CurrentmhnPolicy CP.PHAR.621

Ublituximab-xiiy (Briumvi)

Defines medical necessity criteria, dosing, contraindications, prior authorization and approval durations for Ublituximab-xiiy (Briumvi) for relapsing forms of multiple sclerosis across Commercial, HIM and Medicaid lines of business.

Policy Summary

Payermhn

PolicyUblituximab-xiiy (Briumvi)

Policy CodePolicy CP.PHAR.621

Change TypeRevisions & coding updates

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office notes, labs or other clinical information) supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

Added HCPCS code J2329 (Injection, ublituximab-xiiy, 1 mg).

2Q 2024 annual review removed HCPCS codes C9399 and J3590; references reviewed and updated.

2Q 2025 annual review removed requirements for documentation of baseline relapses/EDSS and specific measures of positive response; removed notation that Extavia is preferred interferon beta-1b for Medicaid; changed HIM and Medicaid continued therapy approval duration to 12 months.

Added step therapy bypass for IL HIM per IL HB 5395.

3FDA-labeled relapsing MS indications covered

1Required specialty prescriber

450 mgMaintenance dose (per 24 weeks)

J2329Primary billing HCPCS code

Coverage Summary

Scope: Defines medical necessity criteria, dosing, contraindications, prior authorization and approval durations for Ublituximab-xiiy (Briumvi) for relapsing forms of multiple sclerosis across Commercial, HIM, and Medicaid lines of business.

Coverage stance: Ublituximab-xiiy (Briumvi) is covered with criteria for FDA-labeled relapsing forms of multiple sclerosis in adults, aligned to the FDA indication and dosing regimen. Coverage applies to Commercial, HIM, and Medicaid line of business. High-level requirements include prescription by or in consultation with a neurologist, absence of active hepatitis B infection (positive HBsAg or anti-hepatitis B tests contraindicate approval), and no concurrent use of other MS disease-modifying therapies.

Policy-level thresholds

Age>= 18 years

Initial dosing150 mg then 450 mg two weeks later

Maintenance dosing450 mg every 24 weeks

Initial Approval Criteria - Multiple Sclerosis

Initial Approval Criteria - Other diagnoses/indications

If request does not fall under initial MS criteria:

Other diagnoses/indications

Recent label change - refer to formulary/no-coverage or non-formulary policies: If drug label recently changed within last 6 months and policy not updated, refer to formulary/no-coverage or non-formulary policies as appropriate (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16).
Off-label use referral: If requested use not listed under section III and criterion 1 above does not apply, refer to off-label use policy for relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53).

Continuation/Duration Criteria - Multiple Sclerosis

For continuation approval the following ALL must be met:

ALL of the following

Continuation eligibility (one required)
- Previously met initial criteria or current Centene benefit: Member currently receiving medication via Centene benefit or member has previously met initial approval criteria.
- Continuity of care: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state-specific addendums CC.PHARM.03A and CC.PHARM.03B).
Positive response: Member is responding positively to therapy.

Not Authorized Indications

Coverage is not authorized for:

Not authorized indications: Non-FDA approved indications which are not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53) or other evidence of coverage documents.

Applicable Codes

HCPCS J-code for ublituximab-xiiyHCPCSCovered

J2329

Injection, ublituximab-xiiy, 1 mg

Provider Actions & Requirements

Documentation Required

Submit supporting clinical documentation

Submit office notes, laboratory results, or other clinical information to document that the member meets all approval criteria for Briumvi.

Prior Authorization

Prior authorization required

Prior authorization may be required for disease modifying therapies for multiple sclerosis. The PA process applies per health plan policies and referenced clinical policy numbers.

CP.CPA.190
HIM.PA.33
CP.PMN.255
HIM.PA.103
CP.PMN.16

Clinical Evidence & References

Evidence: Primary reference — Briumvi Prescribing Information, October 2024.

Guideline referenced — American Academy of Neurology 2018 disease-modifying therapies guideline (reaffirmed Oct 19, 2024).

Background

Background: Ublituximab-xiiy (Briumvi) is a CD20-directed cytolytic antibody that is FDA-approved for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

This policy aligns coverage to the FDA-labeled indications and dosing regimen and emphasizes required neurologist involvement, exclusion for members with active hepatitis B infection, and that Briumvi must not be prescribed concurrently with other disease-modifying therapies for MS.

Definitions

DMTDisease-modifying therapy for multiple sclerosis (see Appendix D list)

HIMHealth Insurance Marketplace line of business

Revision History

05.24.23code_added

Added HCPCS code J2329 (Injection, ublituximab-xiiy, 1 mg).

01.30.24annual_review

2Q 2024 annual review removed HCPCS codes C9399 and J3590; references reviewed and updated.

02.12.25annual_review

Policy Summary

Payermhn

PolicyUblituximab-xiiy (Briumvi)

Policy CodePolicy CP.PHAR.621

Change TypeRevisions & coding updates

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office notes, labs or other clinical information) supporting that member meets all approval criteria.

On This Page

Concurrent therapy exclusion: Briumvi is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D).

Dose increase limit: If request is for a dose increase, new dose does not exceed 450 mg every 24 weeks.

Initial approval duration: Medicaid/HIM 6 months; Commercial 6 months or to the member's renewal date, whichever is longer.

Continued therapy approval duration: Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date, whichever is longer.

Provider actions: submit supporting clinical documentation and confirm continuation eligibility and positive response per policy when requesting continued therapy.

Documentation Required

Hepatitis B testing required

At the time of request the member must not have active hepatitis B infection. Positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B virus test results are contraindications to approval.

Billing Rule

Dosing limits

Dose must follow the specified initial and maintenance regimen; dose increase requests must not exceed the maintenance dose.

J2329
Initial: 150 mg, then 450 mg two weeks later
Maintenance: 450 mg every 24 weeks
Maximum: 450 mg per 24 weeks

Documentation Required

Neurologist involvement

Prescription must be written by a neurologist or by a prescriber in consultation with a neurologist.

Documentation Required

Discontinue concurrent DMTs

Briumvi must not be prescribed concurrently with other disease-modifying therapies for multiple sclerosis. Verify the chart to ensure no concurrent DMTs are being used.

Billing Rule

Approval duration

Initial approval duration and continued therapy durations differ by line of business. Follow the stated time limits when requesting authorization.

Initial: Medicaid/HIM 6 months; Commercial 6 months or to member renewal date, whichever is longer
Continuation: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date, whichever is longer

Step Therapy

Step therapy exceptions for Illinois HIM

For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per Illinois HB 5395; a step therapy bypass was added for IL HIM (policy log entry).

IL HB 5395 effective 1/1/2026
Step therapy bypass added per policy log (06.25.25)

06.25.25policy_logLatest

Added step therapy bypass for IL HIM per IL HB 5395.