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:
Food and Drug Administration (FDA) Indications
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
National Comprehensive Cancer Network (NCCN) Recommendations
Breast Cancer
- 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
Central Nervous System Cancer- Limited Brain Metastases
- As a single-agent treatment for limited brain metastases in individuals with HER2 positive breast cancer with ANY of the following:
- As initial treatment in select patients (e.g., patients with small asymptomatic brain metastases); or
- Recurrent brain metastases; or
- Relapsed disease with either stable systemic disease or reasonable systemic treatment options; or
Central Nervous System Cancer- Extensive Brain Metastases
- Single agent treatment for extensive brain metastases in patients with HER2 positive breast cancer with EITHER of the following:
- As primary treatment in select patients (eg, patients with small asymptomatic brain metastases); or
- Recurrent disease with stable systemic disease or reasonable systemic treatment options; or
Head and Neck Cancers - Salivary Gland Tumors
- As systemic therapy in combination with trastuzumab for recurrent HER2 in certain circumstances which include EITHER of the following:
- Distant metastases in patients with a performance status (PS) of 0-3; or
- Unresectable locoregional recurrence or second primary with prior radiation therapy; or
Non-Small Cell Lung Cancer
- In individuals for the treatment of non-small cell lung cancer (NSCLC) with HER2-positive mutations; or
The use of ado-trastuzumab emtansine (Kadcyla) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature
Procedure Codes
