CurrentallcareadvantagePolicy 100.1

Fenfluramine (Fintepla) for seizures associated with Dravet syndrome — Coverage Criteria

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Prior authorization and coverage criteria for fenfluramine (Fintepla) to treat seizures associated with Dravet syndrome for members aged 2 years and older; applies to prescribers and prior authorization reviewers for AllCare Advantage members.

Policy Summary

Payerallcareadvantage

PolicyFenfluramine (Fintepla) for seizures associated with Dravet syndrome

Policy CodePolicy Policy 100.1

Change TypeNo material change

Effective DateOct 22, 2020

Last ReviewOct 22, 2022

Next Review DateOct 22, 2022

Key ActionObtain prior authorization and approve up to 12 months when all coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2minimum covered age

2required prior anticonvulsant trials

12 moapproval length

ECHOcardiac monitoring

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CurrentallcareadvantagePolicy 100.1

Fenfluramine (Fintepla) for seizures associated with Dravet syndrome — Coverage Criteria

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Policy Summary

Payerallcareadvantage

PolicyFenfluramine (Fintepla) for seizures associated with Dravet syndrome

Policy CodePolicy Policy 100.1

Change TypeNo material change

Effective DateOct 22, 2020

Last ReviewOct 22, 2022

Next Review DateOct 22, 2022

Key ActionObtain prior authorization and approve up to 12 months when all coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥2minimum covered age

2required prior anticonvulsant trials

12 moapproval length

ECHOcardiac monitoring

Coverage Criteria for Fenfluramine (Fintepla)

Initial authorization criteria

Covered when ALL of the following are met

Age: Member is age 2 years or older>=2 years

If not met, deny

Diagnosis: Submitted documentation supports a diagnosis of seizures associated with Dravet syndromeN/A

If not met, deny

Prescriber: Therapy is prescribed by or given in consultation with a neurologistN/A

If not met, deny

Cardiac monitoring: Member has had the required baseline echocardiogram assessment prior to starting treatmentEchocardiogram

If not met, deny

Prior therapy trials: Documentation that the member has tried/failed or has a contraindication to at least two recommended anticonvulsant agents>=2 agents

If met, approve up to 12 months; if not met, deny

This policy applies specifically to use of fenfluramine (FINTEPLA) for the treatment of seizures associated with Dravet syndrome. It does not cover use of fenfluramine for other seizure disorders or non‑Dravet indications. Requests must document a funded diagnosis of seizures associated with Dravet syndrome to be considered under this policy. Members must be age ≥2 years to meet the policy’s scope.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization required; approvals up to 12 months

Prior authorization is required for fenfluramine (Fintepla). When all approval criteria are met, coverage may be authorized for up to 12 months.

Step Therapy

Required trials of ≥2 antiseizure agents

Before approval, documentation must show the member has tried and failed, or has a contraindication to, at least two recommended antiseizure agents.

Documentation must explicitly state trials and outcomes (failure) or documented contraindications for each agent.

Key Definitions

Seizures associated with Dravet syndrome — definition and qualifiers

ConditionSeizures associated with Dravet syndrome (FDA‑approved indication)

Minimum age>= 2 years

Prior therapy requirementMember must have tried and failed, or have contraindications to, at least two recommended anticonvulsant agents

Cardiac monitoring requirementBaseline echocardiogram required prior to starting treatment; ongoing monitoring during and after treatment

Coverage stanceCovered with criteria when all requirements are met

Background

Fenfluramine (FINTEPLA) is FDA‑approved for the treatment of seizures associated with Dravet syndrome. Because fenfluramine and other serotonergic drugs with 5‑HT2B receptor agonist activity have been associated with pulmonary arterial hypertension, cardiac monitoring via echocardiogram is required prior to starting treatment, during treatment, and after treatment to allow early detection of cardiac or pulmonary vascular changes. Prior authorization is required and coverage is provided when criteria are met, including prior trial/failure or contraindication to at least two recommended anticonvulsant agents.

Denial Risk

Triggers for denial

Do not submit requests for members younger than 2 years, or without required documentation; these are grounds for denial. Also deny if therapy is not prescribed by or in consultation with a neurologist, if a baseline echocardiogram is not documented, or if there is no record of trials/failures or contraindications to at least two recommended agents.

Member age < 2 years → Deny.
No documentation supporting a diagnosis of seizures associated with Dravet syndrome → Deny.
Therapy not prescribed by or in consultation with a neurologist → Deny.
No baseline echocardiogram assessment prior to treatment → Deny.
No documentation of trial/failure or contraindication to ≥2 recommended antiseizure agents → Deny.