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Some of the strengths of NICE (the National Institute for Health and Clinical Excellence) are that it ‘sees guidelines as guidelines, not as rules set in stone’, adopts ‘flexible approaches’, and does not ‘expect its pronouncements to be accepted without questioning’ (JRSM 2007;100:442-3).1 It thrives on argument, as the recent papers in the October 2007 issue of the JRSM demonstrate, and grows stronger through debate and controversy. This is hardly surprising, given that it has the task of promoting cost-effective use of resources whilst also encouraging innovation, improving quality and reducing variation in practice, in response to the need to deal with clinical and budgetary uncertainties about therapies (JRSM 2007;100:453-60).2 It stands, therefore, at the controversial intersection of quality, innovation, access and cost, with a remit to operate in a transparent and inclusive way, using cost effectiveness to inform decisions about treatments, without considering their affordability.3 As an organization it is designed to manage conflicts of opinion, not avoid them, and it is becoming increasingly capable of doing so.
NICE was established to correct inequalities and inefficiencies in health care, including unacceptable variations in the uptake of technologies of proven value, failure to provide patients with optimum care for the treatment of common diseases and the too-ready adoption of therapies with no proven clinical benefit.4 It is, therefore, an openly political body. NICE operates a form of deliberative democracy which engages clinicians, researchers, industry, economists and public organizations in an iterative process of decision making. This deliberative democracy has proved beneficial to clinicians, patients and the pharmaceutical industry. For example, the decisions made by NICE about neuropsychiatric agents like the atypical antipsychotics and the cholinesterase inhibitors have lifted restrictions on their funding and facilitated their wider use. Likewise, openness to patient opinion seems to encourage NICE to accept therapies where the evidence base is relatively weak or the cost effectiveness analysis unfavourable.5 While some decisions by NICE lead to high-profile media criticisms supported by parts of the industry and some patient groups, NICE is for politicians a comparatively safe haven from which decisions can be defended in public by those with expertise. It is therefore no stranger in the British NHS but a continuation of attempts to keep clinical decisions away from politicians, even though they sometimes cannot resist becoming embroiled.
Among NICE's political weaknesses are the unrealistic signals that it can send about affordability to politicians and the public and its absence from debates about prioritization.6 The decisions over which services or therapies will be displaced by new treatments approved by NICE are made at local level, whilst cost-effectiveness judgements are made nationally. There is a risk is that therapies may be displaced that are more cost effective than those being introduced, which means that a methodology is now needed to decide how best to disinvest from relatively ineffective but well-established treatments.7 Such arguments about the applicability and implementation of NICE guidelines are, as Gupta and Warner point out, currently central to both clinical governance and commissioning at local level, and have different implications for social services,8 social care,9 nursing10 and general practice.11
Although ‘only in research’ decisions are often seen as rejections12 designed to evade appeals and pressure from lobby groups, their purpose is to generate the additional evidence to allow confident decisions to be made. Influencing the research agenda is not just a good intention, but now has operational expression in research networks designed to facilitate large trials, and in funding streams that supplement industry-funded studies. In the field of dementia, the Dementia & Neurodegenerative Diseases Research Network (DeNDRoN) supports clinical trials and the National Institute of Health Research has recently funded three five-year programmes of projects focusing on non-pharmacological interventions. We are approaching an integrated system of research and development, informed by NICE's assessments.
NICE is certainly ‘here to stay’ (JRSM 2007;100:439)13 partly because it is an organization with very significant intellectual resources at its disposal that is capable of rapid learning. More importantly, it is able to set the agenda for the development of new treatments as well as to evaluate their cost effectiveness, and before long is likely to look beyond the specific therapy under review to the wider system of health services provision. We should look forward to this.
Competing interests SI and JM were members of the NICE/SCIE dementia guidelines development group, 2004-2006
Funding Not applicable
Ethical approval Not applicable
Contributorship Both authors contributed equally