CurrentUnitedHealthcarePolicy IEXD00122.05

Briumvi® (Ublituximab-Xiiy) – Individual Exchange Medical Benefit Drug Policy

Defines medical benefit coverage criteria for Briumvi (ublituximab-xiiy) for treatment of relapsing forms of multiple sclerosis for Individual Exchange plans (excludes MA, NV, NY). Includes initial and continuation authorization criteria, dosing must follow FDA labeling, and authorization periods.

Policy Summary

PayerUnitedHealthcare

PolicyBriumvi® (Ublituximab-Xiiy) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD00122.05

Change TypeReferences updated

Effective DateJanuary 1, 2026

Next Review Date

Key ActionSubmit prior authorization requests with documentation of diagnosis and required supporting information; initial and continuation authorizations limited to 12 months and dosing must follow FDA labeling.

SourceLink

POLICY UPDATE CHANGES

01/01/2026 policy history notes supporting information updated; no clinical policy statement changes indicated.

1Covered Indication (RMS)

12 moAuthorization Duration

J2329Primary HCPCS code

Coverage Summary & Scope

Scope: Defines medical benefit coverage criteria for Briumvi (ublituximab-xiiy) for treatment of relapsing forms of multiple sclerosis for Individual Exchange plans (excludes MA, NV, NY). Coverage stance: Covered with criteria when initial and continuation requirements are met (diagnosis of relapsing forms of MS, not used in combination with specified therapies, dosing per FDA label, authorization ≤ 12 months). Status: CURRENT. Subject: Briumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosis. Brief indication summary: Briumvi is indicated for the treatment of relapsing forms of multiple sclerosis (includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease) in adults; efficacy demonstrated in two randomized controlled trials (ULTIMATE I and II) versus teriflunomide over 96 weeks. Policy effective/last review date: Effective: January 1, 2026; Last review: January 1, 2026.

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Policy Summary

Policy NumberIEXD00122.05

Policy Title (subject)Briumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosis

PayerUnitedHealthcare

Coverage StanceCovered with criteria

Authorization Duration12 months

Primary HCPCSJ2329

Effective Date2026-01-01

Last Review2026-01-01

Initial Therapy (Medically Necessary)

Prior Authorization

Prior authorization required for initial therapy (J2329)

Submit prior authorization for initial Briumvi (J2329) therapy. Initial authorization is limited to no more than 12 months. Dosing must follow FDA‑approved labeling.

Initial authorization limited to no more than 12 months
Dosing must follow FDA approved labeling

Continuation Therapy (Medically Necessary)

Documentation Required

Documentation of positive response for continuation

Provide documentation of positive clinical response to Briumvi to support continuation authorization.

Concurrent Therapy & Exclusions

Billing Rule

Briumvi dosing per FDA label (J2329)

Briumvi dosing must follow the FDA approved labeling: initial infusion 150 mg; second infusion 450 mg two weeks after the first; then 450 mg every 24 weeks thereafter.

Applicable Codes

Covered HCPCSHCPCSCovered

J2329

Injection, ublituximab-xiiy, 1 mg

Relevant ICD-10 Diagnoses (RMS and MS codes listed for reference)ICD-10

G35.A	Relapsing-remitting multiple sclerosis
G35.B0	Primary progressive multiple sclerosis, unspecified
G35.B1	Active primary progressive multiple sclerosis
G35.B2	Non-active primary progressive multiple sclerosis
G35.C0	Secondary progressive multiple sclerosis, unspecified
G35.C1	Active secondary progressive multiple sclerosis
G35.C2	Non-active secondary progressive multiple sclerosis
G35.D	Multiple sclerosis, unspecified

Provider Actions & Documentation Requirements

Documentation Required

Diagnosis documentation

Document diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing‑remitting MS, secondary‑progressive with relapses, progressive‑relapsing with relapses) in the medical record for prior authorization and coverage determination.

Prior Authorization

Prior authorization required for initial and continuation therapy

Prior authorization is required for initial and continuation Briumvi therapy (J2329). Submit a prior authorization request with the required documentation. Authorizations are limited to no more than 12 months.

Billing Rule

Dosing per FDA label

Dosing must follow the FDA approved labeling for Briumvi (J2329): initial 150 mg; second 450 mg two weeks after the first; then 450 mg every 24 weeks. Dosing must be consistent with the FDA label for coverage.

Clinical Evidence Summary

0.08 vs 0.19; RR 0.41ULTIMATE I annualized relapse rate (ublituximab vs teriflunomide)

0.09 vs 0.18; RR 0.51ULTIMATE II annualized relapse rate (ublituximab vs teriflunomide)

47.7%Infusion-related reactions with ublituximab

5.0% vs 2.9%Serious infections (ublituximab vs teriflunomide)

The efficacy of Briumvi was demonstrated in two identically designed randomized, double-blind, active-comparator trials (ULTIMATE I and II) in patients with relapsing forms of MS treated for 96 weeks, comparing IV ublituximab dosing (150 mg initial, 450 mg at two weeks, then 450 mg every 24 weeks) to oral teriflunomide 14 mg daily. Both trials enrolled patients with recent relapses or gadolinium-enhancing lesions and used annualized relapse rate as the primary outcome.

Notable safety signals from the trials included infusion-related reactions in 47.7% of participants receiving ublituximab and serious infections in 5.0% of ublituximab-treated patients versus 2.9% with teriflunomide.

Background & Definitions

Background: Briumvi is a recombinant chimeric monoclonal antibody directed against CD20-expressing B cells (anti-CD20 mAb). The precise mechanism in MS is unknown but is presumed to involve binding CD20 with subsequent B-cell lysis via antibody-dependent cellular cytolysis and complement-dependent cytolysis. Efficacy was demonstrated in the ULTIMATE I and II randomized controlled trials versus teriflunomide over 96 weeks.

Scope comment: This policy applies to Individual Exchange plans and excludes Massachusetts, Nevada, and New York.

Definitions

Relapsing forms of multiple sclerosis (RMS)Includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Revision History

2026-01-01policy_updateLatest

policy history notes supporting information updated; no clinical policy statement changes indicated. Updated References section to reflect the most current information and archived previous policy version IEXD00122.04.

Policy Summary

PayerUnitedHealthcare

PolicyBriumvi® (Ublituximab-Xiiy) – Individual Exchange Medical Benefit Drug Policy

Policy CodePolicy IEXD00122.05

Change TypeReferences updated

Effective DateJanuary 1, 2026

Next Review Date

SourceLink

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