Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p167
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 167/312)
Character Range: 16498238–16505000

a statin as defined in the TGA-approved Product Information.
                                                                                                                           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.
C15440              P15440         CN15440          Niraparib                                                              High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation) in a patient requiring a daily dose of up to 2 tablets
                                                                                                                           The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND
                                                                                                                           The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND
                                                                                                                           Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; OR
                                                                                                                           The condition must have both: (i) been 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.
C15441              P15441         CN15441          Niraparib                                                              High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial first-line maintenance therapy (BRCA1/2 gene mutation) in a patient requiring a daily dose of 3 tablets
                                                                                                                           The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - this has been confirmed by a validated test; AND
                                                                                                                           Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment