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Fintepla — Blue Cross Blue Shield of New Mexico

other FDA labeled indication for requested agent and route of administration

Initial criteria

  • 1. ONE of the following:
  • A. BOTH of the following:
  • 1. Prescriber states patient has been treated with requested agent (not samples) within past 90 days AND is at risk if therapy is changed AND
  • 2. Patient has an FDA labeled indication for the requested agent OR
  • B. BOTH of the following:
  • 1. ONE of:
  • A. Patient has diagnosis of Dravet syndrome (DS), AND ONE of the following:
  • 1. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non‑ERISA ASO/Self‑insured Municipalities/Counties member OR
  • 2. Patient currently being treated with requested agent and is currently stable on requested agent [chart notes required] OR
  • 3. Patient has ONE of the following [chart notes required]:
  • A. Tried and had inadequate response to TWO generic antiseizure agents used in DS (e.g., valproate, clobazam, topiramate) OR
  • B. Tried and had inadequate response to ONE generic antiseizure agent and intolerance or hypersensitivity to ONE generic antiseizure agent used in DS (e.g., valproate, clobazam, topiramate) OR
  • C. Intolerance or hypersensitivity to TWO generic antiseizure agents used in DS (e.g., valproate, clobazam, topiramate) OR
  • 4. FDA labeled contraindication to ALL generic antiseizure agents used in DS [chart notes required] OR
  • 5. TWO generic antiseizure agents used in DS were discontinued due to lack of efficacy/effectiveness/adverse event [chart notes required] OR
  • 6. TWO generic antiseizure agents used in DS expected to be ineffective or not in patient’s interest based on individual characteristics or clinical risks [chart notes required] OR
  • 7. TWO generic antiseizure agents used in DS not in best interest based on medical necessity [chart notes required] OR
  • 8. Patient tried another prescription drug in same pharmacologic class or mechanism as TWO generic antiseizure agents used in DS and it was discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • B. Patient has diagnosis of Lennox‑Gastaut syndrome (LGS) AND ONE of the following:
  • 1. Request is for BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non‑ERISA ASO/Self‑insured Municipalities/Counties member OR
  • 2. Patient currently being treated with requested agent and is stable [chart notes required] OR
  • 3. Patient has ONE of the following [chart notes required]:
  • A. Tried and had inadequate response to TWO generic antiseizure agents used in LGS (e.g., valproate, lamotrigine, rufinamide, topiramate, clobazam, felbamate) OR
  • B. Tried and had inadequate response to ONE generic antiseizure agent and intolerance/hypersensitivity to ONE generic antiseizure agent used in LGS (same examples) OR
  • C. Intolerance or hypersensitivity to TWO generic antiseizure agents used in LGS (same examples) OR
  • 4. FDA labeled contraindication to ALL generic antiseizure agents used in LGS [chart notes required] OR
  • 5. TWO generic antiseizure agents used in LGS were discontinued due to lack of efficacy/effectiveness/adverse event [chart notes required] OR
  • 6. TWO generic antiseizure agents used in LGS expected to be ineffective or not in patient’s interest based on clinical characteristics [chart notes required] OR
  • 7. TWO generic antiseizure agents used in LGS not in best interest based on medical necessity [chart notes required] OR
  • 8. Patient previously tried drug in same pharmacologic class/mechanism as TWO generic antiseizure agents used in LGS and that drug was discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • C. Patient has another FDA labeled indication for the requested agent and route of administration AND
  • 2. If patient has FDA labeled indication, then ONE of:
  • A. Patient’s age within FDA labeling for indication OR
  • B. Support for use of requested agent for patient’s age for that indication AND
  • 2. If patient has diagnosis of DS or LGS, requested agent will NOT be used as monotherapy for seizure management AND
  • 3. Echocardiogram assessment will be obtained before and during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension AND
  • 4. Prescriber is a specialist in area of diagnosis (e.g., neurologist) or has consulted with such specialist AND
  • 5. Patient does NOT have any FDA labeled contraindications to requested agent.
  • For BCBS NM Fully Insured / NM HIM or Ohio Fully Insured/HIM members:
  • • Patient does NOT have any FDA labeled contraindications to requested agent AND
  • • Requested indication is a rare disease AND
  • • ONE of:
  • – Patient has another FDA labeled indication for requested agent and route OR
  • – Indication supported in compendia OR (for Ohio) prescriber has submitted TWO peer‑reviewed journal articles supporting safe and effective use.
  • Compendia accepted: DrugDex level 1, 2A, 2B; AHFS‑DI; NCCN 1 or 2A; Clinical Pharmacology; Lexi‑Drugs Evidence level A.

Reauthorization criteria

  • 1. Patient previously approved for the requested agent through plan’s PA process AND
  • 2. Patient has had clinical benefit with requested agent AND
  • 3. If using for seizure management associated with DS or LGS, requested agent not used as monotherapy AND
  • 4. Echocardiogram assessment obtained during treatment to evaluate for valvular heart disease and pulmonary arterial hypertension AND
  • 5. Prescriber is a specialist in diagnosis area (e.g., neurologist) or consulted with one AND
  • 6. Patient does NOT have any FDA labeled contraindications to requested agent.

Approval duration

12 months