Wija Oortwijn

The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries

OBJECTIVE Middle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage. METHODS We selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA. RESULTS All countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation. CONCLUSIONS The study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies.

Introduction: health technology assessment and the European Union

Health technology assessment (HTA) has become increasingly important in the European Union as an aid to decision making. As agencies and programs have been established, there is increasing attention to coordination of HTA at the European level, especially considering the growing role of the European Union in public health in Europe. This series of papers describes and analyzes the situation with regard to HTA in the 15 members of the European Union, plus Switzerland. The final paper draws some conclusions, especially concerning the future involvement of the European Commission in HTA.

MAPPING OF HEALTH TECHNOLOGY ASSESSMENT IN SELECTED COUNTRIES

OBJECTIVES The aim of this study was to develop and apply an instrument to map the level of health technology assessment (HTA) development at country level in selected countries. We examined middle-income countries (Argentina, Brazil, India, Indonesia, Malaysia, Mexico, and Russia) and countries well-known for their comprehensive HTA programs (Australia, Canada, and United Kingdom). METHODS A review of relevant key documents regarding the HTA process was performed to develop the instrument which was then reviewed by selected HTAi members and revised. We identified and collected relevant information to map the level of HTA in the selected countries. This was supplemented by information from a structured survey among HTA experts in the selected countries (response rate: 65/385). RESULTS Mapping of HTA in a country can be done by focusing on the level of institutionalization and the HTA process (identification, priority setting, assessment, appraisal, reporting, dissemination, and implementation in policy and practice). Although HTA is most advanced in industrialized countries, there is a growing community in middle-income countries that uses HTA. For example, Brazil is rapidly developing effective HTA programs. India and Russia are at the very beginning of introducing HTA. The other middle-income countries show intermediate levels of HTA development compared with the reference countries. CONCLUSIONS This study presents a set of indicators for documenting the current level and trends in HTA at country level. The findings can be used as a baseline measurement for future monitoring and evaluation. This will allow a variety of stakeholders to assess the development of HTA in their country, help inform strategies, and justify expenditure for HTA.

Ethics and HTA: Some lessons and challenges for the future

What have we learned? Is there in the contribution to this special theme a clue as to what is the best way of integrating ethical inquiry into health technology assessment (HTA)? Particularly, what is the significance of the social shaping perspective in this respect? In this concluding paper, we attempt to collect the lessons we have learnt and to answer these questions. Of course, our answer will not be the final one. It is difficult to find an appropriate and widely endorsed model of integrating ethical implications in HTA studies, if there is such a single appropriate model at all. But despite reserves, it is equally fair to claim that it is definitely possible to reach beyond what ethical inquiry in HTA too often concerns, namely to conclude that ‘‘the technology raises serious ethical concerns that must be dealt with.’’ This is truly a death sentence, for both HTA and medical ethics, just when their integration is called for. In the remainder of this paper, we address three questions. First, the main question of this issue is: How could ethical inquiry be integrated into HTA? Or in other words: What methods do we have to address moral aspects of technology in a valid and useful way? This question is addressed by discussing the following aspects: How can ethical issues be identified and addressed, and how could the perspective of social shaping of technology add to this? Second: Who is to face the challenge of ethical inquiry? Under this header, we discuss the role of researchers, policy-makers, laypersons, and ethicists. In addition, we address the issue of moral competence. Poiesis Prax (2004) 2: 247–256 DOI 10.1007/s10202-003-0054-1

The use of societal criteria in priority setting for health technology assessment in the Netherlands: Initial experiences and future challenges

Priority setting for the evaluation of health technologies in the Netherlands is exclusively based on the scientific merits of individual research proposals. This process has not resulted in satisfactory allocation of resources. Therefore, societal criteria for setting priorities for health technology assessment have been proposed as an adjunct to scientific criteria. These societal criteria include the burden of disease, uncertainty about the (cost-)effectiveness of the intervention at issue, the potential benefits of the research project, and its potential impact on health care. To realize the full potential of this model for priority setting, a number of methodological issues need to be addressed. Joint efforts of researchers and policy makers in this field are necessary for future progress.

Harmonization of ethics in health technology assessment: a revision of the Socratic approach.

BACKGROUND Ethics has been part of health technology assessment (HTA) from its beginning in the 1970s, and is currently part of HTA definitions. Several methods in ethics have been used in HTA. Some approaches have been developed especially for HTA, such as the Socratic approach, which has been used for a wide range of health technologies. The Socratic approach is used in several ways, and there is a need for harmonization to promote its usability and the transferability of its results. Accordingly, the objective of this study was to stimulate experts in ethics and HTA to revise the Socratic approach. METHODS Based on the current literature and experiences in applying methods in ethics, a panel of ethics experts involved in HTA critically analyzed the limitations of the Socratic approach during a face-to-face workshop. On the basis of this analysis a revision of the Socratic approach was agreed on after deliberation in several rounds through e-mail correspondence. RESULTS Several limitations with the Socratic approach are identified and addressed in the revised version which consists of a procedure of six steps, 7 main questions and thirty-three explanatory and guiding questions. The revised approach has a broader scope and provides more guidance than its predecessor. Methods for information retrieval have been elaborated. CONCLUSION The presented revision of the Socratic approach is the result of a joint effort of experts in the field of ethics and HTA. Consensus is reached in the expert panel on an approach that is considered to be more clear, comprehensive, and applicable for addressing ethical issues in HTA.

