Proposals to reform the way the National Institute for Health and Care Excellence (NICE) appraises new medicines could represent a step back rather than forward for cancer patients, a leading charity has warned.

NICE’s value-based assessment proposals would remove the rules that ensure that treatments used near the end of patients’ lives are given special consideration – but the end-of-life criteria are the only reason why 12 life-extending cancer drugs have been approved by NICE, says the Rarer Cancers Foundation (RCF).

Without these, there is no guarantee that similar treatments would be approved in the future, the group warns, pointing out that “the Department of Health’s own figures show that up to 12,841 patients a year would have been denied the opportunity of treatment had the end-of-life criteria not been in place.”

‘The government promised patients that they would be able to access the drugs their doctor recommended, yet NICE’s proposed reforms would be a backward step for cancer,” said the Foundation’s chief executive, Andrew Wilson.

“Plans to abolish special rules for drugs used near the end of a patient’s life have been slipped out in the small print of this consultation. They amount to a stealth cut for cancer and could have a devastating impact on access to life-threatening drugs, with no guarantee that other changes to the rationing formula will compensate,” said Mr Wilson, adding: “we will be responding to NICE’s proposals in the strongest possible terms.”

His concerns are echoed by Professor Paul Workman, deputy chief executive of The Institute for Cancer Research (ICR), who said: “the suggestion from NICE that it could remove its end-of-life criteria is extremely worrying and could deny thousands of patients with diseases such as cancer access to life-extending drugs.”

“Approval of cancer drugs via end-of-life care criteria is often the gateway to their use in the NHS earlier in the course of disease, with even greater benefit for patients, and is also a critical step in building up portfolios of new drugs that can be used in combination,” said Prof Workman.

It was also  “disappointing” that NICE had included nothing in its guidance to place greater stress on innovation when evaluating new drugs, he added, and warned that removing end-of-life criteria could in fact stifle innovation by erecting a major barrier to the approval of many innovative new cancer drugs.

“We encourage NICE to think again to find ways of improving access for cancer patients to new drugs and to stimulate innovation, which is essential to improve patient outcomes,” said Prof Workman.