Enhertu®

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.

Background

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.

Questions?

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