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Ado-Trastuzumab Emtansine (Trastuzumab-DM1) for Treatment of HER2-Positive Malignancies

The use of ado-trastuzumab emtansine may be considered medically necessary when the patient has:Human epidermal growth factor receptor 2-positive, metastatic breast cancer who has received prior therapy with 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 has 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.

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