Cholesterol Treatment Coverage Criteria

Transcription

1 Coverage for these four medications is described below: Evolocumab (Repatha) Alirocumab (Praluent) Lomitapide (Juxtapid) Mipomersen (Kynamro) Evolocumab (Repatha) is reserved for requests meeting all three of the criteria below: 1. Repatha is reserved for FDA-approved indications a. Heterozygous Familial Hypercholesterolemia HeFH must be confirmed with clinical criteria such as WHO clinical criteria score >= 6. WHO criteria for the clinical diagnosis of heterozygous familial hypercholesterolemia Family history Criteria First-degree relative with coronary artery disease (male before 55, women before 60 years of age) First-degree relative with tendon xanthomata, or children <18 with LDL-C > 95th percentile (men >= 130, women >= 140). Score 1 Clinical history Patient has premature coronary artery disease (male before 55, women before 60 years of age) Patient has premature cerebral/ peripheral vascular disease 1 Physical examination Tendon xanthomata 6 Arcus cornealis below the age of 45 years 4 LDL-C > 330 mg/dl mg/dl mg/dl mg/dl 1 Reiner Z. ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J 011; 3:1769. coverage criteria. updated December , page 1 of 7

2 b. Atherosclerotic Cardiovascular Disease ASCVD definitions are based on the 013 ACC/AHA Blood Cholesterol Guideline: acute coronary syndromes history of MI stable or unstable angina coronary or other arterial revascularization (CABG, stent placement) previous atherosclerotic cerebral vascular disease (stroke) or TIA peripheral arterial disease due to atherosclerosis positive testing by Cardiology (significant CAD on angiogram, coronary artery calcium CT score >= 400, positive stress test) c. Homozygous Familial Hypercholesterolemia. Repatha is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice 3. Repatha is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. 0-40mg daily) and ezetimibe (Zetia). A trial with Zetia is required unless patients are unlikely to reach goals (LDL cholesterol while taking high-intensity statins >= 130 mg/ dl). LDL cholesterol level <= 100 mg/ dl. Repatha is approved as an adjunct therapy to statins, and statin therapy should be continued. coverage criteria. updated December , page of 7

3 >= 100 mg/ dl. A trial with Zetia is required unless patients are unlikely to reach LDL goals (LDL cholesterol while taking statins >= 130 mg/ dl). Baseline therapy with statins should be continued. Repatha is limited to the FDA-approved dose of 140mg every two weeks.* * Exceptions will be approved for the FDA-approved dose of 40mg monthly for patients with homozygous familial hypercholesterolemia. Initial authorizations are for a period of 3 months. Reauthorizations are given annually for patients with a clinically significant response to treatment (LDL reductions >= 35%). coverage criteria. updated December , page 3 of 7

4 Alirocumab (Praluent) is reserved after Repatha, for requests meeting all four criteria listed below: 1. Praluent is reserved for FDA-approved indications a. Heterozygous Familial Hypercholesterolemia HeFH must be confirmed with clinical criteria such as WHO clinical criteria score >= 6. WHO criteria for the clinical diagnosis of heterozygous familial hypercholesterolemia Family history Criteria First-degree relative with coronary artery disease (male before 55, women before 60 years of age) First-degree relative with tendon xanthomata, or children <18 with LDL-C > 95th percentile (men >= 130, women >= 140). Score 1 Clinical history Patient has premature coronary artery disease (male before 55, women before 60 years of age) Patient has premature cerebral/ peripheral vascular disease 1 Physical examination Tendon xanthomata 6 Arcus cornealis below the age of 45 years 4 LDL-C > 330 mg/dl mg/dl mg/dl mg/dl 1 Reiner Z. ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J 011; 3:1769. b. Atherosclerotic Cardiovascular Disease ASCVD definitions are based on the 013 ACC/AHA Blood Cholesterol Guideline: acute coronary syndromes history of MI stable or unstable angina coronary or other arterial revascularization (CABG, stent placement) previous atherosclerotic cerebral vascular disease (stroke) or TIA peripheral arterial disease due to atherosclerosis positive testing by Cardiology (significant CAD on angiogram, coronary artery calcium CT score >= 400, positive stress test) coverage criteria. updated December , page 4 of 7

5 . Praluent is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice 3. Praluent is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. 0-40mg daily) and ezetimibe (Zetia).* * A trial with Zetia is required unless patients are unlikely to reach goals (LDL cholesterol while taking high-intensity statins >= 130 mg/ dl). LDL cholesterol level <= 100 mg/ dl. Praluent is approved as adjunct therapy to statins, and statin therapy should be continued. >= 100 mg/ dl. A trial with Zetia is also required unless patients are unlikely to reach LDL goals (LDL cholesterol while taking statins >= 130 mg/ dl). Baseline therapy should be continued. 4. Praluent is reserved for patients with documented intolerance to Repatha. Praluent is limited to the FDA-approved dose of mcg every two weeks. Initial authorizations are for a period of 3 months. Reauthorizations are given annually for patients with a clinically significant response to treatment (LDL reductions >= 35%). coverage criteria. updated December , page 5 of 7

6 Lomitapide (Juxtapid) is reserved for requests meeting all three criteria listed below: 1. Juxtapid is reserved for FDA-approved indications a. Homozygous Familial Hypercholesterolemia. Juxtapid is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice 3. Juxtapid is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. 0-40mg daily), Repatha, and ezetimibe (Zetia).* * A trial with Zetia is required unless patients are unlikely to reach goals (LDL cholesterol while taking high-intensity statins and Repatha >= 130 mg/ dl). LDL cholesterol level at or below 100 mg/dl. >= 100 mg/ dl. A trial with Zetia is also required unless patients are unlikely to reach LDL goals (LDL cholesterol while taking statins >= 130 mg/ dl). Baseline therapy should be continued. Juxtapid is limited to the FDA-approved dose of 5mg - 60mg per day. Initial authorizations are for a period of 3 months. Reauthorizations are given annually for patients with a clinically significant response to treatment (LDL reductions >= 35%). coverage criteria. updated December , page 6 of 7

7 Mipomersen (Kynamro) is reserved for requests meeting all three criteria listed below: 1. Kynamro is reserved for FDA-approved indications a. Homozygous Familial Hypercholesterolemia. Kynamro is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice 3. Kynamro is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. 0-40mg daily), Repatha, and ezetimibe (Zetia).* * A trial with Zetia is required unless patients are unlikely to reach goals (LDL cholesterol while taking high-intensity statins and Repatha >= 130 mg/ dl). LDL cholesterol level at or below 100 mg/dl. >= 100 mg/ dl. A trial with Zetia is also required unless patients are unlikely to reach LDL goals (LDL cholesterol while taking statins >= 130 mg/ dl). Baseline therapy should be continued. Kynamro is limited to the FDA-approved dose of 00 mg every week. Initial authorizations are for a period of 3 months. Reauthorizations are given annually for patients with a clinically significant response to treatment (LDL reductions >= 35%). coverage criteria. updated December , page 7 of 7