Vascepa — Blue Cross Blue Shield of Montana
other FDA labeled indications or compendia-supported indications
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