Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p44
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 44/51)
Character Range: 162547–167461

drug (ii) inclisiran; AND
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran, for this PBS indication.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
C16351  P16351  CN16351  Evolocumab             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16351
                                                Initial treatment
                                                The treatment must be 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 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 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