Fintepla (fenfluramide) — Recommended Authorization Criteria
Customize your policy alerts
Sign up for all medical mutual - ohio policy alerts
Know when medical mutual - ohio releases new policies or updates existing guidance.
Monitor payer policy activity
Defines recommended prior authorization and coverage criteria for Fintepla (fenfluramide) for treatment of seizures in Dravet syndrome and Lennox-Gastaut syndrome in patients aged 2 years and older.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
inv-01: Initial Therapy
Covered when ALL of the following are met for initial therapy
All subconditions A–H required
inv-02: Continuation Therapy
Covered when ALL of the following are met for continuation of therapy
All subconditions A–F required
Coverage is provided only for the specific indications and criteria listed in this policy. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. The criteria will be updated as new published data become available.
Uses that are not described in the Recommended Authorization Criteria are generally not recommended for approval. Requests for other indications or uses will be reviewed on a case‑by‑case basis and are unlikely to be supported without evidence of safety and effectiveness for the requested use.
Initial Therapy — Detailed Requirements
inv-11: Initial therapy criteria
Patient age requirement (>=2 years)
Continuation Therapy — Renewal Requirements
inv-12: Continuation criteria
Provider Requirements and Administrative Actions
Prior authorization required for Fintepla
Prior authorization is recommended for pharmacy benefit coverage of Fintepla; approval is recommended only when the patient meets the specified initial therapy criteria (including age, diagnosis, prescriber specialty, MAOI spacing, and echocardiogram requirements).
Step requirement — prior inadequate control required
Before initiating Fintepla for Dravet syndrome or Lennox-Gastaut syndrome, the patient must have been inadequately controlled on at least one antiepileptic drug or other antiseizure treatment as specified by diagnosis.
- Dravet: inadequately controlled on ≥1 AED or other antiseizure treatment (includes vagal nerve stimulation or ketogenic diet).
- LGS: inadequately controlled on ≥1 AED, with or without vagal nerve stimulation and/or ketogenic diet.
Provide documentation upon request
The Company may request additional documentation to support medical necessity; requested documentation must be provided upon request to complete the coverage determination.
- Examples include patient records, test results, and credentials of the provider ordering or performing the service.
- Additional documentation supporting medical necessity must be made available upon request.
Potential denial reasons — medical necessity and billing issues
The Company may deny reimbursement if the drug or service is not medically necessary, is investigational/experimental, is not within the member's benefits, or if there is inappropriate or excessive billing/practice patterns.
- Denial may follow findings that the service is not medically necessary, investigational, or outside member benefits.
- A pattern of inappropriate or excessive billing or practice may also result in denial.
Step Therapy / Prerequisite Treatments
| Step | Requirement | Notes |
|---|---|---|
| 1 | ||
| Patient must be inadequately controlled on at least one antiepileptic drug (AED) or other antiseizure treatment prior to initiating Fintepla | ||
| For Dravet syndrome this includes failure of ≥1 AED or other treatment including vagal nerve stimulation (VNS) or a ketogenic diet; for Lennox‑Gastaut syndrome failure of ≥1 AED (with or without VNS and/or ketogenic diet). |
Clinical Background
Fintepla (fenfluramine) is indicated for the treatment of seizures associated with Dravet syndrome and Lennox‑Gastaut syndrome (LGS) in patients aged 2 years and older. Because fenfluramine has serotonergic activity associated with risks of valvular heart disease and pulmonary arterial hypertension, echocardiogram monitoring is required and use is restricted through the FINTEPLA REMS program. Fintepla is contraindicated within 14 days of MAOI administration and is a Schedule IV controlled substance.
Key Definitions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.