The use of ado-trastuzumab emtansine may be considered medically necessary in individuals with:
Human epidermal growth factor receptor 2-positive (HER2), metastatic breast cancer who have received prior HER2-targeted therapy (e.g., trastuzumab or trastuzumab with a taxane) OR who developed disease recurrence during or within 6 months of completing adjuvant therapy.
Or
Human epidermal growth factor receptor 2-positive, early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.
The use of ado-trastuzumab emtansine is investigational in all other situations, including but not limited to previously untreated progressive or recurrent locally advanced breast cancer, earlier stages of breast cancer, combination treatment with different agents, and treatment of gastric cancer.
