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:
Food and Drug Administration (FDA) Indications
- 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
National Comprehensive Cancer Network (NCCN) Recommendations
- As adjuvant systemic therapy for individuals with HER2-positive invasive breast cancer and locally advanced clinical stage T2 or greater, M0 or N1 or greater, M0 disease following completion of planned chemotherapy and following mastectomy or lumpectomy with surgical axillary staging if EITHER of the following:
- ypT1-4N0 or residual disease; or
- ypN is 1 or greater or node positive.
- As single agent therapy for recurrent or stage IV HER2-positive invasive breast cancer for either hormone receptor negative or hormone receptor positive disease; or
Non-Small Cell Lung Cancer
- In individuals for the treatment of non-small cell lung cancer (NSCLC) with HER2-positive mutations; or
Salivary Gland Cancer
- As a single agent for HER2-positive recurrent disease with:
- distant metastases in patients with a performance status of 0-3; or
- unresectable locoregional recurrence or second primary with prior radiation therapy.
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.