A leading UK charity is ‘sounding the alarm’ that thousands of people with incurable secondary breast cancer in England, Wales and Northern Ireland face being denied treatments that would keep them alive, unless urgent changes are made to the system that decides whether drugs are approved for use on the NHS.
In its new report ‘Setting the bar too high: How the NICE severity modifier is blocking access to life-extending treatments’, published today [Wed 2 July 2025], Breast Cancer Now sets out that an unfair system is failing cancer patients and tragically cutting thousands of lives short.
The report follows the charity’s #EnhertuEmergency campaign, launched in response to the devastating news that groundbreaking treatment, Enhertu, had been rejected for use on the NHS in England, Wales and Northern Ireland for people with HER2-low secondary breast cancer - despite it offering people the hope of six months more to live.[1]
The charity’s report reveals how under the severity modifier (introduced by NICE in 2022) more people with incurable secondary breast cancer, who may only have months left to live, could be told their condition does not qualify for the most severe rating - as happened with Enhertu.[2] The devastating consequence of this is that less money can be spent on their treatments than before, and some could be denied access to the new cutting-edge medicines that are meanwhile made available to patients in multiple other countries.
The charity also warns that this adds to the real risk that pharmaceutical companies will be deterred from taking treatments through the process for approval for use on the NHS in England if they are unlikely to be approved at a price they will accept. This frightening situation has already played out, with other appraisals being suspended or terminated.[3]
Breast Cancer Now argues that the bar for ‘a very severe condition’ was set too high and without evidence, as a move to ensure the new model remained ‘opportunity-cost neutral’ and to stop budgets rising.[4] The unacceptable consequence of this approach is that end of life cancer treatments are being pitted against treatments for other severe conditions, such as cystic fibrosis, for priority.
Breast Cancer Now is calling for immediate action to guarantee secondary breast cancer patients get access to the drugs they need and deserve that could help them live longer. The charity is calling on Wes Streeting, Secretary of State for Health and Social Care, to urgently scrap ‘opportunity-cost neutral’ restraints and for NICE to lower the bar for what it defines as a severe condition.
The charity is also urging people to join their ‘More Time to Live’ campaign and ask their MP to write to the Health Secretary demanding urgent action to change the system: https://action.breastcancernow.org/email-your-mp-give-people-secondary-breast-cancer-more-time-live
Claire Rowney, chief executive at Breast Cancer Now, said:
“The terrifying reality is that unless urgent action is taken thousands of women in the UK with incurable secondary breast cancer could be denied access to vital life-extending treatments because of an unfair system.
“We’re talking about patients missing out on access to cutting-edge, effective treatments that could give them more time to be there for special moments such as birthdays or seeing their children or grandchildren start school. Treatments, such as Enhertu, that patients in other countries, including Scotland, can access, giving them the chance to live longer.
“Women with secondary breast cancer tell us they feel their lives are being deprioritised by the changes to the system. We will not stand by and witness more drugs being rejected or not taken forward, when the devastating cost is thousands more people with secondary breast cancer across England, Wales and Northern Ireland having their lives cut short.
“The system for deciding whether drugs are approved for use on the NHS must change now. We’re calling for immediate action from Wes Streeting, Secretary of State for Health and Social Care, to urgently scrap ‘opportunity-cost neutral’ restraints and for NICE to lower the bar for what it defines as ‘a severe condition’. And we stand ready to work with them.
“People with secondary breast cancer don’t have time to wait, and they deserve #MoreTimeToLive. Please join us now in calling for change, by asking your MP to write to the Health Secretary demanding urgent action to change the system.”
Paula Van Santen, 50, was diagnosed with secondary breast cancer in July 2022, two months after her diagnosis of primary breast cancer. She works as a floral designer and lives in Banbury, Oxfordshire with her husband and two sons, 23 and 21 and her daughter, 19.
“Secondary breast cancer has changed the lives of both myself and my family beyond belief. Coming to terms with my diagnosis is the hardest part because I’ve had to grieve for the life I had, but also the life that I’m not going to have.
“If a new drug can give me another six months, if it gives me another year, it’s worth it. It could allow me to see my daughter get to 21, see my children get married or meet grandchildren. Just to have a picture with a grandchild so they would know that I existed would be so precious. That's what this could give.
