Thousands denied breast cancer drugs over NHS rules

Thousands of women with advanced breast cancer could miss out on life-extending treatment because of what campaigners say is an “unfair” NHS drug approval process.

Health Secretary Wes Streeting is under pressure to scrap current spending rules and overhaul how the NHS decides which treatments to fund.

The calls follow a decision not to approve Enhertu for NHS use in England and Wales, after price talks with manufacturers AstraZeneca and Daiichi Sankyo failed for the third time. The drug is already available to patients in Scotland.

Charity Breast Cancer Now says the National Institute for Health and Care Excellence (Nice) sets the bar too high for what qualifies as a “very severe health condition” – a label that helps more expensive drugs meet approval criteria.

Nice’s severity modifier, introduced in 2022, gives extra weight to treatments for the most serious illnesses.

But Breast Cancer Now’s new report claims women with incurable breast cancer, even with only months to live, may be told they do not meet the threshold for the most severe category.

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 charity is calling for the government to scrap “opportunity-cost neutral” restraints – a policy that ensures the new system does not require more or less overall NHS funding than the previous one.

According to Breast Cancer Now, 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.”

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.

She said: “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”.