CurrentmeridianPolicy MDN.CP.PMN.231

Cenobamate (Xcopri) for partial-onset seizures

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Medical necessity and coverage criteria for cenobamate (Xcopri) when used to treat partial-onset (focal) seizures in adults under Meridian Medicaid and other Meridian-affiliated health plans.

Policy Summary

Payermeridian

PolicyCenobamate (Xcopri) for partial-onset seizures

Policy CodePolicy MDN.CP.PMN.231

Change TypeNo material changes

Effective DateApr 1, 2024

Last ReviewFeb 19, 2024

Next Review DateFeb 19, 2024

Key ActionProvider must submit documentation (such as office notes, lab results, or other clinical information) showing the member meets all approval criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum patient age for coverage

400 mgmaximum daily dose allowed

2tablet-per-day maximum

12 moapproval duration (Medicaid)

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CurrentmeridianPolicy MDN.CP.PMN.231

Cenobamate (Xcopri) for partial-onset seizures

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Medical necessity and coverage criteria for cenobamate (Xcopri) when used to treat partial-onset (focal) seizures in adults under Meridian Medicaid and other Meridian-affiliated health plans.

Policy Summary

Payermeridian

PolicyCenobamate (Xcopri) for partial-onset seizures

Policy CodePolicy MDN.CP.PMN.231

Change TypeNo material changes

Effective DateApr 1, 2024

Last ReviewFeb 19, 2024

Next Review DateFeb 19, 2024

Key ActionProvider must submit documentation (such as office notes, lab results, or other clinical information) showing the member meets all approval criteria when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥18minimum patient age for coverage

400 mgmaximum daily dose allowed

2tablet-per-day maximum

12 moapproval duration (Medicaid)

Coverage Criteria for Cenobamate (Xcopri)

Initial Therapy — Partial-Onset Seizures

Covered when ALL of the following are met:

Initial Approval - Partial-Onset Seizures: 1. Diagnosis of partial-onset seizures; 2. Age >= 18 years; 3. Dose does not exceed both of the following: a. 400 mg per day; b. 2 tablets per day.

Provider must submit documentation supporting criteria.

Continuation Therapy — Partial-Onset Seizures

Covered when ALL of the following are met:

Continued 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 of the following: a. 400 mg per day; b. 2 tablets per day.

Approval duration: Medicaid/HIM - 12 months; Commercial - 12 months or duration of request, whichever is less.

Other Diagnoses/Indications

When requested indication is not listed:

Other diagnoses/indications: 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 one of the following: a. For drugs on the formulary/PDL, see the no coverage criteria policy (CP.PMN.255 for Medicaid); or b. For drugs NOT on the formulary/PDL, see the non-formulary policy (CP.PMN.16 for Medicaid). OR 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III and criterion 1 does not apply, refer to the off-label use policy for the relevant line of business (CP.PMN.53 for Medicaid).

See CP.PMN.255, CP.PMN.16, or CP.PMN.53 as applicable.

Non‑FDA approved indications for cenobamate (Xcopri) are excluded from coverage under this policy unless there is sufficient documentation of efficacy and safety consistent with the Health Plan's off‑label use processes (see CP.PMN.53 for Medicaid) or as permitted by the member's evidence of coverage documents. Requests for uses not addressed in this policy should reference applicable formulary, non‑formulary, or off‑label policies for review and determination.

Cenobamate (Xcopri) is contraindicated in members with familial short QT syndrome and in any member with a known hypersensitivity to cenobamate or any inactive ingredient in the formulation. These contraindications must be documented in the medical record prior to prescribing or authorizing therapy.

Coverage of cenobamate (Xcopri) is subject to all terms, conditions, exclusions and limitations of the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance) and to applicable state and federal requirements. The clinical policy provides guidance for medical necessity determinations but does not guarantee payment; claims may be denied if they do not meet the member's plan terms or applicable regulatory requirements.

Use of cenobamate for indications that are not FDA‑approved and are not specifically addressed in this policy will be considered not covered unless the provider submits sufficient supporting documentation of efficacy and safety in accordance with the Health Plan's off‑label use policy. Requests lacking this documentation are at risk for denial under the plan's off‑label and medical necessity review processes.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required with criteria documentation

Prior authorization is required and the provider must submit documentation showing the member meets all listed approval criteria for the requested indication (partial‑onset seizures), including age and dosing limits.

Approval criteria include: diagnosis of partial‑onset seizures; age ≥ 18 years; dose does not exceed 400 mg/day and 2 tablets per day.

Prior Authorization

Follow plan prior‑authorization and medical necessity processes

This policy is a guide for medical necessity determinations that assist coverage decisions; providers must follow the Health Plan prior authorization process per the member's coverage documents when requesting coverage.

Policy guides medical necessity determinations and does not replace plan authorization procedures.

Step Therapy

Nevada Medicaid step: fail one preferred anticonvulsant first

For Nevada Medicaid requests, prior authorization must document failure of one preferred anticonvulsant indicated for partial seizures unless all preferred agents are contraindicated or caused clinically significant adverse effects.

Applies to Medicaid requests in NV only; see Appendix B for examples of preferred anticonvulsants.
Requirement may be waived if contraindications or significant adverse effects are documented.

Note

Provider action

(No specific action text provided in source.)

Documentation Required

Submit office notes, labs, and other supporting clinical information

Providers must submit supporting clinical documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.

Include notes that document diagnosis, age, prior therapies, treatment response, and dosing details.
Lab results or other testing as applicable to support safety/contraindication claims.

Documentation Required

Adhere to evidence of coverage and plan documents when submitting requests

Providers should follow the member's coverage documents (evidence of coverage, certificate of coverage, policy, contract of insurance) and applicable legal/regulatory requirements when submitting claims and supporting documentation.

Coverage and claims are subject to the terms, conditions, exclusions and limitations in the member's coverage documents.

Denial Risk

Off‑label indications require sufficient supporting documentation or may be denied

Requests for non‑FDA approved indications that are not supported by sufficient documentation of efficacy and safety per the off‑label use policy may be denied and are considered not covered unless adequate evidence is provided.

Non‑FDA indications not addressed in this policy require sufficient documentation per CP.PMN.53 (Off‑Label Use Policy) or evidence of coverage.
If adequate supporting documentation is not provided, the request may be denied as not covered.

Denial Risk

Coverage subject to plan terms, conditions, exclusions and limitations

Coverage decisions and benefit administration are subject to all terms, conditions, exclusions and limitations of the coverage documents and to state and federal requirements; claims may be denied if they do not meet those terms.

This policy is a guide and does not guarantee payment; plan-level terms and legal/regulatory requirements govern coverage.
Providers remain responsible for complying with applicable plan and legal requirements.

Cenobamate (Xcopri) for partial-onset seizures

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Cenobamate (Xcopri) for partial-onset seizures

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Coverage Criteria for Cenobamate (Xcopri)

Dosing and Coding Limits

Provider Requirements and Prior Authorization

Background on Cenobamate (Xcopri)

Key Definitions