Currentmedical mutual - ohioPolicy N/A

Fintepla (fenfluramine)

Defines recommended prior-authorization criteria, initial and continuation approval conditions, monitoring (echocardiograms), prescribing clinician requirements, contraindications, approval durations, and documentation expectations for Fintepla (fenfluramine) for patients aged 2 years and older with Dravet syndrome or Lennox-Gastaut syndrome.

Policy Summary

Payermedical mutual - ohio

PolicyFintepla (fenfluramine)

Policy CodePolicy N/A

Change TypeAnnual review (no material changes)

Effective Date

Next Review DateApr 17, 2025

Key ActionPrior authorization is recommended for Fintepla and approval is recommended only for patients meeting the specified criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes identified in this policy update.

2Covered Indications

>=2yMinimum Age

6Initial Approval (months)

6Extended Approval (months)

Coverage Summary

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Covered with criteria: Fintepla (fenfluramine) is covered for treatment of seizures associated with Dravet syndrome and Lennox-Gastaut syndrome in patients >= 2 years when the prior‑authorization criteria are met. Coverage requires prescribing by or in consultation with a neurologist or specialist, enrollment in the FINTEPLA REMS, avoidance of concomitant or recent (within 14 days) MAOI use, documentation of baseline and follow‑up echocardiogram assessments (with prescriber attestation and specified actions if valvular heart disease or pulmonary arterial hypertension are observed), and acknowledgement that Fintepla is a Schedule IV controlled substance.

Initial Therapy Criteria

Initial Therapy

Patient must meet ALL of the following:

ALL of the following

The patient is 2 years of age or older>= 2 years
The patient has a diagnosis of Dravet Syndrome (Severe Myoclonic Epilepsy in Infancy) or Lennox-Gastaut Syndrome (LGS)
Prescriber specialty requirement: Fintepla is prescribed by or in consultation with a neurologist or a provider who specializes in the treatment of Dravet Syndrome or Lennox-Gastaut Syndrome (LGS)
Initial approval requires specialist involvement
MAOI contraindication: Fintepla will not be used concomitantly or within 14 days of the administration of a monoamine oxidase inhibitor (MAOI)No use within 14 days
Due to increased risk of serotonin syndrome
Echocardiogram prior to initiation: The patient has undergone an echocardiogram prior to initiating therapy with Fintepla
ECHO required before treatment
ONE of
- Valvular heart disease AND pulmonary arterial hypertension were not observed on ECHO
- Valvular heart disease and/or pulmonary arterial hypertension is observed on ECHO and the prescriber attests that the benefits of therapy with Fintepla outweigh the risks
  Benefit-risk attestation required for abnormal ECHO
Diagnosis-specific adequacy of prior therapy
- Dravet-specific: If the diagnosis is Dravet Syndrome: the patient has been inadequately controlled on at least ONE antiepileptic drug (AED) or other antiseizure treatment including vagal nerve stimulation or a ketogenic dietAt least 1 prior AED or other listed therapy failed
- LGS-specific: If the diagnosis is LGS: the patient has been inadequately controlled on at least ONE antiepileptic drug (AED), with or without vagal nerve stimulation and/or ketogenic dietAt least 1 prior AED failed

Continuation of Therapy Criteria

Continuation of Therapy

Patient must meet ALL of the following:

ALL of the following

Duration of use: The patient has been using Fintepla for at least 6 months (patients using <6 months should refer to initial therapy criteria)>= 6 months
Clinical benefit: The patient has had a beneficial response to therapy per the prescriber (e.g., reduced seizure severity, frequency, and/or duration)
Response required for continuation
Diagnosis: The patient has a diagnosis of Dravet Syndrome (Severe Myoclonic Epilepsy in Infancy) or Lennox-Gastaut Syndrome (LGS)
Prescriber specialty requirement: Fintepla is prescribed by or in consultation with a neurologist or a provider who specializes in the treatment of Dravet Syndrome or Lennox-Gastaut Syndrome (LGS)
Follow-up echocardiogram timing: The patient has undergone a follow-up echocardiogram after at least 6 months of therapy and the ECHO was performed within the past 6 monthsECHO within past 6 months; performed after >=6 months of therapy
FDA: ECHOs every 6 months
ONE of
- Valvular heart disease AND pulmonary arterial hypertension were not observed on ECHO
- Valvular heart disease and/or pulmonary arterial hypertension is observed on ECHO and the prescriber attests that the benefits of continuing therapy with Fintepla outweigh the risks
  Benefit-risk attestation allowed for abnormal ECHO

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of Fintepla and approval is recommended only for patients meeting the specified criteria in the policy.

Documentation Required

Prescriber specialty requirement

Initial approval requires Fintepla be prescribed by or in consultation with a neurologist or specialist in Dravet/LGS.

Documentation Required

Echocardiogram monitoring

ECHO required prior to initiating therapy and follow-up ECHO after ≥6 months; ECHO must be within past 6 months for continuation requests.

Documentation Required

MAOI contraindication

Do not use concomitantly or within 14 days of MAOI due to serotonin syndrome risk.

Documentation Required

Benefit-risk attestation for abnormal ECHO

If valvular heart disease and/or pulmonary arterial hypertension are observed on ECHO, prescriber must attest that benefits outweigh risks.

Documentation Required

Documentation of prior therapeutic failure

For Dravet or LGS, provider must document inadequate control on at least one AED (or other listed therapies) prior to initiation.

Denial Risk

Coverage limited to listed indications

Requests for uses not listed in the Recommended Authorization Criteria will be reviewed case-by-case and may be denied.

Clinical Evidence & References

Reference: Fintepla [prescribing information], Zogenix Inc.; April 2025. REMS and safety: FINTEPLA is available only through the FINTEPLA REMS program. There is an association between fenfluramine and valvular heart disease and pulmonary arterial hypertension; echocardiogram assessments are required before, during, and after treatment. FINTEPLA is contraindicated within 14 days of MAOI use and contains a Schedule IV controlled substance.

Background & Definitions

Fintepla is indicated for seizures associated with Dravet syndrome and Lennox‑Gastaut syndrome in patients 2 years of age and older. Use is limited to enrollment in the FINTEPLA REMS program due to risks of valvular heart disease and pulmonary arterial hypertension; echocardiogram monitoring is required prior to and during therapy (repeat ECHOs at least every 6 months per prescribing information). Fintepla is a Schedule IV controlled substance and is contraindicated within 14 days of monoamine oxidase inhibitor (MAOI) administration.

Term	Definition
ECHO
Echocardiogram
MAOI
Monoamine oxidase inhibitor
AED
Antiepileptic drug

Policy Summary

Payermedical mutual - ohio

PolicyFintepla (fenfluramine)

Policy CodePolicy N/A

Change TypeAnnual review (no material changes)

Effective Date

Next Review DateApr 17, 2025

Key ActionPrior authorization is recommended for Fintepla and approval is recommended only for patients meeting the specified criteria.

SourceLink

On This Page

OpenPayer

Fintepla (fenfluramine)

Coverage Summary

Initial Therapy Criteria

Continuation of Therapy Criteria

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History