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    v1.0.31
    OpenPayerPolicy UpdatesHematology/OncologyBCBS Tennessee Bendamustine Coverage | OpenPayer
    Ask Trek AI about this page
    DraftBlue Cross Blue Shield of TennesseePolicy ID_CHS_17052026_1126

    Bendamustine Products Coverage Criteria

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    Prior authorization and coverage criteria for bendamustine products used to treat specified hematologic malignancies and related conditions in Tennessee.

    Policy Summary
    PayerBlue Cross Blue Shield of Tennessee
    PolicyBendamustine Products Coverage Criteria
    Policy CodePolicy ID_CHS_17052026_1126
    Change TypeNo material change
    Effective DateJanuary 30, 2027
    Next Review DateN/A
    Key ActionSubmit prior authorization for bendamustine products and document a covered indication with all applicable clinical criteria satisfied.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsStandard authorization duration
    2FDA-approved indication categories
    20+Compendial disease and treatment categories
    Not medically necessaryOther indications
    >3

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    Prior therapies for specified disorders

    Covered Indications and Medical Necessity Criteria

    FDA-Approved and Compendial Indications

    The following FDA-approved indications and compendial uses are considered a covered benefit when all applicable approval criteria are met and the member has no exclusions to the prescribed therapy.

    Covered indication framework

    • The requested use is an FDA-approved indication or a listed compendial use for bendamustine.
    • All applicable coverage and approval criteria are met.
    • The member has no exclusions to the prescribed therapy.

    FDA-approved indications

    • Chronic lymphocytic leukemia (CLL).
    • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

    Compendial uses

    • Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
    • B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, high-grade B-cell lymphoma (HGBL), histologic transformation of indolent lymphomas to DLBCL, HIV-related B-cell lymphoma, mantle cell lymphoma (MCL), marginal zone lymphoma, nodal marginal zone lymphoma, extranodal marginal zone lymphoma of the stomach (gastric mucosa-associated lymphoid tissue [MALT] lymphoma), extranodal marginal zone lymphoma of nongastric sites (nongastric MALT lymphoma), splenic marginal zone lymphoma, and monomorphic post-transplant lymphoproliferative disorders (PTLD) of B-cell type.
    • Classic Hodgkin lymphoma (cHL).
    • Cold agglutinin disease.
    • Hematopoietic cell transplantation.
    • Multiple myeloma (MM).

    Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

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

    ALL of the following

    • The member has chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL) without chromosome 17p deletion or TP53 mutation.

    B-Cell Lymphomas

    Authorization of 12 months may be granted for treatment of B-cell lymphomas when any of the following criteria are met.

    ONE of

    • DLBCL

      • The member has diffuse large B-cell lymphoma (DLBCL).
      • The requested medication will be used as subsequent therapy.
      • The requested medication will be used in combination with polatuzumab vedotin-piiq, with or without a rituximab product.
    • The member has follicular lymphoma.

    • HGBL

    T-Cell Lymphomas

    Authorization of 12 months may be granted for treatment of T-cell lymphomas when any of the following criteria are met.

    ONE of

    • ATLL

      • The member has adult T-cell leukemia/lymphoma (ATLL).
      • The requested medication will be used as a single agent.
      • The requested medication will be used as subsequent therapy.

    • BIA-ALCL

      • The member has breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

    Multiple Myeloma (MM)

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

    ALL of the following

    • The disease is relapsed or refractory and the member has tried more than 3 prior therapies.

    • ONE of the following regimens

      • The requested medication will be used in combination with lenalidomide and dexamethasone.
      • The requested medication will be used in combination with bortezomib and dexamethasone.
      • The requested medication will be used in combination with carfilzomib and dexamethasone.
      • The requested medication will be used as a single agent.

    POEMS Syndrome, MIDD, or MGRS

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

    ALL of the following

    • The member has POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Protein, Skin Changes) syndrome, plasma cell-related Monoclonal Immunoglobulin Deposition Disease (MIDD), or plasma cell-related Monoclonal Gammopathy of Renal Significance (MGRS).
    • The disease is relapsed or refractory and the member has tried more than 3 prior therapies.

    • ONE of the following regimens

      • The requested medication will be used in combination with lenalidomide and dexamethasone.
      • The requested medication will be used in combination with bortezomib and dexamethasone.

    Classic Hodgkin Lymphoma (cHL)

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

    ALL of the following

    • The member has classic Hodgkin lymphoma (cHL).
    • The requested medication will be used as re-induction, subsequent therapy, or palliative therapy.

