CurrentColorado Rocky Mountain Health PlansPolicy CS2026D00122J

Briumvi® (Ublituximab-Xiiy) – Community Plan Medical Benefit Drug Policyopen_in_new

Defines medical benefit coverage criteria for Briumvi (ublituximab-xiiy) for treatment of relapsing forms of multiple sclerosis for UnitedHealthcare Community Plan (exclusions for certain states noted). Includes initial and continuation authorization criteria, dosing conformity to FDA labeling, and applicable billing/diagnosis codes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyBriumvi® (Ublituximab-Xiiy) – Community Plan Medical Benefit Drug Policyopen_in_new

Policy CodePolicy CS2026D00122J

Change TypeTemplate Update (no clinical changes)

Effective DateApr 1, 2026

Next Review Date

Key ActionInitial authorization limited to no more than 12 months and requires documentation of diagnosis of relapsing forms of MS, exclusion of specified concomitant therapies, and dosing per FDA labeling.

SourceLink

POLICY UPDATE CHANGES

Template Update noted on 04/01/2026 with no clinical policy statement changes.

Relapsing MSCovered Indications

12 monthsMax authorization (initial/continuation)

J2329Primary HCPCS code

Coverage Summary

Concomitant Therapy Exclusions

Briumvi must not be used in combination with specified concomitant therapies. The policy excludes use with disease modifying therapies (examples: interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide), with B-cell targeted therapies (examples: rituximab, belimumab, ofatumumab, ocrelizumab), and with lymphocyte trafficking blockers (examples: alemtuzumab, mitoxantrone).

Applicable Codes

HCPCS - drug administrationHCPCS

J2329

Injection, ublituximab-xiiy, 1mg

ICD-10 - diagnoses referencedICD-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

Prior Authorization

Initial prior authorization required

Initial authorization is limited to no more than 12 months and requires a diagnosis of relapsing forms of multiple sclerosis, documentation that the patient is not receiving excluded concomitant therapies, and that Briumvi dosing follows the FDA-approved labeling.

J2329

Prior Authorization

Continuation prior authorization

Continuation authorization is limited to no more than 12 months and requires prior treatment with Briumvi, documentation of a positive clinical response to therapy, and that dosing follows the FDA-approved labeling.

J2329

Documentation Required

Document concomitant therapy exclusion

Document that Briumvi is not being used in combination with the specified disease modifying therapies, B cell targeted therapies, or lymphocyte trafficking blockers.

Disease modifying therapy: interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide (also dimethyl fumarate listed in instructions)
B cell targeted therapy: rituximab, belimumab, ofatumumab, ocrelizumab
Lymphocyte trafficking blockers: alemtuzumab, mitoxantrone

Clinical Evidence

0.08 vs 0.19 (ULTIMATE I); 0.09 vs 0.18 (ULTIMATE II)Annualized relapse rate: ublituximab vs teriflunomide

47.7%Infusion-related reactions in ublituximab group

5.0% vs 2.9%Serious infections: ublituximab vs teriflunomide

Efficacy was demonstrated in the ULTIMATE I and II trials with reduced annualized relapse rates versus teriflunomide. Safety signals observed included infusion-related reactions and an increased rate of serious infections in the ublituximab groups.

Background

Briumvi (ublituximab-xiiy) is a chimeric anti-CD20 monoclonal antibody indicated for relapsing forms of multiple sclerosis in adults. It is believed to work by binding CD20 on B lymphocytes and causing B-cell lysis. Clinical trials (ULTIMATE I & II) demonstrated efficacy versus teriflunomide; key safety observations include infusion-related reactions and an increased incidence of serious infections.