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icosapent ethyl — Blue Cross Blue Shield of New Mexico

Severe hypertriglyceridemia (fasting triglyceride level ≥ 500 mg/dL)

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:
  • 1. ONE of the following:
  • A. On maximally tolerated statin therapy OR
  • B. Intolerance or hypersensitivity to statin therapy OR
  • C. FDA labeled contraindication to ALL statins AND
  • 2. Fasting triglyceride level ≥ 135 mg/dL AND
  • 3. ONE of the following:
  • A. Established cardiovascular disease OR
  • B. Diabetes mellitus AND 2 or more additional risk factors for cardiovascular disease OR
  • C. Another FDA labeled indication for the requested agent and route of administration OR
  • D. Another indication supported in compendia (AHFS, or DrugDex 1, 2A, or 2B level of evidence) for the requested agent and route of administration AND
  • 2. If the patient has an FDA labeled indication, ONE of the following:
  • A. Age within FDA labeling for the indication OR
  • B. Support for use at patient’s age for the requested indication AND
  • 3. Patient has no FDA labeled contraindications to the requested agent.
  • Additional approval path (Ohio members of Fully Insured or HIM Shop plans):
  • 1. Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH:
  • A. No FDA labeled contraindications to the requested agent AND
  • B. ONE of the following:
  • 1. Another FDA labeled indication for the requested agent and route OR
  • 2. Another indication supported in compendia (DrugDex 1, 2A, or 2B, AHFS-DI) OR
  • 3. Prescriber submits TWO peer-reviewed journal articles (e.g., JAMA, NEJM, Lancet) supporting proposed use as safe and effective (case studies not acceptable).
  • Compendia references: non-oncology: DrugDex level 1, 2A or 2B; AHFS-DI; oncology: NCCN 1 or 2A, AHFS-DI, DrugDex level 1, 2A or 2B, Clinical Pharmacology supportive narrative, LexiDrugs evidence level A, or peer-reviewed literature.

Reauthorization criteria

  • 1. Patient previously approved for the requested agent through plan’s PA process AND
  • 2. Patient has had clinical benefit with the requested agent AND
  • 3. Patient has no FDA labeled contraindications to the requested agent.

Approval duration

12 months