Medical Drug Criteria (MDC)

Policy Num:       P1.001.010
Policy Name:     BRIUMVI^® (ublituximab-xiiy)
Policy ID:          [P1.001.010][Ac/L /MDC/ P+ ]

Last Review:       September 22, 2025
Next Review:      September 20, 2026
 

Related MDC: NONE

BRIUMVI^® (ublituximab-xiiy)

Summary

Briumvi (ublituximab-xiiy) is a CD20-directed monoclonal antibody indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS), including:
 
Clinically isolated syndrome (CIS),
 
Relapsing-remitting MS (RRMS),
 
Active secondary progressive MS (SPMS).

It works by binding to CD20 on the surface of B lymphocytes, inducing antibody-dependent and complement-mediated cell lysis, thereby reducing relapse frequency and delaying disability progression.

objective

To establish criteria for the medically necessary use of Briumvi in relapsing forms of multiple sclerosis, ensuring safe use in accordance with FDA approval and clinical guidelines.

Policy Statements

Briumvi may be considered medically necessary when prescribed for relapsing forms of MS in adults, provided all policy guideline criteria are met.

Policy Guidelines

Authorization: 12 months when prescribed for relapsing MS, including CIS, RRMS, or active SPMS.

DOSAGE/ADMINISTRATION

Pre-assessments: Hepatitis B virus (HBV) screening and quantitative serum immunoglobulin levels prior to initiation.
 
Premedication: Corticosteroid (e.g., methylprednisolone) + antihistamine before each infusion.
 
Infusion schedule:

• First infusion: 150 mg IV
•  
• Second infusion: 450 mg IV (2 weeks after first)
•  
• Subsequent: 450 mg IV every 24 weeks

REQUIRED MEDICAL INFORMATION

Initial Approval Criteria

Initiation of ublituximab-xiiy (Briumvi) meets the definition of medical necessity when ALL of the following criteria are met:

1.    The member is diagnosed with ONE of the following forms of multiple sclerosis (MS):

a.    Relapsing remitting multiple sclerosis [RRMS]

b.   Active secondary progressive MS [SPMS]

c.   First clinical episode and member has MRI features consistent with MS

2.    Ublituximab will not be used in combination with ANY of the following:

a. Alemtuzumab (Lemtrada)

b. Cladribine (Mavenclad)

c. Dimethyl fumarate (Tecfidera)

d. Diroximel fumarate (Vumerity)

e. Fingolimod (Gilenya, Tascenso ODT)

f. Glatiramer acetate (Copaxone, Glatopa)

g. Interferon beta-1a (Avonex, Rebif)

h. Interferon beta-1b (Betaseron, Extavia)

i. Mitoxantrone (Novantrone)

j. Monomethyl fumarate (Bafiertam)

k. Natalizumab (Tysabri)

l. Ocrelizumab (Ocrevus)

m. Ofatumumab (Kesimpta)

n. Ozanimod (Zeposia)

o. Peg-interferon beta-1a (Plegridy)

p. Ponesimod (Ponvory ODT)

q. Rituximab (Rituxan or biosimilars)

r. Siponimod (Mayzent)

s. Teriflunomide (Aubagio)

3. The member does not have an active Hepatitis B viral (HBV) infection

4. The initial dosage does not exceed 150 mg at week 0, followed by 450 mg at week 2 and then 450 mg every 24 weeks thereafter
 
 

Renewal Approval Criteria 

Continuation of ublituximab therapy meets the definition of medical necessity when ALL of the following criteria are met:

1.    Member has demonstrated a beneficial response to therapy for treatment of RRMS, active SPMS, or clinically isolated syndrome

2.    Ublituximab will not be in combination with ANY of the following:

a.    Alemtuzumab (Lemtrada)

b.    Cladribine (Mavenclad)

c.    Dimethyl fumarate (Tecfidera)

d.    Diroximel fumarate (Vumerity)

e.    Fingolimod (Gilenya, Tascenso ODT)

f.    Glatiramer acetate (Copaxone, Glatopa)

g.    Interferon beta-1a (Avonex, Rebif)

h.    Interferon beta-1b (Betaseron, Extavia)

i.    Mitoxantrone (Novantrone)

j.    Monomethyl fumarate (Bafiertam)

k.    Natalizumab (Tysabri)

l.    Ocrelizumab (Ocrevus)

m.    Ofatumumab (Kesimpta)

n.    Ozanimod (Zeposia)

o.    Peg-interferon beta-1a (Plegridy)

p.    Ponesimod (Ponvory)

q.    Rituximab (Rituxan or biosimilars)

r.    Siponimod (Mayzent)

s.    Teriflunomide (Aubagio)

3.    The dose does not exceed 450 mg every 24 weeks
 

EXCLUSION CRITERIA

•    Active hepatitis B virus infection
•    History of life-threatening infusion reaction to ublituximab

BENEFIT APPLICATION

BlueCard/National Account Issues:

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

Briumvi is the third anti-CD20 monoclonal antibody approved for MS (following ocrelizumab and ofatumumab). It provides targeted B-cell depletion with a shorter infusion time, positioning it as a practical alternative in relapsing forms of MS.
 
FDA approval was supported by the ULTIMATE I & II phase III trials, which demonstrated significant reductions in annualized relapse rate and MRI activity versus teriflunomide.

REGULATORY STATUS

FDA approval: December 28, 2022. 

Approved for relapsing forms of MS, including CIS, RRMS, and active SPMS.

RATIONAL

Briumvi offers effective B-cell–directed therapy with demonstrated efficacy in reducing relapses and MRI activity in relapsing MS. Its shorter infusion time may improve adherence and patient experience compared to other anti-CD20 agents.

PRACTICE GUIDELINES AND POSITION STATEMENTS

AAN & NCCN MS Guidelines: Anti-CD20 therapies, including ublituximab, are recommended as highly effective options in relapsing MS.

MEDICARE NATIONAL COVERAGE

No specific NCD. Coverage determined by local contractors.

References

1. Briumvi (ublituximab-xiiy) Prescribing Information. TG Therapeutics Inc. December 2022.
 
 
2. Facts & Comparisons Online. UpToDate Inc. Accessed August 29, 2023.
 
 
3. Florida Blue Medical Coverage Guideline. mcgs.bcbsfl.com.
 
 
4. Hauser SL, et al. Ublituximab versus teriflunomide in relapsing MS (ULTIMATE I & II). NEJM. 2022;387:704–714.

Codes

Applicable Modifiers

N/A

Policy History