Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p33
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 33/51)
Character Range: 117053–121714

treatment with a statin as defined in the TGA-approved Product Information.
                                                One or more of the following must be documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:
                                                (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or
                                                (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or
                                                (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or
                                                (iv) diabetes mellitus with microalbuminuria; or
                                                (v) diabetes mellitus and age 60 years or more; or
                                                (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or
                                                (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher.
                                                Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.
C16334  P16334  CN16334  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 must have had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, at initiation of non-PBS-subsidised treatment with this drug; 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) at initiation of non-PBS-subsidised treatment with this drug; OR
                                                Patient must have had at initiation of non-PBS-subsidised treatment with this drug: (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
                                                Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                Patient must have received at least 1 treatment cycle of non-PBS therapy under this restriction; AND
                                                The treatment must not be more than 4 treatment cycles of therapy (non-PBS and PBS) 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