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    OpenPayerPolicy UpdatesHematology/OncologySecurity Health Polivy Policy Coverage | OpenPayer
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    CurrentSecurity Health Plan of Wisconsin, Inc.Policy N/A

    Polivy (polatuzumab vedotin-piiq) Intravenous Therapy

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    This policy governs coverage, authorization duration, dosing, medical necessity criteria, administration, and billing for intravenous Polivy in adults with specified B-cell lymphomas and related hematologic malignancies.

    Policy Summary
    PayerSecurity Health Plan of Wisconsin, Inc.
    PolicyPolivy (polatuzumab vedotin-piiq) Intravenous Therapy
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date06/24/2025
    Next Review DateN/A
    Key ActionObtain prior authorization and document that the patient meets the applicable approval criteria before requesting Polivy coverage.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    6 moMaximum authorization
    6 cyclesMaximum treatment
    200/21dBillable unit limit
    1.8 mg/kgStandard dose
    18+

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    Minimum age
    62Covered diagnosis entries

    Medical Necessity and Coverage Criteria

    Baseline eligibility and safety

    Coverage is provided when all baseline requirements are met.

    Baseline requirements

    • Patient is at least 18 years of age.Age >=18
    • Patient will receive prophylaxis for Pneumocystis jiroveci pneumonia and herpesvirus.
    • Patient does not currently have Grade 2 or higher peripheral neuropathy.Neuropathy below Grade 2
    • Patient does not have CNS lymphoma.

    Diffuse large B-cell lymphoma

    For diffuse large B-cell lymphoma, coverage requires a qualifying treatment pathway in addition to the baseline requirements.

    DLBCL treatment pathways

    • First-line R-CHP

      • Patient has diffuse large B-cell lymphoma (DLBCL).
      • Polivy is used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP).
      • Treatment is used as first-line therapy.
      • Patient has an International Prognostic Index (IPI) score of at least 2.IPI >=2

    • Subsequent therapy

    HIV-related and high-grade B-cell lymphomas

    Coverage is provided for the specified HIV-related B-cell lymphoma or high-grade B-cell lymphoma pathways.

    HIV-related B-cell lymphoma or HGBL pathways

    • First-line R-CHP

      • ANY of the following

        • Patient has an applicable high-grade B-cell lymphoma (HGBL).
        • Patient has an HIV-related B-cell lymphoma, including diffuse large B-cell lymphoma, primary effusion lymphoma, HHV8-positive diffuse large B-cell lymphoma not otherwise specified, or plasmablastic lymphoma.
      • Polivy is used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP).
      • Treatment is used as first-line therapy; this first-line criterion applies only to HGBL.

    Histologic transformation of indolent lymphoma

    Coverage is provided for qualifying histologic transformation pathways.

    Transformed lymphoma pathways

    • Transformation after minimal or no prior treatment

      • Patient has histologic transformation of an indolent lymphoma to DLBCL after minimal or no prior treatment.
      • Patient has previously been treated with an anthracycline-based regimen.
      • Polivy is used as a single agent or in combination with rituximab, with or without bendamustine, in a patient with no intention to proceed to transplant.
      • Treatment is additional therapy for partial response, no response, progressive disease, or relapse following chemoimmunotherapy.

    • Transformation after multiple prior lines

    Post-transplant lymphoproliferative disorders

    Coverage is provided for monomorphic B-cell post-transplant lymphoproliferative disorder when a qualifying treatment pathway is met.

    Monomorphic B-cell PTLD

    • Patient has monomorphic B-cell post-transplant lymphoproliferative disorder.

    • PTLD treatment pathways

      • Subsequent therapy after later relapse

        • Polivy is used as a single agent or in combination with rituximab, with or without bendamustine, as subsequent therapy in a patient with no intention to proceed to transplant.
        • Disease has relapsed more than 12 months after completion of initial treatment with chemoimmunotherapy.Relapse >12 months

      • Subsequent therapy for early relapse or refractory disease

    Renewal criteria

    Renewal requires that the authorization duration remains within the policy limit.

