CurrentMass General Brigham Health PlanPolicy N/A

Fintepla (fenfluramine) — Coverage Criteria

This policy governs prior authorization, quantity limits, specialty pharmacy dispensing, and medical necessity criteria for Fintepla (fenfluramine) for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyFintepla (fenfluramine) — Coverage Criteria

Policy CodePolicy N/A

Change TypeAdded indication

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and ensure the medication is filled at a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

Added indication of Lennox-Gastaut syndrome.

≥2minimum age for therapy

3 moinitial approval duration

12 moreauthorization duration

Max 13 mgmaximum dose (pediatric)

Requiredspecialty pharmacy

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Initial Therapy - Dravet Syndrome

Covered when ALL of the following are met

Dravet initial: Member has a diagnosis of seizures associated with Dravet Syndrome (DS); member is at least 2 years old; prescriber is a neurologist or documentation of recent neurology consultation; member has had an inadequate response or adverse reaction to at least 2 of the listed anticonvulsant agents OR has a contraindication to ALL of the listed agents; requested use is consistent with the indication.at least 2 prior agents or contraindication to all

Listed anticonvulsants: clobazam; clonazepam; ethosuximide; levetiracetam; phenobarbital; stiripentol; valproic acid; topiramate; zonisamide.

Initial Therapy - Lennox-Gastaut Syndrome

Covered when ALL of the following are met

Lennox-Gastaut initial: Member is at least 2 years old; prescriber is a neurologist or documentation of recent neurology consultation; member will use the medication as adjunctive therapy; member has had an inadequate response or adverse reaction to at least 2 of the listed anticonvulsant agents OR has a contraindication to ALL of the listed agents.at least 2 prior agents or contraindication to all

Listed anticonvulsants for LGS: clobazam; felbamate; lamotrigine; valproic acid; topiramate.

Continuation Therapy / Reauthorization

Reauthorization covered when ALL of the following are met

Continuation: Physician assessment documents a decrease in the number of seizures; reauthorizations will be approved for 12 months after initial approval.documentation of seizure decrease

Initial approvals are for 3 months; reauthorizations for 12 months.

Authorization may not be granted for members who are new to the plan and are not currently receiving the requested medication unless the member meets the policy's coverage criteria. The policy explicitly excludes coverage when the product was obtained only as samples or through a manufacturer patient assistance program; such circumstances do not by themselves establish current use for transition purposes. Providers should confirm ongoing therapy and submit documentation demonstrating the member currently receives the medication or that all coverage criteria are satisfied at the time of the request.

Use of fenfluramine for diagnoses other than Dravet syndrome or Lennox‑Gastaut syndrome does not meet medical necessity under this policy. Requests will be considered not medically necessary when the required elements are not met, including the minimum age of ≥2 years, documentation of the appropriate prescriber specialty (neurologist or recent neurology consultation), and evidence of prior inadequate response or contraindication to the specified anticonvulsant agents for the relevant syndrome. Absent these criteria, approval should not be granted.

Provider Requirements and Authorization Steps

Prior Authorization

Prior Authorization and Specialty Dispensing

Prior authorization is required. This medication is designated specialty and must be filled at a contracted specialty pharmacy. Authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication (excluding products obtained as samples or via manufacturer patient assistance programs). For assistance: Medical and Specialty Medications phone: 877-519-1908, fax: 855-540-3693; Non-Specialty Medications phone: 800-711-4555, fax: 844-403-1029.

Specialty dispensing required: fill at contracted specialty pharmacy
New-to-plan continuity: current users may be authorized (excludes samples and manufacturer PAP)
Contact — Medical & Specialty: 877-519-1908 | Fax: 855-540-3693
Contact — Non-Specialty: 800-711-4555 | Fax: 844-403-1029

Documentation Required

Required Documentation

For initial requests, include documentation that supports the diagnosis and prior treatment history: note confirming diagnosis (Dravet syndrome or Lennox-Gastaut syndrome), member age (>= 2 years), neurologist as prescriber or documentation of recent neurology consultation, and clinical notes detailing seizure frequency and prior response to therapies.

Documented diagnosis: Dravet syndrome OR Lennox-Gastaut syndrome
Member age: >= 2 years
Prescriber: neurologist OR recent neurology consultation documentation
Clinical assessment: baseline seizure frequency and treatment response

Step Therapy

Step Therapy / Prior Treatment Trials

Step therapy: Member must have had an inadequate response or adverse reaction to at least two of the specified anticonvulsant agents, OR have contraindications to all listed agents for the respective diagnosis.

Dravet syndrome — trial of >=2 (or contraindication to all): clobazam; clonazepam; ethosuximide; levetiracetam; phenobarbital; stiripentol; valproic acid; topiramate; zonisamide
Lennox-Gastaut syndrome — trial of >=2 (or contraindication to all): clobazam; felbamate; lamotrigine; valproic acid; topiramate
Trials should document inadequate response or adverse reaction to the agents tried

Note

Continuation of Therapy

For continuation (reauthorization) requests, provide physician assessment documenting a decrease in the number of seizures since initiation of therapy.

Reauthorization requires documentation of clinical benefit — reduction in seizure frequency

OpenPayer

Fintepla (fenfluramine) — Coverage Criteria

Coverage Criteria for Fintepla (fenfluramine)

Coding and Dosing Information

Provider Requirements and Authorization Steps

Background and Clinical Context

Key Definitions