The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Enhertu (made by Daiichi Sankyo and AstraZeneca).
The recommendation means around 1,000 people with HER2-low advanced or metastatic breast cancer whose disease has progressed following treatment, can now be offered the treatment which is available on the NHS.
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.
The final draft guidance is now available for appeal until 5pm on 7 October 2026.
Dr Anne Rigg, consultant medical oncologist and NHS England’s national specialty adviser for chemotherapy said: “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.”