    Renewal requirement

    • The duration of authorization has not been exceeded.Maximum 6 months and up to 6 cycles

    Coverage requires that the patient does not currently have Grade 2 or higher peripheral neuropathy and does not have CNS lymphoma. These exclusions apply in addition to the other baseline eligibility and safety requirements.

    Uses not listed in the approved coverage criteria are excluded because available data are inadequate to support efficacy for those uses.

    Indications not included in the approved coverage criteria are not considered medically necessary under this policy.

    Billing and Coding

    HCPCS CodeHCPCSCovered
    J9309Injection, polatuzumab vedotin-piiq 1 mg; 1 mg = 1 billable unit
    NDC CodesNDCCovered
    50242-0103-xxPolivy 30 mg lyophilized powder for injection, single-dose vial
    50242-0105-xxPolivy 140 mg lyophilized powder for injection, single-dose vial
    Covered Diagnosis CodesICD-10Covered
    C83.30Diffuse large B-cell lymphoma unspecified site
    C83.31Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
    C83.32Diffuse large B-cell lymphoma intrathoracic lymph nodes
    C83.33Diffuse large B-cell lymphoma intra-abdominal lymph nodes
    C83.34Diffuse large B-cell lymphoma lymph nodes of axilla and upper limb
    C83.35Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb
    C83.36Diffuse large B-cell lymphoma intrapelvic lymph nodes
    C83.37Diffuse large B-cell lymphoma, spleen
    C83.38Diffuse large B-cell lymphoma lymph nodes of multiple sites
    C83.39Diffuse large B-cell lymphoma extranodal and solid organ sites
    1–10 of 11
    1/2
    Covered Diagnosis CodesICD-10Covered
    C83.30Diffuse large B-cell lymphoma unspecified site
    C83.31Diffuse large B-cell lymphoma, lymph nodes of head, face, and neck
    C83.32Diffuse large B-cell lymphoma intrathoracic lymph nodes
    C83.33Diffuse large B-cell lymphoma intra-abdominal lymph nodes
    C83.34Diffuse large B-cell lymphoma lymph nodes of axilla and upper limb
    C83.35Diffuse large B-cell lymphoma, lymph nodes of inguinal region and lower limb
    C83.36Diffuse large B-cell lymphoma intrapelvic lymph nodes
    C83.37Diffuse large B-cell lymphoma, spleen
    C83.38Diffuse large B-cell lymphoma lymph nodes of multiple sites
    C83.39Diffuse large B-cell lymphoma extranodal and solid organ sites
    1–10 of 11
    1/2
    Covered Diagnosis CodesICD-10Covered
    C83.80Other non-follicular lymphoma, unspecified site
    C83.81Other non-follicular lymphoma, lymph nodes of head, face and neck
    C83.82Other non-follicular lymphoma, intrathoracic lymph nodes
    C83.83Other non-follicular lymphoma, intra-abdominal lymph nodes
    C83.84Other non-follicular lymphoma, lymph nodes of axilla and upper limb
    C83.85Other non-follicular lymphoma, lymph nodes of inguinal region and lower limb
    C83.86Other non-follicular lymphoma, intrapelvic lymph nodes
    C83.87Other non-follicular lymphoma, spleen
    C83.88Other non-follicular lymphoma, lymph nodes of multiple sites
    C83.89Other non-follicular lymphoma, extranodal and solid organ sites
    1–10 of 20
    1/2
    Covered Diagnosis CodesICD-10Covered
    C85.10Unspecified B-cell lymphoma, unspecified site
    C85.11Unspecified B-cell lymphoma, lymph nodes of head, face, and neck
    C85.12Unspecified B-cell lymphoma, intrathoracic lymph nodes
    C85.13Unspecified B-cell lymphoma, intra-abdominal lymph nodes
    C85.14Unspecified B-cell lymphoma, lymph nodes of axilla and upper limb
    C85.15Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb
    C85.16Unspecified B-cell lymphoma, intrapelvic lymph nodes
    C85.17Unspecified B-cell lymphoma, spleen
    C85.18Unspecified B-cell lymphoma, lymph nodes of multiple sites
    C85.19Unspecified B-cell lymphoma, extranodal and solid organ sites
    1–10 of 14
    1/2
    Covered Diagnosis CodesICD-10Covered
    C85.24Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb
    C85.25Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb
    C85.26Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes
    C85.27Mediastinal (thymic) large B-cell lymphoma, spleen
    C85.28Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites
    C85.29Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites
    C85.80Other specified types of non-Hodgkin lymphoma, unspecified site
    C85.81Other specified types of non-Hodgkin lymphoma, lymph nodes of head, face and neck
    C85.82Other specified types of non-Hodgkin lymphoma, intrathoracic lymph nodes
    C85.83Other specified types of non-Hodgkin lymphoma, intra-abdominal lymph nodes
    1–10 of 16
    1/2
    Covered Diagnosis CodesICD-10Covered
    D47.Z1Post-transplant lymphoproliferative disorder (PTLD)
    Maximum billable units
    Maximum billable units200 billable units
    Billing intervalEvery 21 days
    Limit applicationClaims exceeding this limit may be denied
    Minimum age
    Minimum ageAt least 18 years of age
    Eligibility group

