CurrentmhnPolicy CP.PMN.156

Clinical Policy: Perampanel (Fycompa)

Pharmacy clinical policy governing medical necessity coverage, initial and continuation criteria, step-therapy/redirection exceptions, dosing limits, formulation requirements, approval durations, and exclusions for perampanel (Fycompa) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Perampanel (Fycompa)

Policy CodePolicy CP.PMN.156

Change TypeStep therapy bypass; generic inclusion; wording clarifications

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for IL HIM per IL HB 5395 (effective 01/01/2026).

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

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

Clarified oral solutions to oral suspensions wording.

2FDA-approved indications listed

4Key initial/continuation criteria items

12 mg/dayMaximum dose threshold

Minimum prior exposure for continuation

Coverage Summary

Perampanel (Fycompa) is covered with criteria aligned to FDA-labeled indications: for partial‑onset seizures in patients aged ≥ 4 years and as adjunctive therapy for primary generalized tonic‑clonic seizures in patients aged ≥ 12 years.

Coverage requires documented failure of preferred alternatives (typically two), unless the request is for a member in a state or program with a redirection/step therapy bypass per Appendix D (e.g., Nevada Medicaid single‑drug redirection; IL HIM bypass effective 01/01/2026), or there is documented contraindication or intolerable adverse effects.

Formulation requirements mandate use of generic perampanel tablets for Fycompa tablet requests unless contraindicated or adverse effects occur; for oral suspension requests, generic tablets must be used unless contraindicated, adverse effects occur, or there is documentation of inability to use tablets.

Quick policy thresholds

Maximum daily dose≤ 12 mg/day

Maximum tablets per day≤ 1 tablet/day

Minimum treatment duration prior to continuation≥ 30 days

Age for partial-onset seizures≥ 4 years

Age for primary generalized tonic-clonic seizures≥ 12 years

Initial Therapy Criteria

I. Initial Approval Criteria - B. Primary Generalized Tonic-Clonic Seizures

must meet all

ALL of the following

Diagnosis of partial-onset seizures
Age ≥ 4 years
Member meets one of the following (a or b)
- a: Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D)
- b:

Continuation Therapy Criteria

II. Continuation/Renewal Criteria - All Indications in Section I

must meet all

ALL of the following

Diagnosis of primary generalized tonic-clonic seizures
Age ≥ 12 years
Member meets one of the following (a or b)
- a: Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D)
- b:

Other Indications / Not Authorized

III. Other diagnoses/indications and III. Diagnoses/Indications for which coverage is NOT authorized

must meet all

ALL of the following

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≥ 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

Applicable Codes

Product Availability (for prescribing/billing reference)mixed

N/A	Tablets: 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg
N/A	Oral suspension: 0.5 mg/mL (340 mL)

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required

Perampanel (Fycompa) requires prescriber documentation demonstrating that the patient meets the policy's initial or continuation criteria. Approval duration varies by line of business.

Approval duration per line of business
Refer to policy for specific durations

Documentation Required

Submit supporting documentation

Submit supporting documentation such as office chart notes, laboratory results, or other clinical information that demonstrate the member meets all approval criteria.

Office chart notes

Clinical Evidence

Evidence: FDA Prescribing Information (latest cited) - June 2023.

Clinical guideline references: AAN/AES practice guideline updates (2018) are cited. The policy aligns coverage to FDA indications.

Background & Definitions

Perampanel is a noncompetitive AMPA receptor antagonist.

FDA indications per the label: treatment of partial‑onset seizures with or without secondarily generalized seizures in patients ≥ 4 years, and adjunctive therapy for primary generalized tonic‑clonic seizures in patients ≥ 12 years.

The policy aligns coverage to these FDA indications and applies step‑therapy requirements (failure of preferred alternatives) with state‑specific redirection/step therapy bypasses referenced in Appendix D (e.g., NV Medicaid single‑drug redirection; IL HIM bypass effective 01/01/2026).

Formulation guidance requires use of generic perampanel tablets for Fycompa tablet and oral suspension requests unless contraindicated, adverse effects occur, or inability to use tablets is documented for suspension requests.

Redirection/Step therapy bypass: State‑specific statutory or regulatory restrictions that limit requirements to fail multiple preferred alternatives; Appendix D lists applicable states and program‑specific rules (e.g., Nevada Medicaid single‑drug redirection; IL HIM bypass effective 01/01/2026).

HIM (Health Insurance Marketplace): the health insurance marketplace line of business referenced in the policy; HIM coverage follows policy criteria except where state or federal rules require different handling.

Revision History

01/01/2026policy_added

Added step therapy bypass for Illinois HIM requests per Illinois HB 5395 (step therapy requirements do not apply for Illinois HIM as of 1/1/2026).

08/21/2025policy_revised

Revised policy/criteria to include generic perampanel and added required use of generic perampanel for brand Fycompa requests (per August SDC).

12/03/2025policy_clarified

Clarified required use of generic perampanel tablets for brand tablet and oral solutions requests.

Policy Summary

Payermhn

PolicyClinical Policy: Perampanel (Fycompa)

Policy CodePolicy CP.PMN.156

Change TypeStep therapy bypass; generic inclusion; wording clarifications

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria.

SourceLink

On This Page

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 (must meet both)

a: Dose does not exceed 12 mg per day≤ 12 mg/day
b: Dose does not exceed 1 tablet per day≤ 1 tablet/day

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title": "I. Initial Approval Criteria - A. Partial-Onset Seizures

Failure of two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicated

Fycompa will be used as adjunctive therapy

For Fycompa tablets requests, member must use generic perampanel tablets (generic Fycompa), unless contraindicated or clinically significant adverse effects are experienced

Dose limits (must meet both)

a: Dose does not exceed 12 mg per day≤ 12 mg/day
b: Dose does not exceed 1 tablet per day≤ 1 tablet/day

Dose limits on continuation (must meet both)

a: New dose does not exceed 12 mg per day≤ 12 mg/day
b: New dose does not exceed 1 tablet per day≤ 1 tablet/day

ANY of the following

1: 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 no coverage criteria policy for the relevant line of business (CP.CPA.190 commercial, HIM.PA.33 marketplace, CP.PMN.255 Medicaid)
2: If requested use is NOT specifically listed under section III 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 marketplace, CP.PMN.53 Medicaid)

Other clinical information

Billing Rule

Formulation substitution requirement

Requests for Fycompa tablets or oral suspension must use generic perampanel tablets unless contraindicated or clinically significant adverse effects are experienced. For oral suspension requests, documentation must support inability to use generic perampanel tablets if tablets are not used.

Suspension requests require documentation of inability to use tablets when applicable

Denial Risk

Step therapy failure requirement

Requests may be denied if failure of two preferred alternatives is not documented, unless state-specific step therapy limitations or redirection/bypass apply.

See Appendix B for examples of preferred alternatives

Documentation Required

State-specific step therapy bypass

Redirection/step therapy bypass applies for members in the states listed in Appendix D. Illinois HIM requests are exempt from the step therapy requirement effective 2026-01-01 per IL HB 5395; Nevada Medicaid has single-drug redirection rules as noted in Appendix D.

IL HIM bypass effective 2026-01-01 per IL HB 5395
Nevada Medicaid one-drug redirection rules per Appendix D

01/28/2026administrative_clarificationLatest

Administrative wording clarification: clarified wording from 'oral solutions' to 'oral suspensions'.

01/20/2022policy_revised

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.