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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Briumvi Prior Auth Coverage | OpenPa…
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    CurrentClover HealthPolicy 5738-A

    Briumvi (ublituximab-xiiy) Coverage Criteria

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    This policy governs Medicare Part B coverage and authorization for Briumvi (ublituximab-xiiy), including FDA-approved treatment of relapsing forms of multiple sclerosis and clinically isolated syndrome in adults. It applies to members requesting initial or continuation therapy when the stated coverage criteria are met.

    Policy Summary
    PayerClover Health
    PolicyBriumvi (ublituximab-xiiy) Coverage Criteria
    Policy CodePolicy 5738-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with documentation of a qualifying relapsing form of multiple sclerosis or clinically isolated syndrome.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsInitial authorization for qualifying relapsing forms of multiple sclerosis
    12 monthsInitial authorization for clinically isolated syndrome
    3Continuation criteria required
    1FDA-approved indication category

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Criteria

    Relapsing Forms of Multiple Sclerosis

    Authorization of 12 months may be granted when the member has the qualifying diagnosis.

    Relapsing forms of multiple sclerosis: Member has been diagnosed with a relapsing form of multiple sclerosis, including relapsing-remitting disease or secondary progressive disease for those who continue to experience relapse.

    Authorization duration is 12 months.

    Clinically Isolated Syndrome

    Authorization of 12 months may be granted when the member has clinically isolated syndrome of multiple sclerosis.

    Clinically isolated syndrome: Member has clinically isolated syndrome of multiple sclerosis.

    Authorization duration is 12 months.

    Continuation Therapy

    Authorization of 12 months may be granted when all of the following criteria are met.

    Continuation of therapy

    • Current treatment: Member is currently receiving therapy with Briumvi.
    • Covered indication: Briumvi is being used to treat an indication in the coverage criteria section.
    • Therapeutic benefit: Member is receiving benefit from therapy.

    Members with exclusions to the prescribed therapy are not eligible for coverage under the stated indications, even when other approval criteria are met.

    Provider Actions and Authorization Outcomes

    Prior Authorization

    Initial Briumvi Authorization

    Submit a prior authorization request for Briumvi when the member has a qualifying relapsing form of multiple sclerosis or clinically isolated syndrome. Authorization may be granted for 12 months when the applicable coverage criteria are met and the member has no exclusions to the prescribed therapy.

    • Relapsing forms of multiple sclerosis include relapsing-remitting disease and active secondary progressive disease in members who continue to experience relapse.
    • Clinically isolated syndrome of multiple sclerosis is also covered.
    • The member must be an adult for the listed FDA-approved relapsing multiple sclerosis indication.
    Documentation Required

    Continuation Authorization

    For continuation requests, verify that the member is currently receiving Briumvi, that treatment is for an indication listed in the coverage criteria, and that the member is receiving benefit from therapy. Authorization may be granted for 12 months when all requirements are met.

    • Applies to all members, including new members, requesting continuation of therapy.
    • Current treatment must be with Briumvi.
    Documentation Required

    Compendia Support for Other Indications

    Indications other than those listed in the coverage criteria are assessed individually. Requests for other indications must include supporting evidence from Medicare-approved compendia.

    • Include Medicare-approved compendia support with submissions for nonlisted indications.
    • Compendia support does not replace review of applicable approval criteria or exclusions.
    Denial Risk

    Uncovered Indication or Exclusion

    Coverage is not established when the requested use does not meet a covered indication or when an exclusion applies to the prescribed therapy. Other indications are not automatically covered and require individual assessment with appropriate supporting evidence.

    • Do not assume coverage for indications outside relapsing forms of multiple sclerosis or clinically isolated syndrome.
    • Requests must satisfy all applicable approval criteria and the member must have no exclusions to the prescribed therapy.
    Denial Risk

    Continuation Criteria Not Met

    Deny or do not approve continuation when the member is not currently receiving Briumvi, the drug is not being used for an indication in the coverage criteria, or the member is not receiving benefit from therapy.

    • All continuation requirements must be met.
    • Authorization may not be granted when current treatment, covered indication, or documented benefit is absent.

    Briumvi Background

    Briumvi (ublituximab-xiiy) is indicated for adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. For secondary progressive disease, the member must continue to experience relapse.

    Initial Therapy Criteria

    Initial Therapy: Relapsing Forms of Multiple Sclerosis

    Authorization of 12 months may be granted to members diagnosed with a relapsing form of multiple sclerosis.

    Relapsing forms of multiple sclerosis: Member has a diagnosis of a relapsing form of multiple sclerosis, including relapsing-remitting disease or secondary progressive disease for those who continue to experience relapse.

    Authorization duration is 12 months.

    Initial Therapy: Clinically Isolated Syndrome

    Authorization of 12 months may be granted for treatment of clinically isolated syndrome of multiple sclerosis.

    Clinically isolated syndrome: Member has clinically isolated syndrome of multiple sclerosis.

    Authorization duration is 12 months.

    Continuation Therapy Criteria

    Continuation Therapy

    Authorization for 12 months may be granted when all of the following criteria are met.

    Continuation of Briumvi

    • Member is currently receiving therapy with Briumvi.
    • Briumvi is being used to treat an indication in the coverage criteria section.
    • Member is receiving benefit from therapy.
    Policy Summary
    PayerClover Health
    PolicyBriumvi (ublituximab-xiiy) Coverage Criteria
    Policy CodePolicy 5738-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with documentation of a qualifying relapsing form of multiple sclerosis or clinically isolated syndrome.
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and Authorization OutcomesBriumvi BackgroundInitial Therapy CriteriaContinuation Therapy Criteria