Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p52
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 52/69)
Character Range: 549437–555580

(1) a completed authority prescription form; and
                                                                                                                (2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application ‑ Supporting Information Form; and
                                                                                                                (3) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
                                                                                                                (4) if applicable, the date of completion of blinatumomab treatment for measurable residual disease and the date of the patient's subsequent relapse; and
                                                                                                                (5) the percentage blasts in bone marrow count that is no more than 4 weeks old at the time of application.
C14631              P14631         Blinatumomab                                                                 Measurable residual disease of precursor B‑cell acute lymphoblastic leukaemia (Pre‑B‑cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                Initial treatment of measurable residual disease of Pre‑B‑cell ALL
                                                                                                                Must be treated by a physician experienced in the treatment of haematological malignancies.
                                                                                                                Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
                                                                                                                The condition must not be present in the central nervous system or testis; AND
                                                                                                                Patient must have achieved complete remission following intensive combination chemotherapy for initial treatment of acute lymphoblastic leukaemia (ALL) or for subsequent salvage therapy; AND
                                                                                                                Patient must have measurable residual disease based on measurement in bone marrow, documented after an interval of at least 2 weeks from the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL/as subsequent salvage therapy, whichever was the later, measured using flow cytometry/molecular methods; AND
                                                                                                                The treatment must not be more than 2 treatment cycles 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) a completed authority prescription form; and
                                                                                                                (2) a completed Measurable residual disease positive Acute Lymphoblastic Leukaemia 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.
C14676              P14676         Nivolumab                                                                    Advanced or metastatic