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Tryngolza (olezarsen sodium)Blue Cross Blue Shield of Illinois

familial chylomicronemia syndrome (FCS)

Initial criteria

  • ONE of the following: (A) Patient has a diagnosis of familial chylomicronemia syndrome (FCS) confirmed by EITHER (1) genetic confirmation of bi-allelic pathogenic variants in affected genes (e.g., LPL, ApoA5, ApoC2, LMF1, GPIHBP1, G3PDH1) OR (2) ALL of the following: A. Fasting triglyceride levels > 880 mg/dL for 3 consecutive measurements, B. Secondary causes of hypertriglyceridemia ruled out (e.g., alcohol use, chronic kidney disease, hypothyroidism, uncontrolled diabetes, medications such as atypical antipsychotics, beta-blockers, corticosteroids, oral estrogens), C. History of pancreatitis or unexplained recurrent abdominal pain, D. No response (TG decrease < 20%) to conventional lipid-lowering therapies (e.g., fibrates, omega-3 fatty acids, statins, niacin, ezetimibe, PCSK9 inhibitors); OR (B) Patient has another FDA labeled indication; OR (C) Patient has another indication supported in compendia for the agent and route.
  • If the patient has an FDA labeled indication, then ONE of: (A) Age is within FDA labeling for the indication, OR (B) There is support for use at that age.
  • Prescriber is a specialist in cardiology, endocrinology, genetics, or lipidology, or has consulted with such a specialist.
  • Patient has no FDA labeled contraindications to the agent.

Reauthorization criteria

  • Patient previously approved through plan’s prior authorization process.
  • Patient has had clinical benefit with the requested agent.
  • Prescriber is a specialist (cardiologist, endocrinologist, geneticist, lipidologist) or has consulted with such a specialist.
  • Patient does not have any FDA labeled contraindications.

Approval duration

12 months (BCBSIL and BCBSTX); 6 months all other plans; 12 months for renewal