CurrentCentenePolicy CP PMN.156

Perampanel (Fycompa)

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

Policy Summary

PayerCentene

PolicyPerampanel (Fycompa)

Policy CodePolicy CP PMN.156

Change TypeClarified/Revised/Administrative

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

POLICY UPDATE CHANGES

Added redirection bypass for members in states with limitations on step therapy and Appendix D including Nevada (08.31.23).

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 01/01/2026) in 3Q 2025 annual review.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less (01.20.22; P&T 05.22).

Multiple annual reviews with 'no significant changes' and references updated (2021-2025).

2FDA-approved seizure indications

12 mg/dayMaximum daily dose

4 yrs / 12 yrsMinimum ages (partial-onset / tonic-clonic)

12 months

Typical approval duration (Medicaid/HIM)

Coverage Summary & Scope

Scope: This policy governs medical necessity criteria, prior authorization, and approval durations for perampanel (Fycompa) across Commercial, HIM (health insurance marketplace), and Medicaid lines of business for treatment of seizure disorders.

Background summary: Perampanel (Fycompa) is approved as adjunctive therapy for partial-onset seizures in patients age ≥ 4 years and for primary generalized tonic-clonic seizures in patients age ≥ 12 years. The dosing regimens include titration by 2 mg increments (typically once daily at bedtime) with a recommended maintenance range of 8–12 mg QD and a maximum dose of 12 mg per day. The product labeling contains a boxed warning for serious psychiatric and behavioral adverse reactions. The policy stance is covered_with_criteria and approval durations vary by line of business (Medicaid/HIM typically 12 months; Commercial 12 months or duration of request, whichever is less).

Thresholds

Maximum daily dose12 mg per day

Minimum age - partial-onset seizures>= 4 years

Minimum age - primary generalized tonic-clonic seizures>= 12 years

Initial trial requirementFailure of two preferred alternatives (unless contraindicated or clinically significant adverse effects)

Dosage frequency1 tablet once daily

Initial Approval Criteria — Partial-Onset Seizures

Initial Approval Criteria

Fycompa is medically necessary when ALL of the following are met:

ALL of the following

Partial-onset seizures (must meet all)
- Diagnosis of partial-onset seizures
- Age 4 years or older>= 4 years
  FDA indication lists 4 years and older for partial-onset seizures
- Member meets one of the following
  - Step therapy:

Initial Approval Criteria — Primary Generalized Tonic‑Clonic Seizures

Initial Approval Criteria - Primary Generalized Tonic-Clonic Seizures

Fycompa is medically necessary when ALL of the following are met:

ALL of the following

Primary generalized tonic-clonic seizures (must meet all)
- Diagnosis of primary generalized tonic-clonic seizures
- Age 12 years or older>= 12 years
  FDA indication lists 12 years and older for primary generalized tonic-clonic seizures
- Adjunctive therapy: Fycompa will be used as adjunctive therapy

Continued Therapy (Renewal) Criteria

Renewal is authorized when ALL of the following are met:

Continued therapy (must meet all)

Current use: Member is currently receiving Fycompa via the Centene benefit and has received this medication for at least 30 days>= 30 days on benefit
Documentation required (office chart notes, lab results or other clinical information)
Positive response: Member is responding positively to therapy
Clinical improvement in seizure control as documented in chart notes
Dose limits:

Other Diagnoses, Off‑Label, and Not Authorized Uses

Applicable Codes & Policy Cross‑References

Relevant policy cross-referencesmixed

CP.CPA.190	No coverage criteria policy for commercial (formulary) / non-formulary references
HIM.PA.33	No coverage criteria policy for health insurance marketplace (formulary)
CP PMN.255	No coverage criteria policy for Medicaid (formulary)
HIM.PA.103	Non-formulary policy for health insurance marketplace
CP PMN.16	Non-formulary policy for Medicaid
CP.CPA.09	Off-label use policy for commercial
HIM.PA.154	Off-label use policy for health insurance marketplace
CP.PMN.53	Off-label use policy for Medicaid

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

Requests for Fycompa require prior authorization and must meet the listed initial or continuation criteria. Approval durations vary by line of business.

Commercial
HIM
Medicaid

Documentation Required

Submit supporting documentation

Provider must submit documentation supporting that the member has met all approval criteria.

Office chart notes
Lab results

Clinical Evidence & References

Evidence: Fycompa Prescribing Information (Catalyst Pharmaceuticals Inc.; June 2023).

