Pharmacy Prior Authorization Criteria

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

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

References

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.

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End Notes

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]

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Revision History

• 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

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