Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p47
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 47/51)
Character Range: 174688–178525

Patient must have had an LDL cholesterol level in excess of 5 millimoles per litre at the time non-PBS-subsidised treatment with this drug for this condition was initiated; AND
                                                Patient must have been treated with the maximum recommended dose of atorvastatin (80 mg daily) or rosuvastatin (40 mg daily) according to the TGA-approved Product Information or the maximum tolerated dose of atorvastatin or rosuvastatin for at least 12 consecutive weeks in conjunction with dietary therapy and exercise prior to initiating non-PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have developed a clinically important product-related adverse event necessitating withdrawal of statin treatment to trials of each of atorvastatin 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 an authorised prescriber in consultation with 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 documented in the patient's medical records and must have been no more than 8 weeks old at the time non-PBS-subsidised treatment