“For secondary breast cancer to be classed as moderate is uncaring. It makes me feel very sad, lonely and that I'm not thought about as a human being. I’m really worried this system could block a pathway for new trials and drugs. Especially with the news that Enhertu was rejected for use on the NHS. I'm not at that stage yet, but I might need it in the future.
“It’s about letting people live well for longer and people experiencing life to the full. We've got the ability to do that, so why aren't we? It would give me more peace of mind and hope knowing there’s new available treatment options. It gives you a future, albeit maybe shorter than you would like, but it's still a future.
“If I can give something back to society and help change things so that these drugs are available on the NHS it's going to give me something that I can hold on to.”
Kate Harvey, 44, was diagnosed de novo with secondary breast cancer in 2020 at the age of 39. She is the CEO of a health and safety offshore wind company and lives in Reading, Berkshire with her husband and two daughters who are 11 and 7.
“A secondary breast cancer diagnosis is relentless, it never goes away. It’s like a cloud you have over your life. You never know what’s going to happen and when. I’m five years stable on my current treatment, I could keep on going for several years, or I could die tomorrow. The uncertainty is difficult enough for an adult, let alone for my children.
“Access to potentially life-extending drugs buys me time. Time with my children, my husband, my parents, my friends. Even if it’s just two or three more years, that amount of time is a lot with children. It's so important to me to be able be there for them, for the milestones.
“I watched my little one start school. My eldest is in year 6 now and I was so glad to be here to help her choose her secondary school. I want to watch them learn new skills, be there for them when they go through puberty and get their first partners.
“There’s still so much I want to do in my career too. I love my job and there’s so much I want to achieve in offshore wind. I always dreamt of project directing the construction of an offshore wind farm.
“I should be able to access life-extending drugs on the NHS. I can’t comprehend how a disease that will kill you quite quickly without treatment can be described as moderately severe.
“I do everything I can to stay well. I sleep well, I eat well, I exercise, I don’t smoke, I empower myself with knowledge. These are drugs that I could access for free if I lived in a different place. To fund them myself is impossible, they are so expensive. You either have an NHS that funds drugs or you don’t.”
Read the report and find out more about Breast Cancer Now’s #MoreTimeToLive campaign at: breastcancernow.org/moretimetolive
ENDS
Notes to editors
[1] Trastuzumab deruxtecan (Enhertu) has been rejected for use on the NHS in England for treating HER2-low secondary (metastatic) or unresectable (cannot be removed by surgery) breast cancer after chemotherapy. It is the first treatment licensed for HER2-low secondary breast cancer. https://breastcancernow.org/about-us/media/press-releases/dark-day-as-life-extending-drug-blocked-from-nhs-use-in-england/
Clinical trial DESTINY-Breast 04 found that Enhertu offered an additional 4.8 months of progression free survival than chemotherapy (median 9.9 months for trastuzumab deruxtecan compared to 5.1 months for chemotherapy) and an additional 6.4 months of overall survival (median 23.9 months for trastuzumab deruxtecan versus 17.5 months for chemotherapy).
It is estimated that around 1,000 people would be eligible for treatment with trastuzumab deruxtecan in England each year and more in Wales and Northern Ireland.
[2] Only 7 out of 21 treatments that would previously have qualified for the NICE end-of-life modifier were given the same priority in the new system.
[3] The severity modifier is one of several challenges that companies face in the UK Market which contribute to decisions to delay and terminate appraisals. Examples of delays and terminations in secondary breast cancer include:
- Sacituzumab govitecan (Trodelvy) is already licensed in the UK for people with HR-positive, HER2 negative secondary breast cancer and it’s been approved for use in 18 countries, including France, Canada and Sweden. The NICE appraisal began in 2022, but it is currently stalled.
- In other parts of the world, Enhertu is being considered for use in HR-positive, HER2-low secondary breast cancer, based on findings of the Destiny Breast 06 trial. Again, the appraisal for this use of Enhertu in England has been suspended, so these patients will be unable to access the treatment in England, Wales and Northern Ireland.
- Enhertu is currently available through the Cancer Drugs Fund for two HER2-positive secondary breast cancer indications, one of which qualified for the end-of-life modifier. But the future of these uses is uncertain as the decision on whether it will enter routine commissioning will be made under the severity modifier.
[4] Cost neutral restraints - In introducing the severity modifier an ‘opportunity cost neutral’ approach was used so that it has the same costs as the previous end of life modifier.