CurrentCentenePolicy CP.PHAR.621

Ublituximab-xiiy (Briumvi) for relapsing forms of multiple sclerosis

Defines medical necessity criteria, prior authorization documentation requirements, dosing limits, approved diagnoses, exclusions, approval durations, and coding implications for Briumvi across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyUblituximab-xiiy (Briumvi) for relapsing forms of multiple sclerosis

Policy CodePolicy CP.PHAR.621

Change TypeMultiple revisions (coding, duration, exclusions, step therapy)

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS code J2329

Extended initial approval duration for Medicaid and HIM to 12 months

Added primary progressive MS to section III (not authorized)

Added ICHRA line of business

Added step therapy bypass for IL HIM per IL HB 5395

Removed requirements for documentation of baseline relapses/EDSS and specific measures of positive response

3Covered MS subtypes

2Approval duration options

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18Minimum age (years)

Coverage Summary

Policy status: covered_with_criteria for ublituximab-xiiy (Briumvi) when used for relapsing forms of multiple sclerosis in adults and all listed clinical criteria are met. Effective date: 06.01.23. Last review date: 05.26 (per policy metadata, reviewed 05.26/05.26.26 entry). Scope: defines medical necessity criteria, prior authorization documentation requirements, dosing limits, approved diagnoses, exclusions, approval durations, and coding implications for Briumvi across Commercial, HIM/ICHRA, and Medicaid lines of business.

Key thresholds and dates

Age requirement≥ 18 years

Initial dosing regimen150 mg initial, followed by 450 mg 2 weeks later

Maintenance dose limit450 mg every 24 weeks

Effective date06.01.23

Last review date05.26

Initial Therapy Criteria

Initial Approval Criteria - Multiple Sclerosis

Covered when ALL of the following are met:

ALL of the following

Diagnosis (one of)
- Clinically isolated syndrome, and member is contraindicated to both, or has experienced clinically significant adverse effects to one, of the following at up to maximally indicated doses: an interferon-beta agent (Avonex, Betaseron/Extavia, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa)
- Relapsing-remitting MS, and failure of ALL of the following at up to maximally indicated doses, unless clinically significant adverse effects are experienced or all are contraindicated: dimethyl fumarate (generic Tecfidera); teriflunomide (generic Aubagio); fingolimod (Gilenya); and an interferon-beta agent (Avonex, Betaseron/Extavia, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa)
  Illinois HIM step therapy bypass may apply per IL HB 5395

Continuation Therapy Criteria

Continuation (Renewal) Criteria - Multiple Sclerosis

Covered when ALL of the following are met:

ALL of the following

Member status (one of)
- Currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state addendums CC.PHARM.03A and CC.PHARM.03B)
Member is responding positively to therapy
Briumvi is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D)

Unproven / Exclusions

Diagnoses/Indications Not Authorized

Not covered for the following:

ALL of the following

Non-FDA approved indications not addressed in this policy unless sufficient documentation per off-label use policy CP.CPA.09 / HIM.PA.154 / CP.PMN.53
Primary progressive MS

Applicable Codes

HCPCS codesHCPCSCovered

J2329

Injection, ublituximab-xiiy, 1 mg

Provider Actions

Prior Authorization

Prior authorization required per policy

Prior authorization may be required for Briumvi. Submit a prior authorization request including documentation of prior therapy failures or contraindications as specified in the policy. Affected HCPCS code: J2329 (Injection, ublituximab-xiiy, 1 mg).

Include documentation of prior therapy failures or contraindications per the relapsing-remitting MS criteria

Documentation Required

Submit documentation supporting criteria

Submit documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, laboratory results, or other clinical information showing the member meets the policy requirements.

Office notes
Lab results
Other clinical information

Clinical Evidence & Regulatory Info

Evidence: FDA-approved indication: Treatment of relapsing forms of multiple sclerosis in adults (clinically isolated syndrome, relapsing-remitting, active secondary progressive). Prescribing information citation: Briumvi Prescribing Information. TG Therapeutics, Inc; January 2026.

