Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p15
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 15/51)
Character Range: 40901–45338

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 Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL), (ii) treated with this drug for Pre-B-cell ALL, 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) 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.
C16294  P16294  CN16294  Evolocumab             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 16294
                                                Initial treatment
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                The condition must have been confirmed by genetic testing; OR
                                                The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6; AND
                                                Patient must have an LDL cholesterol