icosapent ethyl — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following: (A) Diagnosis of severe hypertriglyceridemia (fasting triglyceride level ≥500 mg/dL) OR (B) Use to reduce risk of myocardial infarction, stroke, coronary revascularization, or unstable angina requiring hospitalization AND ALL of the following:
• — ONE of the following: (A) Patient is on maximally tolerated statin therapy OR (B) Patient has intolerance or hypersensitivity to statin therapy OR (C) Patient has FDA labeled contraindication to all statins
• — Fasting triglyceride level ≥135 mg/dL
• — ONE of the following: (A) Established cardiovascular disease OR (B) Diabetes mellitus AND ≥2 additional risk factors for cardiovascular disease
• OR the patient has another FDA labeled indication or compendia-supported indication for the requested agent and route of administration
• If patient has an FDA labeled indication, then ONE of the following: (A) Patient’s age within FDA labeling for requested indication OR (B) Support for use at patient’s age
• Patient has no FDA labeled contraindications to requested agent
• Compendia allowed: AHFS, or DrugDex 1, 2A, or 2B level of evidence
• Ohio exception: For residents of Ohio in Fully Insured or HIM Shop plans—approve if no FDA contraindications AND ONE of the following: (1) FDA labeled indication OR (2) compendia-supported indication OR (3) two peer-reviewed journal articles supporting safe and effective use

Reauthorization criteria

• Patient previously approved for requested agent through plan’s prior authorization process
• Patient has had clinical benefit with the requested agent
• Patient does not have any FDA labeled contraindications to the requested agent

Approval duration

12 months