Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p38
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 38/51)
Character Range: 137039–141552

therapy with this drug under the Initial 1 (new patient) restriction to complete 28 weeks treatment; OR
                                                Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 28 weeks treatment; OR
                                                Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 28 weeks treatment; AND
                                                The treatment must provide no more than the balance of up to 28 weeks treatment available under the above restriction.
                                                Must be treated by a rheumatologist; OR
                                                Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
C16341  P16341  CN16341  Blinatumomab           Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                Initial 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 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
                                                Patient must have: (i) achieved complete remission following intensive combination chemotherapy, (ii) measurable residual disease based on measurement in bone marrow, documented after 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) 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