Cholesterol Treatment Coverage Criteria 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 Criteria
Score
First-degree relative with coronary artery disease (male before 55, women before 60 years of age)
1
First-degree relative with tendon xanthomata, or children 95th percentile (men >= 130, women >= 140).
2
Patient has premature coronary artery disease (male before 55, women before 60 years of age)
2
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
8
250-329 mg/dL
5
190-249 mg/dL
3
155-189 mg/dL
1
Family history
Clinical history
Reiner Z. ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J 2011; 32:1769.
For Commercial & Minnesota Health Care Programs. Please see healthpartners.com for Medicare coverage criteria. updated December 11 2015, page 1 of 7
Cholesterol Treatment Coverage Criteria b. Atherosclerotic Cardiovascular Disease ASCVD definitions are based on the 2013 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
2. Repatha is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice providers within these specialties, and other providers in consultation with these specialists.
3. Repatha is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. Standard therapy includes a high intensity statin (atorvastatin 40-80mg daily or Crestor 20-40mg 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). a. Therapeutic failure on standard therapy is defined as an inability to achieve and maintain an LDL cholesterol level = 80%, based on three or more prescriptions fills over six or more months. Current cholesterol lab values and cholesterol treatment history must be submitted. Repatha is approved as an adjunct therapy to statins, and statin therapy should be continued.
For Commercial & Minnesota Health Care Programs. Please see healthpartners.com for Medicare coverage criteria. updated December 11 2015, page 2 of 7
Cholesterol Treatment Coverage Criteria b. Intolerance to statin therapy is defined as increased LFTs (an ALT >= 3x ULN), or intolerable myalgia or myopathy. One retrial of high-intensity statins over three or more months is required. Some patients not tolerating atorvastatin may be able to tolerate Crestor. A second re-trial with lower doses or alternative statins over three or more months is required. Contraindications to high-intensity statin therapy are defined as rhabdomyolysis or myositis (creatine kinase level >= 10x ULN). A therapeutic failure on lower doses or alternative statins is defined as an LDL cholesterol level >= 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 420mg 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%).
For Commercial & Minnesota Health Care Programs. Please see healthpartners.com for Medicare coverage criteria. updated December 11 2015, page 3 of 7
Cholesterol Treatment Coverage Criteria 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 Criteria
Score
First-degree relative with coronary artery disease (male before 55, women before 60 years of age)
1
First-degree relative with tendon xanthomata, or children 95th percentile (men >= 130, women >= 140).
2
Patient has premature coronary artery disease (male before 55, women before 60 years of age)
2
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
8
250-329 mg/dL
5
190-249 mg/dL
3
155-189 mg/dL
1
Family history
Clinical history
Reiner Z. ESC/EAS guidelines for the management of dyslipidaemias. Eur Heart J 2011; 32:1769.
b. Atherosclerotic Cardiovascular Disease ASCVD definitions are based on the 2013 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)
For Commercial & Minnesota Health Care Programs. Please see healthpartners.com for Medicare coverage criteria. updated December 11 2015, page 4 of 7
Cholesterol Treatment Coverage Criteria 2. Praluent is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice providers within these specialties, and other providers in consultation with these specialists. 3. Praluent is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. Standard therapy includes a high intensity statin (atorvastatin 40-80mg daily or Crestor 20-40mg 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). a. Therapeutic failure on standard therapy is defined as an inability to achieve and maintain an LDL cholesterol level = 80%, based on three or more prescriptions fills over six or more months. Current cholesterol lab values and cholesterol treatment history must be submitted. Praluent is approved as adjunct therapy to statins, and statin therapy should be continued. b. Intolerance to statin therapy is defined as increased LFTs (an ALT >= 3x ULN), or intolerable myalgia or myopathy. One retrial of high-intensity statins over three or more months is required. Some patients not tolerating atorvastatin may be able to tolerate Crestor. A second re-trial with lower doses or alternative statins over three or more months is required. Contraindications to high-intensity statin therapy are defined as rhabdomyolysis or myositis (creatine kinase level >= 10x ULN). A therapeutic failure on lower doses or alternative statins is defined as an LDL cholesterol level >= 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 75-150 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%).
For Commercial & Minnesota Health Care Programs. Please see healthpartners.com for Medicare coverage criteria. updated December 11 2015, page 5 of 7
Cholesterol Treatment Coverage Criteria Lomitapide (Juxtapid) is reserved for requests meeting all three criteria listed below: 1. Juxtapid is reserved for FDA-approved indications a. Homozygous Familial Hypercholesterolemia 2. Juxtapid is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice providers within these specialties, and other providers in consultation with these specialists. 3. Juxtapid is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. Standard therapy includes a high intensity statin (atorvastatin 40-80mg daily or Crestor 20-40mg 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). a. Therapeutic failure on standard therapy is defined as an inability to achieve and maintain an LDL cholesterol level at or below 100 mg/dL. Patients must have documented adherence >= 80%, based on three or more prescriptions fills over six or more months. Current cholesterol lab values and cholesterol treatment history must be submitted. b. Intolerance to statin therapy is defined as increased LFTs (an ALT >= 3x ULN), or intolerable myalgia or myopathy. One retrial of high-intensity statins over three or more months is required. Some patients not tolerating atorvastatin may be able to tolerate Crestor. A second re-trial with lower doses or alternative statins over three or more months is required. Contraindications to high-intensity statin therapy are defined as rhabdomyolysis or myositis (creatine kinase level >= 10x ULN). A therapeutic failure on lower doses or alternative statins is defined as an LDL cholesterol level >= 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%). For Commercial & Minnesota Health Care Programs. Please see healthpartners.com for Medicare coverage criteria. updated December 11 2015, page 6 of 7
Cholesterol Treatment Coverage Criteria Mipomersen (Kynamro) is reserved for requests meeting all three criteria listed below: 1. Kynamro is reserved for FDA-approved indications a. Homozygous Familial Hypercholesterolemia 2. Kynamro is reserved for prescribing by Cardiology, Endocrinology, Lipidology, advanced practice providers within these specialties, and other providers in consultation with these specialists. 3. Kynamro is reserved for patients with (a) therapeutic failure on standard therapy or (b) intolerance/ contraindications to standard therapy. Standard therapy includes a high intensity statin (atorvastatin 40-80mg daily or Crestor 20-40mg 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). a. Therapeutic failure on standard therapy is defined as an inability to achieve and maintain an LDL cholesterol level at or below 100 mg/dL. Patients must have documented adherence >= 80%, based on three or more prescriptions fills over six or more months. Current cholesterol lab values and cholesterol treatment history must be submitted. b. Intolerance to statin therapy is defined as increased LFTs (an ALT >= 3x ULN), or intolerable myalgia or myopathy. One retrial of high-intensity statins over three or more months is required. Some patients not tolerating atorvastatin may be able to tolerate Crestor. A second re-trial with lower doses or alternative statins over three or more months is required. Contraindications to high-intensity statin therapy are defined as rhabdomyolysis or myositis (creatine kinase level >= 10x ULN). A therapeutic failure on lower doses or alternative statins is defined as an LDL cholesterol level >= 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 200 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%). For Commercial & Minnesota Health Care Programs. Please see healthpartners.com for Medicare coverage criteria. updated December 11 2015, page 7 of 7
