Katharina Kieslich

Social values and health priority setting in Germany

PURPOSE The purpose of this paper is to provide an overview of health priority setting structures in Germany. It reflects on how and which social values may influence decision making, and in particular investigates the role of the Institute for Quality and Efficiency in Health Care (IQWiG) in integrating evidence-based decision making into the German system. DESIGN/METHODOLOGY/APPROACH The paper applies Clark and Weales framework of analysis for Social Values and Health Priority Setting to the German context. Placing German health care decision making into Clark and Weales framework allows for an analysis of the role and content of social values in different dimensions of decision making. FINDINGS Germany has witnessed significant changes in its health care decision-making procedures in recent decades. The establishment of the Institute of Quality and Efficiency in Health Care (IQWiG) represents an effort to introduce health technology assessment (HTA) as a formal element of decision making in health care. In doing so, Germany has made unique methodological and structural choices that reflect the social values and institutional traditions that underpin its self-governing statutory health insurance (SHI) system. The empirical evidence suggests that the principle of solidarity is upheld as a core value in health priority setting in Germany. ORIGINALITY/VALUE The German case of health priority setting highlights some of the challenges involved when introducing centralised HTA structures to a self-governing SHI system. As such, this paper contributes to an understanding of the different forms that HTA can take, what social values they embody and how they can affect health priority setting in different ways.

Public participation in decision-making on the coverage of new antivirals for hepatitis C

Purpose - New hepatitis C medicines such as sofosbuvir underline the need to balance considerations of innovation, clinical evidence, budget impact and equity in health priority-setting. The purpose of this paper is to examine the role of public participation in addressing these considerations. Design/methodology/approach - The paper employs a comparative case study approach. It explores the experience of four countries - Brazil, England, South Korea and the USA - in making coverage decisions about the antiviral sofosbuvir and involving the public and patients in these decision-making processes. Findings - Issues emerging from public participation ac tivities include the role of the universal right to health in Brazil, the balance between innovation and budget impact in England, the effect of unethical medical practices on public perception in South Korea and the legitimacy of priority-setting processes in the USA. Providing policymakers are receptive to these issues, public participation activities may be re-conceptualized as processes that illuminate policy problems relevant to a particular context, thereby promoting an agenda-setting role for the public. Originality/value - The paper offers an empirical analysis of public involvement in the case of sofosbuvir, where the relevant considerations that bear on priority-setting decisions have been particularly stark. The perspectives that emerge suggest that public participation contributes to raising attention to issues that need to be addressed by policymakers. Public participation activities can thus contribute to setting policy agendas, even if that is not their explicit purpose. However, the actualization of this contribution is contingent on the receptiveness of policymakers.

Public involvement in health priority setting: future challenges for policy, research and society

Purpose - The purpose of this paper is to reflect on the findings of this special issue and discusses the future challenges for policy, research and society. The findings suggest that challenges emerge as a result of legitimacy deficits of both consensus and contestatory modes of public involvement in health priority setting. Design/methodology/approach - The paper draws on the discussions and findings presented in this special issue. It seeks to bring the country experiences and case studies together to draw conclusions for policy, research and society. Findings - At least two recurring themes emerge. An underlying theme is the importance, but also the challenge, of establishing legitimacy in health priority setting. The country experiences suggest that we understand very little about the conditions under which representative, or authentic, participation generates legitimacy and under which it will be regarded as insufficient. A second observation is that public participation takes a variety of forms that depend on the opportunity structures in a given national context. Given this variety the conceptualization of public participation needs to be expanded to account for the many forms of public participation. Originality/value - The paper concludes that the challenges of public involvement are closely linked to the question of how legitimate processes and decisions can be generated in priority setting. This suggests that future research must focus more narrowly on conditions under which legitimacy are generated in order to expand the understanding of public involvement in health prioritization.

The importance of being NICE

Annette Rid, Peter Littlejohns, James Wilson, Benedict Rumbold, Katharina Kieslich and Albert Weale Department of Social Science, Health & Medicine, King’s College London, Strand, London WC2R 2LS, UK Department of Primary Care and Public Health Sciences, King’s College London, Weston Street, London SE1 3QD, UK Department of Philosophy, University College London, London WC1E 6BT, UK Department of Political Science, University College London, London WC1H 9QU, UK Corresponding author: Annette Rid. Email: annette.rid@kcl.ac.uk

Does accountability for reasonableness work? A protocol for a mixed methods study using an audit tool to evaluate the decision-making of clinical commissioning groups in England

Introduction Clinical commissioning groups (CCGs) in England are tasked with making difficult decisions on which healthcare services to provide against the background of limited budgets. The question is how to ensure that these decisions are fair and legitimate. Accounts of what constitutes fair and legitimate priority setting in healthcare include Daniels’ and Sabins accountability for reasonableness (A4R) and Clarks and Weales framework for the identification of social values. This study combines these accounts and asks whether the decisions of those CCGs that adhere to elements of such accounts are perceived as fairer and more legitimate by key stakeholders. The study addresses the empirical gap arising from a lack of research on whether frameworks such as A4R hold what they promise. It aims to understand the criteria that feature in CCG decision-making. Finally, it examines the usefulness of a decision-making audit tool (DMAT) in identifying the process and content criteria that CCGs apply when making decisions. Methods and analysis The adherence of a sample of CCGs to criteria emerging from theories of fair priority setting will be examined using the DMAT developed by PL. The results will be triangulated with data from semistructured interviews with key stakeholders in the CCG sample to ascertain whether there is a correlation between those CCGs that performed well in the DMAT exercise and those whose decisions are perceived positively by interviewees. Descriptive statistical methods will be used to analyse the DMAT data. A combination of quantitative and qualitative content analysis methods will be used to analyse the interview transcripts. Ethics and dissemination Full ethics approval was received by the Kings College London Biomedical Sciences, Dentistry, Medicine and Natural and Mathematical Sciences Research Ethics Subcommittee. The results of the study will be disseminated through publications in peer review journals.

