CurrentCareSourcePolicy N/A

PHARMACY POLICY STATEMENT Arkansas PASSE

Defines CareSource pharmacy policy for coverage and prior authorization requirements for Briumvi (ublituximab-xiiy) when used to treat relapsing forms of multiple sclerosis in adults within the Arkansas PASSE benefit; includes initial authorization, reauthorization, dosing/quantity limits, and exclusions for other indications.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy; annual review (no updates)

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization as a medical benefit (approval granted for 12 months) and ensure prescribing by or in consultation with a neurologist with documentation of relapsing MS diagnosis and required testing/criteria.

SourceLink

POLICY UPDATE CHANGES

New policy for Briumvi created on 01/04/2023.

Annual review on 10/31/2024; no updates.

1Covered Drug (single agent)

12 moInitial Approval Duration

7 then 3Vials QL (first / subsequent 24 wks)

>=18Minimum Age

Coverage Summary

Defines CareSource pharmacy policy for coverage and prior authorization requirements for Briumvi (ublituximab-xiiy) when used to treat relapsing forms of multiple sclerosis in adults within the Arkansas PASSE benefit. Coverage stance: covered_with_criteria. Policy includes initial authorization and reauthorization requirements, dosing and quantity limits, exclusions for other indications, and that the benefit is a medical benefit requiring prior authorization.

Policy key values

Effective date04/01/2025

Last review10/31/2024

StatusPrior Authorization Required (Medical benefit)

Minimum age threshold>= 18 years

Initial approval duration12 months

Vials QL summary7 vials for first 24 weeks; then 3 vials every 24 weeks

Initial Therapy Criteria (Prior Authorization)

Prior Authorization

Prior authorization required

Briumvi is a medical benefit that requires prior authorization. If all initial authorization criteria are met, approval is granted for 12 months.

Continuation Therapy Criteria (Reauthorization)

Documentation Required

Treatment history or disease activity

Document either an inadequate response to at least one preferred disease-modifying MS drug or the prescriber's determination that the disease is highly active/aggressive.

Not Medically Necessary / Exclusions

Denial Risk

Concomitant DMTs prohibited

Briumvi must not be used concurrently with another disease-modifying MS agent. Claims may be denied if Briumvi is used at the same time as another DMT.

Applicable Codes & Benefit

Benefit type / Prior Authorization statusmixed

Benefit Type: Medical; Status: Prior Authorization Required

Billing Rule

Dosing and quantity limits

Follow the specified infusion schedule and quantity limits: first dose 150 mg IV, second dose 450 mg IV two weeks after the first, then 450 mg IV every 24 weeks. Quantity limits: 7 vials for the first 24 weeks, then 3 vials every 24 weeks thereafter.

Provider Actions & Documentation Requirements

Documentation Required

Prescriber specialty and diagnosis

Prescription must be by or in consultation with a neurologist and include documentation of a confirmed diagnosis of relapsing multiple sclerosis (CIS, RRMS, or active SPMS).

Documentation Required

Treatment history or disease activity

Document either an inadequate response to at least one preferred disease-modifying MS drug or the prescriber's expert opinion that the disease is highly active/aggressive.

Documentation Required

Hepatitis B testing or consultation

Provide evidence of a negative test for active hepatitis B or documentation of consultation with a hepatologist prior to initiating Briumvi.

Clinical Evidence

2022FDA approval year

NEJM 2022Key trial: Ublituximab vs Teriflunomide (Steinman et al.)

Every 24wMaintenance infusion interval (every 24 weeks)

150→450 mgInitial dosing: 150 mg then 450 mg at 2 weeks; maintenance 450 mg

Briumvi was approved by the FDA in 2022 as a CD20-directed cytolytic antibody for relapsing forms of multiple sclerosis in adults. Key clinical evidence cited is the randomized trial “Ublituximab versus Teriflunomide in Relapsing Multiple Sclerosis” (N Engl J Med 2022).

Background & Definitions

Briumvi (ublituximab-xiiy) is a CD20-directed cytolytic antibody indicated for relapsing forms of MS in adults. Maintenance dosing is administered by IV infusion every 24 weeks, with the labeled induction/maintenance schedule of 150 mg IV first dose, 450 mg IV 2 weeks after first, then 450 mg IV 24 weeks after first and every 24 weeks thereafter. The policy designates the product as a medical benefit and requires prior authorization.

Relapsing multiple sclerosis: Includes clinically isolated syndrome (CIS), relapsing‑remitting disease (RRMS), and active secondary progressive disease (SPMS) as specified in policy.

Policy Summary

PayerCareSource

PolicyPHARMACY POLICY STATEMENT Arkansas PASSE

Policy CodePolicy N/A

Change TypeNew policy; annual review (no updates)

Effective DateApr 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

PHARMACY POLICY STATEMENT Arkansas PASSE

Coverage Summary

Initial Therapy Criteria (Prior Authorization)

Continuation Therapy Criteria (Reauthorization)

Not Medically Necessary / Exclusions

Applicable Codes & Benefit

Provider Actions & Documentation Requirements

Clinical Evidence

Background & Definitions

Revision History