Justice, Transparency and the Guiding Principles of the UK\u2019s National Institute for Health and Care Excellence

Victoria Charlton

doi:10.1007/s10728-021-00444-y

Abstract

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.

Highlights

In most healthcare systems, the availability of potentially beneficial interventions surpasses the available resources, necessitating decisions about which interventions to adopt and which to reject [1, 10, 41, 43]
In the UK, these decisions are frequently informed by the National Institute for Health and Care Excellence (NICE), whose advice plays a major role in determining which healthcare technologies users of the National Health Service (NHS) in England can access [34]
Given that there is no societal consensus on such matters, NICE has historically sought to ensure that its decisions can be accepted as legitimate and fair by grounding its approach on two normative frameworks: one that sets out the requirements for a just procedure and another that sets out NICE’s general substantive reasons for deciding which technologies to recommend [35, 36, 39, 40]. (Table 1)

Summary

Introduction

The availability of potentially beneficial interventions surpasses the available resources, necessitating decisions about which interventions to adopt and which to reject [1, 10, 41, 43]. NICE’s advice inevitably rests on value judgements about how the needs of different NHS users should be balanced and prioritised. A previous study by this author that empirically examined normative changes to NICE’s approach highlighted two key findings [2]. It showed that while NICE’s independent appraisal committees continue to reach their recommendations through a deliberative process, the substantive basis of these decisions has become more formalised over time, with NICE providing its committees with increasingly specific advice on how to respond to normative concerns. The study showed that NICE’s methods have promoted an increasingly generous view of what constitutes sufficient evidence to recommend a technology’s adoption, accelerating public access to new medicines but with reduced confidence about their likely impacts. The result, the study argued, is that NICE-recommended technologies are increasingly likely to displace more health than they deliver, undermining what NICE claims in SVJ is its foremost substantive goal: an efficient allocation of resources

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