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Briumvi™ (ublituximab-xiiy)

Policy Number: PH-0693



Last Review Date: 10/03/2023

Date of Origin: 02/02/2023

Dates Reviewed: 02/2023, 04/2023, 10/2023

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC unit]:
  • Briumvi 150 mg/6 mL single-dose vial: 1 vial initially, then 3 vials at day 15 and 168 and every 168 days thereafter
  1. Max Units (per dose and over time) [HCPCS Unit]:

Initial dose:

  • 150 billable units (150 mg) on day 1 and 450 billable units (450 mg) on day 15 and 168 

Subsequent doses:

  • 450 billable units (450 mg) every 168 days thereafter
  1. Initial Approval Criteria 1

Coverage is provided in the following conditions:

  • Patient is at least 18 years of age; AND
  • Patient has been screened for the presence of Hepatitis B virus (HBV) prior to initiating treatment AND does not have active disease (i.e., positive HBsAg and anti-HBV tests); AND
  • Patient has had baseline serum immunoglobulins assessed; AND

Universal Criteria 1

  • Patient will not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation of treatment; AND
  • Patient does not have an active infection; AND
  • Used as single agent therapy; AND
  • Patient has not received a dose of ocrelizumab or ublituximab within the past 5 months; AND

Multiple Sclerosis † 1,6,10

  • Patient must have a confirmed diagnosis of multiple sclerosis (MS) as documented by laboratory report (i.e., MRI); AND
  • Patient has a diagnosis of a relapsing form of MS [i.e., relapsing-remitting MS (RRMS)*, active secondary progressive disease (SPMS)**, or clinically isolated syndrome (CIS)***]

FDA Approved Indication(s); Compendium Recommended Indication(s); Ф Orphan Drug

*Definitive diagnosis of MS with a relapsing-remitting course is based upon BOTH dissemination in time and space. Unless contraindicated, MRI should be obtained (even if criteria are met). 10

Dissemination in time

(Development/appearance of new CNS lesions over time)

Dissemination in space

(Development of lesions in distinct anatomical locations within the CNS; multifocal)

  • ≥ 2 clinical attacks; OR
  • 1 clinical attack AND one of the following:
    • MRI indicating simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI compared to baseline scan
    • CSF-specific oligoclonal bands
  • ≥ 2 lesions; OR
  • 1 lesion AND one of the following:
    • Clear-cut historical evidence of a previous attack involving a lesion in a distinct anatomical location
    • MRI indicating ≥ 1 T2-hyperintense lesions characteristic of MS in ≥ 2 of 4 areas of the CNS (periventricular, cortical or juxtacortical, infratentorial, or spinal cord)


**Active secondary progressive MS (SPMS) is defined as the following: 7,10-12,14

  • Expanded Disability Status Scale (EDSS) score ≥ 3.0; AND
  • Disease is progressive ≥ 3 months following an initial relapsing-remitting course (i.e., EDSS score increase by 1.0 in patients with EDSS ≤5.5 or increase by 0.5 in patients with EDSS ≥6); AND
  • ≥ 1 relapse within the previous 2 years; OR
  • Patient has gadolinium-enhancing activity OR new or unequivocally enlarging T2 contrast-enhancing lesions as evidenced by MRI

***Definitive diagnosis of CIS is based upon ALL of the following: 10

  • A monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the CNS
  • Neurologic symptom duration of at least 24 hours, with or without recovery
  • Absence of fever or infection
  • Patient is not known to have multiple sclerosis
  1. Renewal Criteria 1,9,13

Coverage can be renewed based on the following criteria:

  • Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion reactions, severe bacterial and viral infections, progressive multifocal leukoencephalopathy, hypogammaglobulinemia, etc.; AND
  • Continuous monitoring of response to therapy indicates a beneficial response* [manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate (ARR), development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by expanded disability status scale (EDSS), timed 25-foot walk (T25-FW), 9-hole peg test (9-HPT)]


  • Inadequate response, in those who have been adherent and receiving therapy for sufficient time to realize the full treatment effect, is defined as ≥ 1 relapse, ≥ 2 unequivocally new MRI-detected lesions, or increased disability on examination over a one-year period.
  1. Dosage/Administration 1



Multiple Sclerosis

Initial dosing:

  • First Infusion: 150 mg intravenous infusion
  • Second Infusion: 450 mg intravenous infusion administered two weeks after the first infusion.