    Authorization, Documentation, and Denial Risks

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required before treatment. The request must establish the applicable initial approval criteria and support the requested course of therapy.

    Documentation Required

    Document Medical Necessity

    Submit clinical documentation supporting medical necessity for the requested use of Polivy. Documentation should identify the patient’s age, diagnosis, regimen, line of therapy, prior treatment history, and disease response or progression.

    • Document the specific lymphoma diagnosis and relevant disease status.
    • Identify whether treatment is first-line, subsequent, bridging, or alternative systemic therapy.
    • Include the complete regimen, prior therapies, response, relapse timing, and refractory status.

    Therapy Overview

    Polivy (polatuzumab vedotin-piiq) is an intravenous antibody-drug conjugate used for specified B-cell lymphomas, including diffuse large B-cell lymphoma and related transformed or post-transplant disorders. Coverage includes selected first-line R-CHP-based treatment and defined subsequent, salvage, alternative systemic, or bridging therapy for relapsed or refractory disease.

    Clinical Definitions

    Primary refractory or relapsed disease
    Disease statusDisease that has not responded to treatment, has had a partial response, or has progressed
    Relapsed diseaseDisease recurring within the specified time periods after first-line or initial chemoimmunotherapy
    Covered contextsThe term applies to specified DLBCL, HIV-related or high-grade B-cell lymphoma, and monomorphic B-cell PTLD pathways
    Bridging therapy
    DefinitionTreatment given before a planned CAR T-cell product becomes available
    Primary refractory diseaseMay be used for primary refractory disease

    Treatment-Line Criteria

    First-line

    Coverage under a first-line pathway requires all of the following.

    First-line pathway

    • Polivy is used with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP).
    • The indication is applicable DLBCL, HGBL, or HIV-related B-cell lymphoma; the first-line criterion within the HIV-related/HGBL pathway applies only to HGBL.
    • Patient has an IPI score of at least 2.IPI >=2

    Second-line

    Coverage under a second-line or subsequent-therapy pathway requires a qualifying disease setting and treatment approach.

