WHA
 

Fintepla (fenfluramine)

Indications for Prior Authorization

Fintepla (fenfluramine)
  • For diagnosis of Dravet Syndrome
    Indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

  • For diagnosis of Lennox-Gastaut Syndrome
    Indicated for the treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older.

Criteria

Fintepla

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Dravet Syndrome

  • Diagnosis of seizures associated with Dravet syndrome
    • AND
  • Patient is 2 years of age or older
    • AND
  • One of the following:
    • Both of the following:
      • Trial and failure, contraindication or intolerance to one of the following:
        • valproic acid
        • clobazam
        AND
      • Trial and failure, contraindication or intolerance to one of the following:
        • Diacomit (stiripentol)
        • Epidiolex (cannabidiol)
        • topiramate
        • zonisamide
        • levetiracetam
        • Briviact (brivaracetam)
      OR
    • For continuation of prior therapy
    AND
  • Prescribed by or in consultation with a neurologist
Fintepla

Prior Authorization

Length of Approval: When approved; no reauthorization required
For diagnosis of Lennox-Gastaut Syndrome

  • Diagnosis of seizures associated with Lennox-Gastaut syndrome
    • AND
  • Patient is 2 years of age or older
    • AND
  • ONE of the following:
    • Trial and inadequate response, contraindication, or intolerance to TWO formulary anticonvulsants (e.g., topiramate, lamotrigine, valproate) [2, A]
    • For continuation of prior therapy
    AND
  • Prescribed by or in consultation with a neurologist

  • Guideline ID
    GL-598269

  • Formulary
    premium

  • Effective date
    Aug 1, 2026

  • P&T approval date
    Aug 13, 2020

P & T Revisions

2026-05-01, 2026-03-03, 2025-12-18, 2024-05-31, 2023-11-21, 2023-09-01, 2023-08-02, 2022-08-03, 2022-06-17, 2021-08-03, 2021-02-24, 2020-12-15, 2020-07-29

  1. Fintepla prescribing information. Zogenix Inc. Emeryvile, CA. March 2022.
  2. Fattorusso, A., Matricardi et al. The Pharmacoresistant Epilepsy: An Overview on Existing and New Emerging Therapies. Frontiers in Neurology. June 2021. Available at https://www.frontiersin.org/articles/10.3389/fneur.2021.674483/full. Accessed May 6, 2022.
  3. UptoDate. Dravet syndrome: Management and prognosis. Available at: https://www.uptodate.com/contents/dravet-syndrome-management-and-prognosis?search=dravet%20syndrome%20management%20and%20prognosis&source=search_result&selectedTitle=1~29&usage_type=default&display_rank=1&searchCorrelationId=199cdf46-c3ea-4fe2-a7f8-a0084faf7ee4&searchCorrelationTerm=dravet%20syndrome%20management%20and%20prognosis. Accessed May 1, 2026.
  4. Wirrell, E., Hood, V., Knupp, K., et al. International consensus on diagnosis and management of Dravet syndrome. Available at: https://doi.org/10.1111/epi.17274. Accessed May 1, 2026.
  5. Strzelczyk, A., and Schubert-Bast, S. A Practical Guide to the Treatment of Dravet Syndrome with Anti-Seizure Medication. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC8927048/#:~:text=Patients%20with%20Dravet%20syndrome%20are,topiramate%20(TPM)%2C%20bromide%2C. Accessed May 1, 2026.
  6. Samanta, D. A comprehensive review of evolving treatment strategies for Dravet syndrome: Insights from randomized trials, meta-analyses, real-world evidence, and emerging therapeutic approaches. Available at: https://www.epilepsybehavior.com/article/S1525-5050(24)00553-5/abstract. Accessed May 1, 2026.
  7. UptoDate. Lennox-Gastaut syndrome. Available at: https://www.uptodate.com/contents/lennox-gastaut-syndrome?search=lennox%20gastaut%20syndrome%20treatment&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1&searchCorrelationId=d72cefdb-9bc6-4058-be58-f8c421d360c4&searchCorrelationTerm=lennox%20gastaut%20syndrome%20treatment. Accessed May 1, 2026.
  1. The International League Against Epilepsy (ILAE) refers to drug-resistant epilepsy as the failure of adequate trials of two tolerated, appropriately chosen, and used ASM schedules, whether as monotherapy or in combination, to achieve sustained seizure freedom [2]
  • 2026-05-01: 2026 Annual Review.
  • 2026-03-03: Adding to the PA Reduction Program.
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2024-05-31: Annual Review - No criteria changes
  • 2023-11-21: Spelling update
  • 2023-09-01: Removed Documentation of criteria
  • 2023-08-02: Annual review - no criteria changes
  • 2022-08-03: Annual Review, update to remove lamotrigine as a step alternative for Dravet Syndrome
  • 2022-06-17: Update Guideline
  • 2021-08-03: 2021 Annual review, no changes to criteria.
  • 2021-02-24: Corrected typo, no change to clinical criteria.
  • 2020-12-15: Updated to include formulary strategy
  • 2020-07-29: New Program