NICE must not say people are not worth treatingThe National Institute for Health and Clinical Excellence has proposed that drugs for the treatment of dementia be banned to National Health Service patients on the grounds that their cost is too high and “outside the range of cost effectiveness that might be considered appropriate for the NHS”i.1This is despite NICE’s admission that these drugs are effective in the treatment of Alzheimer’s disease and despite NICE having approved even more expensive treatments. The (...) effect is that thousands of Alzheimer’s patients will be denied the only treatment available. It is difficult to think of this as anything but wickedness or folly or more likely both. At the same time, and with no apparent sense of irony, NICE has launched a public consultation document3 on its guidelines on social value judgments. As we shall see these guidelines are ethically illiterate as well as socially divisive.Assuming permanently scarce resources it is clearly crucial that such healthcare resources as are available are not wasted. This point is often made in terms of cost effectiveness and it is argued, not implausibly, that to talk of cost effectiveness implies that we are able to measure just how cost effective each treatment is. To do so of course we need a standard of measurement. NICE has adopted the ubiquitous, but justly infamous QALY, the Quality Adjusted Life Year.The QALY combines life expectancy after treatment with measures of the expected quality of that life. There are two ways in which QALYS can be used. They might be used to determine which of rival therapies to give to a particular patient or which procedure to use to treat a particular condition, in short which of two different treatments is the more …. (shrink)

Michael Rawlins and Andrew Dillon start their defence of Nice in fine polemical style, unfortunately polemics is all they have to offer. They totally fail to justify the Nice proposals on dementia treatments nor do they make any more plausible than formerly their use of the notorious QALY. They say:"Harris’s recent editorial, It’s not NICE to discriminate, is long on both polemic and invective – but short on scholarship. He offers nothing to illuminate the debate about allocating healthcare in circumstances (...) of finite resources; he has no understanding of the quality adjusted life year and its use in health economic evaluation; and he makes ill-researched, unsubstantiated and offensive charges against the Institute and its advisory bodies."Accusations are easy to make, difficult to substantiate. There are a number of claims here, only one of which is true. It is true that my editorial was robust, polemical if you like, but editorials are not the same as research papers and these are important issues which deeply affect real lives. Although Rawlins and Dillon affect to take the high ground their own article contains even more vigorous and much more personal invective than my editorial, I make no complaints. But as to the rest of what they say, well, let’s just see!They claim I offer nothing to illuminate resource allocation and that I have no understanding of the QALY. Both of these claims may well be true, but nothing they say goes any way to support these claims or even towards making them plausible. I have studied and written about the QALY for almost 20 years1,2,3,4,5,6,7,8,9,10,11,12,13,14,15 and Rawlins and Dillon show no evidence of any awareness or indeed any understanding of the issues, whether …. (shrink)

The bottom line is that Claxton and Culyer believe, and are on record as saying, that a therapy or procedure is not cost effective if “the health benefits that it is estimated could be gained from the technology are less than those estimated to be forgone by other patients as other procedures are necessarily curtailed or not undertaken. It is this comparison of health gained and health forgone that is at the heart of the rationale of cost-effectiveness analysis”. To estimate (...) whether the gains made …. (shrink)

Harris’ reply to our defence of the National Institute for Clinical Excellence’s (NICE) current cost-effectiveness procedures contains two further errors. First, he wrongly draws a conclusion from the fact that NICE does not and cannot evaluate all possible uses of healthcare resources at any one time and generally cannot know which National Health Service (NHS) activities would be displaced or which groups of patients would have to forgo health benefits: the inference is that no estimate is or can be made (...) by NICE of the benefits to be forgone. This is a non-sequitur. Second, he asserts that it is a flaw at the heart of the use of quality-adjusted life years (QALYs) as an outcome measure that comparisons between people need to be made. Such comparisons do indeed have to be made, but this is not a consequence of the choice of any particular outcome measure, be it the QALY or anything else. (shrink)