Thousands of women battling advanced breast cancer could be denied access to crucial life-extending medication due to an “unfair” assessment process for NHS drug approval.
Charity Breast Cancer Now has issued an urgent plea to Health Secretary Wes Streeting, demanding “immediate action” to dismantle current spending restraints.
The organisation is also calling for the NHS spending watchdog, the National Institute for Health and Care Excellence (Nice), to lower its threshold for what it classifies as a “very severe health condition.”
Nice’s severity modifier, introduced in 2022, is designed to give greater weight to treatments for more severe illnesses, increasing the likelihood of their recommendation for NHS use.
However, Breast Cancer Now argues that the current criteria are too stringent, potentially preventing thousands of women from accessing vital therapies.
According to Nice, the process raises the threshold for what it considers to be a cost-effective treatment, meaning it can give more expensive drugs the green light.
However, a new report from Breast Cancer Now claims the system means women with incurable breast cancer with months to live may be told their condition does not qualify for the most severe rating.
The call comes after it emerged that the life-extending drug Enhertu will not be made available for women with incurable breast cancer on the NHS in England and Wales.
In November, Nice said talks with manufacturers AstraZeneca and Daiichi Sankyo over the price of the medication had broken down for the third time with no agreement.
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.”
Paula Van Santen, 50, was diagnosed with secondary breast cancer in July 2022, two months after her diagnosis of primary breast cancer.
The mother-of-three, from Banbury in Oxfordshire, said: “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.”
Ms Rowney called for “change” and said Mr Streeting should scrap ‘opportunity-cost neutral’ restraints.
Opportunity cost neutrality in the Nice severity modifier aims to ensure the new system does not require more or less overall NHS funding than the old one.
According to the Breast Cancer Now report, this is “at the root of the issues with the modifier”.
It added: “It pits end-of-life cancer treatments against other severe conditions like cystic fibrosis in a way that’s reductive and unfair to patients. And, ultimately, it creates barriers to the approval of drugs for advanced cancers.”
Ms Rowney said: “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.”
Dr Samantha Roberts, chief executive of Nice, welcomed the report from Breast Cancer Now, saying: “The independent analysis we commissioned recently showed the new severity weighting is working as intended and expected.
“It is able to be applied more widely – for example to treatments for cystic fibrosis, hepatitis D and Duchenne muscular dystrophy – and has contributed to an increase in positive decisions for cancer medicines and non-cancer medicines.
“And other breast cancer treatments have been recommended since we introduced the severity modifier – including for advanced breast cancer.
“We remain deeply disappointed that we were unable to recommend Enhertu for HER2-low advanced breast cancer. We know this was devastating to all those hoping for a different answer.
“It remains the only breast cancer treatment we have been unable to recommend in seven years.”
A Department of Health and Social Care spokesperson said the upcoming 10-year health plan will “transform the NHS and improve care for those facing cancer”.
“This includes rolling out DIY screening kits for cervical cancer, more radiotherapy machines in every region and opening more Community Diagnostic Centres closer to where people live,” they added.
“We know how disappointing it is to many families that the manufacturers of Enhertu are unwilling to sell this life-extending treatment to the NHS at a fair and reasonable price. Our door remains open to supporting the introduction of medicines at a cost-effective price.”
