NICE’s end of life decision making scheme: impact on population health
BMJ 2013; 346 doi: https://doi.org/10.1136/bmj.f1363 (Published 21 March 2013) Cite this as: BMJ 2013;346:f1363
All rapid responses
Collins and Latimer recently estimated the effect on the NHS of the supplementary advice on life-extending end of life treatments introduced by the National Institute for Health and Care Excellence (NICE) in 2009. Their study demonstrates how NICE’s cost effectiveness threshold should work in principle and is useful as a piece of illustrative analysis. However, the authors’ estimates rely on a number of highly simplistic assumptions and should be treated with caution.
Collins and Latimer begin by describing how NICE usually recommends treatments with incremental cost effectiveness ratios (ICERs) of less than £20 000 per quality adjusted life year (QALY) gained but “as the ratio increases from £20 000 to £30 000, there must be a stronger case for supporting the intervention based on the degree of certainty in the ICER, inadequately captured quality of life benefits, or innovation.”1 Whilst this is true, it should also be noted that NICE’s advisory committees are also expected to consider other factors such as how best to allocate limited health care resources fairly within society. These ‘social value judgements’ are informed by preferences based on the views of NICE’s Citizens Council, which has recently been asked to consider a number of topics including health inequalities, severity of illness, and end of life medicines. Members of NICE’s senior leadership team have identified end of life as one of the “special circumstances to which the Institute’s advisory bodies have given special weighting when making judgements about cost-effectiveness”, and there are cases of NICE recommending end of life treatments with ICERs exceeding the normal threshold range prior to the supplementary advice coming into force.
The key assumption underpinning Collins and Latimer’s analysis is that there is “no additional social value to generating additional health in patients at end of life compared to patients not at the end of life”.1 This is contestable. NICE’s Citizens Council, a representative panel of the general population, voted overwhelmingly in favour of NICE taking into account whether “the illness under consideration is extremely severe” and whether “the treatment in question is life-saving” when considering treatments with ICERs exceeding the threshold.6 Public preference studies conducted outside of the UK also indicate that there is increased social value from extending the lives of end of life patients.
Collins and Latimer describe two studies recently conducted in the UK as providing evidence against end of life weighting. However, in the study conducted by Linley and Hughes10 we note that over a third of the respondents expressed a preference for treating the patient group with a remaining life expectancy of 18 months over the patient group with a remaining life expectancy of 60 months – nearly double the proportion who expressed the opposite preference. Indeed, even when the gains from treating the latter group were set to be twice as large as the gains from treating the former group, nearly a quarter of respondents still wished to prioritise the treatment of the end of life group. So, although the evidence for preference for end of life weighting might be inconsistent, to say that society does not wish to give priority to end of life patients may be overstating the facts somewhat. We also note that public preferences regarding the end of life premium are being investigated in the empirical study being undertaken by the Department of Health’s Policy Research Unit in Economic Evaluation of Health and Care Interventions (currently in progress), so the picture is incomplete.
The assertion by Collins and Latimer that the estimated annual expenditure on the newly-approved end of life treatments “is more than the £505m it cost to provide dialysis for the 21 544 patients with kidney failure in 2009”1 is headline-grabbing but we would argue that it is misleading for two reasons. First, the authors’ assumption that “newly recommended drugs are taken up by all of those eligible” is unfortunately far from being the case in practice and does not hold up for many of the treatments recommended by NICE. Second, the nature of displacement and disinvestment in the NHS means that there is no reason to suppose that dialysis for kidney failure patients would be the intervention to make way for the new end of life treatments. To give another example, in the recent paper calculating an empirical estimate of the cost effectiveness threshold it was reported that in 2008/9 the marginal cost per QALY for interventions in the Maternity and Neonates programme budget category was £2,969,208. Thus, it can just as easily be said that the total annual expenditure on the newly-approved end of life treatments would deliver less than 200 QALYs if it were instead spent on maternal and neonatal health care.
Finally, NICE’s supplementary advice on life-extending end of life treatments is unlikely to have been guided by concerns about society’s preferences alone. During the consultation process, comments made in favour of the policy included observations that the QALY does not adequately capture the important issues for end of life patients. This has been demonstrated in a review of the use of QALYs to assess cancer medicines. If the methods used by NICE to evaluate cost effectiveness systematically underestimate the benefits of end of life treatments, then failing to give higher priority to these treatments will lead to suboptimal health care spending decisions.
1.Collins M, Latimer N. NICE’s end of life decision-making scheme: impact on population health. BMJ 2013;346:f1363.
2. NICE. Appraising life-extending, end of life treatments. NICE, 2009.
3. NICE. Social value judgements: principles for the development of NICE guidance. NICE, 2005.
4. NICE. Inequalities in Health: report on NICE Citizens Council meeting. NICE, 2006.
5.NICE. Quality Adjusted Life Years (QALYs) and the severity of illness. NICE, 2008.
6.NICE. Departing from the threshold: report on NICE Citizens Council meeting. NICE, 2008.
7. Rawlins M, Barnett D, Stevens A. Pharmacoeconomics: NICE’s approach to decision-making. British Journal of Clinical Pharmacology 2010;70:346-349.
8. Shah KK, Cookson R, Culyer AJ, Littlejohns P. NICE's social value judgements about equity in health and health care. Health Economics, Policy and Law 2013;8:145-165.
9. Pinto Prades JL, Sanchez-Martinez FI, Corbacho B. Valuing QALYs at the end of life. Universidad Pablo de Olavide working paper, 2011.