    • ONE of the following regimens

      • The requested medication will be used in combination with brentuximab vedotin, with or without nivolumab.
      • The requested medication will be used in combination with gemcitabine and vinorelbine.
      • The requested medication will be used in combination with carboplatin and etoposide.

    Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)

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

    ALL of the following

    • The member has nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).
    • The requested medication will be used as subsequent therapy.
    • The requested medication will be used in combination with a rituximab product.

    Waldenström Macroglobulinemia, Lymphoplasmacytic Lymphoma, or Bing-Neel Syndrome

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

    ONE of

    • The requested medication will be used as a single agent for Waldenström macroglobulinemia, lymphoplasmacytic lymphoma, or Bing-Neel syndrome.
    • The requested medication will be used in combination with a rituximab product for Waldenström macroglobulinemia, lymphoplasmacytic lymphoma, or Bing-Neel syndrome.

    Systemic Light Chain Amyloidosis

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

    ALL of the following

    • The member has systemic light chain amyloidosis.
    • The requested medication will be used in combination with dexamethasone.
    • The requested medication will be used for relapsed or refractory disease.

    Hematopoietic Cell Transplantation

    Authorization of 12 months may be granted for use in hematopoietic cell transplantation when all of the following criteria are met.

    ALL of the following

    • The requested medication will be used as conditioning for autologous transplant.
    • The requested medication will be used in combination with etoposide, cytarabine, and melphalan.

    Hematopoietic Cell Transplantation — Required Coverage Conditions

    Coverage for hematopoietic cell transplantation requires all of the following conditions.

    ALL of the following

    • The requested medication will be used as conditioning for autologous transplant.
    • The requested medication will be used in combination with etoposide, cytarabine, and melphalan.

    Cold Agglutinin Disease

    Authorization of 12 months may be granted when the requested medication is used in combination with a rituximab product.

    ALL of the following

    • The member has cold agglutinin disease.
    • The requested medication will be used in combination with a rituximab product.

    Continuation of Therapy

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

    ALL of the following

    • The member is requesting reauthorization for an indication listed in the coverage criteria section.
    • There is no evidence of unacceptable toxicity while on the current regimen.
    • There is no evidence of disease progression while on the current regimen.

    Applicable Tennessee State Mandate Requirements

    Coverage of off-label indications of FDA-approved drugs is available when the applicable Tennessee mandate requirements are met.

    ALL of the following

    • The requested drug is FDA approved.

    • The off-label use is recognized in ONE of the following

      • A statutorily recognized standard reference compendium.
      • Published peer-reviewed medical literature.

    Authorization, Documentation, and Denial Conditions

    Prior Authorization

    Obtain prior authorization before treatment

    Prior authorization is required for bendamustine products. Authorization may be granted for 12 months when the member has a covered indication and satisfies all applicable clinical criteria.

    Prior Authorization

    Meet autologous transplant conditioning requirements

    Authorization for use in hematopoietic cell transplantation may be granted for 12 months when bendamustine is used as conditioning for an autologous transplant and in combination with etoposide, cytarabine, and melphalan.

    Prior Authorization

    Use the required cold agglutinin disease regimen

    Authorization for treatment of cold agglutinin disease may be granted for 12 months when bendamustine is used in combination with a rituximab product.

    Clinical Background

    Bendamustine is used across a range of hematologic malignancies and related conditions, including chronic lymphocytic leukemia, B-cell and T-cell lymphomas, systemic light-chain amyloidosis, and Waldenström macroglobulinemia, lymphoplasmacytic lymphoma, and Bing-Neel syndrome. The policy identifies specific disease areas and treatment settings for coverage; uses outside the listed indications are considered experimental/investigational and not medically necessary.

    Reference Definitions

    Standard reference compendia
    NCCN GuidelinesNCCN Clinical Practice Guidelines in Oncology
    NCCN compendiumNCCN Drugs & Biologics Compendium
    MicromedexDrugDex Evaluations of Micromedex Solutions
    AHFSAmerican Hospital Formulary Service Drug Information

    Therapy-Line Requirements

    Subsequent Therapy

    Coverage includes the specified subsequent-therapy settings.

    Subsequent therapy: The requested medication will be used as subsequent therapy for a qualifying DLBCL, high-grade B-cell lymphoma, HIV-related B-cell lymphoma, monomorphic B-cell post-transplant lymphoproliferative disorder, adult T-cell leukemia/lymphoma, breast implant-associated anaplastic large cell lymphoma, or peripheral T-cell lymphoma; or as re-induction, subsequent, or palliative therapy for classic Hodgkin lymphoma.

