathered patient - Face, hand, foot restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
C13072 | P13072 | CN13072 | Diroximel fumarate | Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; or The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support). Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 13072 |
C13077 | P13077 | CN13077 | Infliximab | Ankylosing spondylitis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13078 | P13078 | CN13078 | Infliximab | Severe chronic plaque psoriasis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13079 | P13079 | CN13079 | Infliximab | Severe chronic plaque psoriasis Continuing treatment (whole body, or, face/hand/foot) with subcutaneous form or switching from intravenous form to subcutaneous form Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND The treatment must have both:
(i) provided the patient with an adequate response with the preceding supply, (ii) been assessed for response after at least 12 weeks of therapy; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 24 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Where the condition is affecting the whole body, an adequate response to treatment is defined as A Psoriasis Area and Severity Index (PASI) score which is reduced by at least 75%, or, is sustained at this level, when compared with the baseline value for this treatment cycle. State the qualifying PASI score in the authority application. Where the condition is affecting the face/hand/foot, an adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing (i) A reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or, sustained at this level, as compared to the baseline values. Indicate the rating (0=none, 1=slight) for each of these 3 observations in the authority application for each affected area; or (ii) A reduction by at least 75% in the skin area affected, or, sustained at this level, as compared to the baseline value for this treatment cycle. State the qualifying numerical percentage figure in the authority application for each affected area. All assessment findings must be no more than 1 month old at the time of application. Response assessments must be performed on the same affected area assessed at baseline. | Compliance with Authority Required procedures |
C13080 | P13080 | CN13080 | Infliximab | Severe Crohn disease Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13082 | P13082 | CN13082 | Paliperidone | Schizophrenia Patient must have previously received and be stabilised on PBS-subsidised paliperidone three-monthly injection for at least one cycle. or Patient must have previously received and be stabilised on PBS-subsidised paliperidone once-monthly injection for at least 4 consecutive months. | Compliance with Authority Required procedures - Streamlined Authority Code 13082 |
C13094 | P13094 | CN13094 | Infliximab | Complex refractory Fistulising Crohn disease Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13096 | P13096 | CN13096 | Infliximab | Ankylosing spondylitis Balance of supply (including switching formulation) where the full duration of treatment available under a particular treatment phase was not requested in the preceding prescription Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis; AND Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application did not specify the full quantity of repeat prescriptions available under the relevant PBS listing, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; or Patient must be undergoing continuing PBS-subsidised treatment with this benefit, irrespective of formulation, where each of the following is true:
(i) the most recent authority application was for a different formulation of this benefit, (ii) this authority application does not extend the current treatment phase beyond that available under the listing of the most recent authority application, (iii) this Balance of Supply listing is not being accessed on consecutive occasions; Patient must be at least 18 years of age. Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the drug formulation is changing), mark the prescription that is intended for no further supply as 'Cancelled'. | Compliance with Authority Required procedures |
C13097 | P13097 | CN13097 | Infliximab | Severe psoriatic arthritis Initial treatment with the subcutaneous form where a concurrent PBS authority application for the intravenously (IV) administered formulation is being made Must be treated by a specialist prescriber who is the same prescriber completing the PBS authority application for the IV administered formulation of this drug/biological medicine; AND Patient must be undergoing treatment with this benefit where:
(i) there is a concurrent PBS authority application for the IV administered formulation submitted for approval, (ii) the concurrent PBS authority application is approved/in the process of being approved; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The PBS administrator will confirm that (i) there is a concurrent authority application for the intravenous (IV) formulation of this benefit for the patient; (ii) the concurrent authority application for the IV formulation is to be approved before approving this authority application. | Compliance with Authority Required procedures |
C13104 | P13104 | CN13104 | Infliximab | Severe active rheumatoid arthritis Balance of supply for Initial treatment, Continuing treatment - subcutaneous form Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have received insufficient therapy with this drug for this condition under the Initial treatment with subcutaneous form restriction to complete 22 weeks initial treatment (intravenous and subcutaneous inclusive); or Patient must have received insufficient therapy with this drug for this condition under the continuing treatment with subcutaneous form restriction to complete 24 weeks treatment; AND The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly; AND The treatment must provide no more than the balance of up to 22 weeks treatment available under the Initial treatment - subcutaneous form; or The treatment must provide no more than the balance of up to 24 weeks treatment available under the Continuing treatment - subcutaneous form; Patient must be at least 18 years of age. | Compliance with Authority Required procedures |
C13122 | P13122 | CN13122 | Ciclosporin | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; or The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life; AND Must be treated by a medical practitioner who is either:
(i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13122 |
C13127 | P13127 | CN13127 | Ruxolitinib | High risk and intermediate-2 risk myelofibrosis Initial treatment The condition must be either:
(i) primary myelofibrosis, (ii) post-polycythemia vera myelofibrosis, (iii) post-essential thrombocythemia myelofibrosis, confirmed through a bone marrow biopsy report. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) Details (date, unique identifying number/code or provider number) of the bone marrow biopsy report confirming diagnosis of myelofibrosis; and (b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13128 | P13128 | CN13128 | Ruxolitinib | High risk and intermediate-2 risk myelofibrosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C13130 | P13130 | CN13130 | Ruxolitinib | Intermediate-1 risk myelofibrosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C13132 | P13132 | CN13132 | Imatinib | Malignant gastrointestinal stromal tumour Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given at a dose not exceeding 600 mg per day. Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved. A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347 472-80.) | Compliance with Authority Required procedures - Streamlined Authority Code 13132 |
C13134 | P13134 | CN13134 | Brentuximab vedotin | CD30 positive peripheral T-cell lymphoma, non-cutaneous type Initial treatment Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND The treatment must be for first line therapy for this condition; AND The treatment must be for curative intent; AND The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND The treatment must not be more than 6 treatment cycles under this restriction in a lifetime. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and (b) The date of initial diagnosis of Peripheral T-cell lymphoma. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13152 | P13152 | CN13152 | Sunitinib | Metastatic or unresectable malignant gastrointestinal stromal tumour Initial treatment The condition must not be resectable; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must have previously failed or be intolerant to imatinib mesilate. Applications for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Patients who have failed to respond or are intolerant to imatinib are no longer eligible to receive PBS-subsidised imatinib. | Compliance with Written Authority Required procedures |
C13153 | P13153 | CN13153 | Sunitinib | Metastatic or unresectable malignant gastrointestinal stromal tumour Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The condition must not be resectable; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13153 |
C13165 | P13165 | CN13165 | Decitabine with cedazuridine | Chronic Myelomonocytic Leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Up to 6 cycles will be authorised. | Compliance with Authority Required procedures |
C13166 | P13166 | CN13166 | Gilteritinib | Relapsed or refractory Acute Myeloid Leukaemia Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must not be acute promyelocytic leukaemia; AND The condition must be internal tandem duplication (ITD) and/or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition, confirmed through a pathology report from an Approved Pathology Authority; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 prior to treatment initiation. The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file. | Compliance with Authority Required procedures |
C13168 | P13168 | CN13168 | Ciclosporin | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; or The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life; AND Must be treated by a medical practitioner who is either:
(i) a dermatologist, (ii) an accredited dermatology registrar in consultation with a dermatologist. | Compliance with Authority Required procedures - Streamlined Authority Code 13168 |
C13173 | P13173 | CN13173 | Ruxolitinib | Intermediate-1 risk myelofibrosis Initial treatment The condition must be either:
(i) primary myelofibrosis, (ii) post-polycythemia vera myelofibrosis, (iii) post-essential thrombocythemia myelofibrosis, confirmed through a bone marrow biopsy report; AND Patient must have severe disease-related symptoms that are resistant, refractory or intolerant to available therapy. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include a) Details (date, unique identifying number/code or provider number) of the bone marrow biopsy report confirming diagnosis of myelofibrosis; and b) A classification of risk of myelofibrosis according to either the IPSS, DIPSS, or the Age-Adjusted DIPSS; and c) A confirmation that the patient's disease related symptoms are resistant, refractory or intolerant to available therapy. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13175 | P13175 | CN13175 | Sonidegib Vismodegib | Metastatic or locally advanced basal cell carcinoma (BCC) Initial treatment The condition must be inappropriate for surgery; AND The condition must be inappropriate for curative radiotherapy; AND Patient must not have received previous PBS-subsidised treatment with another hedgehog (Hh) inhibitor for this condition; or Patient must have developed intolerance to another hedgehog (Hh) inhibitor of a severity necessitating permanent treatment withdrawal; AND Patient must not receive more than 16 weeks of treatment under this restriction. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) Details (date, unique identifying number/code or provider number) of the histological confirmation of BCC and whether the condition is metastatic or locally advanced; and (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that surgery is inappropriate; and (c) In patients with locally advanced BCC, written confirmation from a radiation oncologist that curative radiotherapy is inappropriate. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Inappropriate for surgery is defined as (i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or (ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or (iii) Medical contraindication to surgery. (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. Inappropriate for curative radiotherapy is defined as (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery and written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
C13177 | P13177 | CN13177 | Vorinostat | Cutaneous T-cell lymphoma Initial treatment Patient must have received systemic treatment with chemotherapy; AND Patient must demonstrate relapsed or chemotherapy-refractory disease; AND Patient must be ineligible for stem cell transplant; AND The treatment must be the sole PBS-subsidised therapy for this condition. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13179 | P13179 | CN13179 | Brentuximab vedotin | CD30 positive cutaneous T-cell lymphoma Initial treatment Patient must have pathologically confirmed CD30 positive cutaneous T-cell lymphoma; AND Patient must have CD30 positivity of at least 3% of malignant cells; AND Patient must have a diagnosis of mycosis fungoides; or Patient must have a diagnosis of Sezary syndrome; or Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND Patient must have received prior systemic treatment for this condition; AND The condition must be relapsed or refractory; AND The treatment must not exceed 4 cycles under this restriction in a lifetime; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) details (date, unique identifying number/code or provider number) of the histopathology report from an Approved Pathology Authority demonstrating the patient has a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and (b) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample or of a flow cytometric analysis of lymphoma cells of the blood showing CD30 positivity of at least 3% of malignant cells; and (c) Date of commencement and completion of the most recent prior systemic treatment. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13181 | P13181 | CN13181 | Brentuximab vedotin | CD30 positive cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved an objective response with this drug; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed 12 cycles under this restriction in a lifetime. An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria. | Compliance with Authority Required procedures |
C13182 | P13182 | CN13182 | Brentuximab vedotin | CD30 positive systemic anaplastic large cell lymphoma Initial treatment The treatment must be for curative intent; AND Patient must have undergone appropriate prior front-line curative intent chemotherapy; AND Patient must demonstrate relapsed or chemotherapy-refractory disease; AND Patient must have responded to PBS-subsidised treatment with this drug if previously used for initial treatment of CD30 positive peripheral T-cell lymphoma, non-cutaneous type; AND The treatment must not exceed 4 cycles under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) details (date, unique identifying number or provider number) of a histology report showing evidence of the tumour's CD30 positivity; and (b) The date of initial diagnosis of systemic anaplastic large cell lymphoma; and (c) Dates of commencement and completion of front-line curative intent chemotherapy; and (d) a declaration of whether the patient's disease is relapsed or refractory, and the date and means by which the patient's disease was assessed as being relapsed or refractory. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13184 | P13184 | CN13184 | Entrectinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; or Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be documented in the patient's medical records (a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material. | Compliance with Written Authority Required procedures |
C13186 | P13186 | CN13186 | Crizotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C13205 | P13205 | CN13205 | Decitabine with cedazuridine | Chronic Myelomonocytic Leukaemia Initial treatment The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder. No more than 3 cycles will be authorised under this restriction in a patient's lifetime. The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and (b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following reports must be documented in the patient's medical records (a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and (b) full blood examination report | Compliance with Authority Required procedures |
C13207 | P13207 | CN13207 | Cabazitaxel | Castration resistant metastatic carcinoma of the prostate The treatment must be in combination with prednisone or prednisolone; AND The condition must be resistant to treatment with docetaxel; or Patient must have a documented intolerance necessitating permanent treatment withdrawal or a contraindication to docetaxel; AND The treatment must not be used in combination with a novel hormonal drug; AND Patient must have a WHO performance status of 2 or less; AND Patient must not receive PBS-subsidised cabazitaxel if progressive disease develops while on cabazitaxel. | Compliance with Authority Required procedures - Streamlined Authority Code 13207 |
C13208 | P13208 | CN13208 | Brentuximab vedotin | Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have undergone a primary autologous stem cell transplant (ASCT) for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 12 cycles of treatment under this restriction. The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime. | Compliance with Authority Required procedures |
C13209 | P13209 | CN13209 | Brentuximab vedotin | Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND Patient must not be suitable for ASCT for this condition; or Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND Patient must have experienced a relapsed CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; or Patient must have experienced a refractory CD30+ Hodgkin lymphoma following at least two prior treatments for this condition; AND Patient must not receive more than 4 cycles of treatment under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13212 | P13212 | CN13212 | Brentuximab vedotin | CD30 positive peripheral T-cell lymphoma, non-cutaneous type Continuing treatment The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND Patient must have completed 6 initial cycles of PBS-subsidised treatment with this drug for this indication; AND Patient must have achieved at least a partial response to the 6 initial cycles of treatment with a combination of this drug and cyclophosphamide, doxorubicin and prednisone for this indication; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. Partial response is defined using Lugano Response Criteria for Non-Hodgkin Lymphoma as (a) Positron emission tomography-based response lymph nodes and extralymphatic sites - a score of 4 (uptake moderately > liver), or 5 (uptake markedly higher than liver and/or new lesions), with reduced uptake compared with baseline and residual mass(es) of any size; nonmeasured lesions - not applicable; organ enlargement - not applicable; new lesions - none; bone marrow - residual uptake higher than uptake in normal marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed). If there are persistent focal changes in the marrow in the context of a nodal response, consideration should be given to further evaluation with MRI or biopsy or an interval scan; OR (b) Computed tomography-based response lymph nodes and extralymphatic sites - greater than or equal to 50% decrease in the sum of the product of the perpendicular diameters for multiple lesions, of up to six (6) target measurable nodes and extranodal sites; non-measured lesions - absent/normal, regressed but no increase; new lesions - none; bone marrow - not applicable. | Compliance with Authority Required procedures |
