ModifiedAnthemPolicy CC-0227

Briumvi (ublituximab) — Clinical Coverage Criteria for Relapsing Multiple Sclerosis

Clinical coverage criteria, coding, quantity limits, and step therapy guidance for Briumvi (ublituximab) used to treat relapsing multiple sclerosis in adults; applies to Anthem plan medical benefit review and prior authorization processes.

Policy Summary

PayerAnthem

PolicyBriumvi (ublituximab) — Clinical Coverage Criteria for Relapsing Multiple Sclerosis

Policy CodePolicy CC-0227

Change TypeOperational coding and step therapy updates

Effective Date

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing relapsing MS diagnosis, ambulation ≥100 meters, and required relapse/MRI history to meet criteria.

SourceLink

POLICY UPDATE CHANGES

Step therapy and step therapy table updates were made on 11/14/2025 and 12/01/2025.

Coding update on 09/03/2025 removed ICD-10-CM G35 and added G35.A and G35.C1 effective 10/1/25.

Added ICD-10CM G37.9 during 11/14/2025 coding review.

24 wksadministration interval

450 mgquantity limit per 24 weeks

>=100 mambulation requirement

J2329

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Coverage Criteria for Briumvi (ublituximab)

High disease activity despite prior DMT

OR - Documentation is provided that the individual has high disease activity despite treatment with a disease-modifying therapy (DMT). High disease activity is defined as all of the following:

ALL of the following

At least one clinical relapse in the previous year while on therapy.
At least 9 T2-hyperintense lesions on cranial MRI.
At least one gadolinium-enhancing lesion on cranial MRI.

Continuation Therapy

Requests for continuation (renewal) of Briumvi (ublituximab) may be approved when ALL of the following are met:

ALL of the following

Documentation that the individual has been on Briumvi (ublituximab).
Clinical benefit is demonstrated (e.g., absence of on-treatment relapses, stability or improvement in disability, or no new/enlarging T2 lesions on MRI).
No active infection (including active hepatitis B) at time of re-initiation/continuation.
No concurrent use with other MS disease-modifying agents as listed in the policy exclusions.

Formulary Preference and Step Therapy

Formulary preference and step therapy requirements vary by payer line. Coverage and utilization management stance includes the following consolidated points:

ANY of the following

Commercial line: Briumvi is designated Non-Preferred; preferred agents include a fumaric acid derivative (generic dimethyl fumarate). Prior trial of a preferred agent (e.g., dimethyl fumarate) or documentation of inadequate response or intolerance may be required before approval (trial and inadequate response may include clinical relapse, new or enlarged MRI lesions, or confirmed disability progression).
Commercial-specific step: trial and inadequate response to preferred fumaric acid derivative; Kesimpta trial failure/intolerance may also be required as noted in commercial criteria.
Medicaid line: Preferred agents include generic dimethyl fumarate, glatiramer, Glatopa, Kesimpta (may require step therapy), and teriflunomide; Briumvi is Non-Preferred. Prior trial(s) of preferred agents as specified by the state plan or step therapy rules may be required for coverage or continuation.
Step therapy: where applicable, documentation of prior trials and inadequate response or intolerance to preferred agent(s) must be provided. 'Preferred' indicates clinically comparable agents favored for clinical evidence and cost-effectiveness.

Coding and Diagnosis Codes

HCPCSHCPCS

J2329

Injection, ublituximab-xiiy, 1mg [Briumvi]

ICD-10 DiagnosisICD-10

G35.A	Relapsing-remitting multiple sclerosis
G35.C1	Active secondary progressive multiple sclerosis
G37.9	Demyelinating disease of central nervous system, unspecified [clinical isolated syndromes]

ICD-10-CM Diagnosis Codes referenced in historyICD-10

G37.9	Disease of central nervous system, unspecified
G35.A	Multiple sclerosis (subcode as designated)
G35.C1	Multiple sclerosis (subcode as designated)

HCPCS / billing codes referenced in document historyHCPCS

J2329	HCPCS code added to policy (see document history)
J3490	HCPCS — previously added then removed per history
J3590	HCPCS — previously added then removed per history

Ambulation distance — requirement for approval

Ambulation requirementIndividual is able to ambulate without aid or rest for at least 100 meters

ContextRequired as part of initial approval criteria for Briumvi (ublituximab) for relapsing MS

Where appliedDocumented ambulation ability must be present at time of prior authorization request for initiation

Prior Authorization, Step Therapy, and Documentation

Prior Authorization

Prior Authorization and Formulary Preference

Prior authorization is required for Briumvi (ublituximab). Plans may designate preferred agents and require step therapy prior to approval. Quantity limit: 450 mg (3 vials) every 24 weeks. For initiation, an override may permit 150 mg (1 vial) on day 1 and 450 mg (3 vials) two weeks after the first dose. Commercial and Medicaid lines have payer-specific preferred/non-preferred designations (e.g., preferred = generic dimethyl fumarate; non-preferred = Briumvi).

Prior authorization required; check payer-specific preferred/non-preferred lists before submission
Quantity limit: 450 mg (3 vials) per 24 weeks
Initiation override dosing allowed as specified

Step Therapy

Step Therapy Requirements and Updates

Plans may require trial and inadequate response or intolerance to preferred agents before approving Briumvi. Step therapy requirements and the list of preferred products are maintained and updated by the payer; providers should verify step requirements for the member's line of business and jurisdiction.

Background and Scope

Briumvi (ublituximab) is a CD20-directed monoclonal antibody FDA-approved for the treatment of adult relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. It is administered intravenously with a regimen that provides dosing every 24 weeks. Phase III studies demonstrated reductions in annualized relapse rates versus teriflunomide; the product labeling and references are cited in the policy.

Key Definitions

Relapsing multiple sclerosis (RMS) — definition and included subtypes

Definition of RMSRelapsing multiple sclerosis (RMS) is a general term for all relapsing forms of MS including clinically isolated syndrome (CIS), relapsing‑remitting MS (RRMS) and active secondary progressive MS (active SPMS)

Included phenotypesClinically isolated syndrome (CIS); Relapsing‑remitting MS (RRMS); Active secondary progressive MS (active SPMS)

Treatment goal relevanceDMTs aim to prevent relapses and slow progressive worsening; RMS is the primary indication group for Briumvi

EDSS — Expanded Disability Status Scale

EDSSExpanded Disability Status Scale (EDSS)

ReferenceExpanded Disability Status Scale (EDSS). Department of Veterans Affairs: Multiple Sclerosis Centers for Excellence; link provided in references