Criteria
Coverage is subject to the specific terms of the member's benefit plan.
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, 2A, or 2B 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.
Procedure Code
