Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p150
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 150/312)
Character Range: 16403870–16410160

rising pattern on consecutive measurements and which is unexplained by other causes; or
                                                                                                                           (iii) Unexplained, persistent elevations of serum transaminases (greater than 3 times the upper limit of normal) during treatment with a statin.
                                                                                                                           If treatment with atorvastatin or rosuvastatin resulted in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must have been treated with the alternative statin (atorvastatin or rosuvastatin) unless there was a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should have occurred after a washout period of at least 4 weeks, or if the creatine kinase (CK) level was elevated, the retrial should not have occurred until CK had 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 stated at the time of application and 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 stated at the time of application and 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.
                                                                                                                           A patient may qualify for PBS-subsidised treatment under this restriction once only.
                                                                                                                           For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.
                                                                                                                           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.
C15371              P15371         CN15371          Olaparib                                                               Early breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have received PBS-subsidised treatment with this drug as adjuvant therapy for this condition; AND
                                                                                                                           Patient must not have developed disease recurrence while receiving treatment with this drug for this condition; AND
                                                                                                                           The treatment must not be 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