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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Datroway Prior Auth | OpenPayer
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    CurrentClover HealthPolicy 6817-A

    Datroway (datopotamab deruxtecan-dlnk) Part B Coverage and Prior Authorization

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    This policy governs Medicare Part B coverage and authorization for Datroway, including FDA-approved and compendial oncology uses in adults with specified breast cancer or non-small cell lung cancer. Coverage requires the applicable clinical criteria, documentation, and continuation-of-therapy requirements to be met.

    Policy Summary
    PayerClover Health
    PolicyDatroway (datopotamab deruxtecan-dlnk) Part B Coverage and Prior Authorization
    Policy CodePolicy 6817-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization for Datroway coverage and submit documentation showing that the applicable clinical criteria are satisfied.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2FDA-approved covered indications
    12 monthsAuthorization period
    6Biomarker or genetic tests
    2Compendial-use disease 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.

    Covered Indications

    Breast cancer: HR-positive, HER2-negative

    Covered when all of the following are met:

    Disease status: The disease is unresectable or metastatic.
    Tumor biomarkers: The cancer cells are hormone receptor positive and HER2-negative.
    Prior treatment: The member has received prior treatment including endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
    Alternative therapy: The member is not a candidate for treatment with fam-trastuzumab deruxtecan-nxki (Enhertu).

    Breast cancer: first-line TNBC

    Covered when all of the following are met:

    Disease status: The disease is recurrent, unresectable, or metastatic.
    Tumor biomarkers: The cancer cells are estrogen receptor, progesterone receptor, and HER2 (ERBB2) negative.
    PD-L1 and BRCA criteria: The tumor's PD-L1 CPS is less than 10 and there are no germline BRCA1/2 pathogenic variants.PD-L1 CPS <10; no germline BRCA1/2 pathogenic variants

    NSCLC: subsequent EGFR mutation-positive treatment

    Covered when all of the following are met:

    Disease status: The NSCLC is recurrent, advanced, or metastatic.
    EGFR status: The NSCLC is EGFR mutation positive.
    Treatment setting: Datroway is being used as subsequent treatment and as a single agent.

    Continuation therapy

    Covered when all of the following are met:

    Current treatment: The member is currently receiving therapy with Datroway.
    Covered indication: Datroway is being used to treat an indication listed in the Coverage Criteria section.
    Clinical benefit: 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.No unacceptable toxicity; no disease progression

    Clinical Coding Details

    PD-L1 CPS Threshold
    MeasurePD-L1 combined tumor positive score (CPS)
    Coverage thresholdLess than 10 (<10)
    Applicable useFirst-line, single-agent treatment of recurrent, unresectable, or metastatic triple-negative breast cancer when other listed criteria are met.

    Authorization and Documentation Requirements

    Prior Authorization

    Initial Authorization — Prior Authorization Required

    Prior authorization is required. Qualifying initial requests may receive authorization for up to 12 months when the applicable coverage criteria are met.

    • Breast cancer: document unresectable or metastatic disease, applicable receptor status, required prior endocrine-based therapy and chemotherapy, and single-agent use.
    • Triple-negative breast cancer: document recurrent unresectable or metastatic disease, ER/PR/HER2 negativity, PD-L1 CPS <10, no germline BRCA 1/2 pathogenic variants, and single-agent use.
    • NSCLC: document EGFR mutation-positive recurrent, advanced, or metastatic disease and subsequent single-agent treatment.
    Prior Authorization

    Continuation Authorization

    Qualifying continuation requests may receive authorization for up to 12 months when the member remains on Datroway and the continuation criteria are met.

    • Applies to all members, including new members requesting continuation of therapy.
    Step Therapy

    Enhertu Alternative-Therapy Eligibility

    For applicable hormone receptor-positive, HER2-negative breast cancer requests, document that the member is not a candidate for fam-trastuzumab deruxtecan-nxki (Enhertu).

    • The request must be for single-agent treatment of unresectable or metastatic disease after prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

    Unsupported block type: documentation

    Denial Risk

    Failure to Meet Covered-Use Criteria

    The request may be denied when the proposed use or required clinical criteria are not covered or are not documented.

