Vascepa (icosapent ethyl) — United Healthcare

Initial criteria

• For Severe Hypertriglyceridemia: BOTH of the following: 1) Diagnosis of severe hypertriglyceridemia (pre-treatment triglyceride level ≥500 mg/dL) AND 2) Patient is on an appropriate lipid-lowering diet and exercise regimen
• For Cardiovascular risk reduction: ALL of the following: 1) Diagnosis of hypertriglyceridemia (pre-treatment triglyceride level ≥150 mg/dL) AND 2) Patient is receiving maximally tolerated statin therapy AND 3) Used to reduce risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization AND 4) ONE of the following: a) Established cardiovascular disease (CVD) OR b) BOTH of the following: i) Diagnosis of diabetes mellitus AND ii) Two additional risk factors for cardiovascular disease (e.g., Men ≥55 years or Women ≥65 years; Cigarette smoker or stopped smoking within past 3 months; Hypertension ≥140/90 mmHg; HDL-C ≤40 mg/dL for men or ≤50 mg/dL for women; High-sensitivity C-reactive protein >3.0 mg/L; Creatinine clearance 30–60 mL/min; Retinopathy; Micro- or macro-albuminuria; Ankle-brachial index <0.9 without symptoms of intermittent claudication)

Reauthorization criteria

• For Severe Hypertriglyceridemia: BOTH of the following: 1) Documentation of positive clinical response to therapy AND 2) Patient is on an appropriate lipid-lowering diet and exercise regimen
• For Cardiovascular risk reduction: BOTH of the following: 1) Documentation of positive clinical response to therapy AND 2) Patient is receiving maximally tolerated statin therapy

Approval duration

12 months