Still elegantly muddling through? NICE and uncertainty in decision making about the rationing of expensive medicines in England

This article examines the “technological appraisals” carried out by the National Institute for Health and Care Excellence as it regulates the provision of expensive new drugs within the English National Health Service on cost-effectiveness grounds. Ostensibly this is a highly rational process by which the regulatory mechanisms absorb uncertainty, but in practice, decision making remains highly complex and uncertain. This article draws on ethnographic data—interviews with a range of stakeholders and decision makers (n = 41), observations of public and closed appraisal meetings, and documentary analysis—regarding the decision-making processes involving three pharmaceutical products. The study explores the various ways in which different forms of uncertainty are perceived and tackled within these Single Technology Appraisals. Difficulties of dealing with the various levels of uncertainty were manifest and often rendered straightforward decision making problematic. Uncertainties associated with epistemology, procedures, interpersonal relations, and technicality were particularly evident. The need to exercise discretion within a more formal institutional framework shaped a pragmatic combining of strategies tactics—explicit and informal, collective and individual—to navigate through the layers of complexity and uncertainty in making decisions

Developing Undergraduate Curriculum Resources on Health and Work in Medical Education

We report on a project commissioned by Public Health England (PHE) to develop a set of online curriculum resources on health and work that will be universally available to all UK medical schools. The project is underpinned by the General Medical Council’s Outcomes for Graduates 2018, which includes an expectation that newly qualified doctors will be able to demonstrate appropriate Communication and Interpersonal Skills. The aim of the project is to improve the health and work dialogue between doctors of the future and patients. The set of learning resources and teaching aids is intended to provide knowledge, tools and techniques to improve future doctors’ confidence to start conversations with patients around health and work and the ‘fit note’. The resources will help new doctors use the fit note as a practical advice system as well as a process for sickness certification. The background to this work lies within the Government’s national vision to reduce health-related worklessness and help individuals achieve their work and health potential, which it set out in its command paper Improving Lives: the Future of Work, Health and Disability. The presentation will outline the process of co-producing curriculum resources via partnership between healthcare professionals, patient and public involvement representatives, academics and national government organisations. We will then set out the planned approach for embedding the new resources via a three-stage process involving (i) piloting, (ii) phasing-in and (iii) full implementation. Some of the barriers and enablers encountered in piloting the resources in medical schools will be discussed

Decision making in NICE single technological appraisals (STAs): How does NICE incorporate patient perspectives?

The National Institute for Health and Care Excellence (NICE) provides guidance and recommendations on the use of new and existing medicines and treatments within the NHS, basing its decisions on a review of clinical and economic evidence principally, at least for STAs, provided by the drug manufacturer. The advice provided by NICE is aimed at overcoming the previously ad hoc, discretionary decisions in order to standardise access to healthcare technologies across England based on evidence. A Single Technological Appraisal (STA) is one element of NICE’s decision-making processes in which evidence about a selected technology (often medicines) is evaluated in 3 distinct phases (scoping, assessment and appraisal). In the last phase of this process an independent Appraisal Committee evaluates evidence in a meeting, partly held in public with the latter half taking place in a ‘closed’ session. During the meeting, the Appraisal Committee considers evidence based on clinical and cost-effectiveness, as well as from statements expressed by patients, commissioning experts and clinical specialists. The Institute encourages experts attending the meeting to provide both written and oral commentary about their personal view in the current management of the condition and the expected role and use of the technology – in particular how it might provide benefit to patients. Yet, NICE and its committees find themselves in a potentially incongruous position: how to take on board the experiential evidence from individual experts along with the evidence on cost-effectiveness when reaching a decision, about whether or not to recommend a treatment on cost-effectiveness grounds. This paper considers how NICE committees incorporate the views of patient perspectives in making rationing decisions about STAs. The findings from the study will discuss where points of tension / conflict arise during meetings and how Committee members navigate experiential accounts with scientific data, which types of patient perspectives are regarded favourably and which perspectives are treated with greater caution (tension between representing patients views vs tokenism), and will highlight how Committee members in fact reflect upon their own personal experience and background in the appraisal process, and thereby are at odds with retaining an element of neutrality in decision-making, as they contend with combining their own subjective views alongside considerations of rationing in the STA process. The analysis is drawn from an ESRC funded study which used an ethnographic approach to understand the decision making process within STAs involving three contrasting pharmaceutical products. Data collection methods included analysis of documentary evidence released by NICE, non-participant unstructured observations of nine STA meetings, and qualitative interviews with key informants (n=41) involved in each of the three case studies