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Familial homozygous hypercholesterolaemia Clinical criteria: Treatment Phase: Initial treatment The treatment must be in conjunction with dietary therapy and exercise, AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 7, AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre, 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. Treatment criteria: Must be treated by a specialist physician; OR Must be treated by an authorised prescriber in consultation with a specialist physician. The qualifying LDL cholesterol level following at least 12 consecutive weeks of treatment with a statin (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. The following must be documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial homozygous hypercholesterolaemia One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.
Curated subset. The full adverse-effect list is in the TGA Product Information; click any citation above to open it.
“Repatha binds selectively and with high affinity to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation.”
Working under the parallel aged-care framework? Aged-care equivalent →
Familial heterozygous hypercholesterolaemia Clinical criteria: Treatment Phase: Initial treatment The treatment must be in conjunction with dietary therapy and exercise, AND The condition must have been confirmed by genetic testing; OR The condition must have been confirmed by a Dutch Lipid Clinic Network Score of at least 6, AND Patient must have an LDL cholesterol level in excess of 1.8 millimoles per litre in the presence of symptomatic atherosclerotic cardiovascular disease; OR Patient must have an LDL cholesterol level in excess of 5 millimoles per litre, 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. Treatment criteria: 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 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 the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. The following must be documented in the patient's medical records: (i) the qualifying Dutch Lipid Clinic Network Score; or (ii) the result of genetic testing confirming a diagnosis of familial heterozygous hypercholesterolaemia One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.
Non-familial hypercholesterolaemia Clinical criteria: Treatment Phase: 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. Treatment criteria: 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 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 the alternative statin, it is recommended that the patient is started with the minimum dose of statin in conjunction with ezetimibe. The dose of the alternative statin should be increased not more often than every 4 weeks until the recommended or maximum tolerated dose has been reached or target LDL-c has been achieved. One of the following must be documented in the patient's medical records regarding prior statin treatment: (i) the patient was treated with atorvastatin 80 mg or rosuvastatin 40 mg or the maximum tolerated dose of either for 12 consecutive weeks; or (ii) the doses, duration of treatment and details of adverse events experienced with trials with each of atorvastatin and rosuvastatin; or (iii) the patient is contraindicated to treatment with a statin as defined in the TGA-approved Product Information. One or more of the following must be documented in the patient's medical records regarding the presence of cardiovascular disease or high risk of experiencing a cardiovascular event: (i) atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories); or (ii) severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels; or (iii) history of at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years; or (iv) diabetes mellitus with microalbuminuria; or (v) diabetes mellitus and age 60 years of more; or (vi) Aboriginal or Torres Strait Islander with diabetes mellitus; or (vii) a Thrombolysis in Myocardial Infarction (TIMI) risk score for secondary prevention of 4 or higher Patients with symptomatic atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.