CurrentUnitedHealthcarePolicy CSOH2026D0122.D

Briumvi (Ublituximab-Xiiy) (for Ohio Only)

Defines UnitedHealthcare Community Plan medical benefit coverage criteria for Briumvi for treatment of relapsing forms of multiple sclerosis for members in Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyBriumvi (Ublituximab-Xiiy) (for Ohio Only)

Policy CodePolicy CSOH2026D0122.D

Change TypeReference update and archival

Effective DateMar 1, 2026

Next Review Date

Key ActionObtain prior authorization for initial and continuation Briumvi therapy with approvals limited to no more than 12 months and document diagnosis and FDA-consistent dosing.

SourceLink

POLICY UPDATE CHANGES

Updated References section to reflect the most current information and archived previous policy version CSOH2026D0122.C.

12 monthsmaximum initial and continuation authorization duration

J2329listed drug HCPCS code

47.7%infusion-related reactions observed in trials

Ohioapplicability state

Coverage Criteria for Briumvi (ublituximab-xiiy)

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Initial Therapy

Covered when ALL of the following are met for initial therapy

Initial therapy criteria: 1) Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses);

Concurrent therapy restriction: 2) Patient is not receiving Briumvi in combination with any of the following: disease-modifying therapies (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide), B-cell targeted therapies (e.g., rituximab, belimumab, ofatumumab, ocrelizumab), or lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone).

Examples of prohibited concurrent therapies are enumerated in policy.

Dosing requirement: 3) Briumvi dosing is in accordance with the United States Food and Drug Administration approved labeling.

Authorization duration: 4) Initial authorization is for no more than 12 months.

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy

Prior treatment: 1) Patient has previously received treatment with Briumvi.

Clinical benefit: 2) Documentation of positive clinical response to Briumvi therapy.

Continuation requires evidence of benefit.

Concurrent therapy restriction: 3) Patient is not receiving Briumvi in combination with any of the following: disease-modifying therapies (e.g., interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, or teriflunomide), B-cell targeted therapies (e.g., rituximab, belimumab, ofatumumab, ocrelizumab), or lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone).

Examples of prohibited concurrent therapies are enumerated in policy.

Dosing requirement:

Use of Briumvi in combination with other disease‑modifying therapies, B‑cell targeted therapies, or lymphocyte trafficking blockers is prohibited. Examples enumerated in the policy include disease‑modifying therapies such as interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, dimethyl fumarate and teriflunomide; B‑cell targeted agents such as rituximab, belimumab, ofatumumab and ocrelizumab; and lymphocyte trafficking blockers such as alemtuzumab and mitoxantrone. Requests that propose concurrent use with any of these agents are not consistent with the coverage criteria and may be denied.

When submitting requests, ensure documentation demonstrates that the member is not receiving any of the listed concurrent therapies. This requirement applies to both initial and continuation therapy determinations and supports the policy’s intent to cover Briumvi only when it is used as a single disease‑modifying agent per the examples provided.

This policy applies only in the state of Ohio. Any requests for services that are described as unproven or that exceed coverage or quantity limits will be evaluated for medical necessity in accordance with Ohio Administrative Code 5160‑1‑01. When a request falls into those categories, reviewers will apply the procedures and standards set forth in that rule to determine whether the service is medically necessary.

Coding and Diagnosis References

Covered HCPCS Codes (reference list)HCPCS

J2329

Injection, ublituximab-xiiy, 1mg.

Diagnosis Codes (reference list)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

EDSS inclusion range in trials

EDSS baseline range in pivotal trials0 to 5.5

Trials requiring relapse or MRI activityPatients enrolled had ≥1 relapse in prior year, or ≥2 relapses in prior 2 years, or a T1 Gd‑enhancing lesion in prior year

EDSS-related disability progression definitionDisability progression = ≥1.0 point increase when baseline EDSS ≤5.5 (confirmed at 12 weeks)

Provider Requirements and Billing Impact

Prior Authorization

Prior Authorization Required

Prior authorization is required for both initial and continuation Briumvi (ublituximab-xiiy) therapy. Approvals are limited to no more than 12 months per authorization period.

Initial and continuation therapy both require prior authorization
Authorization duration: up to 12 months

Documentation Required

Required Documentation

Request must include documentation that supports the medical necessity criteria for Briumvi. Required elements include diagnosis, prior receipt for continuation requests, evidence of clinical response for continuation, and confirmation that dosing follows FDA‑approved labeling.

Diagnosis of relapsing forms of multiple sclerosis (e.g., relapsing‑remitting MS, secondary‑progressive MS with relapses, progressive‑relapsing MS with relapses)
For continuation: documentation that the patient has previously received Briumvi and evidence of positive clinical response
Documentation of Briumvi dosing consistent with FDA‑approved labeling
Requested authorization period (note: approvals limited to ≤ 12 months)

Denial Risk

Combination Therapy Restrictions

Briumvi must not be used concurrently with certain therapies. Requests will be denied if combination therapy with specified agents is present.

Prohibited concurrent use with disease‑modifying therapies (examples: interferon beta preparations, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, cladribine, siponimod, teriflunomide, mitoxantrone)
Prohibited concurrent use with B‑cell targeted therapies (examples: rituximab, ofatumumab, ocrelizumab, belimumab)
Prohibited concurrent use with lymphocyte trafficking blockers (example: alemtuzumab)

OpenPayer

Briumvi (Ublituximab-Xiiy) (for Ohio Only)

Coverage Criteria for Briumvi (ublituximab-xiiy)

Coding and Diagnosis References

Provider Requirements and Billing Impact

Background on Briumvi

Key Definitions