Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p152
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 152/312)
Character Range: 16416839–16421865

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 treated by a specialist physician; OR
                                                                                                                           Must be treated by a physician who has consulted a specialist physician.
                                                                                                                           Symptomatic atherosclerotic cardiovascular disease is defined as:
                                                                                                                           (i) the presence of symptomatic coronary artery disease (prior myocardial infarction, prior revascularisation procedure, angina associated with demonstrated significant coronary artery disease (50% or greater stenosis in 1 or more coronary arteries on imaging), or positive functional testing (e.g. myocardial perfusion scanning or stress echocardiography); or
                                                                                                                           (ii) the presence of symptomatic cerebrovascular disease (prior ischaemic stroke, prior revascularisation procedure, or transient ischaemic attack associated with 50% or greater stenosis in 1 or more cerebral arteries on imaging); or
                                                                                                                           (iii) the presence of symptomatic peripheral arterial disease (prior acute ischaemic event due to atherosclerosis, prior revascularisation procedure, or symptoms of ischaemia with evidence of significant peripheral artery disease (50% or greater stenosis in 1 or more peripheral arteries on imaging)).
                                                                                                                           The qualifying LDL cholesterol level following at least 12 consecutive weeks of combined treatment with a statin, ezetimibe, dietary therapy and exercise (unless treatment with a statin is contraindicated, or following completion of statin trials as described in these prescriber instructions in the event of clinically important adverse events) must be documented in the patient's medical records and must be no more than 8 weeks old.
                                                                                                                           A clinically important product-related adverse event is defined as follows:
                                                                                                                           (i) Severe myalgia (muscle symptoms without creatine kinase elevation) which is proven to be temporally associated with statin treatment; or
                                                                                                                           (ii) Myositis (clinically important creatine kinase 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 results in development of a clinically important product-related adverse event resulting in treatment withdrawal, the patient must be treated with the alternative statin (atorvastatin or rosuvastatin) unless there is a contraindication (e.g. prior rhabdomyolysis) to the alternative statin. This retrial should occur after a washout period of at least 4 weeks, or if the creatine kinase (CK) level is elevated, retrial should not occur until CK has returned to normal.
                                                                                                                           In the event of a trial of