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Drug - Enhertu® (fam-trastuzumab deruxtecan-nxki) [Daiichi Sankyo Inc.]

April 2020

Therapeutic area - Oncology

Initial approval criteria

  • Patient is at least 18 years old AND
  • Patient has a diagnosis of unresectable or metastatic breast cancer AND
  • Patient’s disease is human epidermal growth factor receptor 2 (HER2)-positive AND
  • Patient was previously treated with ado-trastuzumab emtansine and at least one other anti-HER2-based regimens (i.e., trastuzumab, pertuzumab, lapatinib, etc.) for metastatic disease AND
  • Patient does not have pre-existing interstitial lung disease (ILD) or pneumonitis AND
  • Enhertu will be used as single agent therapy AND
  • Female patient of child-bearing age must have a confirmed negative pregnancy test prior to therapy AND
  • Patient will use an effective form of contraception (i.e., females of reproductive potential should use effective contraception during treatment and for at least 7 months following the last dose and male patients with female partners of reproductive potential should use effective contraception during treatment and for at least 4 months after the last dose) AND
  • Baseline left ventricular ejection fraction (LVEF) is within normal limits and provided at time of request AND
  • Therapy will not be substituted with or for trastuzumab or ado-trastuzumab emtansine

Renewal criteria

  • Patient continues to meet initial approval criteria AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: left ventricular dysfunction, pulmonary toxicity (i.e., pneumonitis), neutropenia/febrile neutropenia, etc. AND
  • Left ventricular ejection fraction (LVEF) is >45%; OR LVEF is ≥40% and absolute decrease is <10% from baseline (results must be less than 3 months old)

Quantity limits

  • 600 mg (six 100mg single-dose vials) every 21 days

Billing for Enhertu

Enhertu must be billed as a medical claim.


Enhertu is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Do not substitute Enhertu for or with trastuzumab or ado-trastuzumab emtansine.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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