NICE’s final draft guidance recommends trastuzumab deruxtecan for adults with HER2-low advanced or metastatic breast cancer whose disease has progressed following treatment.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. Trastuzumab deruxtecan 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 trastuzumab deruxtecan 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. 

Helen Knight, director of medicines evaluation at NICE says, 'I'm pleased that a commercial solution, alongside recent changes to NICE's cost-effectiveness thresholds and the use of new methods for assessing quality-of-life, has meant this treatment can now be provided on the NHS. 

However, we know this decision comes too late for many families, and our thoughts are with them today. Our role is important in ensuring NHS spending on new medicines reflects the benefits they deliver while protecting valuable health resources for other essential patient services.'

Dr Anne Rigg, consultant medical oncologist and NHS England’s national specialty adviser for chemotherapy comments, 'This is hugely positive news for women with secondary breast cancer who will now be offered this life-extending treatment on the NHS, giving them the opportunity for more time with their loved ones.

We know how important this will be for women and families affected, and we have shared their determination to find a way to make Enhertu available to everyone who could benefit, so we’re very pleased that a commercial solution has now been agreed with the drug companies which means women can access it from today.'

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

Source: NICE