10. Shmueli A. Survival vs. quality of life: a study of Israeli public priorities in medical care. Social Science & Medicine 1999;49:297-302.
11. Shah K, Tsuchiya A, Risa Hole A, Wailoo A. Valuing health at the end of life: a stated preference discrete choice experiment. NICE Decision Support Unit Report, 2012.
12. Linley WG, Hughes DA. Societal views on NICE, cancer drugs fund and value based pricing criteria for prioritising medicines: a cross-sectional survey of 4118 adults in Great Britain. Health Economics 2012 Sep 7 [Epub ahead of print.]
13. NHS Information Centre. Use of NICE appraised medicines in the NHS in England – 2010 and 2011, Experimental statistics. The Health and Social Care Information Centre, 2012.
14. Stephens P. Bridging the gap: why some people are not offered the medicines that NICE recommends. IMS Health, 2012.
15. Claxton K, Martin S, Soares M, Rice N, Spackman E, Hinde S, et al. Methods for the estimation of the NICE cost-effectiveness threshold. CHE Research Paper 81, 2013.
16. NICE. Appraising life-extending, end of life treatments: response to consultation. NICE, 2009.
17. Garau M, Shah KK, Mason AR, Wang Q, Towse A, Drummond MF. Using QALYs in cancer: a review of the methodological limitations. Pharmacoeconomics 2011;29:673-685.
Competing interests: Association of the British Pharmaceutical Industry
Re: NICE’s end of life decision making scheme: impact on population health
Catchpole’s response to our analysis of NICE’s end of life decision making scheme provides an industry perspective on the issue.[1] He correctly states that the evidence on societal preferences for allocating higher quality adjusted life year (QALY) weights to life extending treatments is mixed, but focuses on evidence in favour of a higher weighting, offering support to NICE’s scheme. However, we believe that Catchpole presents his arguments misleadingly, overstating and misinterpreting the evidence. While we wholeheartedly agree with Catchpole’s assertion that evidence on societal preferences for end of life weighting is contestable, we believe that in the absence of consistent and clear evidence the position of an evidence-based decision-making body such as NICE should be one of neutrality.
Catchpole focuses upon two published sources when presenting evidence in support of allocating higher QALY weights to treatments that extend life: a report by the NICE Citizen’s Council,[2] and the paper by Linley and Hughes (2012).[3] He states that the Citizen’s Council voted overwhelmingly that NICE should take into account whether “the illness under consideration is extremely severe” and whether “the treatment in question is life-saving” when considering departures from the usual cost-effectiveness threshold. This is correct. A majority were also in favour of considering waiving the usual threshold in several other circumstances.[2] However, Catchpole does not mention that only 10 of the 29 members voted in favour of taking into account whether “the treatment is life extending” – with this circumstance being one of only five presented to the Council that did not achieve a favourable majority vote. NICE’s end of life decision making scheme is designed to benefit treatments that extend life in small patient populations with a short life expectancy. The treatments that have benefited from it extend life – they do not save lives. Applying a decision rule that applies higher weighting specifically to treatments that extend life does not appear to be in line with the majority wishes of NICE’s Citizen’s Council.
Catchpole interprets Linley and Hughes’s study in a way that suggests that evidence was supportive of a societal preference in favour of allocating higher weights to treatments that extend life in populations with a short life expectancy. While the statements made by Catchpole are correct (34.4% of respondents favoured prioritising people with an 18 month life expectancy without treatment compared to 17.9% who would prioritise people with a 60 month life expectancy without treatment, all else being equal) 47.6% of respondents would not prioritise a population with an 18 month life expectancy over a population with a 60 month life expectancy. The authors themselves conclude that their study does not provide evidence in support of the end of life premium.[3]
In contrast to Catchpole’s interpretation of our paper, we do not state that society does not wish to give priority to end of life patients. Instead we make the case that evidence on this is unclear and show that if society does not wish to give priority to end of life patients the application of the NICE end of life criteria is likely to have resulted in substantial health losses and budgetary pressures to the NHS and population in England and Wales.[4] Given the caveats stated, this is a matter of fact. We believe that it is reasonable to expect the decision rule of an evidence-based decision-making body to remain neutral with regard to weightings until evidence clearly shows societal preferences for specific patient groups or disease areas. Research has shown societal preferences for certain criteria,[3,5] but these are not those specifically addressed by NICE’s end of life decision making scheme.
References
[1] Catchpole P. Re: NICE’s end of life decision making scheme: impact on population health. BMJ 1 May 2013, available from http://www.bmj.com/content/346/bmj.f1363/rr/643559, accessed on 25/7/2013.
[2] NICE. Departing from the threshold: report on NICE Citizens Council meeting. NICE, 2008.
[3] Linley WG, Hughes DA. Societal views on NICE, cancer drugs fund and value based pricing criteria for prioritising medicines: a cross-sectional survey of 4118 adults in Great Britain. Health Economics 2013;22;8:948-64.
[4] Collins M, Latimer N. NICE’s end of life decision-making scheme: impact on population health. BMJ 2013;346:f1363.
[5] Shah KK, Tsuchiya A, Wailoo AJ. Valuing health at the end of life: an empirical study of public preferences. European Journal of Health Economics 2013; 10.1007/s10198-013-0482-3
Competing interests: NL has undertaken consultancy for GSK, Amgen, Novartis, Pfizer, Astra Zeneca, Sanofi Aventis, and Bayer.