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NICE Recommends Enhertu for Advanced HER2-Positive Breast Cancer Through Cancer Drugs Fund

This article has been update from a previous version to correct a monetary conversion for the price of trastuzumab deruxtecan.

NEW YORK -- The UK's National Institute for Healthcare Excellence (NICE) on Tuesday recommended that the National Health Service provide trastuzumab deruxtecan (Daiichi Sankyo/ AstraZeneca's Enhertu) as a treatment for previously treated, advanced HER2-positive metastatic breast cancer through the Cancer Drugs Fund (CDF).

In a draft guidance, NICE specifically recommended the use of trastuzumab deruxtecan for patients with unresectable or metastatic breast cancer who have received at least two prior HER2-directed therapies. The positive recommendation, according to NICE, is rooted in the limited treatment options available for this patient population; currently, after two lines of HER2-directed therapy, the standard treatment is chemotherapy.

While there are currently no data directly comparing trastuzumab deruxtecan to chemotherapy in this treatment setting, NICE said that it plans to evaluate data from ongoing trials and from within the NHS to address this uncertainty and come to a conclusion about the agent's clinical- and cost-effectiveness.

The list price for trastuzumab deruxtecan is £1,455 (about $2,000) per vial and roughly £118,000 (about $164,000) for a course of treatment. Daiichi Sankyo and AstraZeneca have an arrangement that makes trastuzumab deruxtecan available to the NHS at a discount, though the discounted amount remains confidential.

The US Food and Drug Administration granted accelerated approval to the agent for the same indication in December 2019 based on results from the Phase II DESTINY-Breast01 trial in which 60 percent of 184 patients treated with trastuzumab deruxtecan saw their tumors shrink. The Japanese Ministry of Health, Labor, and Welfare approved the drug in Japan for the same indication in March 2020. In December 2021, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the agent's use in the same population in the EU.

NICE expects to file final draft guidance in May 2021. In the meantime, funding for trastuzumab deruxtecan is available in the UK.