ModifiedmhnPolicy CP.PMN.297

Brivaracetam (Briviact)

Defines medical necessity criteria, dosing limits, and authorization requirements for Briviact (brivaracetam) for treatment of partial-onset seizures for lines of business including Commercial, HIM, and Medicaid.

Policy Summary

Payermhn

PolicyBrivaracetam (Briviact)

Policy CodePolicy CP.PMN.297

Change TypeAdaptation with step therapy bypass additions

Effective DateMay 21, 2019

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age, weight, and that step therapy requirements or approved bypass criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added redirection bypass for members in a State with limitations on step therapy in certain settings (Appendix D) and added step therapy bypass for Illinois HIM per IL HB 5395.

Policy created (adapted from CP.PCH.26) and references updated.

1 monthminimum age for FDA indication

200 mg/daymaximum adult daily dose

12 monthsapproval duration (oral)

C9399, J3490injection billing codes

Coverage Criteria for Brivaracetam (Briviact)

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inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval for Partial-Onset Seizure

Diagnosis and age: Diagnosis of partial-onset seizure AND age >= 1 month
Step therapy or bypass: Either request is for a member in a State with limitations on step therapy (see Appendix D) OR member has failed two preferred agents for partial-onset seizures unless clinically significant adverse effects were experienced or all are contraindicated
IV formulation justification: Either request is for a member in a State with limitations on step therapy (see Appendix D) OR oral Briviact administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis, or other neuromuscular condition)
Weight and dosing limits: Documentation of current weight AND dose does not exceed any of the following: (a) adults and pediatric >=50 kg: 200 mg/day (and either 2 tablets/day or 20 mL/day); (b) pediatric 20 to <50 kg: 4 mg/kg/day; (c) pediatric 11 to <20 kg: 5 mg/kg/day; (d) pediatric <11 kg: 6 mg/kg/day.

Approval Duration: Approval duration: 12 months for oral formulation; 1 month for IV formulation.

inv-02: Continuation Therapy

Covered when ALL of the following are met

Continued Therapy for Partial-Onset Seizure

Current use and response: Currently receiving medication via Centene benefit OR documentation supports member has received Briviact for at least 30 days; member is responding to therapy.
IV formulation justification: Either request is for a member in a State with limitations on step therapy (see Appendix D) OR oral Briviact administration is temporarily not feasible (e.g., status epilepticus, reliance on gastrostomy tube, recent oral or neck surgery, esophageal condition or intraoral infection, myasthenia gravis, or other neuromuscular condition)
Weight and dosing limits: Documentation of current weight AND dose does not exceed any of the following: (a) adults and pediatric >=50 kg: 200 mg/day (and either 2 tablets/day or 20 mL/day); (b) pediatric 20 to <50 kg: 4 mg/kg/day; (c) pediatric 11 to <20 kg: 5 mg/kg/day; (d) pediatric <11 kg: 6 mg/kg/day.

inv-03: Other Diagnoses/Indications

Other/Off-label uses

Other indications: If the drug label has changed within the last 6 months and this policy is not yet updated, follow the applicable no-coverage or non-formulary policy for the relevant line of business (references provided). If the requested use is not specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and the label-change pathways do not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless evidence of coverage documents specify otherwise.

Coverage determinations and the administration of benefits are subject to all terms, conditions, exclusions, and limitations contained in the member's coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies and procedures. Providers should confirm member benefits and any applicable limitations prior to requesting or providing Briviact (brivaracetam).

Use of Briviact (brivaracetam) for non‑FDA approved indications is not authorized under this policy unless the request is accompanied by adequate clinical documentation that meets the Health Plan's off‑label use criteria referenced above. Requests for off‑label use without sufficient supporting evidence per the referenced off‑label policies may be denied.

This clinical policy is a coverage guideline and does not constitute medical advice or a prescription for treatment. It is not intended to dictate how providers practice medicine. Providers must exercise independent professional judgment in diagnosing and treating members and remain solely responsible for medical advice and treatment decisions.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria. Requests lacking sufficient supporting documentation or requests for non‑FDA indications without adequate off‑label support (per CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable) will be denied.

Prior authorization required for brivaracetam (oral and IV)
Include documentation of current weight for dosing
For IV requests, document reason oral administration is temporarily not feasible or applicable step‑therapy bypass per Appendix D/IL HB 5395

Step Therapy

Step Therapy / Failure of Preferred Agents

Providers must demonstrate that step therapy requirements have been met before approval unless the member qualifies for a documented bypass (see Appendix D for states with limitations on redirection and IL HIM step‑therapy exception per IL HB 5395). Standard requirement is failure of two preferred agents for partial‑onset seizures unless clinically significant adverse effects or contraindications exist.

Failure of two preferred agents for partial‑onset seizures (see Appendix B preferred list)
State‑specific bypass: Appendix D lists states/conditions where redirection/step therapy is limited
Illinois HIM: step therapy bypass applies per IL HB 5395 effective 1/1/2026

Documentation Required

Documentation Required — Incomplete Requests Will Be Denied

Requests lacking required documentation (clinical notes, weight for dosing, prior trial history, or justification for IV use) or seeking non‑covered indications without approved off‑label evidence will be denied.

Missing documentation of prior agent trials or adverse effects → denial
Missing current weight for dose calculation → denial
Non‑FDA indications without off‑label support per applicable off‑label policies → denial

Billing Rule

Coding and Billing — Confirm Codes and Coverage

Inclusion or exclusion of any codes in this policy is informational only and does not guarantee coverage. Providers should confirm current coding guidance prior to claim submission.

C9399, J3490 referenced for brivaracetam injection — confirm appropriate HCPCS/CPT coding and PA requirements
Providers must reference up‑to‑date professional coding sources before claim submission

Denial Risk

Denial Risk — Coding Guidance

Coding‑based denial risk: use of omitted, incorrect, or outdated codes may result in claim denial. Inclusion of codes in this policy does not ensure payment; verify code applicability and payor requirements.

Incorrect HCPCS/CPT descriptors for brivaracetam injection can trigger denials
Document clinical justification on the claim and attach supporting records when applicable

OpenPayer

Brivaracetam (Briviact)

Coverage Criteria for Brivaracetam (Briviact)

Coding and Age

Provider Actions, Prior Authorization, and Documentation

Background

Definitions

C9399	Injection, brivaracetam
J3490	Unclassified drugs (used here for injection, brivaracetam)