Description
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.
Criteria
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 (HER2) protein over expression must be verified by ANY ONE of the following FDA approved diagnostic tests:
- An immunohistochemical (IHC) assay with a result of 3+ (positive); or
- A positive fluorescence in situ hybridization (FISH) test (ratio greater than 2.2); or
- In situ hybridization (ISH) positive by ANY of the following:
- Single-probe in situ hybridization (ISH) test with average HER2 copy number greater than or equal to 6.0 signals/cell; or
- Dual-probe ISH test: HER2/CEP17 (chromosome enumeration probe 17) ratio greater than or equal to 2.0; or
- HER2/CEP17 ratio less than 2.0 and average HER2 copy number greater than or equal to 6.0 signals/cell.
Ado-trastuzumab emtansine (Kadcyla) may be considered medically necessary for individuals 18 years of age and older for the following:
Breast Cancer
- As single agent therapy for treatment of HER2-positive metastatic breast cancer:
- In individuals who previously received trastuzumab and a taxane, separately or in combination; and
- Individual has received prior therapy for metastatic disease or developed disease recurrence during or within six months of completed adjuvant therapy; or
- As single agent adjuvant therapy for treatment of HER2-positive early breast cancer in individuals who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment; or
Compendia Sources
- Ado-trastuzumab emtansine (Kadcyla)may be considered medically necessary for treatment of any of the current category 1 or 2A NCCN recommendations.
The use of ado-trastuzumab emtansine (Kadcyla) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
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