Logic models help make sense of complexity in systematic reviews and health technology assessments

OBJECTIVE To describe the development and application of logic model templates for systematic reviews and health technology assessments (HTAs) of complex interventions. STUDY DESIGN AND SETTING This study demonstrates the development of a method to conceptualize complexity and make underlying assumptions transparent. Examples from systematic reviews with specific relevance to Sub-Saharan Africa (SSA) and other low- and middle-income countries (LMICs) illustrate its usefulness. RESULTS Two distinct templates are presented: the system-based logic model, describing the system in which the interaction between participants, intervention, and context takes place; and the process-orientated logic model, which displays the processes and causal pathways that lead from the intervention to multiple outcomes. CONCLUSION Logic models can help authors of systematic reviews and HTAs to explicitly address and make sense of complexity, adding value by achieving a better understanding of the interactions between the intervention, its implementation, and its multiple outcomes among a given population and context. They thus have the potential to help build systematic review capacity-in SSA and other LMICs-at an individual level, by equipping authors with a tool that facilitates the review process; and at a system-level, by improving communication between producers and potential users of research evidence.

REVEALING AND ACKNOWLEDGING VALUE JUDGMENTS IN HEALTH TECHNOLOGY ASSESSMENT

BACKGROUND Although value issues are increasingly addressed in health technology assessment (HTA) reports, HTA is still seen as a scientific endeavor and sometimes contrasted with value judgments, which are considered arbitrary and unscientific. This article aims at illustrating how numerous value judgments are at play in the HTA process, and why it is important to acknowledge and address value judgments. METHODS A panel of experts involved in HTA, including ethicists, scrutinized the HTA process with regard to implicit value judgments. It was analyzed whether these value judgments undermine the accountability of HTA results. The final results were obtained after several rounds of deliberation. RESULTS Value judgments are identified before the assessment when identifying and selecting health technologies to assess, and as part of assessment. They are at play in the processes of deciding on how to select, frame, present, summarize or synthesize information in systematic reviews. Also, in economic analysis, value judgments are ubiquitous. Addressing the ethical, legal, and social issues of a given health technology involves moral, legal, and social value judgments by definition. So do the appraisal and the decision-making process. CONCLUSIONS HTA by and large is a process of value judgments. However, the preponderance of value judgments does not render HTA biased or flawed. On the contrary they are basic elements of the HTA process. Acknowledging and explicitly addressing value judgments may improve the accountability of HTA.

Systems for routine information sharing in HTA. Working group 2 report.

The aim of Working Group 2 has been to develop a system for routine exchange of information concerning ongoing or planned evaluations and their findings, priority setting, and emerging technology. Routine exchange of information in health technology assessment (HTA) is internationally recognized as a needed and beneficial element of health systems development. HTA activities in all European Union (EU) member states can benefit from effective information exchange relating to three major challenges: 1. Avoiding duplication of effort by staying informed about ongoing and/or planned domestic and international HTA projects; 2. Setting priorities among technologies needing assessment; and 3. Keeping abreast of emerging health technologies. Although the scope of Working Group 2 covered six objectives (listed below), the groups work, and the summary below, was directed specifically at objectives 1, 2, and 3. Objective 4 has been addressed separately in a report submitted by the European Information Network on New and Changing Health Technologies (EuroScan), and Objectives 5 and 6 are addressed in greater detail by reports submitted from other working groups in the ECHTA/ECAHI project.

INTEGRATING ETHICS IN HEALTH TECHNOLOGY ASSESSMENT: MANY WAYS TO ROME

OBJECTIVES The aim of this study was to identify and discuss appropriate approaches to integrate ethical inquiry in health technology assessment (HTA). METHODS The key question is how ethics can be integrated in HTA. This is addressed in two steps: by investigating what it means to integrate ethics in HTA, and by assessing how suitable the various methods in ethics are to be integrated in HTA according to these meanings of integration. RESULTS In the first step, we found that integrating ethics can mean that ethics is (a) subsumed under or (b) combined with other parts of the HTA process; that it can be (c) coordinated with other parts; or that (d) ethics actively interacts and changes other parts of the HTA process. For the second step, we found that the various methods in ethics have different merits with respect to the four conceptions of integration in HTA. CONCLUSIONS Traditional approaches in moral philosophy tend to be most suited to be subsumed or combined, while processual approaches being close to the HTA or implementation process appear to be most suited to coordinated and interactive types of integration. The article provides a guide for choosing the ethics approach that appears most appropriate for the goals and process of a particular HTA.