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icosapent ethylBlue Cross Blue Shield of Illinois

other FDA labeled indication for the requested agent and route

Initial criteria

  • ONE of the following: (A) patient has diagnosis of severe hypertriglyceridemia (fasting triglyceride ≥ 500 mg/dL) OR (B) patient is using the requested agent to reduce risk of myocardial infarction, stroke, coronary revascularization, or unstable angina requiring hospitalization AND ALL of the following:
  • 1. ONE of the following: (A) patient is on maximally tolerated statin therapy OR (B) patient has an intolerance or hypersensitivity to statin therapy OR (C) patient has an FDA labeled contraindication to ALL statins
  • 2. patient has fasting triglyceride level ≥ 135 mg/dL
  • 3. ONE of the following: (A) patient has established cardiovascular disease OR (B) patient has diabetes mellitus AND ≥2 additional risk factors for cardiovascular disease OR (C) patient has another FDA labeled indication for the requested agent and route OR (D) patient has another compendia-supported indication for the requested agent and route
  • If the patient has an FDA labeled indication, then ONE of the following: (A) patient's age is within FDA labeling for the requested indication OR (B) there is support for using the requested agent for the patient's age for the requested indication
  • patient does NOT have any FDA labeled contraindications to the requested agent
  • Compendia allowed: AHFS or DrugDex level 1, 2A, or 2B
  • Special case – Ohio resident: (1) member resides in Ohio AND (2) plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: (A) patient has no FDA labeled contraindications to the requested agent AND (B) ONE of the following: 1. patient has FDA labeled indication and route OR 2. patient has compendia-supported indication and route OR 3. prescriber submitted ≥2 peer-reviewed medical journal articles supporting proposed use as generally safe and effective

Reauthorization criteria

  • patient has been previously approved for the 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