CurrentCignaPolicy IP0042

Fintepla (fenfluramine) — Coverage Criteria for Seizures (Dravet syndrome, Lennox‑Gastaut syndrome)

Coverage policy governing prior authorization and medical necessity criteria for Fintepla (fenfluramine oral solution) for treatment of seizures associated with Dravet syndrome and Lennox‑Gastaut syndrome for Cigna-administered plans.

Policy Summary

PayerCigna

PolicyFintepla (fenfluramine) coverage criteria — seizures in Dravet and Lennox‑Gastaut syndromes

Policy CodePolicy IP0042

Change TypeTerminology and continuation criteria updated

Effective Date

Next Review DateJul 15, 2025

Key ActionSubmit prior authorization with documentation of age, prior/concurrent antiseizure medications, and neurologist prescription or consultation.

SourceLink

POLICY UPDATE CHANGES

Updated terminology used for alternative therapy requirement and added 'Patient is Currently Receiving Fintepla' criteria.

Title changed from Fenfluramine to Fintepla and annual content review performed.

2FDA-approved indications (Dravet, LGS)

1 yearApproval duration

≥2Minimum age

PA requiredAuthorization

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Coverage and Medical Necessity Criteria

Dravet Syndrome

Approve if the patient meets ONE of the following (A or B):

Dravet: initial or current therapy: A) Initial Therapy: Approve for 1 year if ALL of (i) patient is >= 2 years; AND (ii) patient meets ONE of (a) patient has tried or is concomitantly receiving at least two other antiseizure medications (examples include valproic acid, topiramate, clonazepam, levetiracetam, zonisamide) OR (b) patient has tried or is concomitantly receiving one of clobazam, Epidiolex, or Diacomit; AND (iii) Fintepla is prescribed by or in consultation with a neurologist. B) Patient is Currently Receiving Fintepla: Approve for 1 year if the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.

Lennox-Gastaut Syndrome

Approve if the patient meets ONE of the following (A or B):

LGS: initial or current therapy: A) Initial Therapy: Approve for 1 year if ALL of (i) patient is >= 2 years; AND (ii) patient has tried or is concomitantly receiving at least two other antiseizure medications (examples include clobazam, Epidiolex, felbamate, lamotrigine, rufinamide, topiramate, valproic acid, levetiracetam, zonisamide, Fycompa, vigabatrin); AND (iii) the medication is prescribed by or in consultation with a neurologist. B) Patient is Currently Receiving Fintepla: Approve for 1 year if the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) as determined by the prescriber.

Fintepla (fenfluramine) for any use other than the indications specifically covered in this policy is not medically necessary and therefore not covered.

Use of Fintepla for indications other than Dravet syndrome or Lennox‑Gastaut syndrome is explicitly stated as not medically necessary and will be denied when submitted for coverage.

Codes and Age Threshold

No specific CPT/HCPCS/ICD-10 codes listedmixed

No codes listed

inv-06: Minimum age

Minimum age>= 2 years

Authorization durationApprovals are provided for 1 year for initial and continuation therapy

Applicable indicationsDravet syndrome and Lennox-Gastaut syndrome (FDA-approved)

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Fintepla. All approvals are provided for the duration noted below (typical approval: 1 year). Initial approval requires the medication to be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurologist).

Prior authorization required for Fintepla
Typical approval duration: 1 year
Initial prescribing by or in consultation with a specialist (neurologist)

Step Therapy

Step / Medication Trial Requirements

Initial therapy requires step/medication trials as follows: for Dravet syndrome, the patient must be ≥ 2 years of age AND have tried or be concomitantly receiving at least two other antiseizure medications OR have tried or be concomitantly receiving one of clobazam, Epidiolex, or Diacomit (with clobazam/Epidiolex/Diacomit option paired with other criteria). For Lennox-Gastaut syndrome, the patient must be ≥ 2 years of age AND have tried or be concomitantly receiving at least two other antiseizure medications. Examples of other antiseizure medications are listed in policy (e.g., valproic acid, topiramate, clonazepam, levetiracetam, zonisamide, felbamate, lamotrigine, rufinamide, clobazam, Epidiolex, Fycompa, vigabatrin).

