Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.31
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCDPHP Herceptin Coverage Prior Auth | OpenPayer
    Ask Trek AI about this page
    CurrentCDPHPPolicy N/A

    Medicaid Coverage Policy for Herceptin (trastuzumab) Injection

    Customize your policy alerts

    Sign up for all cdphp policy alerts

    Know when cdphp releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    This policy governs Medicaid coverage and prior authorization for Herceptin (trastuzumab) injection for specified HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma indications. Trazimera and Kanjinti are preferred unless adequate medical justification supports use of Herceptin.

    Policy Summary
    PayerCDPHP
    PolicyMedicaid Coverage Policy for Herceptin (trastuzumab) Injection
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and use Trazimera and Kanjinti unless adequate medical justification supports use of Herceptin.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2Preferred trastuzumab biosimilars
    150 mg/vialAvailable Herceptin strength
    J9355HCPCS code
    1Prior authorization required

    Covered Indications

    Adjuvant HER2-overexpressing breast cancer

    Covered when both the disease features and one of the specified adjuvant treatment regimens apply.

    Adjuvant breast cancer criteria

    • HER2-overexpressing node-positive or node-negative (ER/PR negative or with one high-risk feature) breast cancer

    • ONE of the following regimens

      • Treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
      • Treatment with docetaxel and carboplatin
      • Single-agent treatment following multi-modality anthracycline-based therapy
    Policy Summary
    PayerCDPHP
    PolicyMedicaid Coverage Policy for Herceptin (trastuzumab) Injection
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionObtain prior authorization and use Trazimera and Kanjinti unless adequate medical justification supports use of Herceptin.
    SourceLink
    On This Page
    Covered IndicationsDiagnosis, Availability, and Billing CodesAuthorization and Documentation RequirementsClinical BackgroundClinical DefinitionsInitial Therapy AuthorizationPreferred Biosimilar SequenceHerceptin Biosimilar Requirements

    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.

    Metastatic HER2-overexpressing breast cancer

    Covered when all of the following treatment criteria are met:

    Metastatic breast cancer treatment

    • HER2-overexpressing breast cancer
    • Treatment is provided as a single agent
    • The patient has received one or more chemotherapy regimens for metastatic disease

    Metastatic gastric or gastroesophageal junction adenocarcinoma

    Covered when all of the following treatment criteria are met:

    Metastatic gastric or gastroesophageal junction adenocarcinoma treatment

    • HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
    • Treatment is provided in combination with cisplatin and capecitabine or 5-fluorouracil
    • The patient has not received prior treatment for metastatic disease

    Diagnosis, Availability, and Billing Codes

    ICD10 Diagnosis CodesICD-10Covered
    C50.011-C50.019ICD10 diagnosis code range listed in the policy
    C50.111-C50-119ICD10 diagnosis code range listed in the policy
    C50.211ICD10 diagnosis code listed in the policy
    C50.219ICD10 diagnosis code listed in the policy
    C50.311-C50.319ICD10 diagnosis code range listed in the policy
    C50.411-C50.419ICD10 diagnosis code range listed in the policy
    C50.511-C50.519ICD10 diagnosis code range listed in the policy
    C50-611-C50.619ICD10 diagnosis code range listed in the policy
    C50.811-C50.819ICD10 diagnosis code range listed in the policy
    C50.911-C50.919ICD10 diagnosis code range listed in the policy
    1–10 of 18
    1/2
    AvailabilityNDC
    NDC 50242-132-01Herceptin 150 mg/vial, one single-dose vial
    NDC 50242-132-10Herceptin 150 mg/vial, carton containing 10 single-dose vials
    HCSPCS CodeHCPCSCovered
    J9355Herceptin (trastuzumab) injection HCPCS code

    Authorization and Documentation Requirements

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required before coverage of Herceptin (trastuzumab) injection.

    • Applies to Herceptin (trastuzumab) injection, including vials (NDC 50242-132-10; HCPCS J9355).
    Step Therapy

    Preferred Trastuzumab Biosimilars Required

    Trazimera and Kanjinti are required for all FDA-approved and compendia-supported indications for Herceptin unless there is adequate medical justification for not using the preferred biosimilars.

    • Preferred trastuzumab biosimilars: Trazimera and Kanjinti.
    • Requirement applies to all FDA-approved and compendia-supported indications.
    Documentation Required

    Document Biosimilar Exception

    When Trazimera or Kanjinti cannot be used, submit adequate medical justification explaining why. Adequate medical justification is required for both preferred formulations.

    • Document the clinical rationale for not using Trazimera.
    • Document the clinical rationale for not using Kanjinti.
    • Ensure the justification supports the requested Herceptin treatment.
    Denial Risk

    Denial Risk When Preferred Biosimilars Are Not Used

    Failure to use Trazimera or Kanjinti without adequate medical justification may result in denial of coverage for Herceptin (trastuzumab) injection.

    • Provide adequate medical justification whenever a preferred biosimilar is not used.
    • Requests without sufficient justification are at risk for denial.

    Clinical Background

    Herceptin (trastuzumab) is used to treat HER2-overexpressing malignancies. This policy addresses coverage for adjuvant and metastatic breast cancer, as well as metastatic gastric or gastroesophageal junction adenocarcinoma. Treatment regimens vary by disease setting and may include combination therapy or single-agent treatment.

    Clinical Definitions

    HER2-overexpressing breast cancer
    TermHER2-overexpressing breast cancer
    DefinitionBreast cancer with overexpression of human epidermal growth factor receptor 2.
    Policy applicationThe policy applies this definition to specified adjuvant and metastatic breast cancer treatment indications.
    ER/PR negative or one high-risk feature
    Hormone receptor featureEstrogen receptor/progesterone receptor (ER/PR) negative disease.
    Alternative featureDisease with one high-risk feature.
    Qualifying disease settingThe requirement applies to node-positive or node-negative HER2-overexpressing breast cancer in the policy’s adjuvant treatment criteria.

    Initial Therapy Authorization

    Initial therapy authorization

    Initial coverage requires all of the following:

    • Prior authorization is obtained for Herceptin (trastuzumab) injection
    • The requested treatment is an FDA-approved or compendia-supported indication for Herceptin
    • Trazimera and Kanjinti are used as the preferred trastuzumab formulations

      If Trazimera and Kanjinti cannot be used, submit adequate medical justification explaining why each preferred formulation cannot be used.

    Preferred Biosimilar Sequence

    StepPreferred therapyException pathwayCoverage
    Step 1Use Trazimera and Kanjinti for all FDA-approved and compendia-supported indications for Herceptin.Herceptin may be used when adequate medical justification explains why Trazimera and Kanjinti cannot be used. Justification is required for both preferred formulations.Required

    Herceptin Biosimilar Requirements

    Billing Rule

    Trazimera required for Herceptin indications

    Trazimera is required for all FDA-approved and compendia-supported indications for Herceptin unless adequate medical justification explains why Trazimera cannot be used.

    Billing Rule

    Kanjinti required for Herceptin indications

    Kanjinti is required for all FDA-approved and compendia-supported indications for Herceptin unless adequate medical justification explains why Kanjinti cannot be used.