    • Breast cancer is not unresectable or metastatic, or the cancer is not hormone receptor positive and HER2-negative when requesting the applicable post-treatment use.
    • Required prior endocrine-based therapy and chemotherapy are not documented for unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer, or the member is a candidate for Enhertu.
    • For first-line TNBC, disease is not recurrent unresectable or metastatic; ER, PR, and HER2 are not all negative; PD-L1 CPS is not <10; or germline BRCA 1/2 pathogenic variants are present.
    • For NSCLC, the disease is not EGFR mutation-positive recurrent, advanced, or metastatic disease, or Datroway is not being used as subsequent single-agent treatment.
    • The requested use is not an indication listed in the Coverage Criteria section or the applicable authorization requirements are otherwise unmet.

    Unsupported block type: documentation

    Unsupported block type: documentation

    Policy Background

    Datroway (datopotamab deruxtecan-dlnk) is covered for specified adult oncology indications involving breast cancer and EGFR-mutated non-small cell lung cancer (NSCLC), subject to applicable approval criteria and exclusions. FDA-approved uses include locally advanced or metastatic EGFR-mutated NSCLC after prior EGFR-directed therapy and platinum-based chemotherapy, and unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer after endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Coverage also includes listed compendial uses for breast cancer and NSCLC; other indications require individual review with supporting evidence from a Medicare-approved compendium.

    Clinical Terms

    NSCLC
    AbbreviationNSCLC
    DefinitionNon-small cell lung cancer.
    Applicable disease settingThe policy includes locally advanced or metastatic EGFR-mutated NSCLC after prior EGFR-directed therapy and platinum-based chemotherapy.
    HR-Positive
    AbbreviationHR-positive
    DefinitionHormone receptor-positive cancer.
    Applicable breast cancer statusThe cancer is hormone receptor positive and treated under the policy's breast cancer criteria.
    HER2-Negative
    ReceptorHuman epidermal growth factor receptor 2 (HER2).
    Negative testing resultsHER2-negative includes IHC 0, IHC 1+, or IHC 2+/ISH-negative.
    Applicable diseaseThis HER2-negative interpretation applies to the FDA-approved breast cancer indication.
    Triple-Negative Breast Cancer
    AbbreviationTNBC
    Estrogen receptor and progesterone receptorNegative.
    HER2/ERBB2Negative.
    PD-L1 Combined Tumor Positive Score
    AbbreviationPD-L1 CPS
    Full termPD-L1 combined tumor positive score.
    Policy thresholdFor the applicable first-line TNBC criteria, the tumor's PD-L1 CPS must be less than 10.

    Initial Authorization Criteria

    Breast cancer: HR-positive, HER2-negative

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

    HR-positive, HER2-negative breast cancer: The disease is unresectable or metastatic; the cancer is hormone receptor positive and HER2-negative; the member received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease; and the member is not a candidate for fam-trastuzumab deruxtecan-nxki (Enhertu).

    Datroway must be used as a single agent.

    Breast cancer: first-line TNBC

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

    First-line TNBC: The disease is recurrent, unresectable, or metastatic; estrogen receptor, progesterone receptor, and HER2 (ERBB2) are negative; PD-L1 CPS is less than 10; and there are no germline BRCA1/2 pathogenic variants.PD-L1 CPS <10; no germline BRCA1/2 pathogenic variants

    Datroway must be used as a single agent.

    NSCLC: subsequent treatment

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

    Subsequent EGFR mutation-positive NSCLC: The NSCLC is recurrent, advanced, or metastatic, has an EGFR mutation, and Datroway is being used as subsequent treatment and as a single agent.

    Continuation Authorization Criteria

    Continuation therapy

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

    Current therapy: The member is currently receiving therapy with the requested medication.
    Indication: The requested medication is being used to treat an indication listed in the Coverage Criteria section.
    Benefit: There is no evidence of unacceptable toxicity and no evidence of disease progression while on the current regimen.No unacceptable toxicity; no disease progression

    Applies to all members, including new members, requesting continuation authorization.

    Required Alternative Therapy Review

    StepRequirement
    1For unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer, the member must not be a candidate for fam-trastuzumab deruxtecan-nxki (Enhertu).
    Policy Summary
    PayerClover Health
    PolicyDatroway (datopotamab deruxtecan-dlnk) Part B Coverage and Prior Authorization
    Policy CodePolicy 6817-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization for Datroway coverage and submit documentation showing that the applicable clinical criteria are satisfied.
    SourceLink
    On This Page
    Covered IndicationsClinical Coding DetailsAuthorization and Documentation RequirementsPolicy BackgroundClinical TermsInitial Authorization CriteriaContinuation Authorization CriteriaRequired Alternative Therapy Review