When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.
This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.
When FDA-approved diagnostic tests do not reveal HER2 protein overexpression, for the indication of breast cancer, Emtansine (Kadcyla®) is considered not medically necessary and, therefore, not covered because the available published peer-reviewed literature does not support its use in the treatment of those diseases.
The individual's medical record must reflect the medical necessity for the care provided. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.
The Company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial for the drug.
Markman, M. Breast Cancer and HER2 Overview of HER2 Breast Cancer. 03/14/2019. Available at: http://emedicine.medscape.com/article/1689966-overview. Accessed April 23, 2019.
Micromedex® Healthcare Series [Internet database]. DRUGDEX® Evaluations.. ado-trastuzumab emtansine. 02/28/2019. Available at: http://www.micromedexsolutions.com/micromedex2/librarian. [via subscription only]. Accessed April 23, 2019.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Breast Cancer.V.1.2019. [NCCN Web site]. 03/14/2019. Available at: https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf
[via free subscription]. Accessed April 23, 2019.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Non-Small Cell Lung Cancer.V.3.2019. [NCCN Web site]. 01/18/2019. Available at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf [via free subscription]. Accessed April 23, 2019.
National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. ado-trastuzumab emtansine. [NCCN Web site]. 2019. Available at: http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=399 [via subscription only].Accessed April 23, 2019.
Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER2/neu oncogene. Science.1987;235(4785):177-182.
Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344(11):783-792.
US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Kadcyla (ado-trastuzumab emtansine). Approval letter. [FDA Web site]. 02/22/13. Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s000Approv.pdf. Accessed April 23, 2019.
US Food and Drug Administration. Center for Drug Evaluation and Research. Kadcyla (ado-trastuzumab emtansine) Package labeling. 12/2018. Available at:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm . Accessed April 23, 2019.
Verma S, Miles D, Gianni L, et al; EMILIA Study Group. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783-91.
Wolff AC, Hammond MEH, Hicks DG, et al. Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update. J Clin Oncol.2013;31(31):3997-4013.
Policy: 08.00.15f:Off-label Coverage for Prescription Drugs and/or Biologics
Policy: 08.00.33o:Trastuzumab (Herceptin®) and Related Biosimilars, Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta)
Policy: 08.00.90k:Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)/(Abraxane® for Injectable Suspension)
Policy: 08.01.07f:Pertuzumab (Perjeta®)