ModifiedmhnPolicy CP.PMN.297

BRIVIACT (PDF)

Defines medical necessity criteria, dosing limits, formulary redirection, IV use conditions, approval durations, contraindications, and preferred alternatives for brivaracetam (Briviact) for commercial, HIM, and Medicaid lines of business affiliated with Centene.

Policy Summary

Payermhn

PolicyBRIVIACT (PDF)

Policy CodePolicy CP.PMN.297

Change TypeModified (includes redirection to generic; step therapy bypasses added)

Effective Date05.21.19

Next Review Date

Key ActionProvider must submit documentation showing diagnosis, age, current weight, prior medication failures per step therapy requirements (unless in state with redirection bypass) and other approval criteria; requests may require prior authorization for preferred agent failures.

SourceLink

POLICY UPDATE CHANGES

Added redirection bypass for members in a State with limitations on step therapy in certain settings (Appendix D)

Added step therapy bypass for Illinois HIM per IL HB 5395

Revised policy/criteria section to also include generic brivaracetam and added redirection to generic brivaracetam for brand Briviact requests

Policy created (adapted from CP.PCH.26, to be retired) on 10.03.24

1FDA approved indication(s)

12m / 1mApproval duration (oral / IV)

≤200 mg/dayMaximum adult dose

Pediatric dosing categories

Coverage Summary

Coverage stance: covered with criteria for Brivaracetam (Briviact) for the FDA-approved indication of treatment of partial-onset seizures. Age threshold: ≥ 1 month. Approval durations: 12 months for oral formulation and 1 month for IV formulation. The policy directs formulary redirection to generic brivaracetam for Briviact brand requests unless contraindicated or clinically significant adverse effects occur. Scope: defines medical necessity criteria, weight-based dosing limits, IV use conditions and restrictions (including state-specific step therapy redirection and bypass provisions), and preferred alternatives/step therapy requirements.

Key thresholds / values

Age≥ 1 month

Approval durationOral: 12 months; IV: 1 month

Maximum adult dose≤ 200 mg/day (adults and pediatric members ≥ 50 kg)

Pediatric dosing categories (summary)≥50 kg: up to 200 mg/day; 20 kg to <50 kg: 4 mg/kg/day; 11 kg to <20 kg: 5 mg/kg/day; <11 kg: 6 mg/kg/day

Formulary redirectionBrand Briviact requests require use of generic brivaracetam unless contraindicated or clinically significant adverse effects

Initial Therapy Criteria - Partial-Onset Seizure

Initial Approval Criteria - Partial-Onset Seizure

Provider must submit documentation supporting that member has met all approval criteria. Brivaracetam is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of partial-onset seizure
Age ≥ 1 month
Member meets ONE of
- Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D)
- Failure of two preferred agents for partial-onset seizures (see Appendix B), unless clinically significant adverse effects are experienced or all are contraindicated

Continuation (Renewal) Criteria - Partial-Onset Seizure

Approval for members currently receiving brivaracetam via Centene benefit requires ALL of the following:

ALL of the following

Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Briviact or brivaracetam for a covered indication and has received this medication for at least 30 days
Member is responding positively to therapy
If request is for IV formulation, ONE of
- Request is for the treatment of a member in a State with limitations on step therapy in certain settings (see Appendix D)

Other Diagnoses / Indications and Exclusions

Applicable Codes

Injection (brivaracetam) HCPCSHCPCS

C9399	Injection, brivaracetam (informational)
J3490	Unclassified drugs (informational)

Provider Actions & Requirements

Prior Authorization

Prior authorization and documentation

Provider must submit documentation (such as office notes, lab results, or other clinical information) demonstrating diagnosis of partial-onset seizure, member age, current weight, and any prior medication failures per step therapy requirements (unless the member is in a State with redirection/step therapy bypass per Appendix D or IL HIM per IL HB 5395). Requests may also require prior authorization to document failure of preferred agents.

Office chart notes
Lab results
Diagnosis, age, current weight
Documentation of prior medication failures per step therapy (unless state redirection bypass applies)
PA may be required to show failure of preferred agents

Billing Rule

Clinical Evidence & References

Evidence references: Prescribing Information: Briviact Prescribing Information, May 2023; Guideline references: AAN/AES practice guideline updates 2018 (efficacy and tolerability of new antiepileptic drugs I & II), NICE epilepsy guidance (2018), and ILAE evidence review. Note: the brief does not provide quantitative trial metrics, therefore no metric_cards are planned.

