Document ID: chunk:federal_register_of_legislation:F2025L00222:schedule:1:p2
Version: federal_register_of_legislation:F2025L00222
Segment Type: schedule
Provision Reference: sch 1 (pt 2/4)
Character Range: 6040–10540

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) details of the proposed prescription; 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 Pre-B-cell ALL in CR 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.
C16308  P16308  Blinatumomab  Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                              Continuing treatment of Pre-B-cell ALL in complete haematological remission (CR)
                              Must be treated by a physician experienced in the treatment of haematological malignancies.
                              Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                              Patient must have achieved a complete remission; AND
                              The condition must be negative for measurable residual disease (MRD) using the same method used to establish initial MRD status; AND
                              Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                              The treatment must 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.
C16334  P16334  Blinatumomab  Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                              Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements for Pre-B-cell ALL in complete haematological remission (CR)
                              Must be treated by a physician experienced in the treatment of haematological malignancies.
                              Patient must have commenced treatment with this medicine for this condition prior to 1 March 2025; AND
                              Patient