    Subsequent therapy

    Disease and Biomarker Requirements

    MYC and BCL6 rearrangements without BCL2 rearrangements
    MYC statusMYC rearranged
    BCL6 statusBCL6 rearranged
    BCL2 statusBCL2 not rearranged
    International Prognostic Index
    International Prognostic IndexIPI score of at least 2
    First-line pathwaysRequired for specified first-line R-CHP pathways
    Transformation pathwayRequired for transformed DLBCL or high-grade B-cell lymphoma receiving R-CHP with the specified rearrangement pattern

    Covered Treatment Regimens

    RegimenCovered use and requirementsCoverage
    Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP)First-line treatment for DLBCL, applicable high-grade B-cell lymphoma, or HIV-related lymphoma when the applicable criterion is met and the patient has an IPI score of ≥2. Also covered after minimal or no prior therapy for transformed DLBCL or HGBL with MYC and BCL6 rearrangements without BCL2 rearrangements, when the IPI score is ≥2.Covered
    RegimenCovered use and requirementsCoverage
    Polivy as a single agent or in combination with rituximab, with or without bendamustineSubsequent therapy for specified DLBCL, HIV-related B-cell lymphoma, transformed lymphoma, or monomorphic B-cell PTLD pathways. Requirements may include no intention to proceed to transplant, relapse more than 12 months after first-line or initial chemoimmunotherapy, or primary refractory disease or relapse within 12 months in a non-candidate for CAR T-cell therapy. Transformed lymphoma also requires the applicable prior anthracycline-based treatment or multiple-line treatment history. Rituximab is excluded for relapsed plasmablastic lymphoma.Covered
    RegimenCovered use and requirementsCoverage
    Polivy as alternative systemic therapyFor relapsed or refractory DLBCL, HIV-related B-cell lymphoma, high-grade B-cell lymphoma, or monomorphic B-cell PTLD in a patient who is not a candidate for CAR T-cell therapy, when Polivy has not been previously used.Covered
    RegimenCovered use and requirementsCoverage
    Polivy as bridging therapyTreatment until a CAR T-cell product is available for primary refractory disease or disease relapsing within 12 months after completion of first-line therapy or initial chemoimmunotherapy, as applicable to the specified DLBCL, HIV-related B-cell lymphoma, high-grade B-cell lymphoma, or monomorphic B-cell PTLD pathway.Covered
    Policy Summary
    PayerSecurity Health Plan of Wisconsin, Inc.
    PolicyPolivy (polatuzumab vedotin-piiq) Intravenous Therapy
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective Date06/24/2025
    Next Review DateN/A
    Key ActionObtain prior authorization and document that the patient meets the applicable approval criteria before requesting Polivy coverage.
    SourceLink
    On This Page
    Medical Necessity and Coverage CriteriaBilling and CodingAuthorization, Documentation, and Denial RisksTherapy OverviewClinical DefinitionsTreatment-Line CriteriaDisease and Biomarker RequirementsCovered Treatment Regimens
    • Patient has DLBCL and no intention to proceed to transplant.
    • Polivy is used as a single agent or in combination with rituximab, with or without bendamustine.

    • ANY of the following

      • Disease has relapsed more than 12 months after completion of first-line therapy.Relapse >12 months
      • Disease is primary refractory, meaning partial response, no response, or progression, or has relapsed less than 12 months after completion of first-line therapy, and the patient is a non-candidate for CAR T-cell therapy.Relapse <12 months or primary refractory disease
      • Polivy is used as alternative systemic therapy, was not previously used, and the disease is relapsed/refractory in a non-candidate for CAR T-cell therapy.
      • Polivy is used as a bridging option until a CAR T-cell product is available for primary refractory disease or relapse less than 12 months after completion of first-line therapy.Relapse <12 months
  1. Patient has an IPI score of at least 2.IPI >=2

  2. Subsequent therapy

    • Polivy is used as a single agent or in combination with rituximab, with or without bendamustine, as subsequent therapy in a patient with no intention to proceed to transplant.

