Vascepa — Medical Mutual

Initial criteria

• Patient age ≥ 18 years; AND
• Vascepa will be used as adjunct to maximally tolerated statin therapy; AND
• Vascepa is being used to reduce risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization; AND
• Fasting baseline triglyceride (TG) level > 150 mg/dL; AND
• Patient has established cardiovascular disease defined as ONE of: multivessel coronary artery disease OR prior MI OR hospitalization for high-risk acute coronary syndrome OR prior ischemic stroke OR symptomatic carotid artery disease with ≥50% stenosis OR asymptomatic carotid artery disease with ≥70% stenosis OR history of carotid revascularization OR ankle brachial index < 0.9 with intermittent claudication OR history of aortoiliac/peripheral arterial intervention; OR
• Patient has diabetes mellitus WITH two or more additional cardiovascular risk factors defined as: age (man ≥ 55 years OR woman ≥ 65 years) OR cigarette smoker or quit within 3 months OR hypertension (BP ≥ 140/90 mm Hg or on antihypertensive) OR low HDL-C (≤40 mg/dL in men or ≤50 mg/dL in women) OR high-sensitivity C-reactive protein > 3 mg/L OR renal dysfunction (CrCl 30–60 mL/min) OR retinopathy OR microalbuminuria/macroalbuminuria OR ankle brachial index < 0.9 without claudication

Reauthorization criteria

• Response to therapy is required for continuation of therapy

Approval duration

1 year initial, 1 year reauth