Fear not the heatBMJ 2006; 333 doi: http://dx.doi.org/10.1136/sbmj.39042.486736.F7 (Published 23 November 2006) Cite this as: BMJ 2006;333:0-f
- Fiona Godlee, editor ()
The United Kingdom's main rationing body, the National Institute for Health and Clinical Excellence (NICE), is in the hot seat, and things look set to get hotter. NICE is facing its first ever legal challenge from the drug industry—about the decision making process behind its recommendation to restrict drug treatments for Alzheimer's disease (doi: 10.1136/bmj.39041.497315.DB). And it is under attack from US drug companies, apparently with White House backing, for stifling innovation in an overt attempt to gain unrestricted access to the NHS as part of a free market (doi: 10.1136/bmj.39041.354074.DB).
What this shows is not that NICE is in trouble but that it is doing its job. It was set up to ensure that treatments available on the NHS provide value for money. Decisions to restrict drug treatments are hugely emotive to patients and clinicians. Controversy is inevitable. But the fact that there is insufficient evidence that the drugs are cost effective in the early stages of dementia is not NICE's fault and does not mean that the process is itself flawed, as Pfizer and others contend. Independent review of NICE's processes by the World Health Organization concluded that they are optimal for health technology assessment. Even if a judicial review recommended changes to the process in this case, the need for a body like NICE to make decisions on cost effectiveness will not go away.
Nor is the UK alone in this. Germany's Institute for Quality and Economic Efficiency in Health Care, which emulates NICE, is under attack from the drug industry for being insufficiently transparent. And as Annette Tufts points out (doi: 10.1136/bmj.39042.547674.94), tensions with the industry have increased since the German government proposed extending the institute's role to include cost effectiveness of drugs as well as their clinical effectiveness. Australia's groundbreaking initiative to establish such a “fourth hurdle” crumbled under pressure from the US drug industry. An unholy deal was struck that allowed Australia access to US markets in exchange for unrestricted access to Australia's pharmaceutical market. Germany must hold its ground, and so too must the UK.
Which is not to say that the UK's process can't be improved. Ann Barrett and colleagues say that the current process is flawed because NICE guidance doesn't state what treatments must be cut when new treatments are recommended. Providing Herceptin (trastuzumab) to patients in their oncology department will cost them £2.3m (€3.4m; $4.4m). “We, not NICE, have to choose which other treatments will not be provided and which of our patients will not be treated.” Their solution is not to limit NICE's remit but to extend it. NICE should, they say, be given the additional responsibility to decide what should be cut to fund the newly recommended technologies or the ability to allocate extra funds for implementation or both.
This whole debate underlines the vital importance of independent and reliable information on the effectiveness of treatments. The BMJ has always aimed to provide such information and now has not one but two high quality sister resources in its portfolio. BMJ Clinical Evidence, now in its seventh year, has undergone a facelift, with a new look and feel to its website (http://clinicalevidence.com), improved accessibility, and new links to BMJ Updates, guidelines, and drug safety alerts. This week it is joined by the Drug and Therapeutics Bulletin, which has been proudly acquired by the BMJ Group and is available to readers on subscription.