The recent changes to NICE’s rules over approving drugs for terminally ill people may make very little difference and fail to improve access to end of life drugs, it has been claimed.
A senior researcher writing on the website of the BMJ today said the new guidelines will do little to improve availability of expensive drugs and could result in other patient groups being denied treatment.
Between 1999 and 2008, NICE rejected 11 drugs on the grounds of cost effectiveness (their cost per quality adjusted life year or QALY was well above NICE’s threshold of £30,000). A QALY is a combined measure of quantity and quality of life.
These decisions, however, sparked ethical, legal and political dilemmas, and prompted a review which recommended that NICE should revise its cost effectiveness threshold for end of life drugs.
The new advice, introduced earlier this month, applies to treatments that affect small numbers of patients who are not expected to live more than 24 months, and that offer demonstrable survival benefits (at least an extra three months of life) compared with current NHS practice.
James Raftery, professor of health technology assessment at University of Southampton, examined the effect the new arrangements would have had on all cancer drugs that NICE has refused or proposed to refuse because of cost effectiveness.
He found that few of the rejected drugs would qualify under the new criteria and most failed to meet the criterion that no alternative treatment with comparable benefits existed.
Professor Raftery also warned that making an exception for any group sets a precedent for other groups, and that setting the threshold higher for some groups within a fixed overall budget results in other patient groups being denied treatment.
“NICE will celebrate its 10th birthday in 2009 having had to make a major change in its methods,” he said. “Its attempt to minimise the effects of these changes will no doubt be tested in future appeals against its findings.”