Department of Global Health and Social Medicine, King's College London, London, UK.
Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora, USA.
BMC Med Ethics. 2024 Mar 6;25(1):28. doi: 10.1186/s12910-024-01016-0.
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.
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.
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.
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.
作为英国主要的医疗保健优先级设定机构,国家卫生与保健卓越研究所(NICE)有充分的理由证明其决策在道德上是合理的。为此,它倾向于依赖成本效益原则的道德合理性以及它采用公平程序的断言。但这两种方法都不能为 NICE 的决策提供完全令人满意的道德辩护依据。在这项研究中,我们采用了一种互补的方法,基于这样的主张,即优先级设定者的道德辩护主张可以部分基于其方法的一致性,并且任何此类主张的可靠性都会因道德体系内存在不和谐而受到破坏。这项研究首次对 NICE 正式方法的一致性进行了实证评估,并在此基础上得出了关于该方法在多大程度上具有道德合理性的基于证据的结论。
该研究基于经验生物伦理学的理论、方法和标准。对 20 份 NICE 政策文件进行了编码,以确定并分类截至 2021 年 12 月 31 日 NICE 技术评估政策中包含的规范性承诺。通过试图将这些承诺纳入狭隘的反思平衡(NRE)并确定不和谐的来源,系统地评估了一致性。
NICE 政策的大部分内容都基于强有力的道德决策基础的一致价值观。然而,NICE 的正式方法也包含了几个不和谐的例子,这些例子破坏了一致性并阻止了 NRE 的完全建立。不和谐主要源于四个来源:i)NICE 对成本效益原则的规定;ii)其对特定群体需求的优先排序方法;iii)其在不确定性背景下对合理性的概念;iv)其对创新作为独立价值的关注。
在分析时,NICE 政策的一致性程度为其技术评估的正式方法在多大程度上具有道德合理性提出了质疑。本文还就为什么在这些发现的基础上,NICE 能够保持其作为医疗保健优先级设定机构的合法性以及可以采取哪些措施来提高一致性进行了思考。