I have worked in health technology assessment (HTA) since 1975, beginning in the United States Congress Office of Technology Assessment (OTA), where we were charged with defining “medical technology assessment”. My main concern in HTA has always been efficacy of healthcare interventions. After years in OTA, I was invited to the Netherlands in 1985, where the Dutch government invited me to head a special commission concerning future healthcare technology and HTA. From there, I became involved in over forty countries, beginning in Europe and then throughout the world. My most intense involvements, outside the United States and Europe, have been in Brazil, China, and Malaysia. During these 40-plus years, I have seen HTA grow from its earliest beginnings to a worldwide force for better health care for everyone. I have also had some growing concerns, outlined in this Perspective article. Within HTA, I am most disappointed by a narrow perspective of cost-effective analysis, which tends to ignore considerations of culture, society, ethics, and organizational and legal issues. In the general environment affecting HTA and health care, I am most concerned about the need to protect the independence of HTA activities from influences of the healthcare industries.

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.

Introduction: The translation of best evidence into practice has become an important purpose of policy making in health care. In Brazil, a country of continental dimensions with widespread regional and social inequalities, the dissemination and use of the best-evidence in policy making is a critical issue for the healthcare system.Objectives: The main purpose of this study is to describe an evidence-based public health policy with special emphasis on guidelines creation for high-cost medicines. We also describe how that strategy was diffused to the judiciary system and to other parts of the healthcare system.Results: We present an 11-year follow-up of a national project for creating and updating guidelines for high-cost medicines in Brazil. A total of 109 national guidelines were published (new or updated versions) for 66 selected diseases, the first such effort in Brazilian history. The project influenced the Brazilian legislature, which has recently established a Federal Law requiring national guidelines for any new technology listed for payment by the Brazilian public healthcare system.Conclusion: We were able to involve many different stakeholders in a partnership between academia and policy makers, which made possible the widespread dissemination of the clinical practice guidelines. Problems and constraints were also encountered. This evolving public health strategy might be useful for other developing 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. (C) 2009 Elsevier Ireland Ltd. All rights reserved.

Aims and Scope:The International Journal of Technology Assessment in Health Care has as its specific scope of interest the generation, evaluation, diffusion, and use of health care technology.It addresses the diverse audience of health care providers within medicine, public health, nursing, and the allied health professions; decision makers in government, industry, and health care organizations; and the scholarly disciplines such as ethics, economics, law, history, sociology, psychology, and engineering.The journal aims to fill the needs of those interested in the complexities of interaction between people and technology; technology as a force in social and organizational change; and technology as it is created, produced, applied, and paid for.It examines descriptively and analytically the effects of technology as perceived from the vantage point of different academic disciplines and policy-making organizations and examines methods necessary to conduct studies and evaluations of technology.The focus of the journal is the international health care community.The experience of different countries in their encounter with health care technology, viewed comparatively, is invaluable to understanding its effects.Further, it is important to establish ties with the scholars, governments, and private institutions concerned with health care technology so that the experiences and learning of the international community in its parts can benefit the whole.The use of technology in health care has created some of the major dilemmas in society today.The journal serves as a forum for the wide range of professionals interested in the assessment of medical technology, its consequences for patients, and its impact on society.

The aim of this report was to describe the history of health technology assessment (HTA) in The Netherlands.This article is a descriptive review from two people who have been very much involved in the events described and is based on review of relevant policy documents and Web sites.HTA has been progressively developed in The Netherlands since (at least) the early 1980s. Beginning in 1985, there were progressive attempts to expand and institutionalized HTA in The Netherlands healthcare system. These attempts were generally successful, but did not result in a national agency for HTA. An important development in HTA in The Netherlands was a special fund (Ontwikkelingsgeneeskunde) designed to support prospective HTAs with the main purpose of affecting insurance coverage decisions. The administration of this fund moved progressively to broaden the subjects chosen for analysis to include such subjects as chronic illness and disability. A more-or-less hidden conflict developed in the question of the leadership and orientation of this fund, with the result that it was largely moved to a more research-oriented and less policy-oriented site.The situation today is that HTA is visible and is used by the government in policy decisions, especially in the areas of prevention and screening. In addition, HTA is influential in insurance coverage decision making, especially in the field of pharmaceuticals. The principles of HTA and evidence-based medicine are generally familiar to physicians and other clinicians, however, the influence of HTA on clinical and administrative decisions is less than in some other countries.

Objectives: The aim of this study was to describe generally the development and present situation with health technology assessment (HTA) in the United Kingdom. Methods: The methods used are a review of important materials that have described the development process and present situation, supplemented by some personal experiences. Results: The United Kingdom has been characterized historically as a country with a strong interest in evidence in health care, both clinical trials for efficacy and cost-effectiveness analyses. However, this evidence was not well-linked to the needs of the National Health Services (NHS) before formation of the NHS R&D Programme in 1991, The R&D Programme brought substantial resources into HTA and related activities, with the central aim of improving health care in Britain and increasing value for money. However, policy makers as well as staff of the R&D Programme were dissatisfied with the use of the HTA results in clinical and administrative practice. Therefore, the National Institute of Clinical Excellence (NICE) was formed in 1999. NICE issues guidance intended to influence practical decision making in health care at the national and local levels, based on efficacy information and, in some cases, economic analyses. NICE is now also seeking ways to maximize impacts on practice. Conclusions: The UK experience shows that information on clinical and cost-effectiveness may not be enough to change practice, at least in the short-run. Still, one may conclude that the United Kingdom now has one of the few most important and influential HTA programs in the world.