    • ANY of the following

      • Disease has relapsed more than 12 months after completion of first-line therapy.Relapse >12 months
      • Disease is primary refractory, meaning partial response, no response, or progression, or has relapsed less than 12 months after completion of first-line therapy, and the patient is a non-candidate for CAR T-cell therapy.Relapse <12 months or primary refractory disease
      • Polivy is used as alternative systemic therapy, was not previously used, and the disease is relapsed/refractory in a non-candidate for CAR T-cell therapy.
      • Polivy is used as a bridging option until a CAR T-cell product is available for primary refractory disease or relapse less than 12 months after completion of first-line therapy.Relapse <12 months
    • Patient has histologic transformation to DLBCL after multiple lines of prior therapy, including at least 2 chemoimmunotherapy regimens for indolent or transformed disease.At least 2 prior chemoimmunotherapy regimens
    • Polivy is used as a single agent or in combination with rituximab, with or without bendamustine, in a patient with no intention to proceed to transplant.

  3. Transformed DLBCL or HGBL with qualifying rearrangements

    • Patient has histologic transformation to DLBCL or HGBL with MYC and BCL6 rearrangements without BCL2 rearrangements.
    • Patient has had minimal or no prior therapy.
    • Patient has an IPI score of at least 2.IPI >=2
    • Polivy is used in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP).
    • Polivy is used as a single agent or in combination with rituximab, with or without bendamustine, as subsequent therapy in a patient with no intention to proceed to transplant.
    • Disease is primary refractory, meaning partial response, no response, or progression, or has relapsed less than 12 months after completion of initial treatment with chemoimmunotherapy, and the patient is a non-candidate for CAR T-cell therapy.Relapse <12 months or primary refractory disease
  4. Polivy is used as alternative systemic therapy, was not previously used, and the disease is relapsed/refractory in a non-candidate for CAR T-cell therapy.
  5. Polivy is used as a bridging option until a CAR T-cell product is available for primary refractory disease or relapse less than 12 months after completion of initial treatment with chemoimmunotherapy.Relapse <12 months
    6. Adults
    Baseline requirementThis requirement applies before coverage is provided for a covered indication
    Peripheral neuropathy
    Peripheral neuropathy requirementNo current Grade 2 or higher peripheral neuropathy
    Excluded conditionCurrent Grade 2 or higher peripheral neuropathy
    Related baseline exclusionThe patient must not have CNS lymphoma
    International Prognostic Index
    International Prognostic IndexIPI score of at least 2
    First-line useRequired for specified first-line R-CHP pathways
    Transformed lymphoma useRequired for the R-CHP pathway when histologic transformation includes the specified rearrangement pattern
    Relapse timing
    Relapse after first-line therapyMore than 12 months after completion of first-line therapy qualifies for the applicable subsequent-therapy pathway
    Early relapseLess than 12 months after completion of first-line therapy may qualify for specified refractory, CAR T-cell, or bridging pathways
    Initial chemoimmunotherapyFor post-transplant lymphoproliferative disorder, timing is measured after completion of initial chemoimmunotherapy
    Dose and frequency
    Dose1.8 mg/kg
    Route and frequencyAdminister intravenously every 21 days
    Treatment duration6 cycles
    Documentation Required

    Document Safety and Prophylaxis

    Document required safety measures and confirm that baseline exclusions do not apply before requesting coverage.

    • Patient is at least 18 years of age.
    • Pneumocystis jiroveci pneumonia and herpesvirus prophylaxis will be provided.
    • Patient does not have current Grade ≥ 2 peripheral neuropathy.
    • Patient does not have CNS lymphoma.
    Documentation Required

    Renewal Documentation

    For renewal, document that the authorization duration has not been exceeded and provide the treatment-cycle and dosing information supporting continued therapy.

    • Authorization is limited to 6 months and up to 6 cycles.
    • Standard dosing is 1.8 mg/kg intravenously every 21 days for 6 cycles.
    Denial Risk

    Baseline Denial Risks

    Coverage may be denied when baseline approval requirements are not met, including age, prophylaxis, neuropathy, or other listed exclusions.

