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    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsClover Health Enhertu Coverage Prior Auth | OpenPa…
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    CurrentClover HealthPolicy 2167-A

    Enhertu and Trastuzumab Biologics Coverage Criteria

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    This policy governs Medicare Part B coverage and prior authorization for Enhertu, trastuzumab, trastuzumab/hyaluronidase, and related trastuzumab biologics for breast, gastric, and gastroesophageal junction cancer in Florida, Puerto Rico, and the U.S. Virgin Islands.

    Policy Summary
    PayerClover Health
    PolicyEnhertu and Trastuzumab Biologics Coverage Criteria
    Policy CodePolicy 2167-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and submit documentation showing that the requested product, cancer diagnosis, HER2 status, disease stage, prior therapy, treatment intent, and regimen meet a covered pathway.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    9Branded products covered
    3Covered cancer indications
    12 monthsAuthorization duration
    HER2-positive or HER2-lowBiomarker requirements
    Individual review

    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.

    Other indications

    Covered Indications and Criteria

    Breast Cancer

    Authorization may be granted for 12 months when at least one of the following criteria groups is met. Each pathway requires all listed criteria unless otherwise noted.

    Breast cancer approval pathways

    • Neoadjuvant or preoperative trastuzumab: The disease is HER2-positive; trastuzumab will be used for neoadjuvant or preoperative treatment; the disease is stage IIA, IIB, IIIA-C, or T3, N1, M0; and trastuzumab will be used in combination with paclitaxel followed by FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide).
    • Adjuvant trastuzumab: The disease is HER2-positive; trastuzumab will be used for adjuvant treatment; the disease is stage I, IIA, IIB, IIIA-C, or T3, N1, M0; and trastuzumab will be used in combination with doxorubicin, cyclophosphamide, and paclitaxel; docetaxel and carboplatin; as a single agent following multimodality anthracycline-based therapy; docetaxel followed by FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide); following chemotherapy; or docetaxel following doxorubicin and cyclophosphamide.
    • Advanced or metastatic hormone receptor-positive disease: The disease is HER2-positive and advanced, recurrent, or metastatic; trastuzumab will be used in combination with an aromatase inhibitor; the member is postmenopausal or receiving concomitant suppression of testicular steroidogenesis; the disease is estrogen-receptor positive; and the member has not received endocrine therapy within one year.
    • Advanced or metastatic trastuzumab or Enhertu use: The disease is HER2-positive and advanced, recurrent, or metastatic; and one of the following applies: trastuzumab will be used with paclitaxel for first-line therapy; trastuzumab will be used as a single agent after one or more chemotherapy regimens for metastatic disease; or Enhertu will be used as a single agent after a prior anti-HER2-based regimen.
    • Advanced or metastatic trastuzumab plus chemotherapy: The disease is HER2-positive and advanced, recurrent, or metastatic; trastuzumab will be used in combination with chemotherapy; and one of the following applies: trastuzumab will be used with docetaxel, vinorelbine, or capecitabine for first-line therapy, or with paclitaxel with or without carboplatin; or the member was previously treated with trastuzumab for breast cancer in a qualifying regimen. The disease must be hormone receptor-negative or hormone receptor-positive and endocrine refractory, and must not be characterized by bone or soft-tissue involvement only or asymptomatic visceral disease.
    • First-line metastatic pertuzumab regimen: The disease is HER2-positive and metastatic; trastuzumab will be used in combination with pertuzumab and docetaxel or the requested product is Phesgo; and the member has not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
    • Neoadjuvant Phesgo or pertuzumab regimen: The disease is HER2-positive and locally advanced, inflammatory, or early stage, with either a tumor greater than 2 cm in diameter or positive nodes; trastuzumab will be used in combination with pertuzumab and chemotherapy or the requested product is Phesgo; the treatment is neoadjuvant; and it is part of a complete treatment regimen for early breast cancer.>2 cm or node positive
    • Adjuvant Phesgo or pertuzumab regimen: The disease is HER2-positive; trastuzumab will be used in combination with pertuzumab and chemotherapy or the requested product is Phesgo; and the treatment is adjuvant treatment of early breast cancer at high risk of recurrence.High risk of recurrence
    • Enhertu for HER2-low breast cancer: The requested product is Enhertu; the disease is HER2-low, defined as an immunohistochemistry score of IHC 1+ or IHC 2+ with a negative in situ hybridization test; Enhertu will be used for unresectable, recurrent, or metastatic disease; and the member has received prior chemotherapy.IHC 1+ or IHC 2+/ISH-negative

    Gastric or Gastroesophageal Junction Cancer

    Authorization may be granted for 12 months when at least one of the following criteria groups is met. Each pathway requires all listed criteria.

