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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Elrexfio Prior Auth | OpenPayer
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    CurrentClover HealthPolicy 6121-A

    Elrexfio (elranatamab-bcmm) Coverage and Prior Authorization

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    This policy governs Medicare Part B coverage and authorization for Elrexfio (elranatamab-bcmm), including initial and continuation therapy. It applies to members receiving treatment for relapsed or refractory multiple myeloma and to providers submitting authorization requests.

    Policy Summary
    PayerClover Health
    PolicyElrexfio (elranatamab-bcmm) Coverage and Prior Authorization
    Policy CodePolicy 6121-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with documentation showing at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsInitial authorization period
    12 monthsContinuation authorization period
    4+Required prior therapies
    3Required treatment categories

    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

    Initial therapy for relapsed or refractory multiple myeloma

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

    Initial therapy criteria

    • Required prior treatment categories: The member has received at least one anti-CD38 monoclonal antibody, at least one proteasome inhibitor, and at least one immunomodulatory agent.At least 1 drug from each of 3 categories

      Examples include daratumumab or isatuximab; bortezomib, ixazomib, or carfilzomib; and lenalidomide, pomalidomide, or thalidomide.

    Continuation therapy

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

    Continuation therapy criteria

    • Benefit from therapy: There is no evidence of unacceptable toxicity while on the current regimen and no evidence of disease progression while on the current regimen.No unacceptable toxicity; no disease progression

      Both conditions are required.

    Provider Actions

    Prior Authorization

    Obtain prior authorization for 12 months

    Prior authorization is required. Initial authorization may be granted for 12 months when the multiple myeloma criteria are met; continuation authorization may be granted for 12 months when the member is currently receiving Elrexfio, is being treated for a covered indication, and is benefiting from therapy.

    Documentation Required

    Document failure of prior therapy

    Upon request, submit chart notes or medical record documentation demonstrating failure of previous lines of therapy.

    Documentation Required

    Support other indications with compendia evidence

    For indications other than the listed FDA-approved indication, submit supporting evidence from Medicare-approved compendia. Other indications are assessed on an individual basis.

    Denial Risk

    Meet all multiple myeloma criteria

    Coverage may be denied if the member does not have relapsed or refractory multiple myeloma or has not received at least four prior therapies, including at least one drug from each required category.

    • Anti-CD38 monoclonal antibody
    • Proteasome inhibitor
    • Immunomodulatory agent
    Denial Risk

    Demonstrate benefit for continuation

    Continuation authorization may be denied if the member is not currently receiving Elrexfio, the medication is not treating an indication listed in the coverage criteria, or the member is not benefiting from therapy. Benefit requires no evidence of unacceptable toxicity and no evidence of disease progression on the current regimen.

    • Currently receiving the requested medication
    • Indication is listed in the coverage criteria
    • No unacceptable toxicity
    • No disease progression

    Policy Background

    Elrexfio (elranatamab-bcmm) is covered for adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including treatment from each of these categories: an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

    For continuation of therapy, the member must be currently receiving Elrexfio for a covered indication and benefiting from treatment, with no evidence of unacceptable toxicity or disease progression on the current regimen.

    Initial Therapy Criteria

    Initial therapy for multiple myeloma

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

    Initial treatment requirements: The member has relapsed or refractory multiple myeloma and has received at least 4 prior therapies, including at least one anti-CD38 monoclonal antibody, at least one proteasome inhibitor, and at least one immunomodulatory agent.At least 4 prior therapies; at least 1 drug from each of 3 categories

    Examples include daratumumab or isatuximab; bortezomib, ixazomib, or carfilzomib; and lenalidomide, pomalidomide, or thalidomide.

    Continuation Criteria

    Continuation of Elrexfio

    All members, including new members, requesting continuation authorization must be currently receiving therapy with the requested agent. Authorization may be granted for 12 months when all of the following criteria are met.

    Continuation therapy

    • Benefit: There is no evidence of unacceptable toxicity while on the current regimen and no evidence of disease progression while on the current regimen.No unacceptable toxicity; no disease progression

      Both conditions are required.

    Policy Summary
    PayerClover Health
    PolicyElrexfio (elranatamab-bcmm) Coverage and Prior Authorization
    Policy CodePolicy 6121-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization requests with documentation showing at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
    SourceLink
    On This Page
    Coverage CriteriaProvider ActionsPolicy BackgroundInitial Therapy CriteriaContinuation Criteria