Fam-trastuzumab deruxtecan-nxki (Enhertu®) is a human epidermal growth factor-2 (HER2)-directed antibody and topoisomerase inhibitor conjugate. Once bound to the HER2 receptor on tumor cells, fam-trastuzumab deruxtecan (Enhertu) undergoes internalization and cleavage of the tetrapeptide-based linker by lysosomal enzymes. Once released from the antibody-drug conjugate, deruxtecan causes DNA damage and apoptosis.
The use of fam-trastuzumab deruxtecan (Enhertu) may be considered medically when the presence of the HER2-overexpression is confirmed by the following:
HER2-overexpression must be verified by ANY ONE of the following FDA approved diagnostic tests:
Confirmatory tests should be performed for borderline results as follows:
The use of fam-trastuzumab deruxtecan (Enhertu) may be considered medically necessary in individuals 18 years of age and older when the following criteria are met:
Breast Cancer
Gastric or Gastroesophageal Junction Adenocarcinoma
HER2-Positive Unresectable or Metastatic Solid Tumors
Non-Small Cell Lung Cancer (NSCLC)
Compendia Sources
Fam-trastuzumab deruxtecan (Enhertu) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of fam-trastuzumab deruxtecan (Enhertu) for any other indication than listed above is considered not medically necessary.
J9358 |
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Note: Do not substitute fam-trastuzumab deruxtecan-nxki (Enhertu) for or with trastuzumab (Herceptin), trastuzumab biosimilars, or ado-trastuzumab emtansine (Kadcyla).
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
Refer to Medical Policy I-21, Trastuzumab (Herceptin), Trastuzumab Biosimilars, and Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta), for additional information.
Refer to Medical Policy I-249 Pennsylvania Cancer Treatment Mandate for additional information.
C06.9 |
C07 |
C08.0 |
C08.1 |
C08.9 |
C15.3 |
C15.4 |
C15.5 |
C15.8 |
C15.9 |
C15.9 |
C16.0 |
C16.1 |
C16.2 |
C16.3 |
C16.4 |
C16.5 |
C16.6 |
C16.8 |
C16.9 |
C18.0 |
C18.1 |
C18.2 |
C18.3 |
C18.4 |
C18.5 |
C18.6 |
C18.7 |
C18.8 |
C18.9 |
C19 |
C20 |
C21.8 |
C33 |
C34.00 |
C34.01 |
C34.02 |
C34.10 |
C34.11 |
C34.12 |
C34.2 |
C34.30 |
C34.31 |
C34.32 |
C34.80 |
C34.81 |
C34.82 |
C34.90 |
C34.91 |
C34.92 |
C48.1 |
C48.2 |
C48.8 |
C50.011 |
C50.012 |
C50.019 |
C50.021 |
C50.022 |
C50.029 |
C50.111 |
C50.112 |
C50.119 |
C50.121 |
C50.122 |
C50.129 |
C50.211 |
C50.212 |
C50.219 |
C50.221 |
C50.222 |
C50.229 |
C50.311 |
C50.312 |
C50.319 |
C50.321 |
C50.322 |
C50.329 |
C50.411 |
C50.412 |
C50.419 |
C50.421 |
C50.422 |
C50.429 |
C50.511 |
C50.512 |
C50.519 |
C50.521 |
C50.522 |
C50.529 |
C50.611 |
C50.612 |
C50.619 |
C50.621 |
C50.622 |
C50.629 |
C50.811 |
C50.812 |
C50.819 |
C50.821 |
C50.822 |
C50.829 |
C50.911 |
C50.912 |
C50.919 |
C50.921 |
C50.922 |
C50.929 |
C53.0 |
C53.1 |
C53.8 |
C53.9 |
C54.0 |
C54.1 |
C54.2 |
C54.3 |
C54.8 |
C54.9 |
C55 |
C56.1 |
C56.2 |
C56.3 |
C56.9 |
C57.00 |
C57.01 |
C57.02 |
C57.10 |
C57.11 |
C57.12 |
C57.20 |
C57.21 |
C57.22 |
C57.3 |
C57.4 |
C57.7 |
C57.8 |
C57.9 |
C78.00 |
C78.01 |
C78.02 |
C78.6 |
C78.7 |
C79.31 |
D37.1 |
D37.8 |
D37.9 |
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This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you need these services, contact the Civil Rights Coordinator.
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.
This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association. Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania. Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York]. All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.
Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.
Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:
If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.
You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:
U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)
Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.