Ado-trastuzumab emtansine (Kadcyla®) is a human epidermal growth factor receptor 2 (HER2) targeted antibody-drug conjugate comprised of trastuzumab and emtansine. Ado-trastuzumab emtansine (Kadcyla) is an antagonist of HER2 that is intended as treatment for individuals with HER2-overexpressing cancer.
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Human epidermal growth factor receptor 2 (HER’s-2) protein over expression must be verified by ANY ONE of the following FDA approved diagnostic tests:
Ado-trastuzumab emtansine (Kadcyla) may be considered medically necessary for adult individuals for the following indications:
Food and Drug Administration (FDA) Indications:
National Comprehensive Cancer Network (NCCN) Recommendations:
Non-Small Cell Lung Cancer
The use of ado-trastuzumab emtansine (Kadcyla) is considered experimental/investigational in all other situations, and therefore non-covered. There is insufficient evidence in the peer reviewed published literature regarding its effectiveness and safety.
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. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.