C13222 | P13222 | CN13222 | Nusinersen | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA) Initial PBS-subsidised treatment in a child The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; Patient must be of an age that is prior to their 19th birthday at the time of this authority application; Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC); Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days:
0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are (i) Failure to meet or regression in ability to perform age-appropriate motor milestones, (ii) Proximal weakness, (iii) Hypotonia, (iv) Absence of deep tendon reflexes, (v) Any active denervation or chronic neurogenic changes found on electromyography, (vi) A compound muscle action potential below normative values for an age-matched child. In this authority application, confirm (1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy, (2) which of the above (i to vi) (at least 1) were present after their 3rd birthday, but before their 19th birthday, (3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed. | Compliance with Written Authority Required procedures |
C13230 | P13230 | CN13230 | Dapagliflozin Empagliflozin | Chronic kidney disease Patient must have a diagnosis of chronic kidney disease, defined as abnormalities of at least one of:
(i) kidney structure, (ii) kidney function, present for at least 3 months, prior to initiating treatment with this drug; AND Patient must have an estimated glomerular filtration rate of between 25 to 75 mL/min/1.73 m2 inclusive prior to initiating treatment with this drug; AND Patient must have a urinary albumin to creatinine ratio of between 200 to 5000 mg/g (22.6-565 mg/mmol) inclusive prior to initiating treatment with this drug; AND Patient must discontinue treatment with this drug prior to initiating renal replacement therapy, defined as dialysis or kidney transplant; AND Patient must not be receiving treatment with another sodium-glucose co-transporter 2 (SGLT2) inhibitor; AND Patient must be stabilised, for at least 4 weeks, on either:
(i) an ACE inhibitor or (ii) an angiotensin II receptor antagonist, unless medically contraindicated, prior to initiation of combination therapy with this drug. Patients with polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis; patients requiring or with a recent history of cytotoxic or immunosuppressive therapy for kidney disease; and patients with an organ transplant are not eligible for treatment with this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 13230 |
C13231 | P13231 | CN13231 | Brentuximab vedotin | Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must not have undergone an autologous stem cell transplant (ASCT) for this condition; AND Patient must not be suitable for ASCT for this condition; or Patient must not be suitable for treatment with multi-agent chemotherapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 12 cycles of treatment under this restriction. The treatment must not exceed a total of 16 cycles of combined initial and continuing treatment in a lifetime. | Compliance with Authority Required procedures |
C13233 | P13233 | CN13233 | Crizotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be documented in the patient's medical records (a) evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Written Authority Required procedures |
C13236 | P13236 | CN13236 | Vedolizumab | Severe Crohn disease Balance of supply - subcutaneous form Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); or Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form. or The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form. | Compliance with Authority Required procedures |
C13237 | P13237 | CN13237 | Vedolizumab | Moderate to severe ulcerative colitis Balance of supply - subcutaneous form Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received insufficient therapy with this drug under the Initial treatment with subcutaneous form to complete 14 to 16 weeks Initial treatment (intravenous and subcutaneous inclusive); or Patient must have received insufficient therapy with this drug under the Continuing treatment to complete 24 weeks of treatment; AND The treatment must provide no more than the balance of doses up to 14 to 16 weeks therapy available under Initial treatment - subcutaneous form. or The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment - subcutaneous form. | Compliance with Authority Required procedures |
C13241 | P13241 | CN13241 | Decitabine with cedazuridine | Acute Myeloid Leukaemia Initial treatment The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND The condition must have 20% to 30% marrow blasts and multi-lineage dysplasia, according to World Health Organisation (WHO) Classification. The following reports must be documented in the patient's medical records (a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and (b) full blood examination report. | Compliance with Authority Required procedures |
C13242 | P13242 | CN13242 | Gilteritinib | Relapsed or refractory Acute Myeloid Leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must not be undergoing or have undergone a stem cell transplant. Progressive disease monitoring via a complete blood count must be taken at the end of each cycle. If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles. Progressive disease is defined as the presence of any of the following (a) Leukaemic cells in the CSF; or (b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or (c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or (d) Extramedullary leukaemia. | Compliance with Authority Required procedures |
C13246 | P13246 | CN13246 | Vorinostat | Cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
C13250 | P13250 | CN13250 | Crizotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing; AND Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition. or Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be documented in the patient's medical records (a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material. | Compliance with Written Authority Required procedures |
C13251 | P13251 | CN13251 | Crizotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C13257 | P13257 | CN13257 | Decitabine with cedazuridine | Myelodysplastic syndrome Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. Up to 6 cycles will be authorised. | Compliance with Authority Required procedures |
C13258 | P13258 | CN13258 | Decitabine with cedazuridine | Acute Myeloid Leukaemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease. | Compliance with Authority Required procedures - Streamlined Authority Code 13258 |
C13259 | P13259 | CN13259 | Brentuximab vedotin | Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone a primary autologous stem cell transplant (ASCT); AND Patient must have experienced a relapsed CD30+ Hodgkin lymphoma post ASCT; or Patient must have experienced a refractory CD30+ Hodgkin lymphoma post ASCT; AND Patient must not receive more than 4 cycles of treatment under this restriction. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13260 | P13260 | CN13260 | Sonidegib | Metastatic or locally advanced basal cell carcinoma (BCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The condition must remain inappropriate for surgery; AND The condition must remain inappropriate for curative radiotherapy; AND Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) Confirmation from the treating doctor that the disease has not progressed; and (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Inappropriate for surgery is defined as (i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or (ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or (iii) Medical contraindication to surgery. (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. Inappropriate for curative radiotherapy is defined as (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
C13261 | P13261 | CN13261 | Brentuximab vedotin | CD30 positive systemic anaplastic large cell lymphoma Continuing treatment Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed 12 cycles under this restriction in a lifetime. | Compliance with Authority Required procedures |
C13267 | P13267 | CN13267 | Decitabine with cedazuridine | Myelodysplastic syndrome Initial treatment The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND The condition must have up to 20% marrow blasts according to World Health Organisation (WHO) Classification. Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations (a) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR (b) 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR (c) 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR (d) 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR (e) Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias. Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations (a) 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR (b) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias. The following information must be provided by the prescriber at the time of application (a) The patient's International Prognostic Scoring System (IPSS) score. The following reports must be documented in the patient's medical records (a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and (b) full blood examination report; and (c) pathology report detailing the cytogenetics demonstrating intermediate-2 or high-risk disease according to the International Prognostic Scoring System (IPSS). No more than 3 cycles will be authorised under this restriction in a patient's lifetime. | Compliance with Authority Required procedures |
C13268 | P13268 | CN13268 | Vismodegib | Metastatic or locally advanced basal cell carcinoma (BCC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The condition must remain inappropriate for surgery; AND The condition must remain inappropriate for curative radiotherapy; AND Patient must not receive more than 16 weeks of treatment per continuing treatment under this restriction. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) Confirmation from the treating doctor that the disease has not progressed; and (b) In patients with locally advanced BCC, written confirmation from a surgically qualified clinician that the condition remains inappropriate for surgery; or written confirmation from a radiation oncologist that the condition remains inappropriate for curative radiotherapy. The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. If the application is made in writing, it is recommended that the application is submitted no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Inappropriate for surgery is defined as (i) Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; or (ii) Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); or (iii) Medical contraindication to surgery. (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. Inappropriate for curative radiotherapy is defined as (i) Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; or (ii) Limitations due to location of tumour; or (iii) Limitations due to cumulative prior radiotherapy dose; or (iv) Progressive disease despite prior irradiation of locally advanced BCC. For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records. | Compliance with Written Authority Required procedures |
C13270 | P13270 | CN13270 | Nusinersen | Spinal muscular atrophy (SMA) Initial PBS-subsidised treatment in an adult who did not initiate PBS subsidy during childhood The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug; Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS-subsidised); Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; or Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND Patient must be undergoing initial PBS-subsidised treatment for untreated disease - prescribe up to 3 repeat prescriptions to enable dosing occurring at days:
0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); or Patient must be undergoing initial PBS-subsidised treatment, but the patient has initiated treatment via non-PBS supply (e.g. clinical trial, sponsor compassionate access) - prescribe zero repeat prescriptions where loading doses are complete; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are (i) Failure to meet or regression in ability to perform age-appropriate motor milestones, (ii) Proximal weakness, (iii) Hypotonia, (iv) Absence of deep tendon reflexes, (v) Failure to gain weight appropriate for age, (vi) Any active denervation or chronic neurogenic changes found on electromyography, (vii) A compound muscle action potential below normative values for an age-matched child. In this authority application, confirm (1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy, (2) which of the above (i to vii) (at least 1) were present during childhood, (3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed. | Compliance with Written Authority Required procedures |
C13276 | P13276 | CN13276 | Entrectinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C13282 | P13282 | CN13282 | Somatrogon | Short stature and slow growth Recommencement of treatment as a reclassified patient Patient must be undergoing treatment that is simultaneously:
(a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a height greater than or equal to 167.7 cm; or Patient must be female and must not have a height greater than or equal to 155.0 cm; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment. 2. Recent growth data (height and weight, not older than three months). 3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13284 | P13284 | CN13284 | Somatrogon | Short stature and slow growth Initial treatment Patient must have a current height at or below the 1st percentile for age and sex; AND Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7 cm; or Patient must be female and must not have a height greater than or equal to 155.0 cm; AND Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; or Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm; AND Must be treated by a specialist or consultant physician in paediatric endocrinology; or Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: 1. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application. 2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years. 3. Confirmation of the patient's maturational or constitutional delay status. 4. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1st adult height percentile. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13287 | P13287 | CN13287 | Somatrogon | Short stature associated with biochemical growth hormone deficiency Continuing treatment as a reclassified patient Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously; AND The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment. 2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations. 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13288 | P13288 | CN13288 | Somatrogon Somatropin | Short stature associated with biochemical growth hormone deficiency Change of drug Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a specialist or consultant physician in paediatric endocrinology; or Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. Definition An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of (a) the 50th percentile growth velocity for bone age; (b) an increase in height standard deviation score for chronological age; (c) a minimum growth velocity of 4 cm per year; (d) a mid-parental height standard deviation score. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years. Where growth data has been supplied within 3 months of this authority application, do not resupply this data. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13290 | P13290 | CN13290 | Avelumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Maintenance therapy - Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13290 |
C13292 | P13292 | CN13292 | Somatrogon | Short stature associated with biochemical growth hormone deficiency Initial treatment Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must have a current height at or below the 1st percentile for age and sex; or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a specialist or consultant physician in paediatric endocrinology; or Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include: 1. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; or (b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex. 2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years. 3. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13293 | P13293 | CN13293 | Mecasermin | Severe growth failure with primary insulin-like growth factor-1 deficiency Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have a bone age of less than 13.5 years (females); or Patient must have a bone age of less than 15.5 years (males); AND The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND The condition must be responsive to this drug treatment as evidenced by each of:
(i) patient is showing catch-up for height standard deviation score against Laron syndrome (growth hormone insensitivity syndrome) growth charts, (ii) patient has a growth velocity of greater than 2 cm per year (extrapolated for time on treatment) at the time of this continuing authority application; or The condition must be yet to respond to this drug treatment only for the reason of sub-optimal dosing; AND Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician; Patient must be aged from 2 years up until their 18th birthday. The continuing treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) The patient's height (cm); (2) Where this authority application seeks to continue treatment where there has been an inadequate response to treatment due to sub-optimal dosing, state each of (i) the most recently prescribed dose (mg/kg) that resulted in an inadequate response; (ii) the dose (mg/kg) (between 0.04 to 0.12) that was/will be subsequently prescribed to address the inadequate response; (3) The patient's weight (kg); (4) The patient's growth velocity in response to the preceding supply of drug (cm/year; extrapolated for time on treatment); (5) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance. Height, growth velocity and weight measurements must not be more than three months old at the time of application. Document growth improvements in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13294 | P13294 | CN13294 | Somatrogon | Short stature associated with biochemical growth hormone deficiency Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; AND The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment. 2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations. 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13297 | P13297 | CN13297 | Somatrogon | Short stature associated with biochemical growth hormone deficiency Recommencement of treatment Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. Recent growth data (height and weight, not older than three months). 2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13298 | P13298 | CN13298 | Somatrogon | Short stature associated with biochemical growth hormone deficiency Recommencement of treatment as a reclassified patient Patient must be undergoing treatment that is simultaneously:
(a) recommencing treatment following a temporary break in treatment (i.e. a lapse), plus (b) reclassifying the PBS indication whilst continuing with the same growth hormone; subsidy through this treatment phase must not: (i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication where the most recent authority approval was for a different growth hormone; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment. 2. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations. 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 4. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13304 | P13304 | CN13304 | Somatrogon | Short stature and slow growth Recommencement of treatment Patient must be undergoing recommencing treatment following a temporary treatment break (i.e. a lapse) from this drug for the stated indication above - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) change the prescribed drug, (iii) reclassify the PBS indication; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not be for the purposes of resuming treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; or Patient must be female and must not have a height greater than or equal to 155.0cm; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. Recent growth data (height and weight, not older than three months). 2. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13308 | P13308 | CN13308 | Somatrogon | Short stature and slow growth Continuing treatment Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication; AND Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply; or Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; or Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; or Patient must have achieved a mid-parental height standard deviation score following the most recent supply; or The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; or Patient must be female and must not have a height greater than or equal to 155.0cm; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years. 3. The final adult height (in cm) of the patient's mother and father (where available). If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13309 | P13309 | CN13309 | Somatrogon Somatropin | Short stature and slow growth Change of drug Patient must be undergoing existing PBS-subsidised growth hormone treatment where the prescribed drug is changing within the same PBS indication - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) recommence treatment, (iii) reclassify the PBS indication; AND Patient must have been treated with PBS-subsidised growth hormone for less than 32 weeks; or Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) having been demonstrated; or Patient must have been treated with PBS-subsidised growth hormone for at least 32 weeks, with an adequate response to treatment (as defined further below) not demonstrated due to at least one of:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance to treatment arising from social/family problems, (v) sub-optimal dosing (i.e. the dose was less than the permitted upper dose range); AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; or Patient must be female and must not have a height greater than or equal to 155.0cm; AND Must be treated by a specialist or consultant physician in paediatric endocrinology; or Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. Definition An adequate response to the preceding supply of growth hormone for which the patient is changing from is one where the patient, for their sex, has achieved at least one of (a) the 50th percentile growth velocity for bone age; (b) an increase in height standard deviation score for chronological age; (c) a minimum growth velocity of 4 cm per year; (d) a mid-parental height standard deviation score. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years. Where growth data has been supplied within 3 months of this authority application, do not resupply this data. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13311 | P13311 | CN13311 | Somatrogon | Short stature associated with biochemical growth hormone deficiency Continuing treatment Patient must be undergoing continuing PBS-subsidised therapy with this drug - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication; AND Patient must have achieved the 50th percentile growth velocity for bone age plus sex following the most recent supply; or Patient must have achieved an increase in height standard deviation score for chronological age plus sex following the most recent supply; or Patient must have achieved a minimum growth velocity of 4 cm per year following the most recent supply; or Patient must have achieved a mid-parental height standard deviation score following the most recent supply; or The treatment must have been administered at a dose that is lower than that recommended in the approved Product Information in the most recent supply; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 2. A bone age result performed within the last 12 months where the patient has a chronological age greater than 2.5 years. 3. The final adult height (in cm) of the patient's mother and father (where available). If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13312 | P13312 | CN13312 | Somatrogon | Short stature and slow growth Continuing treatment as a reclassified patient Patient must be undergoing continuing PBS-subsidised therapy with this drug where the most recent authority approval for this drug was for a different PBS indication to that stated above - subsidy through this treatment phase must not:
(i) initiate treatment, (ii) change the prescribed drug, (iii) recommence treatment, (iv) reclassify the PBS indication where the most recent authority approval was for a different growth hormone, (v) reclassify the PBS indication and recommence treatment simultaneously; AND The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; or Patient must be female and must not have a height greater than or equal to 155.0cm; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where the patient had a chronological age greater than 2.5 years at commencement of treatment. 2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 3. A bone age result performed within the last 12 months where a patient has a chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13313 | P13313 | CN13313 | Avelumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Maintenance therapy - Initial treatment Patient must have received first-line platinum-based chemotherapy; AND Patient must not have progressive disease following first-line platinum-based chemotherapy; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13313 |
C13318 | P13318 | CN13318 | Somatrogon | Short stature and slow growth Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must be undergoing privately funded treatment (e.g. through a clinical trial, a sponsor compassionate access program, supply from an overseas jurisdiction) with this drug at the time of this authority application - subsidy through this treatment phase must only occur once per lifetime; AND The treatment must not be for the purposes of continuing treatment that is known to be non-efficacious for the patient - where an inadequate response has been observed for the most recent supply of this drug, it must have been confounded by at least one of the following:
(i) a significant medical illness, (ii) major surgery (e.g. renal transplant), (iii) an adverse reaction to growth hormone, (iv) non-compliance due to social/family problems, (v) a lower than recommended (as specified by this drug's approved Product Information) dose; AND Patient must have had a height no higher than the 1st percentile for age plus sex at the time treatment first commenced; AND Patient must have had a growth velocity below the 25th percentile for bone age plus sex measured over a 12 month interval (or a 6 month interval for an older child) prior to having commenced treatment; or Patient must have had an annual growth velocity of no higher than 8 cm per year where the patient had either a bone/chronological age no higher than 2.5 years prior to having commenced treatment; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a height greater than or equal to 167.7 cm; or Patient must be female and must not have a height greater than or equal to 155.0 cm; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include 1. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment where a patient had a chronological age greater than 2.5 years at commencement of treatment; OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age plus sex immediately prior to commencing treatment. 2. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months. 3. A bone age result performed within the last 12 months where the patient has chronological age greater than 2.5 years. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction. Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13320 | P13320 | CN13320 | Mecasermin | Severe growth failure with primary insulin-like growth factor-1 deficiency Initial treatment The condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5th percentile adjusted for each of:
(i) age, (ii) gender; AND The condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient's height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of:
(i) age, (ii) gender; AND Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); AND The condition must not be caused by growth hormone deficiency; AND Patient must have a bone age of less than 13.5 years (females); or Patient must have a bone age of less than 15.5 years (males); AND The condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following:
(i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; AND The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician; Patient must be aged from 2 years up until their 18th birthday. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The initial treatment authority application must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include the following (1) Insulin-like growth factor-1 deficiency (2) Short stature (3) Normal growth hormone levels (4) Bone age (where the patient has a chronological age of at least 2.5 years): (5) The patient's weight (kg); (6) The prescribed dose (mg/kg) (between 0.04 to 0.12); (7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance. State each of (a) the patient's most recent basal IGF-1 level measured (ng/mL), (b) the measurement date (dd/mm/yy), (c) the name of the pathology result provider; (2) Short stature (3) Normal growth hormone levels (4) Bone age (where the patient has a chronological age of at least 2.5 years): (5) The patient's weight (kg); (6) The prescribed dose (mg/kg) (between 0.04 to 0.12); (7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance. State the patient's height (cm); (3) Normal growth hormone levels (4) Bone age (where the patient has a chronological age of at least 2.5 years): (5) The patient's weight (kg); (6) The prescribed dose (mg/kg) (between 0.04 to 0.12); (7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance. State the patient's most recent growth hormone level measurement (mcg/L) - this figure must be greater than 6.6 mcg/L; (4) Bone age (where the patient has a chronological age of at least 2.5 years): (5) The patient's weight (kg); (6) The prescribed dose (mg/kg) (between 0.04 to 0.12); (7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance. State each of (a) the patient's bone age in numerical figures at the time when it was most recently determined, (b) the date (dd/mm/yy) of this determination that is within 12 months of this authority application; (5) The patient's weight (kg); (6) The prescribed dose (mg/kg) (between 0.04 to 0.12); (7) The number of vials rounded to the nearest whole number, to provide sufficient drug quantity for 30 days of treatment per dispensing - see the relevant 'NOTE' attached to this listing for guidance. Height, growth velocity and weight measurements must not be more than three months old at the time of application. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13321 | P13321 | CN13321 | Trientine | Chelation of elevated copper levels Patient must have a diagnosis of Wilson disease; AND Patient must be intolerant to penicillamine; AND Must be treated by a specialist medical practitioner, where this authority application is to initiate treatment with this drug, of the following type:
(i) gastroenterologist, (ii) hepatologist, (iii) neurologist; the authority prescription must be completed by the specialist prescriber. or Must be treated by a medical practitioner (of any type), where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types. or Must be treated by a nurse practitioner where this authority application is continuing established trientine treatment (of any specified salt) initiated by one of the above mentioned specialist types. Prior to seeking the initial authority approval, establish evidence of excess copper levels based on at least one of (i) clinical symptoms, (ii) measured serum copper levels, (iii) measured urinary copper levels. Document what these findings were in the patient's medical records. Do not supply them in this authority application. Refer to the following definitions if in doubt over what constitutes an acceptable intolerance to penicillamine Side effects of penicillamine occurring soon after initiation (within first few weeks/months) (i) fever, (ii) rash, (iii) enlarged lymph nodes, (iv) neutropenia, (v) thrombocytopenia, (vi) proteinuria, (vii) severe, persistent nausea. (i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia. Side effects of penicillamine developing later (i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia. At the time of the first authority application for this drug, document the details (date of reaction, severity of reaction, dose of penicillamine, etc) of the penicillamine intolerance, if not already done, in the patient's medical records. Do not supply these details in this authority application. | Compliance with Authority Required procedures |
C13330 | P13330 | CN13330 | Burosumab | X-linked hypophosphataemia Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved normalisation in serum phosphate levels; AND Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion; AND Must be treated by a medical practitioner identifying as at least one of the following specialists:
(i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist. Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X-linked hypophosphataemia. At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. | Compliance with Authority Required procedures |
C13336 | P13336 | CN13336 | Aflibercept Dexamethasone Ranibizumab | Central retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13336 |
C13337 | P13337 | CN13337 | Aflibercept Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to pathologic myopia (PM); AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13340 | P13340 | CN13340 | Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must not be due to pathologic myopia; AND The condition must not be due to age-related macular degeneration; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures - Streamlined Authority Code 13340 |
C13341 | P13341 | CN13341 | Dexamethasone | Diabetic macular oedema (DMO) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND Patient must have had a cataract removed in the treated eye; or Patient must be scheduled for cataract surgery in the treated eye; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or Patient must be unsuitable for treatment with VEGF inhibitors; or Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be as monotherapy; or The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13346 | P13346 | CN13346 | Somatropin | Short stature associated with biochemical growth hormone deficiency Initial treatment Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must have a current height at or below the 1st percentile for age and sex; or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 14 cm per year or less if the patient has a chronological age of 2 years or less; or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a specialist or consultant physician in paediatric endocrinology; or Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND 3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR (b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex; AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13350 | P13350 | CN13350 | Somatropin | Short stature and slow growth Continuing treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; or Patient must be female and must not have a height greater than or equal to 155.0cm; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. The final adult height (in cm) of the patient's mother and father (where available); AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13352 | P13352 | CN13352 | Somatropin | Short stature and slow growth Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature and slow growth category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; or Patient must be female and must not have a height greater than or equal to 155.0cm; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13353 | P13353 | CN13353 | Somatropin | Short stature associated with biochemical growth hormone deficiency Recommencement of treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND Patient must have had a lapse in treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. Recent growth data (height and weight, not older than three months); AND 6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13355 | P13355 | CN13355 | Somatropin | Short stature and slow growth Recommencement of treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND Patient must have had a lapse in treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both:
(i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a height greater than or equal to 167.7 cm; or Patient must be female and must not have a height greater than or equal to 155.0 cm; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient's chronological age was higher than 2.5 years); OR (b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND 4. Recent growth data (height and weight, not older than three months); AND 5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 6. The proprietary name (brand), form and strength of the growth hormone requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13356 | P13356 | CN13356 | Somatropin | Short stature and slow growth Initial treatment Patient must have a current height at or below the 1st percentile for age and sex; AND Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7 cm; or Patient must be female and must not have a height greater than or equal to 155.0 cm; AND Patient must be male and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 160.1 cm; or Patient must be female and must not have maturational or constitutional delay in combination with an estimated mature height equal to or above 148.0 cm; AND Must be treated by a specialist or consultant physician in paediatric endocrinology; or Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND 3. A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. Confirmation of the patient's maturational or constitutional delay status; AND 6. If the patient has maturational or constitutional delay, confirmation that the patient has an estimated mature height below the 1st adult height percentile; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13359 | P13359 | CN13359 | Somatropin | Short stature and slow growth Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature and slow growth; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication short stature associated with chronic renal insufficiency, have undergone a renal transplant and a 12 month period of observation following the transplant, and have an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; or Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both:
(i) a height no higher than the 1st percentile for age plus sex at the time of having commenced treatment with this drug, (ii) over the 12 month interval immediately prior to having commenced treatment, a growth velocity no greater than 8 cm/year where the patient had a bone/chronological age of no greater than 2.5 years; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be male and must not have a height greater than or equal to 167.7cm; or Patient must be female and must not have a height greater than or equal to 155.0cm; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (where the patient's chronological age was higher than 2.5 years); OR (b) Confirmation that the patient has previously received treatment under the indication short stature associated with chronic renal insufficiency, has undergone a renal transplant and a 12 month period of observation following the transplant, and has an estimated glomerular filtration rate of greater than or equal to 30mL/minute/1.73m2 measured by creatinine clearance, excretion of radionuclides such as DTPA, or by the height/creatinine formula; AND 4. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 5. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13360 | P13360 | CN13360 | Somatropin | Short stature associated with biochemical growth hormone deficiency Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13363 | P13363 | CN13363 | Somatropin | Short stature associated with biochemical growth hormone deficiency Continuing treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 4. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 5. The final adult height (in cm) of the patient's mother and father (where available); AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13364 | P13364 | CN13364 | Somatropin | Short stature associated with biochemical growth hormone deficiency Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 6. A bone age result performed within the last 12 months (except for a patient whose chronological age is 2.5 years or less); AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13367 | P13367 | CN13367 | Somatropin | Short stature associated with biochemical growth hormone deficiency Initial treatment Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must have a current height at or below the 1st percentile for age and sex; or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); or Patient must have a current height above the 1st and at or below the 25th percentiles for age and sex and an annual growth velocity of 8 cm per year or less if the patient has a bone age of 2.5 years or less; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a specialist or consultant physician in paediatric endocrinology; or Must be treated by a specialist or consultant physician in general paediatrics in consultation with a nominated specialist or consultant physician in paediatric endocrinology; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of the initial treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for initial treatment; AND 3. (a) A minimum of 12 months of recent growth data (height and weight measurements) or a minimum of 6 months of recent growth data for an older child. The most recent data must not be more than three months old at the time of application; OR (b) Height and weight measurements, not more than three months old at the time of application, for a patient whose current height is at or below the 1st percentile for age and sex; AND 4. A bone age result performed within the last 12 months; AND 5. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13368 | P13368 | CN13368 | Somatropin | Short stature associated with biochemical growth hormone deficiency Recommencement of treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND Patient must have had a lapse in growth hormone treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment; AND 3. Recent growth data (height and weight, not older than three months); AND 4. A bone age result performed within the last 12 months; AND 5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13378 | P13378 | CN13378 | Nintedanib Pirfenidone | Idiopathic pulmonary fibrosis Initial treatment 1 - new patient The condition must be diagnosed through a multidisciplinary team; AND Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND Patient must not have had an acute respiratory infection at the time of FVC measurement; AND Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Must be treated by a medical practitioner who is either:
(i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following:
(i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement. A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis. Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records. Authority applications must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) | Compliance with Written Authority Required procedures |
C13380 | P13380 | CN13380 | Nintedanib Pirfenidone | Idiopathic pulmonary fibrosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Must be treated by a medical practitioner who is either:
(i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. | Compliance with Authority Required procedures |
C13381 | P13381 | CN13381 | Nintedanib Pirfenidone | Idiopathic pulmonary fibrosis Initial treatment 2 - change or recommencement of treatment Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Must be treated by a medical practitioner who is either:
(i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. | Compliance with Authority Required procedures |
C13384 | P13384 | CN13384 | Aflibercept Ranibizumab | Branch retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13387 | P13387 | CN13387 | Aflibercept Dexamethasone Ranibizumab | Branch retinal vein occlusion with macular oedema Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13387 |
C13388 | P13388 | CN13388 | Aflibercept Faricimab Ranibizumab | Diabetic macular oedema (DMO) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have visual impairment due to diabetic macular oedema; AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be as monotherapy; or The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13390 | P13390 | CN13390 | Aflibercept Ranibizumab | Central retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13392 | P13392 | CN13392 | Aflibercept Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to pathologic myopia (PM); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures - Streamlined Authority Code 13392 |
C13393 | P13393 | CN13393 | Somatropin | Short stature associated with biochemical growth hormone deficiency Continuing treatment Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the short stature associated with biochemical growth hormone deficiency category; AND Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment; AND 3. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 4. A bone age result performed within the last 12 months; AND 5. The final adult height (in cm) of the patient's mother and father (where available); AND 6. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13396 | P13396 | CN13396 | Romiplostim | Severe thrombocytopenia Second or Subsequent Continuing treatment The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND Patient must have previously received PBS-subsidised treatment with this drug for this condition under first continuing or re-initiation of interrupted continuing treatment restriction; AND Patient must have demonstrated a continuing response to PBS-subsidised treatment with this drug; AND The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition. The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised. Authority approval will not be given for doses higher than 10 micrograms/kg/week | Compliance with Authority Required procedures |
C13401 | P13401 | CN13401 | Nintedanib | Progressive fibrosing Interstitial lung disease Initial treatment The condition must be diagnosed through a multidisciplinary team; AND The condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication; AND The condition must display, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5); AND Patient must have a current (no older than 2 years) forced vital capacity (FVC) measurement of no less than 45% predicted, adjusted for each of:
(i) age, (ii) gender, (iii) height; AND The condition must be of a progressive nature, observed by, in the 2 years leading up to this authority application, any of:
(i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient's medical records; AND Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND Patient must not have had an acute respiratory infection at the time of FVC measurement; AND Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin that is both:
(i) at least 30% predicted, (ii) no greater than 80% predicted; AND The condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is); AND The condition must not be due to reversible causes (e.g. drug toxicity); AND Must be treated by a medical practitioner who is either:
(i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following:
(i) that certain diagnostic criteria must be met to be eligible to initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement. 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) A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis. Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records. | Compliance with Written Authority Required procedures |
C13402 | P13402 | CN13402 | Aflibercept Faricimab Ranibizumab | Diabetic macular oedema (DMO) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be as monotherapy; or The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13402 |
C13406 | P13406 | CN13406 | Aflibercept Faricimab Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to age-related macular degeneration (AMD); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures - Streamlined Authority Code 13406 |
C13411 | P13411 | CN13411 | Cemiplimab | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Continuing treatment Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first:
(i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs. | Compliance with Authority Required procedures |
C13412 | P13412 | CN13412 | Nintedanib | Progressive fibrosing Interstitial lung disease Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Must be treated by a medical practitioner who is either:
(i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
(i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis. | Compliance with Authority Required procedures |
C13417 | P13417 | CN13417 | Somatropin | Short stature associated with biochemical growth hormone deficiency Continuing treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each continuing treatment phase is 26 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 13 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for continuing treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. Growth data (height and weight) for the most recent 6 month treatment period, including data at both the start and end of the treatment period. The most recent data must not be older than three months; AND 6. A bone age result performed within the last 12 months; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 13 weeks worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13418 | P13418 | CN13418 | Somatropin | Short stature associated with biochemical growth hormone deficiency Recommencement of treatment as a reclassified patient Patient must have previously received treatment under the PBS S100 Growth Hormone Program (treatment) under a category other than short stature associated with biochemical growth hormone deficiency; AND Patient must have had a lapse in treatment; AND The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by a significant medical illness; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by major surgery (e.g. renal transplant); or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by an adverse reaction to growth hormone; or The treatment must not have lapsed due to failure to respond to growth hormone at a dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies), unless response was affected by non-compliance due to social/family problems; AND Patient must have previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and have reached or surpassed 5 years of age (chronological); or Patient must have had a height at or below the 1st percentile for age and sex immediately prior to commencing treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and a growth velocity below the 25th percentile for bone age and sex measured over the 12 month interval immediately prior to commencement of treatment (or the 6 month interval immediately prior to commencement of treatment if the patient was an older child at commencement of treatment); or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 14 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a chronological age of 2 years or less at commencement of treatment; or Patient must have had both a height above the 1st and at or below the 25th percentiles for age and sex immediately prior to commencing treatment and an annual growth velocity of 8 cm per year or less in the 12 month period immediately prior to commencement of treatment, if the patient had a bone or chronological age of 2.5 years or less at commencement of treatment; AND Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 2 pharmacological growth hormone stimulation tests (e.g. arginine, clonidine, glucagon, insulin); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 pharmacological growth hormone stimulation test (e.g. arginine, clonidine, glucagon, insulin) and 1 physiological growth hormone stimulation test (e.g. sleep, exercise); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) with other evidence of growth hormone deficiency, including septo-optic dysplasia (absent corpus callosum and/or septum pellucidum), midline abnormality including optic nerve hypoplasia, cleft lip and palate, midfacial hypoplasia and central incisor, ectopic and/or absent posterior pituitary bright spot, absent empty sella syndrome, hypoplastic anterior pituitary gland and/or pituitary stalk/infundibulum, and genetically proven biochemical growth hormone deficiency either isolated or as part of hypopituitarism in association with pituitary deficits (ACTH, TSH, GnRH or vasopressin/ADH deficiency); or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGF-1 levels; or Patient must have evidence of biochemical growth hormone deficiency, with a peak serum growth hormone concentration less than 10 mU/L or less than or equal to 3.3 micrograms per litre in response to 1 growth hormone stimulation test (pharmacological or physiological e.g. arginine, clonidine, glucagon, insulin, sleep, exercise) and low plasma IGFBP-3 levels; AND Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND Patient must not have an active tumour or evidence of tumour growth or activity; AND Patient must be male and must not have a bone age of 15.5 years or more; or Patient must be female and must not have a bone age of 13.5 years or more; AND Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in paediatric endocrinology; or Must be treated by a medical practitioner in consultation with a nominated specialist or consultant physician in general paediatrics; AND Patient must be undergoing treatment for the stated indication with only one growth hormone at any given time. An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at least 10 years or a bone age of at least 8 years. The maximum duration of each recommencement treatment phase is 32 weeks. Prescribers must determine an appropriate weekly dose in accordance with the dosing arrangements detailed in the National Health (Growth Hormone Program) Special Arrangement 2015 and request the appropriate number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). The authority application must be in writing and must include 1. A completed authority prescription form; AND 2. A completed Growth Hormone Authority Application Supporting Information Form for recommencement of treatment as a reclassified patient; AND 3. (a) A minimum of 12 months of growth data (height and weight measurements) from immediately prior to commencement of treatment, or a minimum of 6 months of growth data from immediately prior to commencement of treatment if the patient was an older child at commencement of treatment; and the result of a bone age assessment performed within the 12 months immediately prior to commencement of treatment (except for a patient whose chronological age was 2.5 years or less at commencement of treatment); OR (b) Height and weight measurements from within three months prior to commencement of treatment for a patient whose height was at or below the 1st percentile for age and sex immediately prior to commencing treatment; OR (c) Confirmation that the patient has previously received treatment under the indication risk of hypoglycaemia secondary to growth hormone deficiency in neonates/infants and has reached or surpassed 5 years of age (chronological); AND 4. Evidence of biochemical growth hormone deficiency, including the type of tests performed and peak growth hormone concentrations; AND 5. Recent growth data (height and weight, not older than three months); AND 6. A bone age result performed within the last 12 months; AND 7. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed). Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written. Biochemical growth hormone deficiency should not be secondary to an intracranial lesion or cranial irradiation for applications under this category. In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy. | Compliance with Authority Required procedures |
C13419 | P13419 | CN13419 | Cemiplimab | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Initial treatment covering the first 3 treatment cycles The condition must be unsuitable for each of:
(i) curative surgical resection, (ii) curative radiotherapy; AND Patient must have had a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
C13422 | P13422 | CN13422 | Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to age-related macular degeneration (AMD); AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13423 | P13423 | CN13423 | Dexamethasone | Central retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13424 | P13424 | CN13424 | Aflibercept Faricimab | Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to age-related macular degeneration (AMD); AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13426 | P13426 | CN13426 | Brolucizumab | Subfoveal choroidal neovascularisation (CNV) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to age-related macular degeneration (AMD); AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye. | Compliance with Authority Required procedures |
C13427 | P13427 | CN13427 | Ranibizumab | Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must not be due to pathologic myopia; AND The condition must not be due to age-related macular degeneration; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13428 | P13428 | CN13428 | Dexamethasone | Diabetic macular oedema (DMO) Continuing treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have had a cataract removed in the treated eye; or Patient must be scheduled for cataract surgery in the treated eye; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND The treatment must be as monotherapy; or The treatment must be in combination with laser photocoagulation; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13428 |
C13429 | P13429 | CN13429 | Dexamethasone | Branch retinal vein occlusion with macular oedema Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND The condition must be diagnosed by optical coherence tomography; or The condition must be diagnosed by fluorescein angiography; AND Patient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; or Patient must have failed prior treatment with VEGF inhibitors; AND The treatment must be the sole PBS-subsidised therapy for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13431 | P13431 | CN13431 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 3 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; or The condition must have progressed after treatment with tepotinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 13431 |
C13432 | P13432 | CN13432 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 13432 |
