Fam-trastuzumab Deruxtecan-nxki (Enhertu) - Medical Clinical Policy Bulletins

Fam-trastuzumab deruxtecan-nxki (Enhertu) is covered for the treatment of various HER2-positive cancers, including breast, cervical, biliary tract, and gastric cancers, provided they are recurrent, metastatic, or unresectable, and have not responded to prior therapies. Key requirements include the use of the medication as a single agent and the submission of a Statement of Medical Necessity for precertification. Important limitations apply to specific cancer types and classifications, such as HER2-low and HER2-ultralow statuses, which must meet defined criteria for coverage.

"Medically necessary for treatment of HER2-positive breast cancer when the disease is recurrent, metastatic, or unresectable, and there has been no response to preoperative systemic therapy."

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