ModifiedCentenePolicy CP.PMN.231

Cenobamate (Xcopri)

Defines medical necessity and prior authorization criteria for cenobamate (Xcopri) for treatment of partial-onset (focal) seizures in adults under Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyCenobamate (Xcopri) for partial-onset seizures

Policy CodePolicy CP.PMN.231

Change TypeMaterial additions to step therapy bypasses and revised approval duration

Effective Date03.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, neurologist involvement, age ≥18, step therapy status or bypass, and dose not exceeding 400 mg/day and 2 tablets/day.

SourceLink

POLICY UPDATE CHANGES

Added redirection bypass for members in a State with limitations on step therapy and included Appendix D with Nevada requirements.

Added step therapy bypass for Illinois HIM per IL HB 5395.

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

≥18age requirement

400 mg/daymax dose

2/daytablet limit

12 monthsapproval duration

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Coverage Criteria

Initial Approval Criteria

Covered when ALL of the following are met for Partial-Onset Seizures:

Initial Approval - Partial-Onset Seizures: 1. Diagnosis of partial-onset seizures; 2. Prescribed by or in consultation with a neurologist; 3. Age ≥ 18 years; 4. Member meets one of the following: (a) request is for the treatment of a member in a State with limitations on step therapy (see Appendix D) OR (b) failure of two preferred anticonvulsants indicated for partial seizures unless clinically significant adverse effects are experienced or all are contraindicated; For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395; 5. Dose does not exceed both: (a) 400 mg per day; (b) 2 tablets per day.

Continuation Therapy Criteria

Covered when ALL of the following are met for Continuation of Therapy:

Continuation Therapy - Partial-Onset Seizures: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Xcopri for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed both: (a) 400 mg per day; (b) 2 tablets per day.

Requests for uses that are not FDA‑approved and not addressed in this policy are excluded from coverage unless the request includes sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, and CP.PMN.53 for Medicaid) or an evidence of coverage document that authorizes the off‑label indication.

For members enrolled in Medicaid programs, when a state Medicaid coverage provision conflicts with the provisions of this clinical policy, the state Medicaid coverage provision takes precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that apply to this policy.

Uses of cenobamate for indications not listed in this policy are considered not authorized unless the provider supplies adequate supporting documentation per the applicable off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or an evidence of coverage that permits the requested indication.

Coding and Dose Limits

inv-06: Maximum daily dose — 400 mg/day

Maximum daily dose400 mg/day

Dose titration referenceMaintenance dose 200 mg PO QD; may increase by 50 mg every 2 weeks to a maximum of 400 mg PO QD

Policy threshold contextInitial and continuation criteria require requested dose to not exceed 400 mg/day

inv-07: Maximum tablets per day — 2 tablets/day

Maximum tablets per day2 tablets/day

Related dosing limitDose must not exceed both 400 mg/day and 2 tablets/day per initial approval criteria

Continuation requirement

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document diagnosis of partial-onset seizures, be prescribed by or in consultation with a neurologist, and the member must be age ≥ 18 years. For initial approvals, the request must also meet the step therapy requirements described below or an applicable step therapy bypass (see Appendix D for state-specific redirection/bypass details). Dose limits: ≤ 400 mg per day and ≤ 2 tablets per day. Commercial approvals are granted for up to 12 months or the duration of the request, whichever is less.

Dose limit: 400 mg/day and 2 tablets/day
Commercial authorization duration: 12 months or duration of request, whichever is less
IL HIM: Step therapy requirements do not apply as of 1/1/2026 per IL HB 5395 (see Appendix D)

Documentation Required

Required Supporting Documentation and Legal Precedence

Provider must submit supporting documentation (such as office chart notes, lab results, medication administration records, or other clinical information) that demonstrates the member meets all approval criteria and medical necessity. For Medicaid members, state Medicaid coverage provisions take precedence where they conflict with this policy; providers must follow applicable state Medicaid manuals and reporting requirements. Requests for non–FDA-approved (off-label) indications that are not addressed in this policy will be denied unless supported by the applicable off-label use policy (commercial: CP.CPA.09; HIM: HIM.PA.154; Medicaid: CP.PMN.53) or other evidence of coverage documents.

Background

Cenobamate (Xcopri) is a small‑molecule antiseizure medication that acts as a voltage‑gated sodium channel inhibitor and as a positive allosteric modulator of the GABAA ion channel. The agent is FDA‑approved for the treatment of partial‑onset (focal) seizures in adults; prescribing and dosing guidance in this policy reflect that approved adult indication and the product’s approved titration and maximum dose limits.

Definitions

inv-17: partial-onset seizures — definition and related label

DefinitionPartial-onset (focal) seizures: the FDA‑approved indication for Xcopri (cenobamate) is treatment of partial‑onset seizures in adult patients.

Diagnosis requirementInitial approval requires a documented diagnosis of partial‑onset seizures and prescriber is a neurologist or in consultation with one.

Age limitationPolicy applies to adults (age ≥ 18 years) with partial‑onset seizures.

Clinical contextCenobamate is a voltage‑gated sodium channel inhibitor and a positive allosteric modulator of the GABAA ion channel used for partial‑onset seizures.