CurrentCentenePolicy CP PMN.157

Rufinamide (Banzel)

Defines Centene clinical coverage criteria for rufinamide (Banzel) for treatment of Lennox-Gastaut Syndrome (LGS) including initial and continuation authorization, dosing limits, required documentation, formulary/non-formulary routing, and state-specific step-therapy exceptions.

Policy Summary

PayerCentene

PolicyRufinamide (Banzel)

Policy CodePolicy CP PMN.157

Change TypeGeneric redirection; state-specific step therapy bypasses

Effective DateDec 1, 2014

Next Review Date

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

POLICY UPDATE CHANGES

For brand name Banzel requests, added requirement to use generic rufinamide unless contraindicated or adverse effects are experienced.

Added state-specific step therapy bypasses and Appendix D listing states with limitations on redirections (including Nevada and Illinois references).

Added generic redirection to Continued Therapy section in 3Q 2025 and step therapy bypass for IL per IL HB 5395.

Multiple annual reviews from 2021-2025 stating 'no significant changes' with reference updates and template/application changes.

1FDA Indication(s)

12 moApproval Duration

≥1 yr

Coverage Summary

Rufinamide (Banzel) is covered with criteria for treatment of Lennox‑Gastaut Syndrome (LGS); initiation requires diagnosis of LGS, prescription by or in consultation with a neurologist, and a minimum age of ≥1 year. Approval duration is 12 months for initial authorizations. Dosing must adhere to policy thresholds: maximum daily dose 3,200 mg/day, maximum 8 tablets/day (tablet formulations), and oral suspension limit 80 mL/day (40 mg/mL = 3,200 mg max).

Initial Therapy Criteria

Prior Authorization

Prior authorization requirement

Requests require prior authorization and must meet initial or continuation criteria; approval duration is 12 months.

Approval duration = 12 months.

Step Therapy

Step therapy / therapeutic alternatives

Failure of two preferred alternatives for LGS is required unless contraindicated or adverse effects.

See Appendix B for examples; alternatives listed may require prior authorization.

Billing Rule

Brand vs generic requirement

For brand name Banzel requests, member must use generic rufinamide unless contraindicated or clinically significant adverse effects are documented.

Continuation Therapy Criteria

Denial Risk

Dose limit denial

Claims or requests exceeding 3,200 mg/day (or 8 tablets/day or 80 mL/day) are not consistent with policy dosing limits and may be denied.

Documentation Required

Support for approval

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

Unproven / Exclusions

Applicable Codes & Formulations

Product codes / formulations mentionedmixed

N/A	Rufinamide (Banzel) film-coated tablets: 200 mg, 400 mg; oral suspension: 40 mg/mL

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization requirement

Prior authorization is required for requests; approval duration is 12 months.

Documentation Required

Documentation

Providers must submit clinical documentation supporting that member meets all approval criteria.

Office chart notes
Lab results
Other clinical information

Clinical Evidence & References

Key evidence and guidance informing the policy include the Banzel Prescribing Information, Eisai Inc., December 2022 and practice guideline and evidence summaries such as AAN/AES practice guideline updates, Cochrane reviews, Lancet Neurology consensus documents, and expert management publications. These efficacy and safety references were used to develop the clinical criteria, dosing limits, and recommended therapeutic alternatives.

Background

Rufinamide is a triazole derivative approved by the FDA as adjunctive treatment of seizures associated with LGS in patients ≥1 year of age. Product formulations include film‑coated tablets (200 mg, 400 mg) and an oral suspension (40 mg/mL). The policy lists a contraindication for familial short QT syndrome. Therapeutic alternatives for LGS (e.g., clobazam, topiramate, valproate, levetiracetam, felbamate, lamotrigine) are provided in Appendix B. The dosing regimen differs by age: pediatric dosing is weight‑based starting at 10 mg/kg/day with titration to a maximum of 45 mg/kg/day (not to exceed 3,200 mg/day), while adult initiation and titration use fixed incremental increases up to a 3,200 mg/day maximum.

Revision History

3Q 2021 (03.16.21); P&T 08.21clarified

For brand name Banzel requests, added requirement to use generic rufinamide unless contraindicated or clinically significant adverse effects are experienced.

3Q 2023 (08.31.23); P&T 08.23added

Added redirection bypass for members in a State with limitations on step therapy in certain settings and Appendix D including Nevada with requirements for single drug redirection for Medicaid requests; removed generic redirection for continuation of therapy requests.

3Q 2024 (05.14.24); P&T 08.24revised

Maintenance update: no significant changes; references reviewed and updated.

Definitions

Definitions: LGS = Lennox‑Gastaut Syndrome. Banzel = brand name for rufinamide.