C13433 | P13433 | CN13433 | Nivolumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial combination treatment (with ipilimumab) as first-line drug therapy The condition must be squamous type non-small cell lung cancer (NSCLC); AND Patient must not have previously been treated for this condition in the metastatic setting; or The condition must have progressed after treatment with tepotinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must be in combination with platinum-based chemotherapy for the first two cycles; AND The treatment must be in combination with ipilimumab. | Compliance with Authority Required procedures - Streamlined Authority Code 13433 |
C13434 | P13434 | CN13434 | Tepotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have a WHO performance status of 2 or less; AND Patient must have evidence of MET exon 14 skipping alterations in tumour material. | Compliance with Authority Required procedures - Streamlined Authority Code 13434 |
C13436 | P13436 | CN13436 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 6 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; or The condition must have progressed after treatment with tepotinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 4 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 13436 |
C13437 | P13437 | CN13437 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 6 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 13437 |
C13441 | P13441 | CN13441 | Tepotinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 13441 |
C13442 | P13442 | CN13442 | Atezolizumab | Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,200 mg administered once every 3 weeks Patient must be both:
(i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or Patient must be continuing existing PBS-subsidised treatment with this drug; or Patient must be both:
(i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; 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 for the purpose of adjuvant therapy following all of:
(i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling:
(i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must be undergoing treatment that does not occur beyond the following, whichever comes first:
(i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. | Compliance with Authority Required procedures - Streamlined Authority Code 13442 |
C13443 | P13443 | CN13443 | Atezolizumab | Locally advanced or metastatic non-small cell lung cancer Initial treatment - 3 weekly treatment regimen Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. or The condition must have progressed after treatment with tepotinib. | Compliance with Authority Required procedures - Streamlined Authority Code 13443 |
C13445 | P13445 | CN13445 | Nivolumab | Locally advanced or metastatic non-small cell lung cancer Initial treatment as second-line drug therapy Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. or The condition must have progressed after treatment with tepotinib. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 13445 |
C13446 | P13446 | CN13446 | Atezolizumab | Locally advanced or metastatic non-small cell lung cancer Initial treatment - 4 weekly treatment regimen Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. or The condition must have progressed after treatment with tepotinib. | Compliance with Authority Required procedures - Streamlined Authority Code 13446 |
C13448 | P13448 | CN13448 | Atezolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment 1 Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND Patient must not have previously been treated for this condition in the metastatic setting; or The condition must have progressed after treatment with tepotinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures - Streamlined Authority Code 13448 |
C13451 | P13451 | CN13451 | Atezolizumab | Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks Patient must be both:
(i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; or Patient must be continuing existing PBS-subsidised treatment with this drug; or Patient must be both:
(i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated; 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 for the purpose of adjuvant therapy following all of:
(i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling:
(i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must be undergoing treatment that does not occur beyond the following, whichever comes first:
(i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. | Compliance with Authority Required procedures - Streamlined Authority Code 13451 |
C13458 | P13458 | CN13458 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Initial treatment - (initial 3) switching from PBS-subsidised pegcetacoplan for pregnancy (induction doses) Patient must be planning pregnancy; or Patient must be pregnant; AND Patient must have received PBS-subsidised treatment with pegcetacoplan for this condition; AND The treatment must not be in combination with any of (i) ravulizumab, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria. | Compliance with Authority Required procedures |
C13459 | P13459 | CN13459 | Eculizumab Ravulizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Return from PBS-subsidised pegcetacoplan - induction doses Patient must have received PBS-subsidised treatment with at least one Complement 5 (C5) inhibitor for this condition; AND Patient must have received PBS-subsidised treatment with pegcetacoplan for this condition; AND Patient must have developed resistance or intolerance to pegcetacoplan; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). For continuing PBS-subsidised treatment with this drug, a 'Returning' patient must proceed under the'Subsequent Continuing Treatment' criteria. | Compliance with Authority Required procedures |
C13464 | P13464 | CN13464 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Grandfather 1 (transition from non-PBS-subsidised treatment) - maintenance phase Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND Patient must have experienced clinical improvement as a result of treatment with this drug; or Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Authority Required procedures |
C13469 | P13469 | CN13469 | Evolocumab | Familial homozygous hypercholesterolaemia Initial treatment The treatment must be in conjunction with dietary therapy and exercise; AND The condition must have been confirmed by genetic testing; or The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7; AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; or Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; or Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND Must be treated by a specialist physician. or Must be treated by a physician who has consulted a specialist physician. The qualifying LDL cholesterol level following at least 12 consecutive weeks of treatment with a statin (unless treatment with a statin is contraindicated or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be stated at the time of application, documented in the patient's medical records and must be no more than 8 weeks old. 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. The following must be stated at the time of application and documented in the patient's medical records (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial homozygous hypercholesterolaemia One of the following must be stated at the time of application and documented in the patient's medical records regarding prior statin treatment (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the dose, duration of treatment and details of adverse events experienced with the trial of atorvastatin or rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information | Compliance with Authority Required procedures |
C13482 | P13482 | CN13482 | Sildenafil Tadalafil | Pulmonary arterial hypertension (PAH) Initial 2 (change) Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH; AND Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND The treatment must be the sole PBS-subsidised PAH agent for this condition; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. Swapping between PAH agents:
Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted. Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
C13484 | P13484 | CN13484 | Sildenafil Tadalafil | Pulmonary arterial hypertension (PAH) Initial 1 (new patients) Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH; AND The treatment must be the sole PBS-subsidised PAH agent for this condition. A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current. (5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current. (5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. The test results must not be more than 6 months old at the time of application. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
C13495 | P13495 | CN13495 | Bosentan | Pulmonary arterial hypertension (PAH) Initial 2 (change) Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND The treatment must be the sole PBS-subsidised PAH agent for this condition; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. Swapping between PAH agents:
Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted. Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction. If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats. Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats. If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information. | Compliance with Authority Required procedures |
C13518 | P13518 | CN13518 | Infliximab | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; 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 to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 22 weeks of treatment under this restriction; Patient must be at least 18 years of age. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13526 | P13526 | CN13526 | Infliximab | Severe Crohn disease Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; Patient must be at least 18 years of age; Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy. or Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. or Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. Applications for authorisation must be made in writing and must include (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and (iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iv) the date of the most recent clinical assessment. Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following (a) patient must have evidence of intestinal inflammation; (b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. (i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. Evidence of intestinal inflammation includes (i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13532 | P13532 | CN13532 | Etanercept | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13533 | P13533 | CN13533 | Etanercept | Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a rheumatologist. or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis. An adequate response to treatment is defined as an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C13538 | P13538 | CN13538 | Etanercept | Severe chronic plaque psoriasis Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. 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 completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition. 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 the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. 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 |
C13556 | P13556 | CN13556 | Adalimumab | 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 16 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, 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. 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 |
C13558 | P13558 | CN13558 | Lorlatinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
C13560 | P13560 | CN13560 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Initial treatment - initial 1 (new patient) induction doses Patient must not have received prior treatment with this drug for this condition; AND Patient must have a diagnosis of PNH established by flow cytometry; AND Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; or Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; or Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; or Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; or Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Authority Required procedures |
C13561 | P13561 | CN13561 | Vericiguat | Chronic heart failure Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. | Compliance with Authority Required procedures - Streamlined Authority Code 13561 |
C13562 | P13562 | CN13562 | Vericiguat | Chronic heart failure Initial treatment Must be treated by a cardiologist; or Must be treated by a medical practitioner who has been directed to prescribe this medicine by a cardiologist; 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 45%; AND The condition must be stabilised following a decompensation event that required at least one of:
(i) hospitalisation in the past 6 months, (ii) intravenous diuretic therapy in the past three months; AND Patient must not have clinical signs of fluid overload; AND Patient must not have received intravenous treatment for fluid overload in the previous 24 hours; AND Patient must not have a systolic blood pressure less than 100 mmHg; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include a beta-blocker, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated; AND The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an ACE inhibitor, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin II antagonist, unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. or The treatment must be an add-on therapy to optimal standard chronic heart failure treatment, which must include an angiotensin receptor with neprilysin inhibitor combination therapy unless contraindicated according to the TGA-approved Product Information or cannot be tolerated. | Compliance with Authority Required procedures |
C13569 | P13569 | CN13569 | Sildenafil Tadalafil | Pulmonary arterial hypertension (PAH) Initial 3 - changing to this drug in combination therapy (dual or triple therapy) The treatment must form part of dual combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of dual combination therapy consisting of:
(i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of triple combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
C13570 | P13570 | CN13570 | Sildenafil Tadalafil | Pulmonary arterial hypertension (PAH) Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag) The treatment must form part of dual combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of dual combination therapy consisting of:
(i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of triple combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; AND Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
C13571 | P13571 | CN13571 | Bosentan | Pulmonary arterial hypertension (PAH) Continuing treatment Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND The treatment must be the sole PBS-subsidised PAH agent for this condition; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
C13572 | P13572 | CN13572 | Sildenafil Tadalafil | Pulmonary arterial hypertension (PAH) Continuing treatment Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND The treatment must be the sole PBS-subsidised PAH agent for this condition; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
C13573 | P13573 | CN13573 | Sildenafil Tadalafil | Pulmonary arterial hypertension (PAH) Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies:
(i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND The treatment must form part of dual combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of dual combination therapy consisting of:
(i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of triple combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
C13584 | P13584 | CN13584 | Infliximab | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 22 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 one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13586 | P13586 | CN13586 | Infliximab | Severe chronic plaque psoriasis Initial treatment - Initial 3, Whole body (re-commencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 22 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. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
C13587 | P13587 | CN13587 | Infliximab | Severe chronic plaque psoriasis Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 22 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. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. The PASI assessment for 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 |
C13593 | P13593 | CN13593 | Etanercept | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; 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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be 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 one month old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13598 | P13598 | CN13598 | Etanercept | 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 16 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. 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. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, 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. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. 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. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C13599 | P13599 | CN13599 | Adalimumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; 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 recently approved PBS-subsidised biological medicine for this condition; or Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. 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. 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13602 | P13602 | CN13602 | Adalimumab | Severe Crohn disease Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; Patient must be at least 18 years of age; Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; or Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; or Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND Patient must not receive more than 16 weeks of treatment under this restriction; AND Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy. or Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. or Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below. The authority application must be made in writing and must include (1) two completed authority prescription forms; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following (a) patient must have evidence of intestinal inflammation; (b) patient must be assessed clinically as being in a high faecal output state; (c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient. (i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. Evidence of intestinal inflammation includes (i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction. All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Services Australia website. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy. An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13609 | P13609 | CN13609 | Adalimumab | Severe Crohn disease Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND Patient must have evidence of intestinal inflammation; or Patient must be assessed clinically as being in a high faecal output state; or Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. The authority application must be made in writing and must include (1) two completed authority prescription forms; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Evidence of intestinal inflammation includes (i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13612 | P13612 | CN13612 | Adalimumab | 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 16 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 |
