fenfluramine hcl oral soln 2.2 MG/ML — Blue Cross Blue Shield of Kansas

Initial criteria

• ONE of the following:
• A. BOTH of the following:
• 1. ONE of the following:
• A. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
• B. 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 AND
• 2. The patient has an FDA labeled indication for the requested agent OR
• B. BOTH of the following:
• 1. ONE of the following:
• A. The patient has a diagnosis of Dravet syndrome (DS), AND ONE of the following:
• 1. The patient has ONE of the following:
• A. Has tried and had an inadequate response to TWO generic antiseizure agents used in the treatment of DS (e.g., valproate, clobazam, topiramate) OR
• B. Has tried and had an inadequate response to ONE generic antiseizure agent and an intolerance or hypersensitivity to ONE generic antiseizure agent used in the treatment of DS (e.g., valproate, clobazam, topiramate) OR
• C. Has an intolerance or hypersensitivity to TWO generic antiseizure agents used in the treatment of DS (e.g., valproate, clobazam, topiramate) OR
• 2. The patient has an FDA labeled contraindication to ALL generic antiseizure agents used in the treatment of DS OR
• B. The patient has a diagnosis of Lennox-Gastaut syndrome (LGS), AND ONE of the following:
• 1. The patient has ONE of the following:
• A. 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
• B. Has tried and had an inadequate response to ONE generic antiseizure agent and an intolerance or hypersensitivity to ONE generic antiseizure agent used in the treatment of LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
• C. Has an intolerance or hypersensitivity to TWO generic antiseizure agents used in the treatment of LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
• 2. The patient has an FDA labeled contraindication to ALL generic antiseizure agents used in the treatment of LGS OR
• C. The patient has another FDA labeled indication for the requested agent and route of administration AND
• 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 AND
• 2. If the patient has a diagnosis of seizures associated with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS), then the requested agent will NOT be used as monotherapy for seizure management AND
• 3. An echocardiogram assessment will be obtained before and during treatment with the requested agent to evaluate for valvular heart disease and pulmonary arterial hypertension