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 (Initial Authorization)

Length of Approval: 12 Month(s)
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 (Initial Authorization)

Length of Approval: 12 Month(s)
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
Fintepla

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications

  • Patient demonstrates positive clinical response to therapy as evidenced by the reduction in seizure frequency from baseline

  • Guideline ID
    GL-147937

  • Formulary
    Premium

  • Effective date
    Aug 1, 2024

  • P&T approval date
    Aug 13, 2020

P & T Revisions

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. LGS Foundation. Lennox-Gastaut Syndrome. Available at https://www.lgsfoundation.org/. Accessed May 8, 2022.
  4. UptoDate. Lennox-Gastaut Syndrome. Available at https://www.uptodate.com/contents/epilepsy-syndromes-in-children?search=lennox%20gastaut%20syndrome&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1#H9. Accessed May 8, 2022.
  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]
  • 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