    • Patient is younger than 18 years.
    • Required Pneumocystis jiroveci pneumonia or herpesvirus prophylaxis is not planned.
    • Current Grade ≥ 2 peripheral neuropathy is present.
    • CNS lymphoma is present.
    Denial Risk

    Indication and Treatment Criteria

    Coverage may be denied unless the diagnosis, regimen, line of therapy, prior treatment, transplant or CAR T-cell eligibility, and disease status meet an approved indication and treatment pathway.

    • Covered pathways include specified B-cell lymphomas, HIV-related B-cell lymphomas, high-grade B-cell lymphomas, histologic transformation of indolent lymphomas, and post-transplant lymphoproliferative disorders.
    • Regimen, first-line or subsequent-therapy status, IPI score, prior anthracycline or chemoimmunotherapy, relapse timing, refractory disease, transplant intent, and CAR T-cell candidacy must align with the applicable criteria.
    Denial Risk

    Unlisted Uses Excluded

    Uses not listed in the policy have inadequate data to support efficacy and are excluded from coverage.

    • Verify that the requested diagnosis and treatment use appears in the policy’s approved indications before submitting the request.
    Denial Risk

    Six-Month/Six-Cycle Limit

    Renewal is not permitted after the maximum authorization period has been reached.

    • Maximum authorization: 6 months.
    • Maximum treatment duration: 6 cycles.
    Billing Rule

    Dosing Limit

    Claims exceeding the stated quantity limit may be denied.

    • Maximum: 200 billable HCPCS units every 21 days.
    Billing Rule

    Follow Applicable CMS Coverage Policy

    Medicare Part B outpatient drug claims must comply with applicable CMS coverage policies. Failure to follow an applicable NCD, LCD, or LCA may affect coverage or payment.

    • Review applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs).
    • Use the CMS Medicare Coverage Database to identify applicable policies and claim-payment requirements.
    Early relapse
    May be used for disease relapsing within 12 months after first-line or initial chemoimmunotherapy
    Non-candidate for CAR T-cell therapy
    DefinitionA patient for whom CAR T-cell therapy is not an appropriate or available treatment option
    Applicable settingDetermination is made under the applicable disease and treatment circumstances
    Policy useThis status supports specified alternative systemic or early-relapse treatment pathways
    Histologic transformation
    DefinitionTransformation of an indolent lymphoma into diffuse large B-cell lymphoma or high-grade B-cell lymphoma
    Specified rearrangementsMay include MYC and BCL6 rearrangement without BCL2 rearrangements
    Treatment contextThe applicable pathway depends on prior treatment and molecular rearrangement status
    Monomorphic B-cell PTLD
    DefinitionA post-transplant lymphoproliferative disorder with monomorphic B-cell histology
    Disease typeMonomorphic B-cell disease
    Covered treatment contextThe policy includes specified subsequent, alternative systemic, and bridging therapy pathways
    • Polivy is used as a single agent or with rituximab, with or without bendamustine.
    • Treatment is used when there is no intention to proceed to transplant.

    • ANY of the following

      • Disease has relapsed more than 12 months after completion of first-line or initial chemoimmunotherapy.Relapse >12 months
      • Disease is primary refractory, meaning partial response, no response, or progression, or has relapsed less than 12 months after completion of first-line or initial chemoimmunotherapy, and the patient is a non-candidate for CAR T-cell therapy.Relapse <12 months or primary refractory disease

    Salvage

    Coverage under a salvage, alternative, or bridging pathway requires one of the following.

    Salvage, alternative, or bridging therapy

    • Polivy is used as alternative systemic therapy, was not previously used, and the disease is relapsed/refractory in a non-candidate for CAR T-cell therapy.
    • Polivy is used as bridging therapy until a CAR T-cell product is available for primary refractory disease or relapse within 12 months after first-line or initial chemoimmunotherapy.Relapse <12 months