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New HTA Decisions in England
May 2021
Drug name
ENHERTU® (trastuzumab deruxtecan)
Decision date
Therapeutic area
Therapeutic sub area
Breast cancer
Recommended (CDF)
Trastuzumab deruxtecan is recommended for use within the Cancer Drugs Fund as an option for treating HER2‑positive unresectable or metastatic breast cancer in adults after 2 or more anti‑HER2 therapies.
Decision Detail
It is recommended only if the conditions in the managed access agreement are followed. The company has a commercial arrangement, this makes trastuzumab deruxtecan available to the NHS with a discount.
Clinical trial evidence is limited and was based on DESTINY-Breast01, a single-arm trial for people with HER2 positive unresectable or metastatic breast cancer previously treated with trastuzumab emtansine. Indirect comparisons of trastuzumab deruxtecan with chemotherapy suggest that it may increase survival and progression-free survival. However, how much longer people live is uncertain because there are differences between trials included in the indirect comparisons, and the final data from the trial of trastuzumab deruxtecan on its own is not available yet. Because of this, the estimates of cost effectiveness are very uncertain and trastuzumab deruxtecan cannot be recommended for routine use in the NHS. Trastuzumab deruxtecan could be cost effective if further data shows that people live longer with treatment. Another ongoing trial is directly comparing trastuzumab deruxtecan with anti-HER2 therapies plus chemotherapy. Data from the trials of trastuzumab deruxtecan and from NHS practice would help address the uncertainty about clinical effectiveness. Trastuzumab deruxtecan is therefore recommended for use in the Cancer Drugs Fund.