Tryngolza — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following: (A) Diagnosis of familial chylomicronemia syndrome (FCS) confirmed by genetic confirmation of bi-allelic pathogenic variants in affected genes (e.g., LPL, ApoA5, ApoC2, LMF1, GPIHBP1, G3PDH1) OR (B) Fasting triglyceride levels > 880 mg/dL for 3 consecutive measurements AND secondary causes ruled out AND history of pancreatitis or recurrent abdominal pain AND no response (TG decrease < 20%) to conventional lipid lowering therapies (e.g., fibrates, omega-3 fatty acids, statins, niacin, ezetimibe, PCSK9 inhibitors) OR (C) another FDA labeled indication for the requested agent and route OR (D) another indication supported in compendia for the requested agent and route
• If the patient has an FDA labeled indication, then ONE of the following: (A) patient’s age is within FDA labeling OR (B) there is support for use by age for the requested indication
• 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
• The patient has no 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
• The patient has had clinical benefit with the requested agent
• 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
• The patient has no FDA labeled contraindications to the requested agent

Approval duration

6–12 months (plan dependent: BCBSIL/BCBSTX = 12 months; others = 6 months initial, 12 months renewal)