NICE at 20BMJ 2019; 364 doi: https://doi.org/10.1136/bmj.l1343 (Published 26 March 2019) Cite this as: BMJ 2019;364:l1343
- Nigel Edwards, chief executive1,
- John Appleby, director of research and chief economist1,
- Nicholas Timmins, senior associate1
- Correspondence to: N Edwards
All healthcare systems ration care. The creation of the NHS in 1948 as a universal tax- funded system, largely free at the point of use, was an explicit rejection of rationing based on price and the ability to pay. But the need to decide between competing demands on a limited budget remained.
For half a century, the NHS grappled with this rationing dilemma through a combination of, as Rudolf Klein has characterised it, delay, dilution, deterrence, denial, and deflection.1 This solved the problem after a fashion, but inconsistently and opaquely. The creation in 1999 of what is now the National Institute for Health and Care Excellence (NICE) was an attempt to tackle that through a systematic, evidence based, and economic approach.2
The essential question it was set up to answer is whether new technologies are not just clinically effective—in the case of medicines, they have to be to get a licence—but cost effective.
NICE has bucked the trend by surviving two decades without the frequent reorganisation and staff changes, or indeed abolition, that other national healthcare bodies have experienced. “Surviving” may seem a rather weak achievement. But it says something important about not only the organisation and its staff but the importance of its role, which goes to the heart of unavoidable prioritising dilemmas in a national health service.
The reasons for setting up NICE as an organisation separate from the body that licenses medicines still apply. Successive secretaries of state (with one exception) have recognised that they are not best placed to make decisions about cost effectiveness and that real political dangers arise should they seek to do so. Initial unease in the pharmaceutical industry—and outright opposition from some companies2—has mellowed for the most part into a somewhat reluctant acceptance of the role of NICE, and an acknowledgment that a clear and fairly transparent process for making decisions about cost effectiveness is better than the alternatives.
The history of NICE has nonetheless been marked by controversy. For example, the extent to which there is a definitive cost per QALY (quality adjusted life year) threshold, whether this is set at the right level,3 the speed of the decision process, and whether it says yes too often or not often enough. But politicians have in the main resisted the temptation to intervene. When they did, through the creation of the Cancer Drugs Fund in 2011 as a separate process outside NICE, the fund’s massive overspend and failure to meet its objectives4 served to demonstrate why NICE was needed in the first place.
Although there are valid concerns that NICE decisions can distort the allocation of resources away from more cost effective treatments that have not been appraised, NICE has largely silenced the vociferous debate about “postcode prescribing” (unjustifiable geographical variation in the provision of treatments). But its effect on the speed of adoption of new technologies seems to have been less than was hoped for. This is particularly true for non-pharmaceutical innovations where, unlike with drugs, commissioners are not required to fund NICE recommendations. Claims are continuing that the NHS is slow to adopt, although it is not clear how far NICE can be held responsible for the complex factors at play.5
Its less headline grabbing work—the development of clinical guidelines—has dealt with the confusing proliferation of guidelines that existed before. The guidelines have undoubtedly improved the quality of care within the NHS, although again it is not clear—partly because it is extremely hard to measure—how far they are truly embedded.
Successes and challenges
Despite these cavils NICE must be judged a success, and a big one. The social and ethical values it has adopted, its processes, the involvement of the public in establishing its underpinning principles, and the formidable network of researchers and advisers it has created are widely admired internationally. It has inspired the work of similar agencies across the world. Its materials are frequently downloaded, translated, and adopted—the provision of these as a publicly available resource is an important contribution to the wider global health community.
It faces, of course, continuing challenges. Some are of its own making; others are of the kind that face health technology assessment globally, such as how far the current assessment processes work well, not just in the case of rare and orphan drugs but for new, more personalised cell and gene therapies, which are eye wateringly expensive and can be difficult to evaluate.
The former challenges include NICE’s edging—through the so called budget impact test6—towards making decisions not just about whether a treatment is cost effective but how fast it should be rolled out if NHS England proves unable to negotiate a price low enough for it to come within the cost effectiveness threshold.
To date, the budget impact test has not had to be applied to a medicine. But NICE was set up merely to judge cost effectiveness, not to rule how quickly the NHS could afford to adopt new technologies. This sullies its original purity in a way that could do lasting damage to its standing.
Competing interests: We have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.
Provenance and peer review: Commissioned; externally peer reviewed.