managed access agreements
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AstraZeneca/Daiichi Sankyo’s Enhertu has been recommended by NICE for advanced breast cancer within a managed access agreement


AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended by the National Institute for Health and Care Excellence (NICE) for the treatment of HER2-positive unresectable or metastatic breast cancer after at least one anti-HER2 therapy, within a managed access agreement.

This recommendation was given following the results of the phase 3 DESTINY-Breast03 trial, in which the study demonstrated a clinically meaningful improvement in overall survival with the use of Enhertu compared to the standard of care trastuzumab emtansine, a finding that was consistent across analysed subgroups such as patients with or without brain metastases. This was demonstrated in patients that had previously been treated with trastuzumab and a taxane.

However, as the trial is yet ongoing, NICE determined that there was not enough evidence demonstrating how much longer patients live with the use of Enhertu. As such, due to the uncertain nature of Enhurtu’s cost-effectiveness, the drug has not been recommended for routine use in the NHS.

Instead, Enhertu has been recommended for use within a managed access agreement, allowing patients to have the treatment whilst more evidence of the drug’s effectiveness is generated. NICE will then use this data to inform their recommendation on regular NHS usage.

Breast cancer globally is a leading cause of cancer-related death, with upwards of two million cases diagnosed in 2020, and one in five patients with breast cancer are HER2-positive. Peter Clark, NHS England Cancer Drugs Fund clinical lead professor, stated: This cutting-edge drug will give hundreds of patients with secondary incurable breast cancer hope, increasing the amount of time people have before their cancer gets worse, and allowing them to live normal healthy lives for longer”.

Definition: Managed Access Agreements (MAAs) are agreements between NHS England and manufacturers to enable a drug to become available for a limited time period at a discounted price. This allows patients to access the drug whilst further evidence is gathered on its real-world effectiveness


AstraZeneca/Daiichi Sankyo’s Enhertu recommended by NICE for advanced breast cancer. PMLive. . Accessed January 4th 2023.

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