New Guidelines 'May Do Little To Improve Availability Of Expensive Drugs'

New guidelines to help improve access to end-of-life drugs for terminally ill patients are unlikely to lead to acceptance of all the drugs provisionally refused, argues a senior researcher on the website, BMJ.com today.

James Raftery, Professor of Health Technology Assessment at Southampton University, says that the new arrangements from the National Institute for Health and Clinical Excellence (NICE) will do little to improve availability of expensive drugs and may result in other patient groups being denied treatment.

During 1999-2008, 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 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 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.

Professor Raftery 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, with most failing to meet the criterion that no alternative treatment with comparable benefits existed.

He also warns 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.

He concludes: "NICE will celebrate its 10th birthday in 2009 having had to make a major change in its methods. Its attempt to minimise the effects of these changes will no doubt be tested in future appeals against its findings."

(JM/BMcC)