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.

National guidelines for high-cost drugs in Brazil: achievements and constraints of an innovative national evidence-based public health policy.

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.

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.

Health technology assessment development in China.

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.

History of the international societies in health technology assessment: International Society for Technology Assessment in Health Care and Health Technology Assessment International.

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.

What is technology assessment?

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.

Office of Technology Assessment health program.

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.

A history of health technology assessment at the European level.

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.

Development of health technology assessment in France.

OBJECTIVES: The aim of this study was to describe the history of health technology assessment (HTA) in France. METHODS: The approach was a descriptive review done by people who have been very much involved in this history. RESULTS: The interest in HTA and evaluation as a tool for health decision making goes back to the 1970s in France. During the 1980s, there were several attempts to develop a national HTA agency, which finally came to fruition with the development of the Agence Nationale de l'Evaluation Medicale (ANDEM) in 1989. ANDEM's main success, perhaps, was in making HTA known in France by developing its own assessments, writing and validating appropriate methodologies for assessing medical technology and medical practices, and by organizing in France the development of programs of consensus development conferences, which the ANDEM either organized itself or supported and validated. In the mid-1990s, the mandate of ANDEM was extended to hospital accreditation and the agency's name was changed to Agence Nationale d'Accreditation et d'Evaluation en Sante (ANAES). Finally, in 2005, the National Authority for Health (HAS) was formed to consolidate efforts to centralize the programs of HTA, aiming at helping decision making regarding reimbursement and pricing, in one agency and to define the optimal use of health technology in France. CONCLUSIONS: HTA has become a strong influence in the healthcare system in France. These developments may be considered rather typical of the approach to public policy questions in France, where regulation is more in use than in other countries (at least in the healthcare field). At the same time, this approach has made lobbying and other attempts to influence decisions common as well, so one might say that HTA is more politicized than in some other countries in Europe.

Health technology assessment in the United Kingdom.

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.

Health technology assessment in Latin America and the Caribbean.

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.

The Netherlands.

OBJECTIVE: The aim of this report was to describe the history of health technology assessment (HTA) in The Netherlands. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

The development of health technology assessment in Brazil.

OBJECTIVES: The aim of this study was to describe the developing health technology assessment (HTA) activities in Brazil, both historically and in the present day. METHODS: This report is a descriptive analysis based on personal experiences of the authors and on selected literature. RESULTS: Interest in HTA in Brazil began in the mid-1980s. Several seminars and consultations were held, often with invited foreign participants. A cadre of people with knowledge and expertise in HTA was gradually developed. In 2003, several policies were developed by the federal government of Brazil to encourage HTA and base clinical, management, and policy decisions on HTA. During the past 5 years, institutional development has been rapid in government, private companies (mainly prepaid health plans), academia, and research institutes. Further policy changes are needed to maximize the impact of these developments. Nevertheless, although the growing network of HTA programs will have a considerable impact on Brazilian health care, further institutional development could stimulate this change. CONCLUSIONS: It would be desirable if the Federal Ministry of Health of Brazil were to proceed to develop a national agency for HTA.

Какова действенность/эффективность, и каковы финансовые и организационные аспекты дородовой помощи?

Дородовая помощь, известная также как антенатальная или перинатальная помощь, – это комплекс медицинских услуг, которые беременная женщина получает от организованной системы медицинского обслуживания. Число различных дородовых услуг, оказываемых в ходе примерно 12–16 посещений беременной женщиной медицинского учреждения, является весьма значительным. Цель дородовой помощи – предупредить или своевременно выявить и скорректировать состояния, которые могут угрожать здоровью плода/новорожденного и/или матери, а также помочь женщине сформировать позитивную установку по отношению к беременности и родам. Дородовая помощь может внести значительный вклад в достижение этой цели и, в частности, она может помочь обеспечить новорожденному хороший старт в жизни. Сеть фактических данных по вопросам здоровья (СФДЗ), работа которой была инициирована и координируется Eвропейским региональным бюро ВОЗ, представляет собой информационную службу для лиц, принимающих решения в области общественного здравоохранения и медицинской помощи, в Европейском регионе ВОЗ. СФДЗ может также быть полезна и другим заинтересованным сторонам.

What is the efficacy/effectiveness of antenatal care and the financial and organizational implications?

Antenatal care, also known as prenatal care, is the complex of interventions that a pregnant woman receives from organized health care services. The number of different interventions in antenatal care is large. These interventions may be provided in approximately 12–16 antenatal care visits during a pregnancy. The purpose of antenatal care is to prevent or identify and treat conditions that may threaten the health of the fetus/newborn and/or the mother, and to help a woman approach pregnancy and birth as positive experiences. To a large extent antenatal care can contribute greatly to this purpose and can in particular help provide a good start for the newborn child. This report is Health Evidence Network’s (HEN’s) response to a question from a decision-maker. It provides a synthesis of the best available evidence, including a summary of the main findings and policy options related to the issue. HEN, initiated and coordinated by the WHO Regional Office for Europe, is an information service for public health and health care decision-makers in the WHO European Region. Other interested parties might also benefit from HEN.

The development of health technology assessment.

The field of health technology assessment (HTA) is still relatively new, but it has shown remarkable growth over the last decade, having spread first from the United States to Europe, and now to the entire world. HTA seeks to couple evidence with decision-making, and thus has similarities to evidence-based health care and evidence-based policy-making. The early history of HTA, beginning around 1975, reveals a first period of synthesising available evidence-principally that dealing with efficacy and cost-effectiveness of health care interventions-so as to put it in a format helpful to health policy-makers, especially those in national governments. From 1985 or so, the focus of the second period was on seeking more effective links with these policy-makers, particularly in Europe. The most recent period, beginning in the late 1990s, has been increasingly devoted to more effective dissemination and implementation in order to influence administrators and clinicians. While early assessments tended to focus on large, expensive, machine-based technologies, the scope has gradually widened to include smaller technologies, 'softer' technologies (such as counselling), and health care needs. Actual assessments have also taken on broader issues, such as organisational, social, and ethical implications. In the Member States of the European Union (EU), HTA activities are increasingly visible, and almost all now have a national focus for HTA associated with the Ministry of Health or its equivalent. Central and Eastern European countries are also developing HTA activities. Most recently, HTA has been highlighted by health policy documents from the European Commission. It seems likely that HTA will in the future be institutionalised in some form as part of EU activities.