C13616 | P13616 | CN13616 | Pegcetacoplan | Paroxysmal nocturnal haemoglobinuria (PNH) First continuing treatment Patient must have received PBS-subsidised treatment with this drug for this condition under the 'Initial' or 'Grandfather' treatment restriction; AND The treatment must not be in combination with a Complement 5 (C5) inhibitor; AND Must be treated by a haematologist; or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details; 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). At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested. At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) | Compliance with Authority Required procedures |
C13624 | P13624 | CN13624 | Leuprorelin | Central precocious puberty Initial treatment Must be treated by a paediatric endocrinologist; or Must be treated by an endocrinologist specialising in paediatrics; Patient must be of an age that is prior to their 10th birthday if female; or Patient must be of an age that is prior to their 11th birthday if male; Patient must have had onset of signs/symptoms of central precocious puberty prior to their 8th birthday if female. or Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if male. | |
C13625 | P13625 | CN13625 | Natalizumab | Clinically definite relapsing-remitting multiple sclerosis Must be treated by a neurologist; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord. or Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 13625 |
C13629 | P13629 | CN13629 | Sildenafil Tadalafil | Pulmonary arterial hypertension (PAH) Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND The treatment must form part of dual combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of dual combination therapy consisting of:
(i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; or The treatment must form part of triple combination therapy consisting of:
(i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. | Compliance with Written Authority Required procedures |
C13632 | P13632 | CN13632 | Bosentan | Pulmonary arterial hypertension (PAH) Initial 1 (new patients) Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND The treatment must be the sole PBS-subsidised PAH agent for this condition; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. A prior PAH agent is any of ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current. (5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current. (5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. The test results must not be more than 6 months old at the time of application. If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats. Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats. If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information. | Compliance with Written Authority Required procedures |
C13639 | P13639 | CN13639 | Infliximab | Severe Crohn disease Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; or Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND Patient must have evidence of intestinal inflammation; or Patient must be assessed clinically as being in a high faecal output state; or Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; Patient must be at least 18 years of age. Applications for authorisation must be made in writing and must include (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application - Supporting Information Form which includes the following (i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and (iii) the date of the most recent clinical assessment. Evidence of intestinal inflammation includes (i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or (ii) faeces higher than normal lactoferrin or calprotectin level; or (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. 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 |
C13640 | P13640 | CN13640 | Infliximab | Severe psoriatic arthritis Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; 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 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND Patient must not receive more than 22 weeks of treatment under this restriction; Patient must be at least 18 years of age. An adequate response to treatment is defined as an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following major active joints, from at least 4, by at least 50% (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include (1) a completed authority prescription form(s); and (2) a completed Severe Psoriatic Arthritis PBS Authority Application - Supporting Information Form. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS-subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment. Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C13641 | P13641 | CN13641 | Infliximab | Complex refractory Fistulising Crohn disease Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy - Initial 1) 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 confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND Patient must have an externally draining enterocutaneous or rectovaginal fistula. Applications for authorisation must be made in writing and must include (a) a completed authority prescription form; and (b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes the following (i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition. The most recent fistula assessment must be no more than 1 month old at the time of application. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial 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. | Compliance with Written Authority Required procedures |
C13646 | P13646 | CN13646 | Etanercept | 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 16 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. Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, 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. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. 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. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C13647 | P13647 | CN13647 | Etanercept | Severe chronic plaque psoriasis Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years) Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age; Must be treated by a dermatologist. 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 completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition. 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 the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. 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 |
C13650 | P13650 | CN13650 | Adalimumab | Severe psoriatic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; 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 to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; or Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be at least 18 years of age. Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application. Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application. The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list of major joints (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason. The 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 they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13655 | P13655 | CN13655 | Pegcetacoplan | Paroxysmal nocturnal haemoglobinuria (PNH) Initial treatment (new patient) Patient must not have received prior treatment with this drug for this condition; AND Patient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND Patient must have experienced an inadequate response to a complement 5 (C5) inhibitor demonstrated by a haemoglobin level of less than 105 g/L; or Patient must be intolerant to C5 inhibitors as determined by the treating physician; AND Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy; AND Must be treated by a haematologist; or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details; 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). At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) | Compliance with Authority Required procedures |
C13660 | P13660 | CN13660 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Grandfather 2 (transition from LSDP-funded eculizumab) Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND Patient must have experienced clinical improvement as a result of treatment with this drug; or Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Authority Required procedures |
C13661 | P13661 | CN13661 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Subsequent Continuing Treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; AND Patient must have experienced clinical improvement as a result of treatment with this drug; or Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13681 | P13681 | CN13681 | Adalimumab | Severe active juvenile idiopathic arthritis Initial treatment - Initial 1 (new patient) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be:
(i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
(i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; or Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of:
(i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; or Patient must have a contraindication/severe intolerance to each of:
(i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be 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 to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable. The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances. The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs. If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application. The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; AND either (a) an active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active joints from the following list (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measurements must be no more than 4 weeks old at the time of initial application. If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13684 | P13684 | CN13684 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Initial treatment - Initial 2 (switching from PBS-subsidised ravulizumab for pregnancy) Patient must be planning pregnancy; or Patient must be pregnant; AND Patient must have received PBS-subsidised treatment with ravulizumab for this condition; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS-subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria. | Compliance with Authority Required procedures |
C13691 | P13691 | CN13691 | Infliximab | Moderate to severe Crohn disease Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or Must be treated by a paediatrician; or Must be treated by a specialist paediatric gastroenterologist; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application - Supporting Information Form which includes the following (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial 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. | Compliance with Authority Required procedures |
C13692 | P13692 | CN13692 | Infliximab | Severe chronic plaque psoriasis Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 22 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. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C13694 | P13694 | CN13694 | Adalimumab | Severe psoriatic arthritis Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a rheumatologist; or Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis; 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 The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND Patient must not receive more than 16 weeks of treatment under this restriction; Patient must be 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 above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response. The authority application must be made in writing and must include (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
C13702 | P13702 | CN13702 | Infliximab | Moderate to severe Crohn disease Initial treatment - Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); or Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; or Must be treated by a paediatrician; or Must be treated by a specialist paediatric gastroenterologist; AND Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including:
(i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; or Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra-indication to each of prednisolone (or equivalent), azathioprine, 6-mercaptopurine and methotrexate; AND Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction. Patient must be aged 6 to 17 years inclusive. Application for authorisation must be made in writing and must include (a) a completed authority prescription form; and (b) a completed Paediatric Crohn Disease PBS Authority Application -Supporting Information Form which includes the following (i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and (ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition. The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose. If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. Details of the accepted toxicities including severity can be found on the Department of Human Services website. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated. This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial 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. | Compliance with Written Authority Required procedures |
C13710 | P13710 | CN13710 | Pegcetacoplan | Paroxysmal nocturnal haemoglobinuria (PNH) Return from PBS-subsidised eculizumab post pregnancy or from PBS-subsidised Complement 5 (C5) inhibitor for reasons other than post pregnancy Patient must have received prior PBS-subsidised treatment with this drug for this condition; AND Patient must have received prior PBS-subsidised treatment with eculizumab through the 'Initial treatment - Initial 3 (switching from PBS-subsidised pegcetacoplan for pregnancy (induction doses)' criteria; or Patient must have received prior PBS-subsidised treatment with at least one C5 inhibitor and returning to pegcetacoplan treatment for reasons other than post pregnancy; AND Patient must have experienced clinical improvement as a result of treatment with this drug; or Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND The treatment must be in combination with one PBS-subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy; AND Must be treated by a haematologist; or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details; 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). At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long-term continuing PBS-subsidised treatment with pegcetacoplan is planned, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria of pegcetacoplan. | Compliance with Authority Required procedures |
C13716 | P13716 | CN13716 | Lorlatinib | Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND Patient must have a WHO performance status of 2 or less; Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing. | Compliance with Authority Required procedures |
C13718 | P13718 | CN13718 | Natalizumab | Clinically definite relapsing-remitting multiple sclerosis Must be treated by a neurologist; AND The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord. or Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug. | Compliance with Authority Required procedures - Streamlined Authority Code 13718 |
C13719 | P13719 | CN13719 | Infliximab | Severe chronic plaque psoriasis Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years) Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must be as systemic monotherapy (other than methotrexate); AND Patient must not receive more than 22 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. 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. 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. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised. The authority application must be made in writing and must include (a) a completed authority prescription form(s); and (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and (ii) details of prior biological treatment, including dosage, date and duration of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
C13726 | P13726 | CN13726 | Pembrolizumab | Relapsed or Refractory Hodgkin lymphoma Initial treatment Patient must have undergone an autologous stem cell transplant (ASCT) for this condition and have experienced relapsed or refractory disease post ASCT; or Patient must not be suitable for ASCT for this condition and have experienced relapsed or refractory disease following at least 2 prior treatments for this condition; AND Patient must not have received prior treatment with a PD-1 (programmed cell death-1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; 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 13726 |
C13727 | P13727 | CN13727 | Pembrolizumab | Relapsed or refractory primary mediastinal B-cell lymphoma Initial treatment The condition must be diagnosed as primary mediastinal B-cell lymphoma through histological investigation combined with at least one of:
(i) positron emission tomography - computed tomography (PET-CT) scan, (ii) PET scan, (iii) CT scan; AND Patient must have been treated with rituximab-based chemotherapy for this condition; AND Patient must be experiencing relapsed/refractory disease; AND Patient must be autologous stem cell transplant (ASCT) ineligible following a single line of treatment; or Patient must have undergone an autologous stem cell transplant (ASCT); or Patient must have been treated with at least 2 chemotherapy treatment lines for this condition, one of which must include rituximab-based chemotherapy; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; 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 13727 |
C13728 | P13728 | CN13728 | Pembrolizumab | Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Initial treatment Patient must be untreated for this PBS indication (i.e untreated for each of:
(i) unresectable disease, (ii) metastatic disease); AND Patient must not have received prior treatment for colorectal cancer with each of:
(i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND Patient must have a WHO performance status of 0 or 1; AND Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; 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 |
C13730 | P13730 | CN13730 | Pembrolizumab | Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; 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 |
C13731 | P13731 | CN13731 | Pembrolizumab | Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND 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 13731 |
C13732 | P13732 | CN13732 | Pembrolizumab | Relapsed or refractory primary mediastinal B-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND 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 13732 |
C13735 | P13735 | CN13735 | Pembrolizumab | Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx Initial treatment The condition must be incurable by local therapies in the locally advanced setting; AND Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND Patient must have had a WHO performance status of 0 or 1; AND The treatment must be either:
(i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; 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 13735 |
C13736 | P13736 | CN13736 | Pembrolizumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND Patient must 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 13736 |
C13739 | P13739 | CN13739 | Pembrolizumab | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy; or The condition must have progressed on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; or The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND Patient must have a WHO performance status of 2 or less; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; 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 13739 |
C13741 | P13741 | CN13741 | Pembrolizumab | Relapsed or Refractory Hodgkin lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND 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 13741 |
