The National Institute for Health and Care Excellence (NICE) is the UK’s primary healthcare priority-setting body, responsible for advising the National Health Service in England on which technologies to fund and which to reject. Until recently, the normative approach underlying this advice was described in a 2008 document entitled ‘Social value judgements: Principles for the development of NICE guidance’ (SVJ). In January 2020, however, NICE replaced SVJ with a new articulation of its guiding principles. Given the significant evolution of NICE’s (...) methods between 2008 and 2020, this study examines whether this new document (‘Principles’) offers a transparent account of NICE’s current normative approach. It finds that it does not, deriving much of its content directly from SVJ and failing to fully acknowledge or explain how and why NICE’s approach has since changed. In particular, Principles is found to offer a largely procedural account of NICE decision-making, despite evidence of the increasing reliance of NICE’s methods on substantive decision-rules and ‘modifiers’ that cannot be justified in purely procedural terms. Thus, while Principles tells NICE’s stakeholders much about how the organisation goes about the process of decision-making, it tells them little about the substantive grounds on which its decisions are now based. It is therefore argued that Principles does not offer a transparent account of NICE’s normative approach (either alone, or alongside other documents) and that, given NICE’s reliance on transparency as a requirement of procedural justice, NICE does not in this respect satisfy its own specification of a just decision-maker. (shrink)

The rapid development in healthcare technologies in recent years has resulted in the need for health services, whether publicly funded or insurance based, to identify means to maximise the benefits and provide equitable distribution of limited resources. This has resulted in the need for rationing decisions, and there has been considerable debate regarding the substantive and procedural ethical principles that promote distributive justice when making such decisions. In this paper, I argue that while the scientifically rigorous approaches of evidence-based healthcare (...) are claimed as aspects of procedural justice that legitimise such guidance, there are biases and distortions in all aspects of the process that may lead to epistemic injustices. Regardless of adherence to principles of distributive justice in the decision-making process, evidential failings may undermine the fairness and legitimacy of such decisions. In particular, I identify epistemic exclusion that denies certain patient and professional groups the opportunity to contribute to the epistemic endeavour. This occurs at all stages of the process, from the generation, analysis and reporting of the underlying evidence, through the interpretation of such evidence, to the decision-making that determines access to healthcare resources. I further argue that this is compounded by processes which confer unwarranted epistemic privilege on experts in relation to explicit or implicit value judgements, which are not within their remit. I suggest a number of areas in which changes to the processes for developing, regulating, reporting and evaluating evidence may improve the legitimacy of such processes. (shrink)

Background As the UK’s main healthcare priority-setter, the National Institute for Health and Care Excellence (NICE) has good reason to want to demonstrate that its decisions are morally justified. In doing so, it has tended to rely on the moral plausibility of its principle of cost-effectiveness and the assertion that it has adopted a fair procedure. But neither approach provides wholly satisfactory grounds for morally defending NICE’s decisions. In this study we adopt a complementary approach, based on the proposition that (...) a priority-setter's claim to moral justification can be assessed, in part, based on the coherence of its approach and that the reliability of any such claim is undermined by the presence of dissonance within its moral system. This study is the first to empirically assess the coherence of NICE’s formal approach and in doing so to generate evidence-based conclusions about the extent to which this approach is morally justified. Methods The study is grounded in the theory, methods and standards of empirical bioethics. Twenty NICE policy documents were coded to identify and classify the normative commitments contained within NICE technology appraisal policy as of 31 December 2021. Coherence was systematically assessed by attempting to bring these commitments into narrow reflective equilibrium (NRE) and by identifying sources of dissonance. Findings Much of NICE policy rests on coherent values that provide a strong foundation for morally justified decision-making. However, NICE’s formal approach also contains several instances of dissonance which undermine coherence and prevent NRE from being fully established. Dissonance arises primarily from four sources: i) NICE’s specification of the principle of cost-effectiveness; ii) its approach to prioritising the needs of particular groups; iii) its conception of reasonableness in the context of uncertainty, and iv) its concern for innovation as an independent value. Conclusion At the time of analysis, the level of coherence across NICE policy provides reason to question the extent to which its formal approach to technology appraisal is morally justified. Some thoughts are offered on why, given these findings, NICE has been able to maintain its legitimacy as a healthcare priority-setter and on what could be done to enhance coherence. (shrink)

Priority-setting policy-makers often face moral and political pressure to balance the conflicting motivations of efficiency and rescue/non-abandonment. Using the conflict between these motivations as a case study can enrich the understanding of institutional design in developed democracies. This essay presents a cognitive-psychological account of the conflict between efficiency and rescue/non-abandonment in health care priority-setting. It then describes three sets of institutional arrangements—in Australia, England/Wales, and Germany, respectively—that contend with this conflict in interestingly different ways. The analysis yields at least three (...) implications for institutional design in developed democracies: (1) indeterminacy at the level of moral psychology can increase the probability of indeterminacy at the level of institutional design; (2) situational constraints in effect require priority-setting policy-makers to adopt normative-moral pluralism; and (3) the U.S. health care system may be in an anti-priority-setting equilibrium. (shrink)