Breast cancer patients have said they are “thrilled” after the health spending watchdog approved a life-extending drug for NHS use. But some patients with incurable breast cancer which has spread to another part of the body have “died waiting” for Enhertu to be made available, campaigners said.

The National Institute for Health and Care Excellence (NICE) announced that it has reversed an initial decision to reject the drug for widespread use in the NHS in England. In 2024 it said that the treatment was “not cost effective”.

But it has now said that the treatment will be made available “from today” for around 1000 women with HER2-low advanced breast cancer after a “commercial solution has now been agreed”.

The treatment has been available in Scotland for more than 2 years.

It is the first licensed targeted treatment for patients with HER2-low breast cancer that cannot be removed surgically or that has spread to other parts of the body, also known as metastatic breast cancer.

Clinical trials have found that women with breast cancer who took the drug survived for around 2 years, compared with 17.5 months for those who had chemotherapy.

Patients React 

Paula Van Santen, who was diagnosed with metastatic breast cancer in July 2022, said that the announcement has given her a “new sense of hope”.

Mother-of-three Van Santen, 51, from Banbury, said: “Today is a day I never thought I’d see. After years of waiting and hoping, there aren’t enough words to express how thrilled I am to see Enhertu finally approved for use on the NHS.

“Having access to this life-extending treatment brings a new sense of hope.

“It gives me the chance of seeing my daughter graduate from university, become a grandparent for the first time and simply be a mum to my children for longer as they continue to grow.”

Charity Breast Cancer Now hailed the announcement as “momentous”.

Claire Rowney, chief executive, said: “This is a momentous day for thousands of people who will now have access to a drug that will give them the opportunity to gain precious extra time with loved ones. More ordinary days that become extraordinary because they were there.

“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. We must now also see Wales and Northern Ireland make Enhertu available for use on the NHS for those who need more time to live.”

She added: “Since 2024 when it was first rejected for use, thousands of people have missed out on access to Enhertu and tragically many have died. We remember with deep gratitude the women who stood alongside us and fought for this very moment.”

Commercial Deal Reached 

NICE said that a commercial solution has now been agreed for Enhertu, also known as trastuzumab deruxtecan made by Daiichi Sankyo and Astra Zeneca, following changes made to its methods as part of the UK/US Pharmaceutical Pricing Agreement.

Helen Knight, director of medicines evaluation at NICE, said: “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, 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.”

Tom Keith-Roach, UK country president for AstraZeneca, said: “Today’s announcement marks a vital milestone for women in England living with HER2 low metastatic breast cancer. It brings access into line with Scotland and 26 other European countries, offering renewed hope to more than 1,000 women living with this particularly aggressive form of the disease.”