Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p157
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 157/312)
Character Range: 16444349–16451373

occur until CK has returned to normal.
                                                                                                                           In the event of a trial of the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved.
                                                                                                                           The following must be documented in the patient's medical records:
                                                                                                                           (i) the qualifying Dutch Lipid Clinic Network Score; or
                                                                                                                           (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia
                                                                                                                           One of the following must be documented in the patient's medical records regarding prior statin treatment:
                                                                                                                           (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or
                                                                                                                           (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or
                                                                                                                           (iii) the patient is contraindicated to treatment with 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.
C15414              P15414         CN15414          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 up to 2 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 with this drug for this condition; 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 a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.
C15416              P15416         CN15416          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