Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p144
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 144/312)
Character Range: 16370306–16375502

elevation, with or without muscle symptoms) demonstrated by results twice the upper limit of normal on a single reading or a 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.
                                                                                                                           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.
                                                                                                                           One or more of the following must be stated at the time of application and documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event:
                                                                                                                           (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or
                                                                                                                           (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or
                                                                                                                           (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or
                                                                                                                           (iv) diabetes mellitus with microalbuminuria; or
                                                                                                                           (v) diabetes mellitus and age 60 years or more; or
                                                                                                                           (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or
                                                                                                                           (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher.
                                                                                                                           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