olezarsen sod subcut soln auto-inject 80 MG/0.8ML — Blue Cross Blue Shield of Texas

Initial criteria

• 1. 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) (medical records) OR (2) ALL of the following: (A) Fasting triglyceride (TG) levels > 880 mg/dL for 3 consecutive measurements (medical records) AND (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) AND (C) History of pancreatitis or unexplained recurrent abdominal pain AND (D) No response (TG decrease < 20%) to conventional lipid lowering therapies (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.
• 2. 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.
• 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., cardiologist, endocrinologist, geneticist, lipidologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis.
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent.
• Additional approval (Ohio-only): The member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: (1) The patient does NOT have any FDA labeled contraindications to the requested agent AND (2) ONE of the following: (a) The patient has another FDA labeled indication for the requested agent and route of administration OR (b) The patient has another indication that is supported in compendia for the requested agent and route of administration OR (c) The prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective; accepted study designs include randomized, double-blind, placebo-controlled clinical trials; case studies are not acceptable.

Reauthorization criteria

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

Approval duration

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