Priority setting for expensive biopharmaceuticals is one of the most important challenges for publicly funded health systems. One of the drivers of rising healthcare expenditures is pharmaceuticals (i.e., drugs). Moreover, people are living longer and their expectation of, and demand for, health care, drugs, and services are continually increasing. The overall aim of this research was to describe and evaluate reimbursement decisions for six expensive biopharmaceuticals across five countries in order to ascertain if the processes were legitimate and fair. I conducted qualitative case studies of six expensive biopharmaceuticals in order to describe and evaluate the priority setting activities of eight committees across five countries, including Canada, England and Wales, Australia, Israel and the United States. Data sources included: 1) 32 documents and 2) 56 interviews with informants. The recommendations process of each committee partially met the four conditions of ‘accountability for reasonableness’. My main finding is that, while a number of values were considered by committees when making reimbursement decisions, committees tended to focus on values of evidence, effectiveness and efficiency, but not the full range of relevant values. Thus, these contexts did not fully meet the conditions of legitimacy and fairness. I have provided an in-depth description of the eight committees’ priority setting activities regarding the study drugs, as well as committee members’, patients’ and industry representatives’ views regarding the process. I developed practical guidance for leaders for improving reimbursement decisions for expensive biopharmaceuticals, the implementation of which would enhance the fairness and legitimacy of priority setting. This study has demonstrated that in order to create a fair and legitimate drug reimbursement process, we need to ensure the incorporation of a wide range of values, and the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes.

Priority setting for expensive biopharmaceuticals is one of the most important challenges for publicly funded health systems. One of the drivers of rising healthcare expenditures is pharmaceuticals (i.e., drugs). Moreover, people are living longer and their expectation of, and demand for, health care, drugs, and services are continually increasing. The overall aim of this research was to describe and evaluate reimbursement decisions for six expensive biopharmaceuticals across five countries in order to ascertain if the processes were legitimate and fair. I conducted qualitative case studies of six expensive biopharmaceuticals in order to describe and evaluate the priority setting activities of eight committees across five countries, including Canada, England and Wales, Australia, Israel and the United States. Data sources included: 1) 32 documents and 2) 56 interviews with informants. The recommendations process of each committee partially met the four conditions of ‘accountability for reasonableness’. My main finding is that, while a number of values were considered by committees when making reimbursement decisions, committees tended to focus on values of evidence, effectiveness and efficiency, but not the full range of relevant values. Thus, these contexts did not fully meet the conditions of legitimacy and fairness. I have provided an in-depth description of the eight committees’ priority setting activities regarding the study drugs, as well as committee members’, patients’ and industry representatives’ views regarding the process. I developed practical guidance for leaders for improving reimbursement decisions for expensive biopharmaceuticals, the implementation of which would enhance the fairness and legitimacy of priority setting. This study has demonstrated that in order to create a fair and legitimate drug reimbursement process, we need to ensure the incorporation of a wide range of values, and the involvement of multiple stakeholder groups within the deliberative and appeals/revisions processes.

Background During the 1990s, Tanzania, like many other developing countries, adopted health sector reforms. The most common policy change under health sector reforms has been decentralisation, which involves the transfer of power and authority from the central levels to the local governments. However, while decentralisation of health care planning and priority-setting in Tanzania gained currency in the last decade, its performance has, so far, been less than satisfactory. In a five-year EU-supported project, which started in 2006, ways of strengthening fairness and accountability in priority-setting in district health management were studied through action research. As part of this overall project, this doctoral thesis aims to analyse the existing health care organisation and management systems, and explore the potential and challenges of implementing Accountability for Reasonableness approach to priority setting in Tanzania. Methods A qualitative case study in Mbarali district formed the basis of exploring the socio-political and institutional contexts within which health care decision-making takes place. The thesis also explores how the Accountability for Reasonableness intervention was shaped, enabled and constrained by the interaction between the contexts and mechanisms. Key informant interviews were conducted with the Council Health Management Team, local government officials, and other stakeholders, using a semi-structured interview guide. Relevant documents were also gathered and group priority-setting processes in the district were observed. Main findings The study revealed that, despite the obvious national rhetoric on decentralisation, actual practice in the district involved little community participation. The findings showed that decentralisation, in whatever form, does not automatically provide space for community engagement. The assumption that devolution to local government promotes transparency, accountability and community participation, is far from reality. In addition, the thesis found that while the Accountability for Reasonableness approach to priority setting was perceived to be helpful in strengthening transparency, accountability, stakeholder engagement and fairness, integrating the innovation into the current district health system was challenging.   Conclusion This thesis underscores the idea that greater involvement and accountability among local actors may increase the legitimacy and fairness of priority-setting decisions. A broader and more detailed analysis of health system elements, and socio-cultural context, can lead to better prediction of the effects of the innovation, pinpoint stakeholders’ concerns, and thereby illuminate areas requiring special attention in fostering sustainability. Additionally, the thesis stresses the need to recognise and deal with power asymmetries among various actors in priority-setting contexts.

全民健保醫療給付範圍的相關決策缺乏資訊公開性與參與性，引發許多醫療給付的糾紛案件，加上醫療資源有限，醫療需求隨國內人口平均餘命提升而增加，醫療資源優先配置的問題更顯其重要性。本研究建立一個合理的醫療資源優先配置決策程序評估架構，以改善目前國內資源優先配置決策程序，使用Daniels & Sabin(1997)所提出的「要求合理性的課則」（Accountability for Reasonableness）作為評估架構的主要構面，採用文獻分析法與層級分析法建構出一個完整的評估架構並且比較指標間的相互權重，接著使用深度訪談法試圖探索評估指標相對權重背後所代表的意涵。研究結果顯示醫事團體代表強調相關性與決策修正機會，政府代表則注重公開性與執行力，兩者對於醫療資源優先配置決策程序的期待有相當大的落差。基於研究發現，本研究主張應該增加協商機會以減少決策成員間的認知落差，帶動社會大眾對於資源優先配置的認識與參與，並針對目前決策程序的公開性、相關性、決策修正機會與執行力進行改善。 / The lack of information publicity and participation in the payment system of National Health Insurance (NHI) in Taiwan has been a critical issue. Besides numerous insurance payment disputations, the limited health resources and increasing health demand all call for an immediate solution to the problem of health resource priority setting in NHI.. This study aims to establish a systemic evaluative framework to improve on the health resources priority settings. In answer to the need, analytical hierarchy process and in-depth interviews have been conducted to develop a framework based on Accountability for Reasonableness. Qualitative and quantitative analysis of the surveys indicate some criteria and the meaning of the relative weight of each criterion. The results show a discrepancy between the governmental representatives and the healthcare organization ones on the expectation of health resources priority settings. The former focus on relevance, revision and appeals while the latter emphasize publicity and enforcement. According to the findings, this study suggests that an increase of negotiation is necessary to eliminate the discrepancy between the two groups. The government also need to introduce the public the idea of health resources priority settings and to modify the current procedure based on the four factors in Accountability for Reasonableness.