Guideline: AAN/AES practice guideline updates on new antiepileptic drugs (2018).

Note: The Prescribing Information includes the boxed warning for serious psychiatric and behavioral adverse reactions.

Background & Definitions

Perampanel is a non-competitive AMPA (a-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist.

Approved indications: adjunctive therapy for partial-onset seizures in patients 4 years of age and older, and adjunctive therapy for primary generalized tonic-clonic seizures in patients 12 years of age and older.

Dosing: initiate at 2 mg PO QHS (higher starting dose if on CYP3A4 inducers), increase by 2 mg QD no more frequently than weekly as tolerated. Recommended maintenance doses are typically 8–12 mg QD for partial-onset seizures (some patients respond at 4 mg QD) and 8 mg QD for tonic-clonic seizures with the option to increase to 12 mg per day if tolerated. Administration is once daily (1 tablet per day).

Boxed warning: product labeling contains a boxed warning for serious or life-threatening psychiatric and behavioral adverse reactions. Contraindications: none reported.

Definitions: 'Redirection bypass / Step therapy limitation' — policy allowance to bypass step therapy requirements for members in states with legal limitations on step therapy in certain settings (see Appendix D for listed states; Nevada example allows a single redirection for Medicaid).

'Adjunctive therapy' — use of Fycompa in addition to other anti-seizure medications rather than as monotherapy.

Revision History

01.20.22approval_duration_revision

Revised Commercial approval duration from 'length of benefit' to '12 months or duration of request, whichever is less' (P&T 05.22).

08.31.23step_therapy_bypass_added

Added redirection bypass for members in states with limitations on step therapy and updated Appendix D to include Nevada with requirements allowing a single redirection for Medicaid requests (material change).

03Q 2025review_recorded

3Q 2025 annual review recorded; added step therapy bypass for Illinois Health Insurance Marketplace (HIM) per IL HB 5395 (effective 01/01/2026) (material change noted in review).

Policy Summary

PayerCentene

PolicyPerampanel (Fycompa)

Policy CodePolicy CP PMN.156

Change TypeClarified/Revised/Administrative

Effective DateNov 16, 2016

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

On This Page

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

Failure of 2 preferred alternatives

See Appendix B for examples of preferred alternatives

Redirection bypass: Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D)

This functions as a redirection bypass in specified states

Dose limits: Dose does not exceed 12 mg per day<= 12 mg per day

Maximum daily dose

Dosage form/administration: 1 tablet per day (i.e., once daily)1 tablet/day

Maximum of 1 tablet per day

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Use in addition to other anti-seizure medications

Member meets one of the following

Step therapy: Failure of two preferred alternatives (see Appendix B for examples), unless clinically significant adverse effects are experienced or all are contraindicatedFailure of 2 preferred alternatives
See Appendix B for examples of preferred alternatives
Redirection bypass: Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D)
This functions as a redirection bypass in specified states; for Illinois HIM the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395

Dose limits: Dose does not exceed 12 mg per day<= 12 mg per day

Maximum daily dose

Dosage form/administration: 1 tablet per day (i.e., once daily)1 tablet/day

Maximum of 1 tablet per day

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Dose does not exceed 12 mg per day

If request is for a dose increase, new dose must not exceed 12 mg/day

Other clinical information

Billing Rule

Approval duration

Approval durations by line of business are specified below.

Medicaid/HIM: 12 months
Commercial: 12 months or duration of request, whichever is less

Step Therapy

Step therapy requirement

Generally requires failure of two preferred alternatives unless contraindicated or clinically significant adverse effects are experienced; exceptions and bypasses apply in states with limitations on step therapy and for Illinois HIM per IL HB 5395.

States with limitations: redirection bypass per Appendix D (e.g., Nevada allows a single redirection for Medicaid)
Illinois HIM: step therapy requirement does not apply as of 01/01/2026 per IL HB 5395

01/01/2026regulatory_effective_date

IL HB 5395 step therapy provision becomes effective: for Illinois HIM requests the step therapy requirement does not apply as of 01/01/2026 (material change).

2021-2025administrative_reviews

Multiple annual reviews across 3Q 2021 through 3Q 2025 with no significant clinical policy statement changes; references and templates updated as applicable (administrative, non-material).

08.25.25last_reviewLatest

Last review completed with no significant clinical policy statement changes; P&T approval date recorded for 3Q 2025 review (added IL HIM bypass per IL HB 5395).