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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Columvi Coverage Policy | OpenPayer
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    CurrentClover HealthPolicy 6023-A

    Columvi (glofitamab-gxbm) Coverage Criteria

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    This policy governs Medicare Part B prior authorization and continuation coverage for Columvi, including FDA-approved and specified compendial uses in adult patients with relapsed or refractory B-cell lymphomas. Coverage requires satisfaction of the applicable clinical criteria and absence of exclusions to therapy.

    Policy Summary
    PayerClover Health
    PolicyColumvi (glofitamab-gxbm) Coverage Criteria
    Policy CodePolicy 6023-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization when the member meets the applicable B-cell lymphoma pathway, including required obinutuzumab pretreatment and disease-specific treatment criteria.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsInitial authorization period
    12 cyclesMaximum continuation authorization
    2 or morePrior systemic therapy lines required
    7 daysObinutuzumab pretreatment timing

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    6
    Compendial disease categories

    Coverage Criteria

    Initial Therapy

    Authorization of 12 months may be granted when the member will be pretreated with a single dose of obinutuzumab (Gazyva) 7 days before initiation with the requested medication and ANY of the following criteria are met:

    ALL of the following

    • The member will be pretreated with a single dose of obinutuzumab (Gazyva) 7 days before initiation with the requested medication.

    • ANY of the following

      • ALL of the following

        • The requested medication will be used as subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin) for relapsed/refractory disease.

        • One of the following subtypes

          • Diffuse large B-cell lymphoma (DLBCL).
          • High grade B-cell lymphoma.
          • HIV-related B-cell lymphoma, including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL, not otherwise specified, and HIV-related plasmablastic lymphoma.
          • Post-transplant lymphoproliferative disorder (B-cell type).

      • ALL of the following

        • The requested medication will be used as a single agent after at least 2 prior lines of systemic therapy.

        • The member has one of the following disease statuses

          • Partial response.
          • No response.
          • Progressive disease.
          • Relapsed disease.
          • Refractory disease.

        • One of the following subtypes

      • ALL of the following

        • The requested medication will be used for treatment of mantle cell lymphoma as single-agent subsequent therapy for progressive disease after CAR T-cell therapy and pirtobrutinib (Jaypirca).
        • The member is ineligible for CAR-T cell therapy.

    Continuation Therapy

    All members, including new members, requesting authorization for continuation of therapy must be currently receiving therapy with the requested medication. Authorization of 12 months, up to a maximum of 12 cycles, may be granted when ALL of the following criteria are met:

    ALL of the following

    • The member is currently receiving therapy with the requested medication.
    • The requested medication is being used to treat an indication in the coverage criteria section.

    • The member is receiving benefit from therapy, defined as both of the following

      • No evidence of unacceptable toxicity while on the current regimen.
      • No evidence of disease progression while on the current regimen.

    Authorization Requirements

    Prior Authorization

    Initial Authorization — B-Cell Lymphoma

    Prior authorization may be granted for 12 months for Columvi treatment of B-cell lymphoma when the member will be pretreated with a single dose of obinutuzumab (Gazyva) 7 days before initiation and meets one of the applicable treatment pathways below.

    • Relapsed/refractory disease: Columvi will be used in combination with GemOx (gemcitabine and oxaliplatin) for diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, HIV-related B-cell lymphoma—including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL not otherwise specified, and HIV-related plasmablastic lymphoma—or B-cell post-transplant lymphoproliferative disorder.
    • After at least 2 prior lines of systemic therapy: Columvi will be used as a single agent for disease that is partially responsive, nonresponsive, progressive, relapsed, or refractory in DLBCL, high-grade B-cell lymphoma, histologic transformation of indolent lymphoma to DLBCL, HIV-related B-cell lymphoma—including HIV-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL not otherwise specified—or monomorphic B-cell post-transplant lymphoproliferative disorder.
    • Mantle cell lymphoma: Columvi will be used as single-agent subsequent therapy for progressive disease after CAR T-cell therapy and pirtobrutinib (Jaypirca), or when the member is ineligible for CAR T-cell therapy.
    Prior Authorization

    Clinical Background

    Columvi (glofitamab-gxbm) is covered for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy, provided applicable approval criteria are met and no exclusions apply.

    The policy also recognizes specified compendial uses in adults with diffuse large B-cell lymphoma, high-grade B-cell lymphoma, histologic transformation of indolent lymphoma to DLBCL, HIV-related B-cell lymphoma, post-transplant lymphoproliferative disorder, and mantle cell lymphoma.

