Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p155
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 155/312)
Character Range: 16433969–16440381

in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND
                                                                                                                           Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
                                                                                                                           Patient must be undergoing treatment with this drug class for the first time; OR
                                                                                                                           Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.
                                                                                                                           A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
                                                                                                                           Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.
                                                                                                                           Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.
C15410              P15410         CN15410          Evolocumab                                                             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 15410
                                                                                                                           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 level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR
                                                                                                                           Patient must have an LDL cholesterol level in excess of 5 millimoles per litre; 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 concomitant PBS-subsidised treatment with any of: (i) another monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9), (ii) inclisiran, for this PBS indication.
                                                                                                                           Must be