Accounting for Technical, Ethical, and Political Factors in Priority Setting

Abstract—This article investigates two cases of priority setting to explore how, in addition to technical considerations, ethical and political factors shape the allocation of health resources. First, we discuss how Thai authorities adjudicated a coverage decision for HLA-B*1502 screening, which meets the national cost-effectiveness threshold for only some of the conditions it can detect. Second, we consider Englands Cancer Drugs Fund to investigate the interplay of technical decision making and political reality. Our findings suggest four concluding observations for policy makers and others considering priority-setting processes. First, we observe that different methods can produce conflicting recommendations, which makes priority setting very complex. Second, we suggest that robust processes for generating and weighing political, ethical, and technical evidence are essential because there is no absolute standard by which resource allocation decisions can be made. Third, priority setting is inherently political, and improving its technical and ethical validity means constructing political importance for these other factors. Fourth, we argue that transparency in the trade-offs required to set priorities is important ethically and can help build support politically.

Cost effective but unaffordable: an emerging challenge for health systems

New “budget impact test” is an unpopular and flawed attempt to solve a fundamentally political problem

Setting standards and monitoring quality in the NHS 1999-2013: a classic case of goal conflict: English National Health Service

Abstract 2013 saw the National Health Service (NHS) in England severely criticized for providing poor quality despite successive governments in the previous 15 years, establishing a range of new institutions to improve NHS quality. This study seeks to understand the contributions of political and organizational influences in enabling the NHS to deliver high‐quality care through exploring the experiences of two of the major new organizations established to set standards and monitor NHS quality. We used a mixed method approach: first a cross‐sectional, in‐depth qualitative interview study and then the application of principal agent modeling (Waterman and Meier broader framework). Ten themes were identified as influencing the functioning of the NHS regulatory institutions: socio‐political environment; governance and accountability; external relationships; clarity of purpose; organizational reputation; leadership and management; organizational stability; resources; organizational methods; and organizational performance. The organizations could be easily mapped onto the framework, and their transience between the different states could be monitored. We concluded that differing policy objectives for NHS quality monitoring resulted in central involvement and organizational change. This had a disruptive effect on the ability of the NHS to monitor quality. Constant professional leadership, both clinical and managerial, and basing decisions on best evidence, both technical and organizational, helped one institution to deliver on its remit, even within a changing political/policy environment. Application of the Waterman–Meier framework enabled an understanding and description of the dynamic relationship between central government and organizations in the NHS and may predict when tensions will arise in the future.

Setting standards and monitoring quality in the NHS 1999–2013: a classic case of goal conflict

Abstract 2013 saw the National Health Service (NHS) in England severely criticized for providing poor quality despite successive governments in the previous 15 years, establishing a range of new institutions to improve NHS quality. This study seeks to understand the contributions of political and organizational influences in enabling the NHS to deliver high‐quality care through exploring the experiences of two of the major new organizations established to set standards and monitor NHS quality. We used a mixed method approach: first a cross‐sectional, in‐depth qualitative interview study and then the application of principal agent modeling (Waterman and Meier broader framework). Ten themes were identified as influencing the functioning of the NHS regulatory institutions: socio‐political environment; governance and accountability; external relationships; clarity of purpose; organizational reputation; leadership and management; organizational stability; resources; organizational methods; and organizational performance. The organizations could be easily mapped onto the framework, and their transience between the different states could be monitored. We concluded that differing policy objectives for NHS quality monitoring resulted in central involvement and organizational change. This had a disruptive effect on the ability of the NHS to monitor quality. Constant professional leadership, both clinical and managerial, and basing decisions on best evidence, both technical and organizational, helped one institution to deliver on its remit, even within a changing political/policy environment. Application of the Waterman–Meier framework enabled an understanding and description of the dynamic relationship between central government and organizations in the NHS and may predict when tensions will arise in the future.

Setting standards and monitoring quality in the NHS 1999–2013

Abstract 2013 saw the National Health Service (NHS) in England severely criticized for providing poor quality despite successive governments in the previous 15 years, establishing a range of new institutions to improve NHS quality. This study seeks to understand the contributions of political and organizational influences in enabling the NHS to deliver high‐quality care through exploring the experiences of two of the major new organizations established to set standards and monitor NHS quality. We used a mixed method approach: first a cross‐sectional, in‐depth qualitative interview study and then the application of principal agent modeling (Waterman and Meier broader framework). Ten themes were identified as influencing the functioning of the NHS regulatory institutions: socio‐political environment; governance and accountability; external relationships; clarity of purpose; organizational reputation; leadership and management; organizational stability; resources; organizational methods; and organizational performance. The organizations could be easily mapped onto the framework, and their transience between the different states could be monitored. We concluded that differing policy objectives for NHS quality monitoring resulted in central involvement and organizational change. This had a disruptive effect on the ability of the NHS to monitor quality. Constant professional leadership, both clinical and managerial, and basing decisions on best evidence, both technical and organizational, helped one institution to deliver on its remit, even within a changing political/policy environment. Application of the Waterman–Meier framework enabled an understanding and description of the dynamic relationship between central government and organizations in the NHS and may predict when tensions will arise in the future.