olezarsen — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of familial chylomicronemia syndrome (FCS) as confirmed by ONE of the following:
• 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 (TG) levels greater than 880 mg/dL for 3 consecutive measurements AND
• B. Secondary causes of hypertriglyceridemia have been ruled out (e.g., alcohol use, chronic kidney disease, hypothyroidism, uncontrolled diabetes, medications [e.g., atypical antipsychotics, beta-blockers, corticosteroids, oral estrogens]) AND
• C. History of pancreatitis or unexplained recurrent abdominal pain AND
• D. No response (TG decrease less than 20%) to conventional lipid lowering therapies (e.g., fibrates, omega-3 fatty acids, statins, niacin, ezetimibe, PCSK9 inhibitors) OR
• B. The patient has another FDA labeled indication for the requested agent and route of administration OR
• C. The patient has another indication that is supported in compendia for the requested agent and route of administration AND
• If the patient has an FDA labeled indication, then ONE of the following:
• A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
• B. 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 a specialist in the area of the patient’s diagnosis 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 a specialist in the area of the patient’s diagnosis AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 6 months; renewal 12 months