CurrentmhnPolicy CP.PMN.246

Fenfluramine (Fintepla) for Dravet and Lennox-Gastaut syndromes

Defines medical necessity, prior authorization, dosing limits, and continuation criteria for Fintepla when used to treat seizures in patients with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) age ≥2, for Centene-affiliated health plans.

Policy Summary

Payermhn

PolicyFenfluramine (Fintepla) for Dravet and Lennox-Gastaut syndromes

Policy CodePolicy CP.PMN.246

Change TypeNo material changes in this revision

Effective DateSep 1, 2020

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing diagnosis, specialist involvement, age ≥2, adjunctive use, prior trials for LGS when required, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2 yrsmin age

12 moapproval dur (Medicaid/HIM)

26 mg/daymax dose (no Diacomit)

17 mg/daymax dose (with Diacomit+clob)

2.2 mg/mLoral conc

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Coverage Criteria for Fenfluramine (Fintepla)

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial approval for DS or LGS: 1. Diagnosis of Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS). 2. Prescribed by or in consultation with a neurologist. 3. Age ≥ 2 years. 4. Will be used as adjunctive therapy with at least one other antiepileptic drug. 5. Member meets one of the following: (a) Request is for a member in a State with limitations on step therapy in certain settings (see Appendix E); OR (b) Both of the following: i. For LGS, failure of two of the following agents unless clinically significant adverse effects are experienced or all are contraindicated: clobazam, clonazepam, felbamate, lamotrigine, rufinamide, topiramate; ii. Failure of a ≥ 3 month trial of Epidiolex® (cannabidiol) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced. 6. Dose does not exceed policy limits: a. Members not on concomitant Diacomit (stiripentol): 26 mg per day (12 mL/day); b. Members on concomitant Diacomit plus clobazam: 17 mg per day (8 mL/day).age >= 2 years; dose limits as specified

For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued therapy for DS or LGS: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Fintepla for a covered indication and has received this medication for at least 30 days. 2. Member is responding positively to therapy. 3. Fintepla will continue to be used as adjunctive therapy with at least one other antiepileptic drug. 4. If request is for a dose increase, the new dose does not exceed policy limits: a. Members not on concomitant Diacomit: 26 mg per day (12 mL/day); b. Members on concomitant Diacomit plus clobazam: 17 mg per day (8 mL/day).>=30 days on therapy for continuation

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

inv-03: Dosing and administration (DS and LGS)

Dosing and formulation information provided in the policy:

Fenfluramine dosing and product information: Initial and maintenance dose: 0.1 mg/kg PO BID; may be increased weekly based on efficacy and tolerability. Oral solution concentration: 2.2 mg/mL. Maximum doses: without concomitant stiripentol (Diacomit) — 26 mg/day (12 mL/day); with concomitant Diacomit plus clobazam — 17 mg/day (8 mL/day).

Dosing adjustments and monitoring should follow prescribing information.

inv-04: State step therapy/redirection exceptions

State-specific exceptions to step therapy/redirection:

Redirection/step therapy bypass for specified states: Policy includes a redirection bypass for members in states with limitations against redirections in certain settings (see Appendix E). Appendix E lists Nevada with specific Medicaid single-drug redirection requirements and other state limitations; a step therapy/redirection bypass for Illinois HIM was added per IL HB 5395.

Where state Medicaid coverage provisions conflict with this clinical policy, state Medicaid coverage provisions take precedence.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the request includes sufficient documentation of efficacy and safety per the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or other governing evidence-of-coverage documents.

When state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers and reviewers should consult the applicable state Medicaid manual for any specific coverage rules that apply to Medicaid members.

Use of fenfluramine for non‑FDA approved indications without sufficient supporting evidence or documentation as required by the referenced off‑label policies is considered not authorized and may be denied.

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member meets all applicable approval criteria, including diagnosis, specialist involvement, age, and planned adjunctive use.

Approval requires documentation of diagnosis (Dravet Syndrome or Lennox-Gastaut Syndrome), that therapy is prescribed by or in consultation with a neurologist, age ≥ 2 years, and use as adjunctive therapy with at least one other antiepileptic drug.
Requests must demonstrate fulfillment of any applicable step therapy requirements or documented contraindications/adverse effects to prior agents where required (see policy criteria).

Denial Risk

State Redirection/Step Therapy Limitations

Requests that do not adhere to state‑specific redirection or step therapy limitations may be at risk for denial in those states. A redirection/step therapy bypass is provided for members in states listed in Appendix E where limitations apply (for example, Nevada for certain Medicaid requests).

Appendix E lists states with limitations on redirections in certain settings — providers should review Appendix E when submitting requests.
Illinois HIM: as of 1/1/2026 per IL HB 5395, the step therapy requirements do not apply for HIM requests (step therapy bypass added).

Documentation Required

Supportive Documentation Required

Provide supportive documentation to substantiate the request. References and prescribing information should be available to support clinical rationale and prior treatment history.

Include office progress notes, medication history with dates and durations of prior antiepileptic trials, lab results, and specialist consultation notes.
Attach relevant references such as the Fintepla Prescribing Information and cited clinical guidelines when requesting coverage for on‑ or off‑label use.

Definitions

inv-18: DS — Dravet syndrome

AbbreviationDS = Dravet syndrome

Disorder classSevere developmental and epileptic encephalopathy beginning in infancy

Policy relevanceListed diagnosis for which Fintepla/ fenfluramine coverage criteria apply (age ≥2 years, adjunctive therapy)

inv-19: LGS — Lennox-Gastaut syndrome

AbbreviationLGS = Lennox-Gastaut syndrome

Disorder classSevere epilepsy syndrome characterized by multiple seizure types, often including drop seizures

Policy relevanceListed diagnosis for which Fintepla/ fenfluramine coverage criteria apply (age ≥2 years, adjunctive therapy)

inv-20: Dravet syndrome (DS) — Description of condition and treatment goals

Core descriptionDravet syndrome (DS) is a severe form of epilepsy in which complete seizure control is typically not achievable; primary goal of therapy is reduction in seizure frequency (per international consensus).

Therapeutic role of FinteplaUsed as adjunctive therapy to reduce seizure frequency in patients with DS (coverage requires use with at least one other antiepileptic drug).

Dosing noteInitial and maintenance dosing typically 0.1 mg/kg PO BID with titration as tolerated; maximum daily dose limits specified in policy (26 mg/day without stiripentol; 17 mg/day with stiripentol plus clobazam).

inv-21: Lennox-Gastaut syndrome (LGS) — Description of condition and treatment goals

Core descriptionLennox-Gastaut syndrome (LGS) is a severe epilepsy syndrome with uncertain optimal treatment; multiple agents may be used as add-on therapy and choice should be individualized.

Therapeutic goalImprove seizure control (including reduction of drop seizures) as adjunctive therapy when used with other antiepileptic drugs; clobazam may assist with drop seizures.

Dosing noteFintepla dosing for LGS follows the same regimen as DS (0.1 mg/kg PO BID with weekly titration as tolerated) with the same policy maximums (26 mg/day without stiripentol; 17 mg/day with stiripentol plus clobazam).

OpenPayer

Fenfluramine (Fintepla) for Dravet and Lennox-Gastaut syndromes

Coverage Criteria for Fenfluramine (Fintepla)

Dosing Limits and Code-related Values

Prior Authorization, Documentation, and Step Therapy

Drug Background and Indication Summary

Definitions