    Salvage Therapy

    Coverage includes salvage therapy for refractory hepatosplenic T-cell lymphoma.

    Salvage therapy: The member has hepatosplenic T-cell lymphoma with refractory disease after two first-line therapy regimens.2 first-line therapy regimens

    Biomarker Requirements

    Chromosome 17p deletion
    BiomarkerChromosome 17p deletion
    Required statusAbsent
    Applicable conditionChronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL)
    TP53 mutation
    BiomarkerTP53 mutation
    Required statusAbsent
    Applicable conditionChronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL)

    Required and Permitted Treatment Regimens

    ConditionRequired regimenCoverage
    Diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), HIV-related B-cell lymphoma, or monomorphic B-cell PTLDSubsequent therapy in combination with polatuzumab vedotin-piiq, with or without a rituximab productCovered
    Follicular lymphomaBendamustine-containing regimen; the policy identifies follicular lymphoma as a qualifying diagnosisCovered
    Histologic transformation of an indolent lymphoma to DLBCLPolatuzumab vedotin-piiq, with or without a rituximab product; requires prior anthracycline-based treatment and no transplant candidacyCovered
    Mantle cell lymphomaRituximab product combination; RBAC500 (rituximab, bendamustine, and cytarabine); or acalabrutinib with a rituximab productCovered
    Marginal zone lymphomaRituximab product or obinutuzumab combinationCovered
    ConditionRequired regimenCoverage
    Relapsed or refractory multiple myeloma after more than 3 prior therapiesLenalidomide and dexamethasone; bortezomib and dexamethasone; carfilzomib and dexamethasone; or single-agent therapyCovered
    Relapsed or refractory POEMS syndrome, plasma cell-related MIDD, or plasma cell-related MGRS after more than 3 prior therapiesLenalidomide and dexamethasone; bortezomib and dexamethasone; carfilzomib and dexamethasone; or single-agent therapyCovered
    ConditionRequired regimenCoverage
    Multiple myeloma with CNS diseaseCombination with systemic chemotherapyCovered
    ConditionRequired regimenCoverage
    Classic Hodgkin lymphomaRe-induction, subsequent, or palliative therapy with brentuximab vedotin, with or without nivolumab; gemcitabine and vinorelbine; carboplatin and etoposide; or single-agent therapyCovered
    ConditionRequired regimenCoverage
    Nodular lymphocyte predominant Hodgkin lymphomaSubsequent therapy in combination with a rituximab productCovered
    Waldenström macroglobulinemia, lymphoplasmacytic lymphoma, or Bing-Neel syndromeSingle-agent therapy or combination with a rituximab productCovered
    ConditionRequired regimenCoverage
    Relapsed or refractory systemic light-chain amyloidosisCombination with dexamethasoneCovered
    Treatment settingRequired regimenCoverage
    Conditioning for autologous hematopoietic cell transplantationBendamustine in combination with etoposide, cytarabine, and melphalanCovered
    ConditionRequired regimenCoverage
    Cold agglutinin diseaseBendamustine in combination with a rituximab productCovered
    Policy Summary
    PayerBlue Cross Blue Shield of Tennessee
    PolicyBendamustine Products Coverage Criteria
    Policy CodePolicy ID_CHS_17052026_1126
    Change TypeNo material change
    Effective DateJanuary 30, 2027
    Next Review DateN/A
    Key ActionSubmit prior authorization for bendamustine products and document a covered indication with all applicable clinical criteria satisfied.
    SourceLink
    On This Page
    Covered Indications and Medical Necessity CriteriaAuthorization, Documentation, and Denial ConditionsClinical BackgroundReference DefinitionsTherapy-Line RequirementsBiomarker RequirementsRequired and Permitted Treatment Regimens
  1. Nodular lymphocyte predominant Hodgkin lymphoma (NLPHL).
  2. POEMS (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal Protein, Skin Changes) syndrome.
  3. Plasma cell-related Monoclonal Immunoglobulin Deposition Disease (MIDD).
  4. Plasma cell-related Monoclonal Gammopathy of Renal Significance (MGRS).
  5. Systemic light chain amyloidosis.
  6. T-cell lymphomas, including adult T-cell leukemia/lymphoma (ATLL), breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), hepatosplenic T-cell lymphoma (HSTCL), peripheral T-cell lymphoma (PTCL), and T-cell prolymphocytic leukemia.
  7. Waldenström macroglobulinemia, lymphoplasmacytic lymphoma, or Bing-Neel syndrome.
    8. The member has high-grade B-cell lymphoma (HGBL).
  8. The requested medication will be used as subsequent therapy.
  9. The requested medication will be used in combination with polatuzumab vedotin-piiq, with or without a rituximab product.