    Initial Therapy

    Initial Therapy

    Authorization for 12 months may be granted for B-cell lymphoma when the member receives required obinutuzumab pretreatment and meets at least one covered disease-specific treatment pathway.

    Initial Columvi therapy

    • The member will be pretreated with a single dose of obinutuzumab (Gazyva) before initiation of Columvi.7 days before initiation

    • ONE of the following treatment pathways

      • GemOx combination pathway

        • Columvi will be used as subsequent therapy in combination with GemOx (gemcitabine and oxaliplatin) for relapsed or refractory disease.

        • ONE of the following lymphoma subtypes

    Continuation Therapy

    Continuation Therapy

    Continuation authorization may be granted for 12 months, up to a maximum of 12 cycles, when all continuation criteria are met.

    Continuation of Columvi

    • The member is currently receiving therapy with Columvi.

      Includes new members requesting continuation authorization.

    • Columvi is being used to treat an indication listed in the coverage criteria.

    • Clinical benefit

      • There is no evidence of unacceptable toxicity while the member is on the current regimen.
      • There is no evidence of disease progression while the member is on the current regimen.

    Step Therapy Requirements

    StepRequirementTiming
    1Pretreatment with a single dose of obinutuzumab (Gazyva) before Columvi initiation7 days before initiation
    StepRequirementTiming
    2For mantle cell lymphoma, use Columvi as subsequent single-agent therapy after CAR T-cell therapy and pirtobrutinib (Jaypirca), or when the member is ineligible for CAR-T cell therapyAfter prior CAR T-cell therapy and pirtobrutinib, unless the member is ineligible for CAR-T cell therapy

    Quantity Limits

    Quantity Limits
    Authorization period12 months
    Maximum quantity12 cycles
    Continuation requirementThe member must be currently receiving Columvi
    Clinical benefitNo evidence of unacceptable toxicity and no evidence of disease progression on the current regimen
    Policy Summary
    PayerClover Health
    PolicyColumvi (glofitamab-gxbm) Coverage Criteria
    Policy CodePolicy 6023-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit prior authorization when the member meets the applicable B-cell lymphoma pathway, including required obinutuzumab pretreatment and disease-specific treatment criteria.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization RequirementsClinical BackgroundInitial TherapyContinuation TherapyStep Therapy RequirementsQuantity Limits
    • Diffuse large B-cell lymphoma (DLBCL).
    • High grade B-cell lymphoma.
    • Histologic transformation of indolent lymphoma to DLBCL.
    • HIV-related B-cell lymphoma, including HIV-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL, not otherwise specified.
    • Monomorphic post-transplant lymphoproliferative disorder (B-cell type).

    Continuation Authorization — Up to 12 Months/12 Cycles

    For all members, including new members requesting continuation, confirm that the member is currently receiving Columvi. Authorization may be granted for 12 months, up to a maximum of 12 cycles, when all continuation requirements are met.

    • The member is currently receiving therapy with Columvi.
    • Columvi is being used to treat an indication listed in the coverage criteria section.
    • The member is receiving benefit from therapy, defined as no evidence of unacceptable toxicity on the current regimen and no evidence of disease progression on the current regimen.
  1. Diffuse large B-cell lymphoma (DLBCL).
  2. High-grade B-cell lymphoma.
  3. HIV-related B-cell lymphoma, including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL not otherwise specified, and HIV-related plasmablastic lymphoma.
  4. Post-transplant lymphoproliferative disorder of B-cell type.

  5. Single-agent pathway after prior systemic therapy

    • Columvi will be used as a single agent after at least 2 prior lines of systemic therapy.At least 2 prior lines of systemic therapy

    • ONE of the following disease statuses

      • Partial response.
      • No response.
      • Progressive disease.
      • Relapsed disease.
      • Refractory disease.

    • ONE of the following lymphoma subtypes

      • Diffuse large B-cell lymphoma (DLBCL).
      • High-grade B-cell lymphoma.
      • Histologic transformation of indolent lymphoma to DLBCL.
      • HIV-related B-cell lymphoma, including HIV-related DLBCL, primary effusion lymphoma, and HHV8-positive DLBCL not otherwise specified.
      • Monomorphic post-transplant lymphoproliferative disorder of B-cell type.

  6. Mantle cell lymphoma pathway

    • Columvi will be used as single-agent subsequent therapy for progressive mantle cell lymphoma.

    • ONE of the following prior-treatment pathways

      • The disease progressed after CAR T-cell therapy and pirtobrutinib (Jaypirca).
      • The member is ineligible for CAR-T cell therapy.