Tryngolza — Blue Cross Blue Shield of New Mexico

Initial criteria

• ONE of the following: A. Diagnosis of familial chylomicronemia syndrome (FCS) 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, certain medications) AND C. History of pancreatitis or unexplained recurrent abdominal pain AND 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. The patient has another FDA labeled indication for the requested agent and route of administration OR C. The patient has another indication supported in compendia for the requested agent and route of administration
• If the patient has an FDA labeled indication, ONE of the following: A. Age is within FDA labeling for the requested indication OR B. There is support for using the requested agent for the patient's age for the indication
• 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
• The patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval: BCBSIL and BCBSTX plans 12 months; all other plans 6 months
• Additional approval pathway for Ohio residents: member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND ALL of the following: 1. No FDA labeled contraindications to the requested agent AND 2. ONE of the following: • The patient has another FDA labeled indication for the requested agent and route • The patient has another indication supported in compendia for the agent and route • The prescriber has submitted TWO peer-reviewed medical journal articles (e.g., JAMA, NEJM, Lancet) supporting the proposed use as generally safe and effective (case studies not acceptable) Length of Approval: 12 months

Reauthorization criteria

• Patient previously approved for the requested agent through plan’s Prior Authorization process
• Patient has had clinical benefit with the requested agent
• Prescriber is a specialist in the area of the diagnosis (e.g., cardiologist, endocrinologist, geneticist, lipidologist) OR has consulted with such a specialist
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Length of Approval: 12 months

Approval duration

6–12 months (plan dependent)