CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Briumvi (ublituximab-xiiy) — Intravenous coverage criteria for relapsing multiple sclerosis

Covers clinical authorization, dosing, and renewal criteria for intravenous Briumvi for adults with relapsing forms of multiple sclerosis for Neighborhood Health Plan of Rhode Island members across Medicaid, Commercial, and MMP lines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBriumvi (ublituximab-xiiy) — Intravenous coverage criteria for relapsing multiple sclerosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization: initial approvals granted for 6 months and may be renewed annually with required clinical documentation (diagnosis, HBV screening, baseline immunoglobulins).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 moinitial authorization length

450 mgmaintenance dose

J2329HCPCS code

G35covered diagnosis

73150-0150-xxNDC (150 mg vial)

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conditionalNCD/LCD conditional

Coverage Criteria for Briumvi (ublituximab-xiiy)

Initial Approval Criteria

Covered when ALL of the following are met:

Initial approval criteria: Patient is >= 18 years of age

Initial approval criteria: Patient has been screened for hepatitis B virus (HBV) prior to initiating treatment and does not have active disease (i.e., positive HBsAg and anti-HBV tests)

Initial approval criteria: Baseline serum immunoglobulins have been assessed

Initial approval criteria: Briumvi is prescribed by or in consultation with a neurologist

Initial approval criteria: Patient will not receive live or live-attenuated vaccines while on therapy or within 4 weeks prior to initiation

Initial approval criteria: No active infection at time of initiation

Initial approval criteria: Confirmed diagnosis of multiple sclerosis documented by laboratory report or MRI

Initial approval criteria: Briumvi will be used as single-agent therapy

Initial approval criteria: Patient has not received a dose of ocrelizumab or ublituximab within the past 5 months

Initial approval criteria: Confirmed diagnosis of a relapsing form of MS (relapsing-remitting MS, active secondary progressive MS, or clinically isolated syndrome) as documented by laboratory report or MRI

See diagnostic definitions for RRMS, active SPMS, and CIS

Initial approval criteria: MMP patients who have received this medication within the past 365 days are exempt from step therapy requirements

Renewal Criteria

Renewal is allowed when ALL of the following are met:

Renewal criteria: Patient continues to meet the universal and other indication-specific criteria in the initial approval section

Renewal criteria: Patient has not received a dose of ocrelizumab or ublituximab within the past 5 months

Renewal criteria: No unacceptable toxicity from the drug (examples include severe infusion reactions, severe infections, progressive multifocal leukoencephalopathy, hypogammaglobulinemia)

Renewal criteria: Continuous monitoring shows beneficial response to therapy as evidenced by relapse rate, MRI activity (new/worsening T2 hyperintensities or enhancing lesions), or functional measures (EDSS, T25-FW, 9-HPT)

Inadequate response is defined as >= 1 relapse, >= 2 new MRI lesions, or increased disability over one year in adherent patients

Clinical coverage criteria (general)

Covered when ALL of the following are met

Alignment with FDA labeling: Use is consistent with FDA-approved labeling and/or relevant clinical literature

Per P&T-adopted criteria

Documentation provided: Prescriber submits clinical information supporting medical necessity and the indicated use

Neighborhood will give individual consideration based on submitted information

Cost-effectiveness considered: More cost-effective therapeutic options have been considered or tried when applicable

Criteria intended to promote cost-effective prescribing

Coverage is excluded when there is an active infection or evidence of active hepatitis B at the time of treatment initiation. Specifically, the policy requires screening for HBV prior to starting therapy and documents that patients with positive HBsAg and anti‑HBV tests (i.e., active disease) are not eligible for coverage.

Medicare policy may supersede plan criteria where applicable. National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) apply to Medicare Part B outpatient drugs and must be followed when relevant; the plan notes that additional indications may be covered at the plan's discretion. For INTEGRITY (Medicare‑Medicaid) members, these plan criteria apply only in the absence of an applicable NCD or LCD.

These coverage criteria address relapsing forms of multiple sclerosis. Primary progressive MS is generally not covered under these relapsing‑form criteria because patients with primary progressive disease typically do not experience clinical relapses or develop new MRI lesions; separate criteria would apply for that population.

Requests for use that are inconsistent with the FDA‑approved labeling or relevant clinical literature and that lack supporting prescriber documentation may be considered not medically necessary. The plan will consider individual justification submitted by the prescriber, but non‑concordant indications or insufficient clinical rationale increase the risk of denial.

Coding and Billing

Covered HCPCS CodesHCPCSCovered

J2329

Injection, ublituximab-xiiy, 1mg

NDC - Vial StrengthsNDCCovered

73150-0150-xx

Briumvi 150 mg/6 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

G35	Multiple Sclerosis

Medicare Part B Covered Diagnosis CodesICD-10

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

MAC Jurisdictions / Contractorsmixed

MAC jurisdictions list

Medicare Part B Administrative Contractor (MAC) jurisdiction mappings to states and contractors (see appendices)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required where applicable. For Medicare/INTEGRITY members, National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) take precedence when they exist; compliance with those CMS policies is required. Neighborhood will consider requests based on prescriber-submitted medical necessity documentation consistent with FDA labeling and relevant clinical literature. Initial approvals are provided for 6 months and may be renewed annually thereafter. Requests that do not demonstrate alignment with FDA-approved indications, clinical evidence, or plan criteria may be denied.

