Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p51
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 51/69)
Character Range: 544025–549938

not be more than 2 treatment cycles under this restriction in a lifetime.
                                                                                                                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 microgram 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.
                                                                                                                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.
C14588              P14588         Blinatumomab                                                                 Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                                Induction treatment
                                                                                                                The condition must be relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
                                                                                                                The condition must not be present in the central nervous system or testis; AND
                                                                                                                Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
                                                                                                                Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
                                                                                                                Patient must not have received more than 1 line of salvage therapy; AND
                                                                                                                The condition must be one of the following: (i) untreated with this drug for measurable residual disease, (ii) treated with this drug for measurable residual disease, but the condition has not relapsed within 6 months of completing that course of treatment; AND
                                                                                                                The condition must have more than 5% blasts in bone marrow; 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 9 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 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
                                                                                                                An amount of 651 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 1. An amount of 784 microgram, which may be obtained under Induction treatment ‑ balance of supply restriction, will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
                                                                                                                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 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