Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p31
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 31/51)
Character Range: 109883–114111

in conjunction with dietary therapy and exercise; AND
                                                Patient must have symptomatic atherosclerotic cardiovascular disease; AND
                                                Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre; AND
                                                Patient must have atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); OR
                                                Patient must have severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; OR
                                                Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; OR
                                                Patient must have diabetes mellitus with microalbuminuria; OR
                                                Patient must have diabetes mellitus and be aged 60 years or more; OR
                                                Patient must be an Aboriginal or Torres Strait Islander with diabetes mellitus; OR
                                                Patient must have a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher; 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; OR
                                                Patient must have developed clinically important product-related adverse events necessitating withdrawal of statin treatment to trials of each of atorvastatin and rosuvastatin; 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; 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