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.
Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Trastuzumab emtansine. (T-DM1). TEC Specialty Pharmacy Reports 2013; #03-2013.
Breastcancer.org WebSite. HER2 status. 03/2015. Available at: http://www.breastcancer.org/symptoms/diagnosis/her2#. Accessed August 29, 2017.
Carlson B. New automated HER2 test promises faster, more accurate testing. Biotechnol Healthc. 2011;8(4): 32–33.
Elsevier Gold Standard’s Clinical Pharmacology Compendium. ado-trastuzumab emtansine (Kadcyla). 05/23/16. Available at: https://www.clinicalkey.com/#!/ [via subscription only]. Accessed August 29, 2017.
Genentech. Kadcyla (ado-trastuzumab emtansine), injection for intravenous use. Package labeling. 07/2016. Available at: http://www.gene.com/download/pdf/kadcyla_prescribing.pdf . Accessed August 23, 2017.
Giordano SH, Temin S, Kirshner JJ, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol.2014;32(19):2078-99.
Hammond MEH, Hayes DF, Dowsett M, et al. ASCO-CAP Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer. J Clin Oncol. 2010;28(16):2784-2795.
Harris L, Fritsche H, Mennel R, et al. American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer. J Clin Oncol. 2007;25(33):5287-5312.
Lexi-Drugs Compendium. ado-trastuzumab emtansine (Kadcyla). 08/23/17. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/4177902. Accessed August 29, 2017.
Markman, M. Breast Cancer and HER2 Overview of HER2 Breast Cancer. 08/08/2017. Available at: http://emedicine.medscape.com/article/1689966-overview. Accessed August 28, 2017.
Micromedex® 2.0. DrugDex® Evaluations.[Micromedex Web site]. ado-trastuzumab emtansine. 06/13/2017. Available at: http://www.micromedexsolutions.com/micromedex2/librarian. [via subscription only]. Accessed August 29, 2017.
National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology - Breast Cancer.V.2.2017. [NCCN Web site]. 04/06/2017. Available at: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf [via free subscription]. Accessed August 23, 2017.
National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. ado-trastuzumab emtansine. [NCCN Web site]. 2017. Available at: http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=399 [via subscription only]. Accessed August 23, 2017.
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 August 30, 2017.
US Food and Drug Administration. Center for Drug Evaluation and Research. Kadcyla (ado-trastuzumab emtansine) Package labeling. 07/2016. Available at:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm . Accessed August 22, 2017.
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: 08.00.15d:Off-label Coverage for Prescription Drugs and/or Biologics
Policy: 08.00.33l:Trastuzumab (Herceptin®) and Related Biosimilars
Policy: 08.00.90i:Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) / (Abraxane® for Injectable Suspension)
Policy: 08.01.07e:Pertuzumab (Perjeta®)