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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Bizengri Part B Coverage | OpenPayer
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    CurrentClover HealthPolicy 6756-A

    Bizengri (zenocutuzumab-zbco) Part B Coverage

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    Medicare Part B coverage and prior authorization for Bizengri in adults with specified advanced, unresectable, metastatic, or recurrent NRG1 gene fusion-positive NSCLC or pancreatic adenocarcinoma.

    Policy Summary
    PayerClover Health
    PolicyBizengri (zenocutuzumab-zbco) Part B Coverage
    Policy CodePolicy 6756-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation confirming the member’s NRG1 gene fusion status for initial approval when requested.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsAuthorization period
    2FDA-approved indications
    2Compendial uses
    NRG1 fusionRequired biomarker
    Single agentTreatment regimen

    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: NSCLC

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

    NSCLC initial therapy

    • Disease status and prior therapy: The member has experienced disease progression on or after prior systemic therapy.
    • Biomarker status: The member has neuregulin 1 (NRG1) gene fusion-positive disease.
    • Regimen: The requested medication will be used as a single agent.

    Initial therapy: pancreatic adenocarcinoma

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

    Pancreatic adenocarcinoma initial therapy

    • Disease status and prior therapy: The member has experienced disease progression on or after prior systemic therapy.
    • Biomarker status: The member has neuregulin 1 (NRG1) gene fusion-positive disease.
    • Regimen: The requested medication will be used as a single agent.

    Continuation therapy

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

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

    • Clinical benefit

      • Tolerability: No evidence of unacceptable toxicity while on the current regimen.
      • Disease control: No evidence of disease progression while on the current regimen.

    Authorization and Documentation Guidance

    Prior Authorization

    Initial Authorization — 12-Month Approval

    Prior authorization is required. Authorization for 12 months may be granted for advanced unresectable, metastatic, or recurrent NSCLC or pancreatic adenocarcinoma when all applicable criteria are met.

    • Disease progression on or after prior systemic therapy.
    • Neuregulin 1 (NRG1) gene fusion-positive disease.
    • Bizengri will be used as a single agent.
    Denial Risk

    Initial Therapy Criteria Not Met

    Initial authorization should be denied when the requested therapy does not meet all applicable coverage criteria for NSCLC or pancreatic adenocarcinoma.

    • No advanced unresectable, metastatic, or recurrent NSCLC or pancreatic adenocarcinoma.

    Policy Background

    Bizengri (zenocutuzumab-zbco) is covered for selected adults with advanced, unresectable, metastatic, or recurrent non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma whose tumors harbor an NRG1 gene fusion. For the listed advanced or metastatic indications, the disease must have progressed on or after prior systemic therapy. The policy also recognizes recurrent NSCLC and recurrent pancreatic adenocarcinoma as covered compendial uses, subject to applicable approval criteria.

    Initial Therapy Criteria

    NSCLC initial therapy

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

    • Disease progression: The member has experienced disease progression on or after prior systemic therapy.
    • NRG1 status: The member has neuregulin 1 (NRG1) gene fusion-positive disease.
    • Treatment regimen: The requested medication will be used as a single agent.

    Pancreatic adenocarcinoma initial therapy

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

    Continuation Therapy Criteria

    Bizengri continuation therapy

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

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

    • Benefit

      • Tolerability: No evidence of unacceptable toxicity while on the current regimen.
    Policy Summary
    PayerClover Health
    PolicyBizengri (zenocutuzumab-zbco) Part B Coverage
    Policy CodePolicy 6756-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit documentation confirming the member’s NRG1 gene fusion status for initial approval when requested.
    SourceLink
    On This Page
    Coverage CriteriaAuthorization and Documentation GuidancePolicy BackgroundInitial Therapy CriteriaContinuation Therapy Criteria
  1. No documented disease progression on or after prior systemic therapy.
  2. Disease is not NRG1 gene fusion-positive.
  3. Bizengri will not be used as a single agent.
    4. Documentation Required

    NRG1 Gene Fusion Documentation

    For initial approval, documentation confirming the member’s NRG1 gene fusion status must be available upon request.

    • Submit documentation of NRG1 gene fusion-positive disease when requested.
    Prior Authorization

    Continuation Authorization — 12-Month Period

    Continuation authorization for 12 months may be granted only when the member is currently receiving Bizengri, the treatment is for an indication listed in the coverage criteria, and benefit from therapy is demonstrated.

    • The member is currently receiving Bizengri, including new members requesting continuation.
    • The medication is being used for NSCLC or pancreatic adenocarcinoma as listed in the coverage criteria.
    • Benefit requires no unacceptable toxicity on the current regimen and no disease progression on the current regimen.
    Denial Risk

    Continuation Benefit Not Demonstrated

    Continuation authorization should be denied when the member is not currently receiving Bizengri, the indication is not listed in the coverage criteria, or benefit from therapy has not been demonstrated.

    • The member is not currently receiving the requested medication.
    • The requested medication is being used for an indication not listed in the coverage criteria.
    • There is unacceptable toxicity or disease progression on the current regimen.
    Documentation Required

    Evidence for Other Indications

    For indications other than recurrent NSCLC or recurrent pancreatic adenocarcinoma, submissions must include supporting evidence from Medicare-approved compendia for individual assessment.

    • All other indications are assessed on an individual basis.
    • Provide Medicare-approved compendial evidence supporting the requested indication.
    Documentation Required

    Unlisted Indication Requires Compendial Support

    An unlisted indication requires supporting evidence from Medicare-approved compendia and individual assessment before coverage can be considered.

    • The requested indication is not recurrent NSCLC or recurrent pancreatic adenocarcinoma.
    • Submit evidence from Medicare-approved compendia supporting the unlisted use.
    • Coverage is subject to individual review and assessment.
    • Disease progression: The member has experienced disease progression on or after prior systemic therapy.
    • NRG1 status: The member has neuregulin 1 (NRG1) gene fusion-positive disease.
    • Treatment regimen: The requested medication will be used as a single agent.
    Disease control: No evidence of disease progression while on the current regimen.