Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p34
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 34/51)
Character Range: 121374–126407

under this restriction in a lifetime.
                                                According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle.
                                                For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.
                                                An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
                                                Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                The authority application must be made in writing and must include:
                                                (1) details of the proposed prescription; and
                                                (2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and
                                                (3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; and
                                                (4) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.
                                                Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
C16336  P16336  CN16336  Evolocumab             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16336
                                                Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran
                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
C16338  P16338  CN16338  Risankizumab           Severe psoriatic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                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