Initial authorization length: 6 months; renewals: annually
Medicare/INTEGRITY members: NCD/LCD precedence where applicable
Prescriber must submit clinical justification and documentation of medical necessity consistent with labeling
Denial risk for requests not demonstrating FDA/clinical/plan concordance

Step Therapy

Step Therapy and Exceptions

Background and Clinical Evidence

Briumvi (ublituximab‑xiiy) is indicated for adults with relapsing forms of multiple sclerosis. Neighborhood Health Plan of Rhode Island adopted P&T‑reviewed clinical coverage criteria to align use with FDA labeling and relevant literature. Efficacy evidence supporting approval includes randomized controlled trials (ULTIMATE 1 and 2), which demonstrated significant reductions in annualized relapse rate versus teriflunomide; common adverse events reported include infusion reactions, headache, and nasopharyngitis. The plan requires documentation of a confirmed relapsing‑form diagnosis (e.g., MRI) and baseline screening (including HBV testing and serum immunoglobulins) prior to initiation to ensure appropriate and safe use.

Definitions and Diagnostic Criteria

Relapsing‑remitting MS (RRMS) — diagnostic definition and MRI guidance

DefinitionRelapsing-remitting MS (RRMS) diagnosis requires BOTH dissemination in time and dissemination in space; MRI is recommended unless contraindicated.

Dissemination in timeDevelopment/appearance of new CNS lesions over time (e.g., new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI compared to baseline).

Dissemination in spaceLesions in distinct anatomical CNS locations (multifocal) demonstrated by clinical attacks or MRI showing ≥2 lesions or ≥1 lesion plus supportive findings such as CSF-specific oligoclonal bands or historical attack in a different location).

Active secondary progressive MS (SPMS) — definition and activity criteria

Core definitionActive secondary progressive MS (SPMS) is defined by progressive disease after a relapsing‑remitting course plus activity criteria.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBriumvi (ublituximab-xiiy) — Intravenous coverage criteria for relapsing multiple sclerosis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2023

Next Review DateN/A

Key ActionObtain prior authorization: initial approvals granted for 6 months and may be renewed annually with required clinical documentation (diagnosis, HBV screening, baseline immunoglobulins).

SourceLink

On This Page

Step therapy preferences apply when appropriate; the plan prefers cost-effective therapeutic options first. MMP (Medicare-Medicaid Plan) patients who have received this medication within the past 365 days are exempt from step therapy requirements. Prescribers should document prior therapies and dates to support exceptions.

Step therapy preference: cost-effective options preferred when applicable
Step therapy exception: MMP patients with prior receipt of medication within past 365 days are exempt

Documentation Required

Documentation Requirements

Required clinical documentation must be provided to support the request. Include confirmation of diagnosis, relevant labs/imaging, baseline immunoglobulin levels, and documentation that a neurologist prescribed or consulted on therapy. Also document HBV screening results and absence of active infection, and prior biologic timing where applicable.

Diagnosis confirmation: MRI or other lab reports demonstrating relapsing form of MS
Hepatitis B screening: results prior to initiation; no active HBV infection
Baseline serum immunoglobulins assessed
Neurologist involvement: prescribed by or in consultation with a neurologist
Prior biologic timing: no dose of ocrelizumab or ublituximab within past 5 months

Denial Risk

Clinical Justification and Denial Risk

Prescriber-submitted justification must establish medical necessity and an indication consistent with FDA labeling and accepted clinical practice. For Medicare/INTEGRITY members, apply NCD/LCD where present; otherwise, Neighborhood will individually consider submitted clinical information. Requests lacking supporting documentation or clinical concordance may be denied.

Submit medical necessity rationale consistent with FDA labeling and clinical literature
Medicare/INTEGRITY: follow NCD/LCD when applicable; if none, plan criteria apply
Denial risk if documentation does not support FDA/clinical/plan concordance

Expanded Disability Status Scale (EDSS) score ≥ 3.0.

Progression timeframe and magnitudeDisease progression ≥ 3 months after initial relapsing‑remitting course (EDSS increase by 1.0 if baseline EDSS ≤ 5.5, or by 0.5 if baseline EDSS ≥ 6).

Activity requirement (relapse or MRI)Either ≥1 relapse within the previous 2 years OR MRI evidence of disease activity (gadolinium‑enhancing lesions or new unequivocally enlarging T2 lesions).

Clinically isolated syndrome (CIS) — definition and diagnostic boundaries

DefinitionClinically isolated syndrome (CIS) is a monophasic clinical episode with focal or multifocal inflammatory demyelinating CNS findings and neurologic symptoms lasting ≥24 hours.

Symptom durationNeurologic symptoms lasting at least 24 hours, with or without recovery.

Exclusion criteriaAbsence of fever or infection at the time of the event and patient is not known to have multiple sclerosis.

NCD/LCD — CMS determinations and precedence over plan policy

DefinitionNCD (National Coverage Determination) or LCD (Local Coverage Determination) are CMS policies governing Medicare coverage for outpatient Part B drugs.

PrecedenceWhere applicable, NCDs/LCDs take precedence over the plan's clinical coverage criteria for Medicare/INTEGRITY members.

Location of determinationsNCDs/LCDs are available from the CMS Medicare Coverage Database (https://www.cms.gov/medicare-coverage-database/search.aspx).