Fintepla (fenfluramine) — Blue Cross Blue Shield of Alabama

Initial criteria

• - The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR the prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
• - The patient has an FDA labeled indication for the requested agent OR meets one of the following disease-specific criteria:
• • Dravet syndrome (DS):
• - Has tried and had an inadequate response to TWO generic antiseizure agents used in the treatment of DS (e.g., valproate, clobazam, topiramate) OR
• - Has tried and had an inadequate response to ONE generic antiseizure agent and an intolerance or hypersensitivity to ONE generic antiseizure agent used in DS (e.g., valproate, clobazam, topiramate) OR
• - Has an intolerance or hypersensitivity to TWO generic antiseizure agents used in DS (e.g., valproate, clobazam, topiramate) OR
• - Has an FDA labeled contraindication to ALL generic antiseizure agents used in DS
• • Lennox-Gastaut syndrome (LGS):
• - Has tried and had an inadequate response to TWO generic antiseizure agents used in the treatment of LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
• - Has tried and had an inadequate response to ONE generic antiseizure agent and an intolerance or hypersensitivity to ONE generic antiseizure agent used in LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
• - Has an intolerance or hypersensitivity to TWO generic antiseizure agents used in LGS OR
• - Has an FDA labeled contraindication to ALL generic antiseizure agents used in LGS
• - The patient’s age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient’s age for the requested indication
• - If used for seizures associated with DS or LGS, the requested agent will NOT be used as monotherapy
• - An echocardiogram assessment will be obtained before and during treatment with the requested agent to evaluate for valvular heart disease and pulmonary arterial hypertension
• - The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) or has consulted with a specialist
• - 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
• - The patient has had clinical benefit with the requested agent
• - If using for seizure management associated with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS), the requested agent will NOT be used as monotherapy

Approval duration

12 months