Objectives:This study is to review health technology assessment (HTA) development in China during the past two decades, and to facilitate further development of HTA and its integration into policy making.Methods:The study depends very much on the extensive experiences of the authors in involvement of HTA in China. In addition, literature review and Web site searching have been used to trace the process of growth of HTA in China.Results:With its rapid economic development, the Chinese health system has had many achievements in the past 30 years. However, there are some weaknesses that have developed during this period. HTA is traced back to the early 1990s in China. First, HTA knowledge transfer and establishment of HTA units were effective ways to develop HTA in China. By the end of 1990s, the policy makers of the Ministry of Health (MoH) made efforts to merge HTA with policy making to improve the quality and efficiency of health care. The main government authorities related to health technology are the State Food and Drug Administration, the Ministry of Labor and Social Security, and the MoH. Their involvements in HTA are varied.Conclusion:A technology licensure mechanism based on HTA, including technology permission for use, institution licensure, and workforce licensure, is being gradually carried out by the MoH in China. Moreover, HTA can play an important role in technology market entry, insurance benefit coverage, formulary, clinical pathway, reimbursement, and so on. There is a great opportunity for HTA to be an important part of health reform, especially to help policy makers within the health sector to make difficult decisions.

This study summarizes the experience with health technology assessment (HTA) at the European level. Geographically, Europe includes approximately fifty countries with a total of approximately 730 million people. Politically, twenty-seven of these countries (500 million people) have come together in the European Union. The executive branch of the European Union is named the European Commission, which supports several activities, including research, all over Europe and in many other parts of the world. The European Commission has promoted HTA by several policy positions and has funded a series of projects aimed at strengthening HTA in Europe. Around fifteen of the European countries now have formal national programs on HTA and some also have regional public programs. All countries that are members of the European Union and do not have a national approach to HTA have an interest in becoming more involved. The HTA projects sponsored by the European Commission have focused on networking and collaboration among established agencies and institutions for HTA, however, also on capacity building, support, and facilitation in creating mechanisms for HTA in European countries that still do not have any program in the field.

For the past several years, we have discussed the idea of producing a publication on the history of health technology assessment (HTA). It seemed important to us to develop this history now, while those who lived it can give their own accounts. An exception is Seymour Perry, the first president of ISTAHC and the Director of the first national public program in HTA, the U.S. National Center for Health Care Technology (NCHCT). See the In Memoriam in this issue.

The International Society for Technology Assessment in Health Care (ISTAHC) was formed in 1985. It grew out of the increasing awareness of the international dimensions of health technology assessment (HTA) and the need for new communication methods at the international level. The main function of ISTAHC was to present an annual conference, which gradually grew in size, and also to generally improve in quality from to year. ISTAHC overextended itself financially early in the first decade of the 2000s and had to cease its existence. A new society, Health Technology Assessment international (HTAi), based on many of the same ideas and people, grew up beginning in the year 2003. The two societies have played a large role in making the field of HTA visible to people around the world and providing a forum for discussion on the methods and role of HTA.

The U.S. Congressional Office of Technology Assessment (OTA) established a health program in 1975. During the next few years, OTA's health program published a series of reports dealing with different aspects of health technology assessment (HTA) in some depth. The key report in this series concerned the efficacy and safety of health technology, which in many ways played a ground-breaking role. It pointed out the pervasive lack of accessible information on efficacy and safety, despite more-than-adequate methods of assessment. It also pointed to many problems that resulted from this lack, and the limited use of such information in clinical practice and policy making. It promoted synthesis of existing literature as a practical method of assessment. Other key reports developed other aspects of HTA, including cost-effectiveness. These reports are generally considered to have shaped the field of HTA at least into the 1990s. OTA also pioneered the use of HTA in determining what preventive services to cover in public healthcare programs.

Technology is generally defined as "science or knowledge applied to a definite purpose." Technology assessment has been defined as a form of policy research that examines short- and long-term consequences (for example, societal, economic, ethical, legal) of the application of technology. The goal of technology assessment was said to be to provide policy makers with information on policy alternatives. Health technology assessment (HTA) grew out of this field and was developed in the U.S. Office of Technology Assessment (OTA). However, the OTA was closed in 1995. The links between technology assessment and health technology assessment were more-or-less lost after the dissolution of OTA, and few workers in the field of HTA seem familiar with the roots of the field in the more general and social-oriented technology assessment.

The Pan American Health Organization (PAHO), Regional Office of the World Health Organization (WHO) for the Americas, has tried to promote health technology assessment (HTA) in Latin America for 25 years. A certain awareness of HTA developed in several countries because of these efforts. In the late 1990's, there was a strong movement for health reform in Latin America, and HTA became part of that movement. Countries that now are actively institutionalizing HTA include Brazil, Mexico, Chile, and Argentina. Other countries, such as Costa Rica, Colombia, Cuba, Peru, Panamá, Paraguay, Trinidad and Tobago, and Uruguay, are following these trends and some others seem to be moving in this direction within the next few years.

Cost-effectiveness analysis as an aid to decision making has been increasingly publicized and discussed during the past two to three decades. However, the total body of cost-effectiveness analyses in health care is actually rather small, and high-quality studies are rather rare. Furthermore, the applications of economic analysis to health policy have been hampered by a number of problems, including those that are methodological and contextual. We consider a number of areas of public health policy but pay special attention to a growing area of inquiry and application: the overall coverage of health services. Cost-effectiveness analysis has played a relatively small role in general coverage decisions, but in recent years, it has been applied increasingly to decisions concerning pharmaceutical coverage. We speculate on concerning reasons for this particular focus in cost-effectiveness analysis. Future progress will depend heavily on discussion and consensus building.

The issue of evidence for decision-making, including formal policy-making and public health policy, has increased rapidly in prominence during the past few years. The term “evidence-based” was first used in health care in 1992, when Sackett and others coined the term “evidence-based medicine” (42). More recently, many have asked if public health activities are based on evidence (2;8;13;19;30).