CurrentCignaPolicy IP0545

Briumvi (Injectable - CD20-Directed Cytolytic Antibody)

This Cigna drug coverage policy governs prior authorization, approval criteria, dosing duration, and coding for Briumvi (ublituximab-xiiy) for adults with relapsing forms of multiple sclerosis for health benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyBriumvi (Injectable - CD20-Directed Cytolytic Antibody)

Policy CodePolicy IP0545

Change TypeMaterial: specialist prescribing requirementcontinuation criteria added

Effective Date11/01/2025

Next Review Date

Key ActionObtain prior authorization and document that Briumvi is prescribed by or in consultation with a neurologist or MS specialist.

SourceLink

POLICY UPDATE CHANGES

Added a specialist prescribing requirement.

Added criteria for patients currently receiving Briumvi for ≥ 1 year.

Added a definition for documentation.

Removed Employer Plans preferred product requirements.

Policy name changed to add 'Injectable - CD20-Directed Cytolytic Antibody' and a policy statement was added.

Removed documentation requirements (per early annual revision).

≥18minimum patient age for approval

1 yrapproval duration

J2329HCPCS code

IP0545

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Coverage Criteria for Briumvi (ublituximab-xiiy)

FDA-Approved Indication: Multiple Sclerosis, Relapsing Forms

Approve for 1 year if the patient meets one of the following (A or B):

Overall: Patient meets A OR B

A) Initial Therapy: Approve if the patient meets all the following (i, ii, and iii)

A.i: Patient is >= 18 years of age

A.ii: Patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease)

A.iii: Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

B) Currently Receiving Briumvi >= 1 Year: Approve if the patient meets all of the following (i, ii, iii, and iv)

Patient with <1 year or restarting should be considered under Initial Therapy

B.i: Patient is >= 18 years of age

B.ii: Patient has a relapsing form of multiple sclerosis (examples include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease)

B.iii: Patient meets one of the following: (1) experienced a beneficial clinical response when assessed by at least one objective measure OR (2) experienced stabilization, slowed progression, or improvement in at least one symptom

Examples of objective measures include MRI (absence or decrease in gadolinium enhancing lesions or new/enlarging T2 lesions), EDSS, NEDA3/NEDA4, FSIQ-RMS, relapse reduction, six-minute walk/12-Item MS Walking Scale, MSFC, or attenuation of brain volume loss. Symptom examples include motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling.

B.iv: Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis

Briumvi (ublituximab-xiiy) for any indication other than the FDA‑approved indication for relapsing forms of multiple sclerosis is considered not medically necessary. This includes uses not described in the policy's approval criteria and any other off‑label or non‑covered indications.

The concurrent use of Briumvi with other disease‑modifying agents for multiple sclerosis is considered not medically necessary. The policy specifies that these agents are not indicated for combined use and additional data are required to establish safety and benefit for combination therapy.

Coding

HCPCS CodesHCPCSCovered

J2329

Injection, ublituximab-xiiy, 1mg

Provider Actions and Billing Rules

Prior Authorization

Prior authorization required

Prior authorization is required for benefit coverage of Briumvi; approval is recommended when the patient meets the policy criteria and dosing. Approvals are provided for 1 year.

Submit prior authorization requests for HCPCS J2329 when seeking coverage.
Requests for doses outside established dosing will be reviewed case-by-case by a clinician.

Step Therapy

No combination therapy — not medically necessary

Concurrent use of Briumvi with other disease-modifying multiple sclerosis agents is considered not medically necessary; examples of such agents are listed in the policy Appendix.

Do not prescribe Briumvi in combination with other disease-modifying MS agents (see Appendix for examples).

Definitions

Relapsing forms of multiple sclerosis — includes clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

DefinitionRelapsing forms of multiple sclerosis include clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease.

PopulationApplies to adults (age ≥ 18 years).

Clinical contextMost patients present with a relapsing course at onset; relapsing disease may transition to secondary progressive MS over time.

Indication linkBriumvi (ublituximab-xiiy) is indicated for treatment of these relapsing forms of MS in adults.

Examples of relapsing coursesClinically isolated syndrome and relapsing remitting MS are examples of relapsing forms; active secondary progressive MS is included as relapsing forms when there is disease activity.

Background

Briumvi (ublituximab‑xiiy) is a CD20‑directed cytolytic antibody indicated for adults with relapsing forms of multiple sclerosis, which include clinically isolated syndrome, relapsing‑remitting MS, and active secondary progressive MS. The therapy targets CD20‑expressing B cells and is intended to reduce disease activity in patients meeting the policy’s specified criteria for treatment and continuation.