CurrentUnitedHealthcarePolicy 2025D0122D

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

Defines medical necessity criteria, dosing alignment with FDA labeling, authorization durations, applicable HCPCS and diagnosis codes, and continuation criteria for Briumvi (ublituximab-xiiy) for treatment of relapsing forms of multiple sclerosis for UnitedHealthcare community plan members.

Policy Summary

PayerUnitedHealthcare

PolicyBriumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosis

Policy CodePolicy 2025D0122D

Change TypeAdministrative/template and typographical updatesinitial publication 01/01/2025

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization limited to no more than 12 months for initial and continuation therapy and document prior Briumvi treatment plus positive clinical response for continuation; ensure dosing aligns with FDA labeling and that patient is not receiving prohibited concomitant therapies.

SourceLink

POLICY UPDATE CHANGES

01/01/2025 - Archived previous policy version 2024D0122C and published current policy effective 01/01/2025.

07/01/2025 - Template Update; Updated Benefit Considerations section.

08/13/2025 - Corrected typographical error.

1HCPCS code listed

1Diagnosis codes listed

12 monthsAuthorization duration (initial/continuation)

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Coverage Summary

Scope: This policy defines medical necessity criteria for Briumvi (ublituximab-xiiy) for the treatment of relapsing forms of multiple sclerosis (RMS) for UnitedHealthcare community plan members, and lists applicable HCPCS (J2329) and relevant diagnosis code (G35).

Coverage stance: Briumvi is covered with criteria. Initial authorization is limited to no more than 12 months with dosing required to align with the United States Food and Drug Administration approved labeling. Continuation authorization is also limited to no more than 12 months and requires prior Briumvi treatment and documentation of a positive clinical response.

Initial Therapy Criteria

Initial therapy - Medically necessary criteria

Briumvi is medically necessary for the treatment of relapsing forms of multiple sclerosis (MS) when ALL of the following criteria are met:

ALL of the following

Diagnosis
- Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses)
Prohibited concomitant therapies
- Disease modifying therapy (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide)
- B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab, ocrelizumab)
- Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)
FDA-aligned dosing: Briumvi dosing is in accordance with the United States Food and Drug Administration approved labeling
Authorization duration: Initial authorization is for no more than 12 months

Clinical context: Efficacy demonstrated in randomized trials (ULTIMATE I and II) supporting use in relapsing forms of MS and FDA indication for relapsing forms of MS.

Continuation Therapy Criteria

Continuation therapy - Medically necessary criteria

Continuation of Briumvi is medically necessary when ALL of the following criteria are met:

ALL of the following

Prior treatment and response
- Prior receipt: Patient has previously received treatment with Briumvi
- Clinical response: Documentation of positive clinical response to Briumvi therapy
Prohibited concomitant therapies
- Disease modifying therapy (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide)

Applicable Codes

Covered HCPCSHCPCSCovered

J2329

Injection, ublituximab-xiiy, 1 mg

Relevant Diagnosis CodesICD-10

G35	Multiple sclerosis

Provider Actions & Requirements

Prior Authorization

Prior authorization required for initial and continuation therapy

Initial authorization limited to no more than 12 months; continuation authorization limited to no more than 12 months and dosing must be in accordance with FDA-approved labeling.

J2329

Documentation Required

Documentation of concomitant therapies

Provider must document that the patient is not receiving Briumvi in combination with specified disease-modifying therapies, B-cell targeted therapies, or lymphocyte trafficking blockers.

Disease-modifying therapies (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide)
B-cell targeted therapies (e.g., rituximab, belimumab, ofatumumab, ocrelizumab)
Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)

Clinical Evidence

0.08ULTIMATE I ARR (ublituximab) vs 0.19 teriflunomide; rate ratio 0.41 (P < 0.001)

0.09ULTIMATE II ARR (ublituximab) vs 0.18 teriflunomide; rate ratio 0.51 (P = 0.002)

47.7%Infusion-related reactions (ublituximab)

5.0%Serious infections (ublituximab) vs 2.9% teriflunomide

Background: Briumvi is a recombinant chimeric anti-CD20 monoclonal antibody; its therapeutic effect is presumed to occur via antibody-dependent cellular cytolysis and complement-dependent cytolysis after binding CD20 on B cells.

Efficacy: Clinical efficacy was demonstrated in two randomized, double-blind, active-comparator trials (ULTIMATE I and II) in patients with relapsing forms of MS treated for 96 weeks, showing reductions in annualized relapse rate compared with teriflunomide (ULTIMATE I: 0.08 vs 0.19; rate ratio 0.41; P < 0.001; ULTIMATE II: 0.09 vs 0.18; rate ratio 0.51; P = 0.002).

Safety: Key safety signals included infusion-related reactions in 47.7% of participants receiving ublituximab and a higher rate of serious infections (5.0% vs 2.9%) compared with teriflunomide.

Background & Definitions

Briumvi is a recombinant chimeric monoclonal antibody directed against CD20-expressing B cells. The exact mechanism in multiple sclerosis is unknown but is presumed to involve binding to CD20 on pre-B and mature B lymphocytes and causing cell lysis through antibody-dependent cellular cytolysis and complement-dependent cytolysis.

Trial evidence: Efficacy was established in two randomized, double-blind, double-dummy, parallel-group, active-comparator trials of identical design (ULTIMATE I and II) in patients with relapsing forms of MS treated for 96 weeks.

Definitions: Relapsing forms of multiple sclerosis (RMS) includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

Revision History

2025-01-01clarified

Archived previous policy version 2024D0122C and published current policy effective 01/01/2025.

2025-07-01revised

Template update to Benefit Considerations section (administrative/template update).

2025-08-13revisedLatest