ModifiedmhnPolicy CP.PMN.156

Perampanel (Fycompa) prior authorization and coverage criteria

Defines medical necessity, approval criteria, and prior authorization requirements for perampanel (Fycompa) across Commercial, HIM, and Medicaid lines of business for treatment of partial-onset seizures and primary generalized tonic-clonic seizures.

Policy Summary

Payermhn

PolicyPerampanel (Fycompa) prior authorization and coverage criteria

Policy CodePolicy CP.PMN.156

Change TypeMaterial revisions (generic requirement, step therapy bypasses, approval duration)

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation and use generic perampanel tablets for Fycompa requests unless contraindicated or inability to use tablets is documented.

SourceLink

POLICY UPDATE CHANGES

Step therapy bypass for Illinois HIM requests as of 1/1/2026 per IL HB 5395.

Required use of generic perampanel tablets for Fycompa tablet and oral suspension requests (with limited exceptions).

Commercial approval duration changed to 12 months or duration of request, whichever is less.

Added redirection bypass for members in states with limitations on step therapy and included Appendix D with Nevada-specific single drug redirection requirements for Medicaid.

Revised policy/criteria to include generic perampanel and added required use of generic perampanel for brand Fycompa requests.

≥4Minimum age (partial-onset)

≥12

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Coverage Criteria

Initial Therapy — Partial-Onset Seizures

Covered when ALL of the following are met:

ALL of the following

Diagnosis of partial-onset seizures.
Age >= 4 years.
Member meets one of the following:
- Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D).
- Failure of two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated.
For Fycompa tablets requests, member must use generic perampanel tablets (generic Fycompa), unless contraindicated or clinically significant adverse effects are experienced.
For Fycompa oral suspension requests, member must use generic perampanel tablets (generic Fycompa), unless contraindicated, clinically significant adverse effects are experienced, or documentation supports inability to use generic perampanel tablets.
Dose limits
- Dose does not exceed 12 mg per day.
- Dose does not exceed 1 tablet per day.
For Illinois HIM requests, the step therapy requirements above do not apply as of 1/1/2026 per IL HB 5395.

Initial Therapy — Primary Generalized Tonic-Clonic Seizures

Covered when ALL of the following are met:

ALL of the following

Diagnosis of primary generalized tonic-clonic seizures.
Age >= 12 years.
Member meets one of the following:
- Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D).
- Failure of two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated.

Continuation Therapy

Covered for continuation when ALL of the following are met:

ALL of the following

Member is currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Fycompa for seizures and has received this medication for at least 30 days.
Member is responding positively to therapy.
For Fycompa tablets requests, member must use generic perampanel tablets (generic Fycompa), unless contraindicated or clinically significant adverse effects are experienced.
For Fycompa oral suspension requests, member must use generic perampanel tablets (generic Fycompa), unless contraindicated, clinically significant adverse effects are experienced, or documentation supports inability to use generic perampanel tablets.
Dose increase limits

Other Diagnoses/Indications (Off-Label or New Label Considerations)

If requested use is not listed in approved indications:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to the applicable policy for formulary/non-formulary status: CP.CPA.190 (commercial) or HIM.PA.33 (HIM) or CP.PMN.255 (Medicaid) for formulary/PDL agents; CP.CPA.190 (commercial) or HIM.PA.103 (HIM) or CP.PMN.16 (Medicaid) for non-formulary agents.
If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 (commercial), HIM.PA.154 (HIM), or CP.PMN.53 (Medicaid).

Non-FDA approved indications, which are not addressed in this policy, are not authorized unless there is sufficient documentation of efficacy and safety according to the off-label use policies: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or other evidence of coverage documents.

For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy.

Product Coding & Dosing

TabletsNDCCovered

2 mg	Tablet strength — 2 mg
4 mg	Tablet strength — 4 mg
6 mg	Tablet strength — 6 mg
8 mg	Tablet strength — 8 mg
10 mg	Tablet strength — 10 mg
12 mg	Tablet strength — 12 mg

Oral SuspensionNDCCovered

0.5 mg/mL (340 mL)

Oral suspension concentration and bottle size

Maximum daily dose

Maximum daily dose12 mg/day

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required with diagnosis, age, prior therapy/step-therapy bypass, and dosing

Prior authorization is required. The request must document the diagnosis, the member's age, prior therapy failure or applicable step-therapy bypass, and that dosing does not exceed policy maximums.

Document diagnosis (e.g., partial-onset or primary generalized tonic-clonic seizures).
Document member age meeting indication-specific minimums (≥4 years for partial-onset; ≥12 years for primary generalized tonic-clonic).
Document failure of two preferred alternatives or applicable step-therapy bypass.
Document dosing not to exceed 12 mg per day and 1 tablet per day.

