NICE finally backs Enhertu for HER2-low breast cancer

Around 1,000 patients in England with a form of incurable breast cancer will be able to get access to AstraZeneca and Daiichi Sankyo's life-extending drug, Enhertu, via the NHS from today.

Final draft guidance from reimbursement authority NICE recommends Enhertu (trastuzumab deruxtecan) for adults with HER2-low advanced or metastatic breast cancer whose disease has progressed following prior treatment.

The decision comes two years after NICE rejected Enhertu for advanced HER2-low breast cancer, on the grounds that it was too expensive to be cost-effective, and follows the changes to the agency's standard cost-effectiveness threshold for appraising new medicines, which was introduced alongside the UK-US trade deal announced last December and came into effect in April.

NICE said the recommendation was also facilitated by a new method for assessing quality of life, the EQ-5D-5L value set, which came into effect in August. In general, treatments that extend how long people live tend to become more cost-effective under the new value set, while those that improve quality of life without extending it tend to become less cost-effective.

Clinical trial evidence showed that Enhertu helps people with HER2-low advanced breast cancer live longer – extending overall survival by around seven months – and can also increase the time before their cancer gets worse compared with standard chemotherapy.

Women in Scotland with this type of breast cancer have had access to Enhertu since 2023, and it is also available in most other European countries.

In the intervening period, patient advocacy groups, celebrities, and some MPs have waged a campaign to equalise access to the drug across the UK, and NICE's decision has been hailed as "momentous" by Claire Rowney, chief executive of Breast Cancer Now.

"This milestone victory belongs to every person who refused to accept that access to a life-extending treatment was out of reach. For people in England, the wait for Enhertu is finally over," she said.

"But we can't celebrate this momentous decision without remembering the devastating cost of this delay. Since 2024, when it was first rejected for use, thousands of people have missed out on access to Enhertu and tragically many have died," added Rowney.

"We are calling on the government, NICE, NHS England, and the pharmaceutical industry to work together to fix this broken system, so that people with incurable metastatic breast cancer are not forced to spend precious months and years campaigning for treatments that could give them more time."

There are now calls for Wales and Northern Ireland – which often implement NICE decisions – to quickly follow suit. Funding for Enhertu will be provided from today under the Cancer Drugs Fund, ahead of a move to routine NHS commissioning within 90 days.

AZ's UK president, Tom Keith-Roach, said the new guidance brings England into line with Scotland and 26 other European countries.

He added: "Delivering faster, more equitable patient access in the future requires continued strong collaboration across the healthcare system, building on recent changes which improve how the UK values new medicines relative to other countries."

Photo by Sasun Bughdaryan on Unsplash