Background

Background: Brivaracetam (Briviact) is an FDA-approved anticonvulsant indicated for partial-onset seizures in patients aged 1 month and older. The policy aligns coverage with formulary status and step therapy requirements, including state-specific redirection or step-therapy prohibitions (see Appendix D) and an Illinois HIM step therapy bypass per IL HB 5395. Definition: IV = Intravenous.

Revision History

03.25.26policy_revisionLatest

Revised policy/criteria to include generic brivaracetam and added redirection to generic brivaracetam for brand Briviact requests (generic redirection requirement).

11.24P&T_approval

P&T Approval Date 11.24 (historic).

10.03.24policy_created

Policy created (adapted from CP.PCH.26, to be retired) on 10.03.24.

Policy Summary

Payermhn

PolicyBRIVIACT (PDF)

Policy CodePolicy CP.PMN.297

Change TypeModified (includes redirection to generic; step therapy bypasses added)

Effective Date05.21.19

Next Review Date

SourceLink

On This Page

May require prior authorization; for Illinois HIM requests, step therapy bypass applies per IL HB 5395

If request is for intravenous (IV) formulation, ONE of

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

For Briviact (brand) requests, member must use brivaracetam (generic Briviact), unless contraindicated or clinically significant adverse effects are experienced

Documentation of member's current weight for dose calculation purposes

Dose limits (must not exceed any of the following)

Adults and pediatric members weighing ≥ 50 kg
- Maximum 200 mg per day
- AND one of
  - 2 tablets per day
  - 20 mL per day
Pediatric members weighing 20 kg to < 50 kg: 4 mg/kg per day
Pediatric members weighing 11 kg to < 20 kg: 5 mg/kg per day
Pediatric members weighing < 11 kg: 6 mg/kg per day

Oral 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)

For Briviact (brand) requests, member must use brivaracetam (generic Briviact), unless contraindicated or clinically significant adverse effects are experienced

Documentation of member's current weight for dose calculation purposes

Dose limits (must not exceed any of the following)

Adults and pediatric members weighing ≥ 50 kg
- Maximum 200 mg per day
- AND one of
  - 2 tablets per day
  - 20 mL per day
Pediatric members weighing 20 kg to < 50 kg: 4 mg/kg per day
Pediatric members weighing 11 kg to < 20 kg: 5 mg/kg per day
Pediatric members weighing < 11 kg: 6 mg/kg per day

Formulary redirection to generic

Brand Briviact requests will be redirected to generic brivaracetam unless the generic is contraindicated or the member experiences clinically significant adverse effects. The policy was revised to add redirection to generic brivaracetam for brand Briviact requests.

Prior Authorization

IV formulation restriction

IV (injection) formulation is approved only if the request is for a member in a State with limitations on step therapy in certain settings (see Appendix D) or if oral administration is temporarily not feasible (for example: status epilepticus, reliance on a gastrostomy tube, recent oral or neck surgery, esophageal or intraoral infection, myasthenia gravis, or other neuromuscular condition). Approval duration for IV formulation is 1 month.

C9399
J3490

Documentation Required

Weight documentation for dosing

Providers must document the member's current weight in the clinical record for dose calculation purposes.

Denial Risk

Dose exceedance risk

Requests that exceed the policy-specified maximum doses for the applicable weight category (adults and pediatric tiers) may be denied. Refer to the policy dose limits by weight when submitting requests.

Adults and pediatric ≥ 50 kg: maximum 200 mg/day
Pediatric 20 kg to < 50 kg: 4 mg/kg/day
Pediatric 11 kg to < 20 kg: 5 mg/kg/day
Pediatric < 11 kg: 6 mg/kg/day

08.26.25material_change

Added redirection bypass for members in a State with limitations on step therapy in certain settings and Appendix D (Appendix D redirection bypass).

08.26.25material_change

Added step therapy bypass for Illinois HIM per IL HB 5395, effective 1/1/2026 (IL step therapy bypass).