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olezarsen — Blue Cross Blue Shield of Alabama

Other FDA labeled indications

Initial criteria

  • ONE of the following:
  • - Diagnosis of familial chylomicronemia syndrome (FCS) confirmed by ONE of the following:
  • • Genetic confirmation of bi-allelic pathogenic variants in affected genes (e.g., LPL, ApoA5, ApoC2, LMF1, GPIHBP1, G3PDH1)
  • OR
  • • ALL of the following:
  • – Fasting triglyceride (TG) levels >880 mg/dL for 3 consecutive measurements
  • – Secondary causes of hypertriglyceridemia ruled out (e.g., alcohol use, chronic kidney disease, hypothyroidism, uncontrolled diabetes, medications [e.g., atypical antipsychotics, beta-blockers, corticosteroids, oral estrogens])
  • – History of pancreatitis or unexplained recurrent abdominal pain
  • – No response (TG decrease <20%) to conventional lipid lowering therapies (e.g., fibrates, omega-3 fatty acids, statins, niacin, ezetimibe, PCSK9 inhibitors)
  • OR
  • - The patient has another FDA labeled indication for the requested agent and route of administration
  • OR
  • - The patient has another indication that is supported in compendia (AHFS or DrugDex 1 or 2a level of evidence) for the requested agent and route of administration
  • AND
  • - If the patient has an FDA labeled indication, then ONE of the following:
  • • The patient’s age is within FDA labeling for the requested indication for the requested agent
  • OR
  • • There is support for using the requested agent for the patient’s age for the requested indication
  • AND
  • - The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, endocrinologist, geneticist, lipidologist), or has consulted with such a specialist
  • AND
  • - The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • - The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • AND
  • - The patient has had clinical benefit with the requested agent
  • AND
  • - The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, endocrinologist, geneticist, lipidologist), or has consulted with such a specialist
  • AND
  • - The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6 months initial, 12 months renewal