  10. Histologic transformation

    • The member has histologic transformation of an indolent lymphoma to diffuse large B-cell lymphoma.
    • The requested medication will be used in combination with polatuzumab vedotin-piiq, with or without a rituximab product.
    • The member has received treatment with an anthracycline-based regimen, such as doxorubicin.
    • The member is not a candidate for transplant.

  11. HIV-related B-cell lymphoma

    • The member has HIV-related B-cell lymphoma, including HIV-related DLBCL, primary effusion lymphoma, HHV8-positive DLBCL, or plasmablastic lymphoma.
    • The requested medication will be used as subsequent therapy.
    • The requested medication will be used in combination with polatuzumab vedotin-piiq, with or without a rituximab product.

  12. MCL

    • ALL of the following

      • The member has mantle cell lymphoma (MCL).
      • The requested medication will be used in combination with a rituximab product.

    • ALL of the following

      • The member has MCL.
      • The requested medication will be used as a component of RBAC500 (rituximab, bendamustine, and cytarabine).

    • ALL of the following

      • The member has MCL.
      • The requested medication will be used in combination with acalabrutinib and a rituximab product.

  13. Marginal zone lymphoma

    • The member has nodal marginal zone lymphoma, extranodal marginal zone lymphoma of the stomach (gastric MALT lymphoma), extranodal marginal zone lymphoma of nongastric sites (nongastric MALT lymphoma), or splenic marginal zone lymphoma.
    • The requested medication will be used in combination with a rituximab product or obinutuzumab.

  14. PTLD

    • The member has monomorphic post-transplant lymphoproliferative disorders (PTLD) of B-cell type.
    • The requested medication will be used as subsequent therapy.
    • The requested medication will be used in combination with polatuzumab vedotin-piiq, with or without a rituximab product.
    15. The requested medication will be used as a single agent.
  15. The requested medication will be used as subsequent therapy.

  16. HSTCL

    • The member has hepatosplenic T-cell lymphoma (HSTCL).
    • The requested medication will be used as a single agent.
    • The requested medication will be used for refractory disease after 2 first-line therapy regimens.

  17. PTCL

    • The member has peripheral T-cell lymphoma (PTCL), including anaplastic large cell lymphoma, PTCL not otherwise specified, angioimmunoblastic T-cell lymphoma, enteropathy-associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma, nodal PTCL with TFH phenotype, or follicular T-cell lymphoma.
    • The requested medication will be used as a single agent.
    • The requested medication will be used as palliative or subsequent therapy.

  18. T-cell prolymphocytic leukemia

    • The member has T-cell prolymphocytic leukemia.
    • The requested medication will be used as a single agent for symptomatic disease.
    19. The requested medication will be used in combination with carfilzomib and dexamethasone.
  19. The requested medication will be used as a single agent.
  20. The requested medication will be used as a single agent.
    21. Prior Authorization

    Request reauthorization every 12 months

    Authorization for continued treatment may be granted for 12 months for an indication listed in the coverage criteria when there is no unacceptable toxicity or disease progression while the member remains on the current regimen.

    Documentation Required

    Document the transplant conditioning regimen

    Document that the requested medication will be used as conditioning for an autologous transplant and in combination with etoposide, cytarabine, and melphalan.

    Documentation Required

    Document the required rituximab combination

    Document that bendamustine will be used in combination with a rituximab product for treatment of cold agglutinin disease.

    Documentation Required

    Document clinical status for continuation therapy

    For reauthorization, document the applicable covered indication and that the member has no unacceptable toxicity or disease progression on the current regimen.

    Denial Risk

    Avoid unsupported or non-qualifying indications

    Coverage may be denied when the indication is not an FDA-approved or listed compendial use, when applicable approval criteria are not met, or when an exclusion applies. All other indications are considered experimental/investigational and not medically necessary.

    Denial Risk

    Verify every indication-specific criterion

    Coverage may be denied when the requested disease state, line of therapy, treatment regimen, combination therapy, prior-treatment history, transplant status, or single-agent requirement does not meet the applicable indication-specific criteria.

    Denial Risk

    Monitor for toxicity and disease progression

    Continuation or reauthorization may not be approved when there is unacceptable toxicity or disease progression while the member is receiving the current regimen.