CurrentCareSourcePolicy N/A

Fintepla (fenfluramine) — Pharmacy coverage for Dravet syndrome

This pharmacy policy governs prior authorization, coverage criteria, and site-of-service for Fintepla (fenfluramine) under the CareSource pharmacy benefit for members in Arkansas PASSE programs.

Policy Summary

PayerCareSource

PolicyFintepla (fenfluramine) — Pharmacy coverage for Dravet syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document seizure frequency, weight, ECG, and prior AED trial in chart notes.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Prior Authorizationcoverage requirement

Homeallowed site of service

3 monthsinitial approval

12 monthsreauthorization

>=2 yrsminimum age

Coverage Criteria for Fintepla (fenfluramine)

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial Authorization for Dravet Syndrome: 1) Medication prescribed by or in consultation with a neurologist; AND 2) Member is 2 years old or older; AND 3) Diagnosis of seizures associated with Dravet Syndrome; AND 4) Chart notes document the member's seizure frequency on current treatment; AND 5) Member's weight is documented in chart notes for dosing; AND 6) Chart notes show that an electrocardiogram (ECG) has been done or will be done before starting treatment; AND 7) Member has tried and failed (or has a contraindication to) at least one anti-epileptic drug. Dosing per package insert and concomitant therapy: a) Without stiripentol (Diacomit): 0.35 mg/kg twice daily, up to 26 mg/day; b) With concomitant stiripentol and clobazam: 0.2 mg/kg twice daily, up to 17 mg/day.

If all met, approve for 3 months

inv-02: Continuation Therapy / Reauthorization

Covered when ALL of the following are met for reauthorization:

Reauthorization for Dravet Syndrome: Chart notes must document a reduction in convulsive seizure frequency since starting Fintepla.

Policy Summary

PayerCareSource

PolicyFintepla (fenfluramine) — Pharmacy coverage for Dravet syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2022

Next Review DateN/A

Key ActionObtain prior authorization and document seizure frequency, weight, ECG, and prior AED trial in chart notes.

SourceLink

On This Page

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If met, approve for an additional 12 months

CareSource covers Fintepla (fenfluramine) only for indications and clinical scenarios expressly detailed in this policy. Prior authorization is required and coverage is limited to members who meet the specific clinical criteria described for Dravet Syndrome. Use of Fintepla outside the listed, approved indication(s) in this document is not covered.

Fintepla (fenfluramine) is not medically necessary and therefore not covered when prescribed for indications other than those explicitly listed in this policy. This policy's covered indication is seizures associated with Dravet Syndrome; use for any other disease state will be denied as not medically necessary. Prior authorization is required under the pharmacy benefit and billing must use a valid NDC code.

Billing, Codes, and Age Limits

Billing / NDCNDC

NDC required

Must use valid NDC code for billing Fintepla

Minimum age — >= 2 years

Minimum member ageMust be 2 years of age or older

Age verificationMember's age must be documented in the chart or medical record

Applies toApplies to initial and continuation authorizations for Fintepla (fenfluramine)

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Fintepla (fenfluramine) as a non-preferred product under the pharmacy benefit. Billing must use a valid NDC code.

Benefit type: Pharmacy
Site of service allowed: Home
Quantity limits: See dosage allowed / package insert for titration schedule

Documentation Required

Required documentation

Chart documentation must demonstrate clinical information to support initiation and continuation of therapy.

Documented seizure frequency on current treatment (baseline)
Member weight recorded in chart notes for dosing
ECG has been performed or is scheduled prior to initiation of therapy
Documentation of neurologist involvement: prescribed by or in consultation with a neurologist
For initial therapy: member age documented (must be ≥ 2 years)
Diagnosis documented: seizures associated with Dravet syndrome

Prior Authorization

Required prior AED trial

Member must have tried and failed (or have a documented contraindication to) at least one anti‑epileptic drug prior to approval; dosing guidance varies based on concomitant stiripentol (Diacomit) and clobazam use.

Without Diacomit (stiripentol): prior trial and dosing context listed (reference clinical record)
With concomitant Diacomit and clobazam: alternate dosing context applies
Dosage allowed: follow package insert for titration schedule

Denial Risk

Denial triggers

Requests will be denied if prior authorization is not obtained or if required clinical criteria and documentation are missing.

Denial triggers include: lack of prior authorization, diagnosis not listed (non‑Dravet syndromes), absence of neurologist involvement, missing age documentation, missing weight, no ECG documentation, no documented prior AED trial or contraindication, or failure to document seizure frequency improvement on reauthorization.

Clinical Background

Dravet syndrome is a severe epileptic encephalopathy characterized by recurrent, often treatment-resistant convulsive seizures beginning in infancy. Fenfluramine (Fintepla) is indicated in this policy specifically to reduce convulsive seizure frequency in patients with Dravet Syndrome; dosing and titration follow the package insert and vary depending on concomitant use of stiripentol (Diacomit) and clobazam. Baseline and ongoing documentation required for therapy includes neurologist involvement, member age ≥ 2 years, documented seizure frequency, recorded weight for dosing, and an electrocardiogram (ECG) performed or planned prior to initiation.

Definitions

Dravet Syndrome seizures — Convulsive seizures associated with Dravet Syndrome

DefinitionConvulsive seizures associated with Dravet Syndrome

Indication contextFintepla is covered when member has a diagnosis of seizures associated with Dravet Syndrome and meets all listed criteria

Documentation requiredChart notes must document the member's seizure frequency on current treatment

Initial Authorization Criteria

inv-13: Initial Authorization

Initial authorization criteria summary

Initial: Prescribed by or in consultation with a neurologist; age >= 2 years; diagnosis of seizures associated with Dravet Syndrome; documentation of seizure frequency on current treatment; member weight documented for dosing; ECG done or planned before initiation; tried and failed (or contraindication to) at least one anti-epileptic drug; dosing per package insert with adjustments for concomitant stiripentol and clobazam (see detailed dosing).

If all met, approve for 3 months

Reauthorization Criteria

inv-14: Reauthorization

Reauthorization requirements

Reauthorization: Chart notes must document a reduction in convulsive seizure frequency since starting Fintepla.

If met, approve for an additional 12 months

Step Therapy Requirements

Step	Requirement	Notes
1	Member must have tried and failed (or have a contraindication to) at least one anti-epileptic drug	Dosing guidance depends on concomitant use of stiripentol (Diacomit) and clobazam: without stiripentol — 0.35 mg/kg twice daily, up to 26 mg/day; with concomitant stiripentol and clobazam — 0.2 mg/kg twice daily, up to 17 mg/day.

Dosage and Quantity Limits

Fintepla (fenfluramine) — Dosage and maximums

Dosage guidanceRefer to package insert for titration schedule; dosing varies with concomitant stiripentol and clobazam

Maximum without stiripentol0.35 mg/kg twice daily, up to 26 mg/day

Maximum with stiripentol and clobazam0.2 mg/kg twice daily, up to 17 mg/day

Quantity limit noteSee 'dosage allowed' / package insert for exact titration and mg/day limits

Site of Service

Note

Home administration allowed

Home administration is an allowed site of service for Fintepla.

Site of service allowed: Home