ModifiedCentenePolicy CP PHAR.621

Ublituximab-xiiy (Briumvi) for relapsing multiple sclerosis

Defines medical necessity criteria, initial and continuation approval requirements, dosing limits, contraindications, approval durations, billing HCPCS code, and formulary/off-label handling for Briumvi across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyUblituximab-xiiy (Briumvi) for relapsing multiple sclerosis

Policy CodePolicy CP PHAR.621

Change TypeCoding and criteria updates (2023–2025)

Effective DateJun 1, 2023

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) supporting that member meets all approval criteria; prior authorization may be required for all disease-modifying therapies for MS.

POLICY UPDATE CHANGES

Added HCPCS code J2329.

2Q 2024 annual review removed HCPCS codes C9399 and J3590 and updated references; no significant coverage changes.

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, and standardized HIM/Medicaid continued therapy approval duration to 12 months.

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

1FDA-approved indication (relapsing forms of MS)

J2329Primary HCPCS code added

18+Minimum age requirement

450 mgMaintenance dose limit

Coverage Summary

Coverage stance: covered_with_criteria. Scope: policy defines medical necessity criteria including diagnosis requirements (clinically isolated syndrome, relapsing‑remitting MS, active secondary progressive MS), step therapy exceptions for Illinois HIM, initial and continued therapy requirements, dosing limits, contraindications, approval durations, billing HCPCS code, and formulary/off‑label handling across lines of business. FDA indication: approved for relapsing forms of multiple sclerosis in adults. Age threshold: > 18 years.

Initial Approval Criteria

Briumvi is medically necessary when ALL of the following are met:

ALL of the following

Diagnosis of one of the following
- Clinically isolated syndrome
  For clinically isolated syndrome: member is contraindicated to both, or has experienced clinically significant adverse effects to one, of the listed agents (interferon-beta agents or glatiramer).
- For relapsing-remitting MS
  - Dimethyl fumarate (Tecfidera)
  - Teriflunomide (Aubagio)
  - Fingolimod (Gilenya)
  - An interferon-beta agent (Avonex, Betaseron/Extavia, Rebif, or Plegridy) or glatiramer (Copaxone, Glatopa)
- Active secondary progressive MS
Age > 18 years
Prescribed by or in consultation with a neurologist
Briumvi is not prescribed concurrently with other disease-modifying therapies for MS (see Appendix D)
Member does not have active hepatitis B infection (negative for hepatitis B surface antigen and anti-hepatitis B virus tests) at time of request
Dose does not exceed specified dosing limits (initial and maintenance dosing below)

Dosing Limits (part of Initial/Continued Therapy)

Dose must adhere to the following:

Initial dose: 150 mg IV, followed by a second 450 mg IV dose 2 weeks later.

Maintenance dose: 450 mg IV every 24 weeks.

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

Continued Therapy

For continuation approval, ALL of the following must be met:

ALL of the following

Member meeting one of
- Member is currently receiving medication via Centene benefit
- Member has previously met initial approval criteria
Member is responding positively to therapy
Removed specific measures of positive response per 2Q 2025 review
Briumvi is not prescribed concurrently with other disease-modifying therapies for MS (see Appendix D)

Other Diagnoses / Non-Formulary / Off-Label

Coverage for other diagnoses/indications requires meeting one of the following:

If drug is on formulary/PDL for relevant line, follow no-coverage criteria policy

Commercial: CP.CPA.190; HIM (marketplace): HIM.PA.33; Medicaid: CP.PMN.255

If drug is NOT on formulary/PDL for relevant line, follow non-formulary policy

Commercial: CP.CPA.190; HIM (marketplace): HIM.PA.103; Medicaid: CP.PMN.16

If requested use is not listed under Diagnoses/Indications NOT authorized, refer to off-label use policy

Commercial: CP.CPA.09; HIM (marketplace): HIM.PA.154; Medicaid: CP.PMN.53

Applicable Codes

HCPCS — drug administration code for ublituximab-xiiyHCPCSCovered

J2329

Injection, ublituximab-xiiy, 1 mg

Provider Actions & Billing Rules

Prior Authorization

Prior authorization and documentation required

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member meets all approval criteria; prior authorization may be required for all disease-modifying therapies for MS.

Prior authorization may be required for all disease-modifying therapies for MS

Documentation Required

Hepatitis B testing required prior to approval

At time of request, member must not have active hepatitis B infection; documentation of negative hepatitis B surface antigen and anti-hepatitis B virus tests is required.

Hepatitis B surface antigen (HBsAg) — negative

Clinical Evidence & References

Prescribing information: Briumvi Prescribing Information, October 2024 (accessed Jan 24, 2025).

Guideline: American Academy of Neurology (AAN) 2018 disease‑modifying therapies guideline; reaffirmed Oct 19, 2024.

Background

Background: Briumvi (ublituximab‑xiiy) is a CD20‑directed cytolytic antibody FDA‑approved for the treatment of relapsing forms of multiple sclerosis in adults. Dosing per label is an initial 150 mg IV followed two weeks later by 450 mg IV, then maintenance 450 mg IV every 24 weeks. The policy aligns formulary handling, step therapy, and prior authorization requirements across Commercial, HIM, and Medicaid lines of business and includes the HCPCS billing code J2329 for ublituximab‑xiiy.

Key clinical metadata

Effective date06.01.23

Last review05.25 (P&T Approval Date 05.25 per 2Q 2025 review)

Policy numberCP PHAR.621

Minimum age threshold> 18 years

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 and updated references; no significant coverage changes (no clinical policy statement changes).

05.25annual_review

2Q 2024 annual review P&T approval noted (references updated, no significant coverage changes).

Policy Summary

PayerCentene

PolicyUblituximab-xiiy (Briumvi) for relapsing multiple sclerosis

Policy CodePolicy CP PHAR.621

Change TypeCoding and criteria updates (2023–2025)

Effective DateJun 1, 2023

Next Review Date

On This Page

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

Anti-hepatitis B virus tests — negative

Billing Rule

Dose billing limit

Ensure dosing billed does not exceed initial and maintenance dosing limits (initial 150 mg then 450 mg at 2 weeks; maintenance 450 mg every 24 weeks).

HCPCS code: J2329
Initial dosing limit: 150 mg then 450 mg two weeks later
Maintenance dosing limit: 450 mg every 24 weeks

Denial Risk

Concurrent disease-modifying therapy exclusion

Requests will be denied if Briumvi is prescribed concurrently with other disease-modifying therapies for MS.

Step Therapy

Step therapy waiver for Illinois HIM

As of 01/01/2026 (per IL HB 5395), step therapy requirements do not apply for Illinois HIM requests; policy later added step therapy bypass for IL HIM per IL HB 5395 effective 06/25/25.

Effective date of IL step therapy bypass per brief: 06/25/25 (IL HB 5395); step therapy requirements do not apply as of 01/01/2026 for Illinois HIM

05.25.25annual_review

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; standardized HIM/Medicaid continued therapy approval duration to 12 months.

06.25.25policy_updateLatest

Added step therapy bypass for Illinois HIM per IL HB 5395 (effective 06.25.25); noted step therapy requirements do not apply for Illinois HIM as of 01/01/2026.