Vascepa (icosapent ethyl) — United Healthcare

Initial criteria

• Diagnosis of hypertriglyceridemia (pre-treatment triglyceride level ≥150 mg/dL)
• Patient currently has or is considered high or very high risk for cardiovascular disease (CVD) as evidenced by ONE of the following:
• EITHER both of the following: age ≥45 years AND established CVD confirmed by ONE of the following: acute coronary syndrome, history of myocardial infarction, stable or unstable angina, coronary or other arterial revascularization, stroke, transient ischemic attack, peripheral arterial disease
• OR all of the following: diagnosis of type 2 diabetes AND two of the following CVD risk factors: (1) Men ≥55 years and women ≥65 years, (2) Cigarette smoker or stopped smoking within the past 3 months, (3) Hypertension (pretreatment blood pressure ≥140 mmHg systolic or ≥90 mmHg diastolic), (4) HDL-C ≤40 mg/dL for men or ≤50 mg/dL for women, (5) High-sensitivity C-reactive protein >3.0 mg/L, (6) Creatinine clearance >30 and <60 mL/min, (7) Retinopathy, (8) Micro- or macro-albuminuria, (9) Ankle-brachial index (ABI) <0.9 without symptoms of intermittent claudication
• Submission of medical records documenting ONE of the following:
• Patient has been receiving ≥12 consecutive weeks of high-intensity statin therapy (atorvastatin 40–80 mg or rosuvastatin 20–40 mg) and will continue at a maximally tolerated dose
• OR patient is unable to tolerate high-intensity statin due to intolerable persistent (more than 2 weeks) myalgia or myositis (CK <10× ULN) AND has been receiving ≥12 consecutive weeks of low- or moderate-intensity statin therapy (atorvastatin 10–20 mg, rosuvastatin 5–10 mg, simvastatin ≥10 mg, pravastatin ≥10 mg, lovastatin 20–40 mg, fluvastatin XL 80 mg, fluvastatin 20–40 mg up to 40 mg twice daily, or pitavastatin ≥1 mg) and will continue at maximally tolerated dose
• Submission of medical record documenting ONE of the following:
• Patient has been receiving ≥12 consecutive weeks of ezetimibe (Zetia) therapy as adjunct to maximally tolerated statin therapy
• OR patient has a history of contraindication or intolerance to ezetimibe
• OR patient has LDL-C <100 mg/dL while on maximally tolerated statin therapy
• Used as an adjunct to a low-fat diet and exercise

Reauthorization criteria

• Used for cardiovascular risk reduction
• Documentation of positive clinical response to therapy
• Patient is on an appropriate low-fat diet and exercise regimen
• Patient is receiving maximally tolerated statin therapy

Approval duration

12 months