Prior Authorization

Updated authorization durations and generic-use requirement

Authorization durations were updated: Commercial approvals are limited to 12 months or the duration of the request, whichever is less; prior authorization requests must also indicate use of generic perampanel when required by the policy.

Background

Perampanel (Fycompa) is a noncompetitive AMPA (α‑amino‑3‑hydroxy‑5‑methyl‑4‑isoxazolepropionic acid) glutamate receptor antagonist indicated for treatment of partial‑onset seizures and as adjunctive therapy for primary generalized tonic‑clonic seizures. The product is available as tablets (multiple strengths) and an oral suspension; dosing generally starts at 2 mg once daily at bedtime (adjusted to 4 mg if the patient is on a CYP3A4 inducer) with typical maintenance doses of 8–12 mg once daily and a maximum daily dose of 12 mg. Indication age limits include age ≥ 4 years for partial‑onset seizures and age ≥ 12 years for primary generalized tonic‑clonic seizures.

Definitions

Perampanel (Fycompa) — drug summary, indications, age thresholds

Drug class & namePerampanel (Fycompa) — a noncompetitive AMPA glutamate receptor antagonist

Indication: partial-onset seizuresTreatment of partial-onset seizures with or without secondarily generalized seizures in patients ≥ 4 years of age

Indication: primary generalized tonic-clonic seizuresAdjunctive therapy for primary generalized tonic-clonic seizures in patients ≥ 12 years of age

Product availabilityTablets (2, 4, 6, 8, 10, 12 mg) and oral suspension (0.5 mg/mL)

Step therapy redirection — definition

DefinitionStep therapy redirection is a policy mechanism requiring trial and failure of preferred alternatives prior to coverage of the requested agent, with exceptions and state-specific limitations documented in Appendix D.

Policy Summary

Payermhn

PolicyPerampanel (Fycompa) prior authorization and coverage criteria

Policy CodePolicy CP.PMN.156

Change TypeMaterial revisions (generic requirement, step therapy bypasses, approval duration)

Effective DateNov 16, 2016

Next Review Date

Key ActionSubmit prior authorization with documentation and use generic perampanel tablets for Fycompa requests unless contraindicated or inability to use tablets is documented.

SourceLink

On This Page

Step Therapy

Step therapy: two preferred alternatives required unless exceptions apply

Step therapy requires trial and failure of two preferred alternatives unless the member is in a state with step therapy limitations or has clinically significant adverse effects or contraindications.

Failure of two preferred alternatives (see Appendix B) is required unless contraindicated or intolerant.
Member in a State with limitations on step therapy (see Appendix D) may meet criteria without two failures.

Note

State redirection bypasses and Nevada/Illinois specifics

Policy includes redirection bypass provisions for members in states with limits on step therapy and specifies Nevada single‑drug redirection rules for Medicaid; Illinois HIM step therapy bypass applies per IL HB 5395.

Appendix D lists states with limitations and Nevada-specific single-drug redirection for Medicaid (failure of one preferred alternative).
Step therapy bypass added for Illinois HIM requests effective 1/1/2026 per IL HB 5395.

Documentation Required

Authorization must show updated approval durations and generic use when applicable

Prior authorization requests must reflect the revised approval durations and indicate use of generic perampanel when required by the policy.

Commercial requests should specify the requested approval period (up to 12 months or duration of request).
Requests for brand Fycompa must note whether generic perampanel was used or document why generic is not appropriate.

Denial Risk

Incomplete documentation or unsupported off‑label requests risk denial

Requests that lack documentation demonstrating the member meets all approval criteria, or that request non‑FDA indications without sufficient off‑label evidence, may be denied or not authorized.

Off‑label uses not addressed in this policy require sufficient evidence per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Billing Rule

Generic perampanel required for Fycompa tablet/suspension requests unless exceptions apply

The policy requires use of generic perampanel tablets for Fycompa tablet and oral suspension requests unless contraindicated, clinically significant adverse effects occur, or inability to use tablets is documented; brand requests may be impacted if generic is not used.

For tablet requests: member must use generic perampanel tablets unless contraindicated or clinically significant adverse effects.
For oral suspension requests: member must use generic perampanel tablets unless contraindicated, adverse effects, or documented inability to use tablets.

Health Plan — definition

DefinitionHealth Plan — a plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC or any of its affiliates.

ApplicabilityThis clinical policy applies to Commercial, HIM, and Medicaid lines of business as adopted by the Health Plan.

State precedence noteFor Medicaid members, state Medicaid coverage provisions take precedence when they conflict with this clinical policy (refer to state Medicaid manual).