Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p149
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 149/312)
Character Range: 16399216–16404395

and rosuvastatin prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
                                                                                                                           Patient must be contraindicated to treatment with a HMG CoA reductase inhibitor (statin) as defined in the TGA-approved Product Information; AND
                                                                                                                           Patient must have been treated with ezetimibe for at least 12 consecutive weeks in conjunction with a statin (if tolerated), dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; 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 a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) 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 must have been measured 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 stated at the time of application, documented in the patient's medical records and must have been no more than 8 weeks old at the time non-PBS-subsidised treatment with this drug for this condition was initiated.
                                                                                                                           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