    Gastric or gastroesophageal junction cancer approval pathways

    • Enhertu after trastuzumab-based therapy: The requested product is Enhertu; the disease is HER2-positive and locally advanced or metastatic gastric or gastroesophageal junction cancer; and the member has received a prior trastuzumab-based regimen.
    • First-line metastatic trastuzumab regimen: The disease is HER2-positive and metastatic; the member has not received prior treatment for metastatic disease; and trastuzumab will be used in combination with 5-fluorouracil or with cisplatin and capecitabine.

    Indications other than breast cancer, gastric cancer, or gastroesophageal junction cancer are not automatically covered under this policy and require individual assessment. Submissions for these indications should include supporting evidence from Medicare-approved compendia.

    For the specified advanced, recurrent, or metastatic breast cancer pathway involving trastuzumab in combination with chemotherapy, coverage is not available when the disease is characterized by bone or soft-tissue involvement only or by asymptomatic visceral disease.

    Initial Authorization Requirements

    Initial Authorization

    Initial authorization requires that the requested product and clinical circumstances match an applicable covered disease-specific pathway.

    Applicable product and disease criteria: The requested product, cancer diagnosis, HER2 status, disease stage or setting, prior therapy, treatment intent, and combination regimen must match one of the covered breast cancer, gastric cancer, or gastroesophageal junction cancer criteria pathways in this policy.

    Breast cancer has nine approval pathways; gastric or gastroesophageal junction cancer has two approval pathways.

    Authorization and Documentation Requirements

    Prior Authorization

    Obtain prior authorization for covered uses

    Prior authorization is required for the listed products and covered indications. Authorization may be granted for 12 months when the applicable approval criteria are satisfied and all approval criteria and absence of exclusions are established.

    Documentation Required

    Maintain complete clinical records

    Maintain medical records identifying the condition being treated, disease staging when applicable, prior therapy, and the patient's response to prior therapy.

    Documentation Required

    Keep the ordering physician's order

    Policy Background

    This policy addresses HER2-directed antibody and antibody-drug conjugate therapies—including trastuzumab biologics and Enhertu—for breast, gastric, and gastroesophageal junction cancers. Coverage depends on the member’s HER2 status, disease stage or treatment setting, prior therapy, and whether the requested product is used as a single agent or in a specified combination regimen. Enhertu includes additional pathways for HER2-low breast cancer and for previously treated HER2-positive gastric or gastroesophageal junction cancer.

    Biomarker Definitions

    HER2-low
    DefinitionBreast cancer with an immunohistochemistry score of IHC 1+ or IHC 2+ and a negative in situ hybridization (ISH) test.
    Eligible productEnhertu (fam-trastuzumab-deruxtecan-nxki).
    Clinical settingUnresectable, recurrent, or metastatic disease after prior chemotherapy.
    HER2-positive
    DefinitionHuman epidermal growth factor receptor 2 (HER2) status used as a biomarker requirement for treatment eligibility.
    Treatment contextsHER2-positive status appears in covered breast, gastric, and gastroesophageal junction cancer treatment pathways.
    Policy Summary
    PayerClover Health
    PolicyEnhertu and Trastuzumab Biologics Coverage Criteria
    Policy CodePolicy 2167-A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and submit documentation showing that the requested product, cancer diagnosis, HER2 status, disease stage, prior therapy, treatment intent, and regimen meet a covered pathway.
    SourceLink
    On This Page
    Covered Indications and CriteriaInitial Authorization RequirementsAuthorization and Documentation RequirementsPolicy BackgroundBiomarker Definitions

    When the service provider is not the referring or ordering physician, maintain a copy of the referring or ordering physician's order for the chemotherapy drug.

    Documentation Required

    Support other indications with evidence

    For indications other than breast cancer, gastric cancer, or gastroesophageal junction cancer, submit supporting evidence from Medicare-approved compendia. These indications are assessed on an individual basis.

    Denial Risk

    Confirm the indication and clinical criteria

    Coverage may not be approved when the requested use does not meet one of the enumerated cancer indications and is not supported by evidence from Medicare-approved compendia, or when the applicable disease, biomarker, stage, treatment combination, prior-therapy, or disease-status criteria are not met.

    Denial Risk

    Provide all requested documentation

    Submissions may be denied or delayed if requested medical records are unavailable, including documentation of the treated condition, staging when applicable, prior therapy, response to prior therapy, and the ordering physician's chemotherapy order when the servicing provider is different.

    Examples of qualifying settings
    Covered pathways include neoadjuvant or adjuvant treatment, advanced or metastatic disease, and first-line metastatic therapy.