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Fintepla — Blue Cross Blue Shield of Montana

Lennox-Gastaut syndrome (LGS)

Initial criteria

  • ONE of the following:
  • A. BOTH of the following:
  • 1. 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 request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
  • 2. The patient is currently being treated with the requested agent and is currently stable on the requested agent [chart notes required] OR
  • 3. Has tried and had an inadequate response to TWO generic antiseizure agents used in DS (e.g., valproate, clobazam, topiramate) OR
  • 4. Has tried and had an inadequate response to ONE generic antiseizure agent and intolerance or hypersensitivity to ONE other generic antiseizure agent used in DS OR
  • 5. Has an intolerance or hypersensitivity to TWO generic antiseizure agents used in DS OR
  • 6. The patient has an FDA labeled contraindication to ALL generic antiseizure agents used in DS [chart notes required] OR
  • 7. TWO generic antiseizure agents used for DS were discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required] OR
  • 8. TWO generic antiseizure agents for DS are expected to be ineffective or not in best interest of patient based on medical necessity [chart notes required] OR
  • 9. The patient has tried another drug in the same pharmacologic class as TWO generic antiseizure agents for DS and discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • B. The patient has a diagnosis of Lennox-Gastaut syndrome (LGS), AND ONE of the following:
  • 1. The request is for a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
  • 2. The patient is currently being treated with and stable on the requested agent [chart notes required] OR
  • 3. Has tried and had an inadequate response to TWO generic antiseizure agents used in LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
  • 4. Has tried and had an inadequate response to ONE generic antiseizure agent and intolerance or hypersensitivity to ONE other antiseizure agent used in LGS OR
  • 5. Has an intolerance or hypersensitivity to TWO generic antiseizure agents used in LGS OR
  • 6. Has an FDA labeled contraindication to ALL generic antiseizure agents used in LGS [chart notes required] OR
  • 7. TWO generic antiseizure agents used for LGS were discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • 8. TWO generic antiseizure agents for LGS are expected to be ineffective or not in best interest of patient based on medical necessity [chart notes required] OR
  • 9. The patient has tried another drug in same pharmacologic class as TWO generic antiseizure agents for LGS and discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • C. The patient has another FDA labeled indication 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 OR
  • B. There is support for use of the requested agent for the patient’s age for the requested indication AND
  • If the patient has DS or LGS, the agent will NOT be used as monotherapy for seizure management AND
  • An echocardiogram assessment will be obtained before and during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension AND
  • The prescriber is a specialist in neurology or has consulted with a specialist AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • The requested agent will also be approved when ONE of the following is met:
  • 1. For BCBS NM Fully Insured or NM HIM member: patient has no FDA labeled contraindications, indication is a rare disease, and indication is FDA labeled or supported in compendia OR
  • 2. For members in Ohio with Fully Insured or HIM Shop (SG) plans: patient has no FDA labeled contraindications, and indication is FDA labeled, supported in compendia, or supported by two peer-reviewed journal articles showing safety and efficacy (case studies not acceptable).

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • The patient has had clinical benefit with the requested agent AND
  • If using for seizure management associated with DS or LGS, the agent will NOT be used as monotherapy AND
  • An echocardiogram is obtained during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension AND
  • The prescriber is a specialist in the area of diagnosis or has consulted with a specialist AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months