Drug Background

Fintepla (fenfluramine) is the agent addressed by this policy; it is indicated for seizure disorders included in this coverage (Dravet syndrome and Lennox‑Gastaut syndrome). Use of Fintepla outside of these FDA‑approved seizure indications is considered not medically necessary and is not covered under the policy.

Definitions of Indications

inv-12: Dravet syndrome

DefinitionRare genetic epileptic encephalopathy with onset in the first year of life

Key clinical featuresFrequent and/or prolonged seizures beginning in infancy; multiple seizure types (myoclonic, tonic-clonic, absence, atypical absence, atonic, focal aware/impaired awareness, status epilepticus)

Treatment contextOften refractory to medications; two or more antiseizure medications frequently needed; ketogenic diet or vagus nerve stimulation may help

inv-13: Lennox-Gastaut syndrome

DefinitionSevere epileptic and developmental encephalopathy typically beginning between ages 3 and 5 years

Key clinical featuresMultiple seizure types with high morbidity; commonly atonic (drop) and tonic seizures; often resistant to therapy and typically requires combination antiseizure medications

Policy Changes and Revision Notes

2025-07-15annual_reviewLatest

Annual review noted with no content changes to clinical policy statements.

2024-08-01material_revision

Updated terminology for alternative therapy requirement and added 'Patient is Currently Receiving Fintepla' continuation criteria; title changed from Fenfluramine to Fintepla (operationalized continuation criteria).

Policy Summary

PayerCigna

PolicyFintepla (fenfluramine) coverage criteria — seizures in Dravet and Lennox‑Gastaut syndromes

Policy CodePolicy IP0042

Change TypeTerminology and continuation criteria updated

Effective Date

Next Review DateJul 15, 2025

Key ActionSubmit prior authorization with documentation of age, prior/concurrent antiseizure medications, and neurologist prescription or consultation.

SourceLink

On This Page

Dravet syndrome initial therapy: age ≥ 2 years AND ( ≥2 other antiseizure meds OR tried/concomitant clobazam, Epidiolex, or Diacomit)
Lennox-Gastaut syndrome initial therapy: age ≥ 2 years AND ≥2 other antiseizure meds
Examples of other antiseizure medications: valproic acid, topiramate, clonazepam, levetiracetam, zonisamide, clobazam, Epidiolex, felbamate, lamotrigine, rufinamide, Fycompa, vigabatrin

Documentation Required

Documentation Requirements

Required documentation for initial approval includes: patient age (must be ≥ 2 years for FDA indications), documentation of prior or concomitant antiseizure medication trials per indication, evidence the prescriber is a specialist or that consultation with a neurologist occurred, and prescriber assessment of clinical need. For continuation therapy, documentation that the patient is responding to therapy (e.g., reduced seizure severity, frequency, and/or duration) is required. Note: receipt of sample product does not satisfy coverage criteria.

Document patient age (≥ 2 years)
Document trials or concomitant use of required antiseizure medications
Document prescriber specialty or consultation with a neurologist
For continuation: document clinical response (reduced seizure severity/frequency/duration)
Receipt of sample product does not meet criteria

Denial Risk

Denial Conditions / Triggers

Requests that do not meet FDA-approved indication criteria (Fintepla for any other use), that lack required documentation (age, required medication trials, prescriber specialty/consultation, or evidence of clinical response for continuation), or that are based solely on receipt of sample product may be denied. Claims submitted without covered diagnosis/procedure codes or for non-FDA uses will be denied as not covered.

Denial triggers: requests for non‑FDA uses (not medically necessary)
Denial triggers: missing required documentation (age, medication trials, prescriber specialty/consultation, clinical response)
Denial triggers: receipt of sample product only
Denial triggers: claims lacking covered diagnosis/procedure codes

Treatment contextManagement includes ASMs, dietary therapy (ketogenic diet), and device/surgical options (vagus nerve stimulation, corpus callosotomy); several FDA‑approved drugs exist including Fintepla