Subsequent doses:

  • 450 mg intravenous infusion administered 24 weeks after the first infusion and every 24 weeks thereafter
  1. Billing Code/Availability Information


  • J2329 – Injection, ublituximab-xiiy, 1mg; 1 billable unit = 1 mg


  • Briumvi 150 mg/6 mL single-dose vial: 73150-0150-xx
  1. References
  1. Briumvi [package Insert]. Morrisville, NC; TG Therapeutics, Inc.; December 2022. Accessed September 2023.
  2. Steinman L, Fox E, Hartung HP, et al; ULTIMATE I and ULTIMATE II Investigators. Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis. N Engl J Med. 2022 Aug 25;387(8):704-714. doi: 10.1056/NEJMoa2201904.
  3. Gawronski KM, Rainka MM, Patel MJ, Gengo FM. Treatment Options for Multiple Sclerosis: Current and Emerging Therapies. Pharmacotherapy. 2010; 30(9):916-927.
  4. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan 22; 58(2):169-78.
  5. Freedman MS, Selchen D, Arnold DL, et al. Treatment optimization in MS: Canadian MS Working Group updated recommendations. Can J Neurol Sci. 2013 May;40(3):307-23.
  6. Polman CH, Reingold SC, Banwell B, et al. Diagnostic criteria for multiple sclerosis: 2010 Revisions to the McDonald criteria. Ann Neurol. 2011 Feb; 69(2): 292–302. doi:  10.1002/ana.22366.
  7. Lublin FD, Reingold SC, Cohen JA, et al. Defining the clinical course of multiple sclerosis: the 2013 revisions. Neurology. 2014 Jul 15;83(3):278-86.
  8. Multiple Sclerosis Coalition. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. 2019 September. Accessed 9/2023.
  9. Rae-Grant, A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Neurology® 2018;90:777-788.
  10. Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2.
  11. Kappos L, Bar-Or A, Cree BAC, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018;391(10127):1263. Epub 2018 Mar 23.
  12. Lorscheider J, Buzzard K, Jokubaitis V, et al, on behalf of the MSBase Study Group. Defining secondary progressive multiple sclerosis. Brain, Volume 139, Issue 9, September 2016, Pages 2395–2405,
  13. Freedman MS, Devonshire V, Duquette P, et al; Canadian MS Working Group. Treatment Optimization in Multiple Sclerosis: Canadian MS Working Group Recommendations. Can J Neurol Sci. 2020 Jul;47(4):437-455. doi: 10.1017/cjn.2020.66.
  14. Cree BAC, Arnold DL, Chataway J, et al. Secondary Progressive Multiple Sclerosis: New Insights. Neurology. 2021 Aug 24;97(8):378-388. doi: 10.1212/WNL.0000000000012323. Epub 2021 Jun 4.

Appendix 1 – Covered Diagnosis Codes


ICD-10 Description


Multiple Sclerosis

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):  N/A

Medicare Part B Administrative Contractor (MAC) Jurisdictions


Applicable State/US Territory


E (1)


Noridian Healthcare Solutions, LLC

F (2 & 3)


Noridian Healthcare Solutions, LLC



Wisconsin Physicians Service Insurance Corp (WPS)



National Government Services, Inc. (NGS)

H (4 & 7)


Novitas Solutions, Inc.



Wisconsin Physicians Service Insurance Corp (WPS)

N (9)


First Coast Service Options, Inc.

J (10)


Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)


National Government Services, Inc. (NGS)



CGS Administrators, LLC





BRIUMVI™ (ublituximab-xiiy) Prior Auth Criteria
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