ModifiedMass General Brigham Health PlanPolicy N/A

Fintepla (fenfluramine)

Prior authorization policy for Fintepla (fenfluramine) under the pharmacy benefit for Commercial/Exchange members (specialty pharmacy required). Defines initial and continuation criteria, age limits, diagnosis-specific requirements for Dravet syndrome and Lennox-Gastaut syndrome, approvals durations, and quantity limit.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFintepla (fenfluramine)

Policy CodePolicy N/A

Change TypeClinical & administrative updates

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization and ensure Fintepla is prescribed by or in consultation with a neurologist and dispensed via a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

Updated language for members new to the Plan and specialist prescriber requirements; removed LGS adjunctive requirement; reauthorization now requires documentation of a positive response to therapy.

Added indication of Lennox-Gastaut syndrome in 11/15/2023 review.

2Covered Indications

>=2Minimum Age

12 mLDaily Quantity Limit

Coverage Summary

Coverage stance: covered_with_criteria under the pharmacy benefit for Commercial/Exchange members. Scope: applies to the specialty-designated product Fintepla (fenfluramine) and requires dispensing through a contracted specialty pharmacy. Age limit: >= 2 years. Quantity limit: 12 mL/day.

Initial Therapy Criteria

Coverage Eligibility (general)

Authorization may be granted when the following general or continuity conditions are met:

Either

Allows continuity of care for recent plan entrants
- Continuity of care: Member is new to the plan within the past 90 days and currently receiving treatment with the requested medication (excluding when the product is obtained as samples or via manufacturer's patient assistance programs).
OR Diagnosis-specific criteria (all must be met)
- ONE of the following diagnoses
  - Diagnosis: Seizures associated with Dravet Syndrome (DS)
  - Diagnosis: Lennox-Gastaut Syndrome (LGS)
- Age requirement: Member is 2 years of age or older>= 2 years
  Refer to age threshold
- Prescriber requirement: Requested medication is prescribed by or in consultation with a neurologist
- Either inadequate response or contraindication pathway
  - Inadequate response/adverse reaction pathway: Member has had an inadequate response or adverse reaction to at least 2 of the listed anticonvulsant agents>= 2 agents
    See diagnosis-specific agent lists
  - Contraindication pathway: Member has a contraindication to ALL of the listed anticonvulsant agents for the specific diagnosisAll agents contraindicated
    See diagnosis-specific agent lists

ref

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy (Reauthorization)

Requests for reauthorization will be approved when ALL of the following are met:

Continuation of Therapy (Reauthorization): Documentation member has had a positive response to therapy (e.g., decrease in number or frequency of seizures member is experiencing)

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit for Fintepla. The medication is designated specialty and must be dispensed through a contracted specialty pharmacy.

Documentation Required

Specialist prescribing

Fintepla must be prescribed by or in consultation with a neurologist. Include documentation showing neurologist involvement with the prescribing (e.g., consult note, co-signature, or documentation of specialist participation).

Documentation Required

Failure or contraindication documentation

Document an inadequate response or adverse reaction to at least 2 of the listed anticonvulsant agents OR document a contraindication to all listed agents for the specific diagnosis (agents listed by diagnosis).

Documentation Required

Reauthorization documentation

For reauthorization provide documentation that the member has had a positive response to therapy (for example, a decrease in the number or frequency of seizures).

Billing Rule

Specialty pharmacy fill

Fintepla is designated a specialty medication and must be filled at a contracted specialty pharmacy. Contact the payer for specialty pharmacy contact information.

Applicable Codes & Limits

Quantity limitmixedCovered

Fintepla oral solution

Quantity Limit: 12 mL per day (policy lists 1 = 12 mL per day)

Note: The brief does not list NDCs or other billing codes. Specialty pharmacy dispense is required at a contracted specialty pharmacy and the 12 mL/day quantity limit applies. Contact the payer (pharmacy benefit contact) for contracted specialty pharmacy information and any specialty pharmacy billing codes.

Background & Definitions

Background: Fintepla (fenfluramine) is indicated for treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients 2 years of age and older. The medication is designated as a specialty product and is covered under the pharmacy benefit. Prior authorization is required. Initial approvals are typically limited (initial approval 3 months) with reauthorization criteria requiring documentation of a positive response to therapy.

Definitions: Specialty pharmacy — a contracted pharmacy designated by the plan to dispense specialty medications; Fintepla must be filled at a contracted specialty pharmacy.

Revision History

2025-11-01material_revisionLatest

Material update effective 11/01/2025 per 08/13/2025 P&T: updated language for members new to the Plan and specialist prescriber requirements; removed Lennox-Gastaut syndrome adjunctive-use requirement; reauthorization now requires documentation of a positive response to therapy.

2024-01-01material_addition

Material change effective 01/01/2024: Lennox-Gastaut syndrome indication added (reviewed 11/15/2023).

Policy Summary

PayerMass General Brigham Health Plan

PolicyFintepla (fenfluramine)

Policy CodePolicy N/A

Change TypeClinical & administrative updates

Effective DateNov 1, 2025

Next Review Date

Key ActionObtain prior authorization and ensure Fintepla is prescribed by or in consultation with a neurologist and dispensed via a contracted specialty pharmacy.

SourceLink

On This Page

OpenPayer

Fintepla (fenfluramine)

Coverage Summary

Initial Therapy Criteria

Continuation Therapy Criteria (Reauthorization)

Provider Actions & Prior Authorization

Applicable Codes & Limits

Clinical Evidence & References

Background & Definitions

Revision History