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UK NICE · UK · 17 Sep 2026 · Approval & opinion

NICE recommends Enhertu for people with HER2-low advanced breast cancer

AI-generated summary

NICE recommends Enhertu (trastuzumab deruxtecan) for routine NHS use in adults with HER2-low advanced or metastatic breast cancer whose disease has progressed after treatment, benefiting around 1,000 people. The recommendation follows a commercial agreement and changes to NICE's cost-effectiveness thresholds and quality-of-life assessment methods implemented in April and August 2026. Clinical evidence shows Enhertu extends survival and delays cancer progression compared with standard chemotherapy. Final draft guidance is available for appeal until 5 October 2026.

From UK NICE

Around 1,000 people with HER2-low advanced breast cancer can now be offered Enhertu after NICE recommended it for routine NHS use.

NICE’s final draft guidance recommends Enhertu (trastuzumab deruxtecan made by Daiichi Sankyo and Astra Zeneca) for adults with HER2-low advanced or metastatic breast cancer whose disease has progressed following treatment.

Previously, NICE’s independent committee had been unable to recommend it at the price proposed by the companies. Enhertu for this group of people remained the only breast cancer drug that NICE had been unable to recommend since 2018. In that period 25 other breast cancer treatments have received positive recommendations from NICE and been made available on the NHS.

A commercial solution has now been agreed on the use of Enhertu for this group of people following changes made to NICE methods as part of the UK/US Pharmaceutical Pricing Agreement.

Those changes involved an increase in the cost effectiveness thresholds NICE uses to establish if medicine provides value for money for the taxpayer, that came into effect in April, and a new method for assessing quality of life that was published on 27 August 2026.

Clinical trial evidence showed that Enhertu helps people with HER2-low advanced breast cancer live longer, and can also increase the time before their cancer gets worse compared with standard chemotherapy.

This recommendation was made through NICE's review process, which allows guidance to be reconsidered when new evidence or commercial arrangements become available.

The final draft guidance is now available for appeal until 5pm on 7 October 2026

Excerpt from the official page. The original is authoritative.