C13743 | P13743 | CN13743 | Pegcetacoplan | Paroxysmal nocturnal haemoglobinuria (PNH) Subsequent continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Return' criteria; AND Patient must have experienced clinical improvement as a result of treatment with this drug; or Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND The treatment must not be in combination with a Complement 5 (C5) inhibitor; AND Must be treated by a haematologist; or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details; 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). At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
C13745 | P13745 | CN13745 | Bortezomib | Newly diagnosed systemic light chain amyloidosis Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total Patient must be undergoing concurrent treatment with PBS-subsidised daratumumab for this PBS indication. | |
C13746 | P13746 | CN13746 | Pomalidomide | Multiple myeloma Initial treatment - dual therapy in combination with dexamethasone The treatment must form part of dual combination therapy limited to:
(i) this drug, (ii) dexamethasone; AND Patient must have undergone or be ineligible for a primary stem cell transplant; AND Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information. Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide. 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. 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 (1) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with lenalidomide, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide according to the relevant TGA-approved Product Information; and (2) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with bortezomib, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to bortezomib according to the relevant TGA-approved Product Information. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13748 | P13748 | CN13748 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive polymerase chain reaction (PCR) test result; or Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset; Patient must be each of:
(i) identify as Aboriginal or Torres Strait Islander, (ii) at least 30 years of age, (iii) at high risk. For the purpose of administering this restriction, high risk is defined as the presence of at least one of the following conditions 1. The patient is in residential aged care 2. The patient has disability with multiple comorbidities and/or frailty 3. Neurological conditions, including stroke and dementia and demyelinating conditions 4. Respiratory compromise, including COPD, moderate or severe asthma (required inhaled steroids), and bronchiectasis, or caused by neurological or musculoskeletal disease 5. Heart failure, coronary artery disease, cardiomyopathies 6. Obesity (BMI greater than 30 kg/m2) 7. Diabetes type I or II, requiring medication for glycaemic control 8. Renal impairment (eGFR less than 60mL/min) 9. Cirrhosis 10. The patient has reduced, or lack of, access to higher level healthcare and lives in an area of geographic remoteness classified by the Modified Monash Model as Category 5 or above 11. Past COVID-19 infection episode resulting in hospitalisation. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records. For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 13748 |
C13752 | P13752 | CN13752 | Daratumumab | Relapsed and/or refractory multiple myeloma Initial treatment as second-line drug therapy for weeks 1 to 9 (administered once weekly) The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with bortezomib and dexamethasone; AND Patient must have progressive disease after only one prior therapy (i.e. use must be as second-line drug therapy; use as third-line drug therapy or beyond is not PBS-subsidised); AND Patient must be undergoing treatment with this drug in one of the following situations:
(i) for the first time, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment for the same PBS indication. 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. A line of therapy is defined as 1 or more cycles of a planned treatment program. This may consist of 1 or more planned cycles of single-agent therapy or combination therapy, as well as a sequence of treatments administered in a planned manner. A new line of therapy starts when a planned course of therapy is modified to include other treatment agents (alone or in combination) as a result of disease progression, relapse, or toxicity, with the exception to this being the need to attain a sufficient response for stem cell transplantation to proceed. A new line of therapy also starts when a planned period of observation off therapy is interrupted by a need for additional treatment for the disease. | Compliance with Authority Required procedures |
C13753 | P13753 | CN13753 | Leflunomide | Severe active rheumatoid arthritis Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND The treatment must be initiated by a physician. | |
C13755 | P13755 | CN13755 | Pomalidomide | Multiple myeloma Continuing treatment - dual therapy in combination with dexamethasone Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must form part of dual combination therapy limited to:
(i) this drug, (ii) dexamethasone. 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). | Compliance with Authority Required procedures |
C13757 | P13757 | CN13757 | Pomalidomide | Multiple myeloma Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) The condition must be confirmed by a histological diagnosis; AND The treatment must form part of triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; AND Patient must have progressive disease after at least one prior therapy that is either:
(i) lenalidomide monotherapy, (ii) contains lenalidomide; AND Patient must have undergone or be ineligible for a stem cell transplant. 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 |
C13759 | P13759 | CN13759 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive polymerase chain reaction (PCR) test result; or Patient must have received a positive rapid antigen test (RAT) result; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND The treatment must be initiated within 5 days of symptom onset; or The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic; Patient must be at least 70 years of age. Access to this drug through this restriction is permitted irrespective of vaccination status. Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 13759 |
C13768 | P13768 | CN13768 | Pomalidomide | Multiple myeloma Continuing treatment with triple therapy (this drug, bortezomib and dexamethasone) Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must form part of triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; AND Patient must not have developed disease progression while receiving PBS-subsidised 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 |
C13769 | P13769 | CN13769 | Brolucizumab | Subfoveal choroidal neovascularisation (CNV) Initial treatment Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND The condition must be due to age-related macular degeneration (AMD); AND Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with:
1. Aflibercept and/or 2. Ranibizumab and/or 3. Faricimab; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have previously received PBS-subsidised treatment with this drug for this condition. Authority approval for initial treatment of each eye must be sought. The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report. (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If the application is submitted through HPOS form upload or mail, it must include (a) A completed authority prescription form; and (b) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). All reports must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
C13771 | P13771 | CN13771 | Leflunomide | Severe active psoriatic arthritis Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND The treatment must be initiated by a physician. | |
C13774 | P13774 | CN13774 | Daratumumab | Newly diagnosed systemic light chain amyloidosis Continuing treatment from week 25 onwards (administered once every four weeks) Patient must have previously received PBS-subsidised treatment with this drug for this condition; 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 continuing treatment that does not extend treatment duration beyond whichever comes first:
(i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime. | Compliance with Authority Required procedures |
C13782 | P13782 | CN13782 | Lenalidomide | Relapsed and/or refractory multiple myeloma Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone Patient must be undergoing concurrent treatment with elotuzumab obtained through the PBS; AND Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing. | Compliance with Authority Required procedures |
C13785 | P13785 | CN13785 | Lenalidomide | Multiple myeloma Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21-day treatment cycle The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND The treatment must form part of triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; AND Patient must not have been treated with lenalidomide or bortezomib for this condition; AND The treatment must not exceed a total of 4 cycles under this restriction. The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and (2) nomination of which disease activity parameters will be used to assess response. (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 - the percentage of plasma cells; 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. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided (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 - the percentage of plasma cells; 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 will be used to determine response, results for either (a) or (b) or (c) should be provided 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) should be stated/declared. 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 held on the patient's medical records. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13786 | P13786 | CN13786 | Lenalidomide | Multiple myeloma Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28-day treatment cycle The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND The treatment must form part of triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; AND Patient must not have been treated with lenalidomide or bortezomib for this condition; AND The treatment must not exceed a total of 4 cycles under this restriction. The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and (2) nomination of which disease activity parameters will be used to assess response. (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 - the percentage of plasma cells; 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. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided (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 - the percentage of plasma cells; 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 will be used to determine response, results for either (a) or (b) or (c) should be provided 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) should be stated/declared. 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 held on the patient's medical records. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13787 | P13787 | CN13787 | Lenalidomide | Multiple myeloma Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must form part of dual combination therapy limited to:
(i) this drug, (ii) dexamethasone. 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 |
C13791 | P13791 | CN13791 | Lenalidomide | Multiple myeloma Initial treatment with lenalidomide monotherapy in newly diagnosed disease The treatment must be as monotherapy; AND The condition must be confirmed by a histological diagnosis; AND Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND Patient must not have progressive disease following autologous stem cell transplant (ASCT). 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 (1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and (2) the date the autologous stem cell transplant was performed; and (3) nomination of which disease activity parameters will be used to assess progression. (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 - the percentage of plasma cells; 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. To enable confirmation of eligibility for treatment, the details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f) of at least one of the following must be provided (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 - the percentage of plasma cells; 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 will be used to determine progression, results for either (a) or (b) or (c) should be provided 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) should be stated/declared. 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 held in the patient's medical records. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13801 | P13801 | CN13801 | Lenalidomide | Myelodysplastic syndrome Continuing treatment Patient must have received PBS-subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS-subsidised therapy with lenalidomide; AND Patient must not have progressive disease; AND The condition must not have progressed to acute myeloid leukaemia. The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone. The following evidence of response must be provided at each application (i) a haemoglobin level taken within the last 4 weeks; and (ii) the date of the last transfusion; and (iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application; All reports must be documented in the patient's medical records. For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13803 | P13803 | CN13803 | Lenalidomide | Multiple myeloma Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease The condition must be confirmed by a histological diagnosis; AND The treatment must be as monotherapy; or The treatment must form part of 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 have undergone or be ineligible for a primary stem cell transplant. 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. 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 (1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and (2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and (3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and (4) details of the basis of the diagnosis of progressive disease or failure to respond; and (5) nomination of which disease activity parameters will be used to assess response. (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 - the percentage of plasma cells; 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. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided (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 - the percentage of plasma cells; 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 will be used to determine response, results for either (a) or (b) or (c) should be provided 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) should be stated/declared. 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 held in the patient's medical records. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13804 | P13804 | CN13804 | Lenalidomide | Multiple myeloma Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be as monotherapy. 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 |
C13805 | P13805 | CN13805 | Lenalidomide | Multiple myeloma Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease Patient must have previously received PBS-subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND The treatment must be as monotherapy. or The treatment must form part of dual combination therapy limited to:
(i) this drug, (ii) dexamethasone. | Compliance with Authority Required procedures |
C13810 | P13810 | CN13810 | Lenalidomide | Myelodysplastic syndrome Initial treatment The treatment must be limited to a maximum duration of 16 weeks; AND Patient must be classified as Low risk or Intermediate-1 according to the International Prognostic Scoring System (IPSS); AND Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND Patient must be red blood cell transfusion dependent. Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias. Classification of a patient as Intermediate-1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations 1. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 0/1 cytopenias; OR 2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR 3. less than 5% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR 4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR 5. 5%-10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR 6. 5%-10% marrow blasts with good karyotypic status (normal, -Y alone, -5q alone, -20q alone), and 2/3 cytopenias; OR 7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias. Classification of a patient as red blood cell transfusion dependent requires that (i) the patient has been transfused within the last 8 weeks; and (ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS-subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and (b) details (date, unique identifying number/code or provider number) of the full blood examination report; and (c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate-1 disease according to the IPSS (note using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS -5q is acceptable); and (d) details of transfusion requirements including (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application. All the reports must be documented in the patient's medical records. If the application is submitted through HPOS upload or mail, it must include (a) a completed authority prescription form; and (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
C13811 | P13811 | CN13811 | Lenalidomide | Multiple myeloma Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21-day treatment cycles) Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND The treatment must form part of triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; AND The treatment must not exceed a total of 4 cycles under this restriction. | Compliance with Authority Required procedures |
C13812 | P13812 | CN13812 | Lenalidomide | Multiple myeloma Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation The condition must be newly diagnosed; AND The condition must be confirmed by a histological diagnosis; AND Patient must be ineligible for a primary stem cell transplantation; AND The treatment must form part of dual combination therapy limited to:
(i) this drug, (ii) dexamethasone. 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 (1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma, and (2) confirmation of ineligibility for prior stem cell transplant; and (3) nomination of which disease activity parameters will be used to assess response. (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 - the percentage of plasma cells; 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. To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided (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 - the percentage of plasma cells; 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 will be used to determine response, results for either (a) or (b) or (c) should be provided 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) should be stated/provided. 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 held on the patient's medical records. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
C13813 | P13813 | CN13813 | Lenalidomide | Multiple myeloma Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28-day treatment cycles) Patient must have received PBS-subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND The treatment must form part of triple combination therapy limited to:
(i) this drug, (ii) bortezomib, (iii) dexamethasone; AND The treatment must not exceed a total of 2 cycles under this restriction. | Compliance with Authority Required procedures |
