Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p151
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 151/312)
Character Range: 16409674–16417388

a PBS-subsidised benefit beyond a total of 52 weeks of treatment (including any non-PBS-subsidised supply); AND
                                                                                                                           The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab.
C15391              P15391         CN15391          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 (BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets
                                                                                                                           The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase: Initial first-line maintenance therapy (BRCA1/2 gene mutation); 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.
C15395              P15395         CN15395          Evolocumab                                                             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 15395
                                                                                                                           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), dietary therapy and exercise; OR
                                                                                                                           Patient must have developed clinically important product-related adverse event/contraindication as defined in the TGA approved Product Information necessitating withdrawal of ezetimibe; AND
                                                                                                                           Patient must not be receiving