In three years time the National Institute for Clinical Health and Excellence (NICE) will be taking more of a back-seat role in the UK drug approval process. At the Royal Society of Medicine in London yesterday, the British health minister Earl Howe said that NICE will take on a more generalized advisory role, instead of conducting cost-effective analyses for individual drugs, according to the In Vivo blog. When those changes kick in, the National Health Service (NHS) will also have the option of ignoring the agency’s advice as to which drugs it can afford to buy.
Why 2013? That’s when the UK’s current drug-pricing arrangement with pharmaceutical companies, the Pharmaceutical Price Regulation Scheme (PPRS) is set to expire. The PPRS is based on capping drug companies’ profits, rather than the prices of the drugs themselves. In place of that agreement, Howe said the government will introduce a new ‘value-based pricing’ system focusing on adjusting the price of individual drugs. How this pricing will be decided is still unclear. Many governments in Europe have already slashed drug prices by as much as 25% to make their health budgets stretch a little further.
Although half of the 18 agencies within the Department of Health are being considered for elimination or reorganization under the Conservative government’s cost-cutting measures, NICE was spared the government axe. But all the while, there have been signals that NICE would soon be put on the back burner. In June, after NICE gave the thumbs-down to Tyverb, an oral breast cancer drug, the Department of Health said in a statement that NICE “must be allowed to continue to issue guidance free from political interference. However, we believe that there are fundamental failings within the wider system for drug pricing and access”.
NICE has also come under scrutiny from academics for the way that it determines cost-effectiveness. In 2009, for instance, a paper in PLoS Medicine determined that randomized clinical trials, which NICE heavily relies upon when advising the NHS, often fail to indicate how a drug actually performs in clinical practice.
If the agency hopes to stay relevant in the years ahead, it looks like it’s time to play nice.