C13819 | P13819 | CN13819 | Romosozumab | Severe established osteoporosis Initial treatment Patient must be at very high risk of fracture; AND Patient must have a bone mineral density (BMD) T-score of -3.0 or less; AND Patient must have had 2 or more fractures due to minimal trauma; AND Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The treatment must not exceed a lifetime maximum of 12 months therapy; AND Patient must not have received treatment with PBS-subsidised teriparatide; or Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND Must be treated by a consultant physician. A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body. If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated. If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated. Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum. Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application. | Compliance with Authority Required procedures |
C13820 | P13820 | CN13820 | Romosozumab | Severe established osteoporosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed a lifetime maximum of 12 months therapy; AND Must be treated by a medical practitioner identifying as either:
(i) a consultant physician, (ii) a general practitioner. | Compliance with Authority Required procedures |
C13821 | P13821 | CN13821 | Nirmatrelvir and ritonavir | SARS-CoV-2 infection Patient must have received a positive polymerase chain reaction (PCR) test result; or Patient must have received a positive rapid antigen test (RAT) result; AND Patient must have at least one sign or symptom attributable to COVID-19; AND Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND Patient must satisfy at least one of the following criteria:
(i) be moderately to severely immunocompromised with risk of progression to severe COVID-19 disease due to the immunocompromised status, (ii) has experienced past COVID-19 infection resulting in hospitalisation; AND The treatment must be initiated within 5 days of symptom onset; Patient must be at least 18 years of age. For the purpose of administering this restriction, 'moderately to severely immunocompromised' patients are those with 1. Any primary or acquired immunodeficiency including 2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. a. Haematologic neoplasms leukaemias, lymphomas, myelodysplastic syndromes, multiple myeloma and other plasma cell disorders, b. Post-transplant solid organ (on immunosuppressive therapy), haematopoietic stem cell transplant (within 24 months), c. Immunocompromised due to primary or acquired (HIV/AIDS) immunodeficiency; OR 2. Any significantly immunocompromising condition(s) where, in the last 3 months the patient has received 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. a. Chemotherapy or whole body radiotherapy, b. High-dose corticosteroids (at least 20 mg of prednisone per day, or equivalent) for at least 14 days in a month, or pulse corticosteroid therapy, c. Biological agents and other treatments that deplete or inhibit B cell or T cell function (abatacept, anti-CD20 antibodies, BTK inhibitors, JAK inhibitors, sphingosine 1-phosphate receptor modulators, anti-CD52 antibodies, anti-complement antibodies, anti-thymocyte globulin), d. Selected conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) including mycophenolate, methotrexate, leflunomide, azathioprine, 6-mercaptopurine (at least 1.5mg/kg/day), alkylating agents (e.g. cyclophosphamide, chlorambucil), and systemic calcineurin inhibitors (e.g. cyclosporin, tacrolimus); OR 3. Any significantly immunocompromising condition(s) where, in the last 12 months the patient has received an anti-CD20 monoclonal antibody treatment, but criterion 2c above is not met; OR 4. Others with very high-risk conditions including Down Syndrome, cerebral palsy, congenital heart disease, thalassemia, sickle cell disease and other haemoglobinopathies; OR 5. People with disability with multiple comorbidities and/or frailty. Details of the patient's medical condition necessitating use of this drug must be recorded in the patient's medical records For the purpose of administering this restriction, signs or symptoms attributable to COVID-19 are fever greater than 38 degrees Celsius, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, loss of smell. Access to this drug through this restriction is permitted irrespective of vaccination status. Where PCR is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record. Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record. This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection. | Compliance with Authority Required procedures - Streamlined Authority Code 13821 |
C13839 | P13839 | CN13839 | Nivolumab | Unresectable Stage III or Stage IV malignant melanoma Maintenance treatment Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND The treatment must be as monotherapy for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this PBS indication. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. 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 13839 |
C13845 | P13845 | CN13845 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) First Continuing Treatment Patient must have received PBS-subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) | Compliance with Authority Required procedures |
C13857 | P13857 | CN13857 | Eculizumab | Paroxysmal nocturnal haemoglobinuria (PNH) Balance of Supply (transition from non-PBS-subsidised treatment during induction phase) Patient must have received non-PBS-subsidised eculizumab for this condition prior to 1 March 2022; AND Patient must have received insufficient quantity to complete the induction treatment phase; AND Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; or Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; or Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; or Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; or Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan; AND Must be treated by a haematologist. or Must be treated by a non-specialist medical physician who has consulted a haematologist on the patient's drug treatment details. 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). At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information. At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided (i) Haemoglobin (g/L) (ii) Platelets (x109/L) (iii) White Cell Count (x109/L) (iv) Reticulocytes (x109/L) (v) Neutrophils (x109/L) (vi) Granulocyte clone size (%) (vii) Lactate Dehydrogenase (LDH) (viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory (ix) the LDH ULN ratio (in figures, rounded to one decimal place) | Compliance with Authority Required procedures |
C13867 | P13867 | CN13867 | Ruxolitinib | Moderate to severe chronic graft versus host disease (cGVHD) Continuing treatment Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease at 24 weeks compared with baseline, demonstrated by either a:
(i) partial response, (ii) complete response; AND The treatment must be the sole PBS-subsidised treatment for this condition with the exception of:
(i) corticosteroids, (ii) calcineurin inhibitors; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13867 |
C13868 | P13868 | CN13868 | Sapropterin | Maternal hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Initial treatment - responsiveness testing The treatment must be for the purpose of ascertaining the patient's response to treatment over a period of 7 days, with the intent to then use the drug to control phenylalanine levels under the treatment phase:
First continuing treatment, Indication: Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU); AND Patient must have a baseline blood phenylalanine level above 250 micromol/L prior to commencing treatment with this drug despite best efforts to rely on dietary modifications to control phenylalanine levels; AND Must be treated by a metabolic physician; AND Patient must be undergoing treatment with this drug for the first time; AND Patient must not be undergoing treatment with this drug under this Treatment phase, more than once per lifetime following completion of this authority application; AND Patient must not be undergoing simultaneous treatment with this drug under another PBS-listing (apply under either listing type, but not both simultaneously); Patient must be one of:
(i) planning conception, (ii) pregnant. | Compliance with Authority Required procedures |
C13876 | P13876 | CN13876 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a:
(i) partial response (ii) complete response; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13876 |
C13880 | P13880 | CN13880 | Sapropterin | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) First continuing treatment Must be treated by a metabolic physician; or Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND Patient must have previously received PBS-subsidised treatment under the Initial treatment - responsiveness testing restriction with this drug for this condition; AND Patient must have demonstrated a response to treatment with this drug of greater than or equal to a 30% reduction in phenylalanine levels from baseline during initial responsiveness testing. Blood phenylalanine levels must be based on measurements taken during stable periods of the condition. Dietary phenylalanine intake must be maintained at a constant level. | Compliance with Authority Required procedures |
C13885 | P13885 | CN13885 | Sapropterin | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Initial treatment - responsiveness testing Must be treated by a metabolic physician; AND Patient must be untreated with this drug; or Patient must have completed prior responsiveness testing on only 1 occasion - this occurred when the patient was less than 1 month of age, but this benefit is for a second attempt at responsiveness testing in a patient aged at least 1 month old; AND Patient must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age; or Patient must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age; AND The treatment must be for the purpose of initial responsiveness testing for a period of 24 hours in a patient less than one month of age. or The treatment must be for the purpose of initial responsiveness testing for a period of 7 days in a patient aged more than one month. Dietary phenylalanine intake must be maintained at a constant level. Patients or their parent/guardian should be assessed for their ability to comply with the sapropterin protocol and PKU diet prior to conducting initial responsiveness testing. | Compliance with Authority Required procedures |
C13886 | P13886 | CN13886 | Calcitonin salmon | Hypercalcaemia The treatment must be initiated in a hospital; AND The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease. | Compliance with Authority Required procedures |
C13887 | P13887 | CN13887 | Methyldopa | Hypertension Patient must be pregnant. | Compliance with Authority Required procedures |
C13892 | P13892 | CN13892 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a:
(i) partial response (ii) complete response; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13892 |
C13900 | P13900 | CN13900 | Nivolumab | Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer The condition must have histological evidence confirming a diagnosis of a least one of:
(i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records; AND The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy; AND The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either:
(i) at least ypT1, (ii) at least ypN1; document this evidence in the patient's medical records; AND Patient must have/have had, 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 therapy for this condition; AND Patient must be undergoing treatment with a dosing regimen as set out in the drug's approved Australian Product Information; AND Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first:
(i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs. | Compliance with Authority Required procedures |
C13906 | P13906 | CN13906 | Ruxolitinib | Moderate to severe chronic graft versus host disease (cGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following:
(i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND The treatment must be the sole PBS-subsidised treatment for this condition with the exception of:
(i) corticosteroids, (ii) calcineurin inhibitors; AND Must be treated by a haematologist; or Must be treated by an oncologist with allogeneic bone marrow transplantation experience; or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation. The severity of cGVHD is defined by the National Institutes of Health (NIH) criteria (Jagasia et al., 2015) (a) Moderate cGVHD at least one organ (not lung) with a score of 2, 3 or more organs involved with a score of 1 in each organ, or lung score of 1 (b) Severe cGVHD at least 1 organ with a score of 3, or lung score of 2 or 3 Steroid-refractory disease is defined as (a) a lack of response or disease progression after administration of a minimum prednisone dose of 1 mg/kg/day for at least 1 week (or equivalent); or (b) disease persistence without improvement despite continued treatment with prednisone at greater than 0.5 mg/kg/day or 1 mg/kg/every other day for at least 4 weeks (or equivalent). Steroid-dependent disease is defined as an increased prednisone dose to greater than 0.25 mg/kg/day after two unsuccessful attempts to taper the dose (or equivalent). Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 24 weeks after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as defined by the National Institutes of Health (NIH) criteria (Lee et al., 2015). Note that response is relative to the assessment of organ function affected by cGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as complete resolution of all signs and symptoms of cGVHD in all evaluable organs without initiation or addition of new systemic therapy. (b) partial response is defined as an improvement in at least one organ (e.g. improvement of 1 or more points on a 4-to-7-point scale, or an improvement of 2 or more points on a 10-to-12-point scale) without progression in other organs or sites, initiation or addition of new systemic therapies. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13906 |
C13907 | P13907 | CN13907 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following:
(i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Steroid-refractory disease is defined as (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13907 |
C13911 | P13911 | CN13911 | Ruxolitinib | Grade II to IV acute graft versus host disease (aGVHD) Initial treatment Patient must have received prior systemic steroid treatment for this condition; AND Patient must be one of the following:
(i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment; AND Must be treated by a haematologist. or Must be treated by an oncologist with allogeneic bone marrow transplantation experience. or Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types. The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Steroid-refractory disease is defined as (a) progression after at least 3 days of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD; or (b) failure to achieve a partial response after 5 days at the time of initiation of high-dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II-IV aGVHD. (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid-dependent disease is defined as failed corticosteroid taper involving either one of the following criteria (a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or (b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days. Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal. Details of prior steroid use should be documented in the patient's medical records. A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment. Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib. (a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. (b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non-response of aGVHD. The assessment of response must be documented in the patient's medical records. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. | Compliance with Authority Required procedures - Streamlined Authority Code 13911 |
C13912 | P13912 | CN13912 | Sapropterin | Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU) Subsequent continuing Must be treated by a metabolic physician; or Must be treated by a nurse practitioner experienced in the treatment of phenylketonuria in consultation with a metabolic physician; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND Patient must be undergoing regular phenylalanine testing and assessment of adherence to dietary modifications. | Compliance with Authority Required procedures |
C13913 | P13913 | CN13913 | Calcitonin salmon | Symptomatic Paget disease of bone The treatment must be for a patient who cannot tolerate bisphosphonates due to kidney disease. | Compliance with Authority Required procedures |
C13920 | P13920 | CN13920 | Abacavir | Human immunodeficiency virus (HIV) infection Patient must be less than 13.00 years of age; Patient must be unable to take a solid dose form of this drug; AND The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures |
C13921 | P13921 | CN13921 | Lenvatinib | 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 and pembrolizumab 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. | Compliance with Authority Required procedures - Streamlined Authority Code 13921 |
C13922 | P13922 | CN13922 | Methylphenidate | Attention deficit hyperactivity disorder Patient must be aged between the ages of 6 and 18 years inclusive; or Patient must have had a diagnosis of ADHD prior to turning 18 years of age if PBS-subsidised treatment is continuing beyond 18 years of age; or Patient must have a retrospective diagnosis of ADHD if PBS-subsidised treatment is commencing after turning 18 years of age; or Patient must have had a retrospective diagnosis of ADHD if PBS-subsidised treatment is continuing in a patient who commenced PBS-subsidised treatment after turning 18 years of age; Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND Patient must require continuous coverage over 8 hours; AND The treatment must not exceed a maximum daily dose of 80 mg with this drug. A retrospective diagnosis of ADHD for the purposes of administering this restriction is (i) the presence of pre-existing childhood symptoms of ADHD (onset during the developmental period, typically early to mid-childhood); and (ii) documentation in the patient's medical records that an in-depth clinical interview with, or, obtainment of evidence from, either a (a) parent, (b) teacher, (c) sibling, (d) third party, has occurred and which supports point (i) above. | Compliance with Authority Required procedures |
C13923 | P13923 | CN13923 | Asciminib | Chronic Myeloid Leukaemia (CML) Continuing treatment for patients without T315I mutation The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must have received initial PBS-subsidised treatment with this drug 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. | Compliance with Authority Required procedures - Streamlined Authority Code 13923 |
C13925 | P13925 | CN13925 | Asciminib | Chronic Myeloid Leukaemia (CML) Initial PBS-subsidised treatment for patients with T315I mutation The condition must not be in the blast phase; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must be expressing the T315I mutation confirmed through a bone marrow biopsy pathology report; AND 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 one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority. or Patient must have experienced intolerance, not failure to respond, to at least one tyrosine kinase inhibitor as confirmed through a pathology report from an Approved Pathology Authority. 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). The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating evidence of the T315I mutation; and (iv) where there has been a loss of response to imatinib or dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. All reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). 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 Up to a maximum of 18 months of treatment may be authorised under this initial restriction. | Compliance with Written Authority Required procedures |