Background & Definitions

Background: Ublituximab-xiiy (Briumvi) is a CD20-directed cytolytic antibody. It was FDA-approved for relapsing forms of MS in adults. Therapeutic alternatives are listed and include interferon-beta products, glatiramer, teriflunomide, dimethyl fumarate, fingolimod, and other disease-modifying therapies for MS. Contraindications include active hepatitis B virus infection and a history of life‑threatening infusion reaction to Briumvi.

Definitions

MSMultiple sclerosis

HIMHealth Insurance Marketplace

Revision History

05/24/2023code_added

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

01/30/2024code_removed

Removed prior generic HCPCS codes C9399 and J3590.

2Q 2025documentation_requirements_removed

Removed documentation requirements for baseline relapses/EDSS and specific measures of positive response.

Policy Summary

PayerCentene

PolicyUblituximab-xiiy (Briumvi) for relapsing forms of multiple sclerosis

Policy CodePolicy CP.PHAR.621

Change TypeMultiple revisions (coding, duration, exclusions, step therapy)

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

SourceLink

On This Page

Secondary progressive MS

Prescribed by or in consultation with a neurologist

Briumvi is not prescribed concurrently with other disease modifying therapies for MS (see Appendix D)

At the time of request, member does not have active hepatitis B infection (provide results for hepatitis B surface antigen and anti-hepatitis B virus tests)

Dose limits (must meet both)

Initial dose: 150 mg, followed by a second 450 mg dose 2 weeks later150 mg then 450 mg at 2 weeks
Maintenance dose: 450 mg every 24 weeks450 mg every 24 weeks

Initial Approval Criteria - Other diagnoses/indications

If not covered above, follow one of the two paths:

ANY of the following

If this drug has recently (within the last 6 months) undergone a label change not yet reflected in this policy, follow the referenced formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255; or CP.CPA.190, HIM.PA.103, CP.PMN.16)
If the requested use is not listed under section III and criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09, HIM.PA.154, CP.PMN.53)

If request is for a dose increase, new dose does not exceed 450 mg every 24 weeks450 mg every 24 weeks

Documentation Required

Hepatitis B testing required

At the time of request, provide hepatitis B testing demonstrating the member does not have active hepatitis B infection. Required tests: hepatitis B surface antigen and anti‑hepatitis B virus test results.

Hepatitis B surface antigen result
Anti-hepatitis B virus test result

Billing Rule

Dose limitations

Dosing must follow the specified regimen: initial dose 150 mg, followed by a second 450 mg dose two weeks later; maintenance dosing 450 mg every 24 weeks. Requests for dose increases must not exceed 450 mg every 24 weeks. Applicable HCPCS code: J2329.

Initial: 150 mg, then 450 mg at 2 weeks
Maintenance: 450 mg every 24 weeks
Dose increases must not exceed 450 mg every 24 weeks

Step Therapy

Step therapy for relapsing-remitting MS

For relapsing‑remitting MS, the member must have failed dimethyl fumarate, teriflunomide, fingolimod, and an interferon‑beta agent or glatiramer at up to maximally indicated doses unless clinically significant adverse effects are experienced or all are contraindicated. For Illinois HIM requests, step therapy requirements do not apply per IL HB 5395 (step therapy bypass).

Fail dimethyl fumarate (Tecfidera)
Fail teriflunomide (Aubagio)
Fail fingolimod (Gilenya)
Fail an interferon‑beta agent (Avonex, Betaseron/Extavia, Rebif, Plegridy) or glatiramer (Copaxone, Glatopa)
Illinois HIM requests: step therapy bypass per IL HB 5395

06/25/2025policy_revision

Added step therapy bypass for Illinois HIM per IL HB 5395 (step therapy requirements do not apply for IL HIM as of 1/1/2026).

2Q 2026approval_duration_extendedLatest

Extended initial approval duration for Medicaid and HIM from 6 months to 12 months for this maintenance medication for a chronic condition.

2Q 2026exclusion_addedLatest

Added primary progressive MS to Diagnoses/Indications Not Authorized (section III) to align with other MS agents.