Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p163
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 163/312)
Character Range: 16475294–16483063

commencement, duration of therapy) of prior biological medicine treatment; and
                                                                                                                           (c) if applicable, the eosinophil count and date; and
                                                                                                                           (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and
                                                                                                                           (e) if applicable, the IgE result and date; and
                                                                                                                           (f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy).
C15428              P15428         CN15428          Niraparib                                                              High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets
                                                                                                                           Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           The treatment must not exceed a total of 36 months of combined non-PBS-subsidised/PBS-subsidised treatment for patients who are in complete response.
C15430              P15430         CN15430          Inclisiran                                                             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           The treatment must be in conjunction with dietary therapy and exercise; AND
                                                                                                                           Patient must have symptomatic atherosclerotic cardiovascular disease; AND
                                                                                                                           Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND
                                                                                                                           Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR
                                                                                                                           Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR
                                                                                                                           Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR
                                                                                                                           Patient must have diabetes mellitus with microalbuminuria; OR
                                                                                                                           Patient must have diabetes mellitus and be aged 60 years or more; OR
                                                                                                                           Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
                                                                                                                           Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; AND
                                                                                                                           Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise; OR
                                                                                                                           Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; OR
                                                                                                                           Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
                                                                                                                           Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated),