Objectives: The aim of this study was to review the history of health technology assessment (HTA) in Italy.

Methods: Founded in 1978, the Italian National Health Service (NHS) has been strongly regionalized mainly after a constitutional reform, which started a devolution process. HTA started in the 1980s at the National Institute of Health and in a few University Hospitals, with a focus on big ticket technology: that process was driven by clinical engineers.

Results: In recent years, HTA is becoming an important tool for decision-making processes at central, regional, and local levels. In particular, the National Agency for Regional Health Services (AGENAS) and five regions (of twenty-one) are strongly committed to develop HTA initiatives connected with the planning process.

Conclusions: At the local level, the hospital-based HTA activity is probably the most important peculiarity of the country and the real driver of the HTA movement.

Objectives: The aim of this study was to describe the history and present situation with health technology assessment (HTA) in Israel.

Methods: The method used in this study was a historical analysis based mainly on the knowledge of the authors, but supplemented by the published literature.

Results: HTA originated in Israel as a centralized function conducted under the auspice of research, developing into an active multidisciplinary center. Throughout the expansion of the field, HTA was performed in affiliation with several local and international bodies, while providing direct and indirect support at the national level. Today, mainly as a result of vigorous dissemination of the principles, methodology and tools for HTA by the Israeli Center for Technology Assessment in Health Care (ICTAHC), this discipline is increasingly a decentralized activity conducted by a great variety of institutions. Israeli health policy decisions are increasingly based on the results of HTA.

Conclusions: ICTAHC's role and functioning has expanded since its beginnings. HTA has become an important part of health care in Israel.

Objectives: To describe how Lithuania is attempting to develop health technology assessment (HTA) structures.

Methods: The case study of the history of development of HTA in Lithuania is presented.

Results: Historical steps of HTA development are as follows: in 1993, a few conferences on HTA; eight people were trained in Sweden at SBU; the book First Steps of HTA in Lithuania (5) was issued together with SBU in 1993; participation in the International Society of Technology Assessment in Health Care (ISTAHC) conferences; participation in development of training courses and European networks of HTA; new people in HTA were trained in health accreditation service, Sickness Fund, and Ministry of Health. The major step was establishment of an evidence-based medicine library.

In 1994, Article 54 in the Health Care System Law, which declares that the use of healthcare technologies that have not been assessed or approved shall be prohibited, except in cases provided by law, was passed. The procedure of healthcare technologies assessment and approval was to be established by the Ministry of Health Care. A policy of HTA was approved with the program for HTA in 1999 in the Ministry of Health. Currently, enthusiasts of HTA fully realize that technology assessment is a developing frontier for creative and constructive thinking from all disciplinary view points.

Conclusions: Unfortunately, in this country, there is still a very small demand for HTA reports from the decision-maker's side. Hopefully joining the network of European Union Network for Health Technology Assessment (EUnetHTA) will give a new challenge for further policy development.

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.

Objectives: The aim of this study was to describe the Norwegian contribution to the broad picture of our international health technology assessment (HTA) history.

Methods: A general examination of some pre-HTA activities, as consensus conferences, closer reading of all background papers to the establishment of an HTA agency in Norway, the ongoing activities of this agency, its evaluation, and its merge into a broader knowledge center for the health services were performed. All information and statements are the authors’ own understandings, but also were reviewed by some of the people taken part in these processes.

Results: The Norwegian HTA activity was set up rather late compared to, for instance, Sweden, and our involvement in Nordic early warning activities. This may be related to Norwegian scientists being more involved in the Cochrane Collaboration. However, when established, the HTA agency was regarded as highly successful in involving clinical experts and responding to questions arising from the macro- as well as micro-levels of decision makers. International collaboration was essential in building the capacity to serve all levels. After 6 years, the agency was merged with some related health service knowledge activities, into a new center.

Conclusions: During the 10 years’ time, HTA has become a well-established activity in Norway.

In 1989, Poland started to slowly release itself not only from the burden of a half-century of communist indoctrination and soviet exploitation, but also from the consequences of the Semashko model of healthcare organization: low doctors' salaries, primary care based on multispecialty groups, overdeveloped hospital infrastructure, and limited access to sophisticated interventions overcome by patients' unofficial payments.

A few years after the 1998 workshop on health technology assessment (HTA) in Budapest, the first HTA reports were elaborated in the National Center for Quality Assessment in Health Care, which could mark the beginning of HTA in Poland. Several individuals and organizations have been involved in developing HTA, both from noncommercial and commercial standpoints.

A goal to establish a national HTA agency appeared among the priorities of the Polish Ministry of Health in 2004 and was realized a year later. The Agency for HTA in Poland published guidelines on HTA and established a sound and transparent two-step (assessment-appraisal) process for preparing recommendations on public financing of both drugs and nondrug technologies. The recommendations of the Agency's Consultative Council were warmly welcomed by the public payer. However, the recent major restructuring of the Agency and new drug reimbursement decisions aroused doubts as to keeping transparency of the decision-making processes.

Objectives: The aim of this study was to describe the characteristics of the introduction and diffusion of health technology assessment (HTA) in Spain.

Methods: A survey to summarize the evolution of HTA was sent to representatives of different HTA initiatives in Spain.

Results: HTA was introduced in the late 1980s. The main factors were the trend to an increase in healthcare expenditure, concerns regarding efficiency in providing health care, as well as in the level of rationality introducing high technology. Spain has direct (i.e., regulation) and indirect (i.e., payment systems, evidence-based programs, HTA) mechanisms to control health technologies. A recent high priority regulation has established the need of HTA to decide the introduction of a new health technology in the lists of public healthcare coverage, although similar regulations existed in the past and were scarcely implemented. HTA initiatives started at the regional government level. Its introduction followed a progressive pattern among regions. In the beginning, resources were scarce and expertise limited, with work done at intramural level. With time, expertise increase, and promotion of commissioned work was implemented. HTA knowledge transfer in the healthcare system has been carried out through courses, publications, and commissioned research. Currently, there are seven HTA units/agencies, which coordinate their work.

Conclusions: HTA in Spain is in its maturity. Facing the unavoidable change of health care environment over time, HTA is also evolving and, currently, there is a trend to broaden the areas of influence of HTA by devolving capacity to hospitals and applying principles to very early phases of health technology development, under the umbrella of regional HTA units/agencies. However, there are two main challenges ahead. One is to have a real impact at the highest level of healthcare policy coordination among Spanish regions, which is done at the Central Ministry of Health. The other is to avoid the influence of political waves in the level of recognition of HTA at the policy decision-making level and to have an adequate and stable funding of HTA initiatives.

Objectives and Methods: To review Switzerland's mixed public and private healthcare system with regard to health technology assessment (HTA).

Results: In the past, remarkable work in HTA was done. Accomplishments include the following: (i) Switzerland became an early member of the International Network of Agencies for Health Technology Assessment. (ii) HTA has its legal bases in terms of effectiveness, appropriateness, and efficiency. (iii) The federal law allows the introduction of new technologies for a limited time for evaluation. (iv) A Swiss Network for Health Technology Assessment was established. In 2004, federal HTA activities moved from the Swiss Federal Office “of Social Security” to the one for “Public Health.” The Office mainly mandates, manages, and coordinates evaluations attached to its prevention and intervention sections in the fields of AIDS, illegal drugs, and legal drugs.

Conclusions: Because of the absence of a governmental institution assessing and reporting on new health technologies, private and for profit organizations became more important for the decision-making processes. In a regulated market, the implications may be crucial for the public health.

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.

The Cochrane Database of Systematic Reviews (CDSR) evolved in response to Archie Cochrane's challenge to the medical profession to assemble “a critical summary, adapted periodically, of all . . . relevant randomized controlled trials”. CDSR has been an electronic publication from its inception and this has meant that Cochrane reviews (i) need not be constrained by lack of space; (ii) can be updated as new information becomes available and when mistakes or other ways of improving them are identified; and (iii) can be cross-linked to other, related sources of relevant information. Although CDSR has become widely cited, it must continue to evolve in the light of technological and methodological developments, and in response to the needs of people making decisions about health care.

Objectives: Although health technology assessment (HTA) has been well established in all developed countries, it has not found a firm footing in many developing countries. This is especially true of the Asia Pacific region, which has much of the world population.

Methods: The beginnings of HTA in this region go back to the work of Dr. David Banta in China and the establishment of the Asian HTA Network. The Network embarked on increasing awareness and building capacity among personnel from the region. Attempts were made to introduce HTA in countries where it did not exist, as well as to strengthen existing HTA programs. The Network had regular meetings, and also carried out a study on the diffusion and utilization of magnetic resonance imaging in the region. In an attempt to boost the efforts of the Network, the author spearheaded the organization of the Asian Regional HTA Conferences in Kuala Lumpur in 2000 and 2003, and in Manila, Philippines, in 2004. In addition, the author carried out a survey on HTA in the region. There are two broad categories of countries in the region: Australia, Malaysia, Singapore, New Zealand, China, Philippines, Korea, Thailand, and Taiwan, which have formal HTA programs, and others for which informal mechanisms or related activities exist, which include Bangladesh, Bhutan, Brunei, Cambodia, India, Indonesia, Laos, Maldives, Mongolia, Nepal, Pakistan, Sri Lanka, and Vietnam.

Results: It is important that once HTA is established, it is used effectively. Perseverance and dedication is needed to ensure the success of an HTA program.

Conclusion: Some countries in the region have effective HTA programs, whereas in some, efforts are being made to establish HTA, or HTA-related activities are being carried out in the absence of a formal HTA program.

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.

There has been a rapid growth of healthcare technology assessment (HTA) activities among health service researchers and physicians in Japan in the younger generation since the mid-1980s. HTA has become visible since the Ministry of Health, Labor, and Welfare (MHLW) set up the several committees related to HTA in the late 1990s. The MHLW had to participate in regulatory and administrative reform, coping with the serious economic stagnation since 1991, following the economic recession in the 1980s. However, HTA has not been developed as expected. The most important failure is that the application of HTA to health policy has been neglected by the MHLW. Only application to clinical practice has been implemented by developing evidence-based clinical practice guidelines. The MHLW had the main aim of containing costs by reducing excess or useless healthcare services through guidelines, rather than to implement a radical reform. Without a central organization for HTA, several researchers have still continued to do HTA studies, but most researchers and physicians promoting HTA have been moved into diverse related areas. Ultimately, increasing efficiency may be the only way of reconciling rising demands for health care with public financing constraints. Therefore, the reconsideration and reorganization of HTA, which covers not only healthcare services but also the healthcare system as a whole, is becoming an urgent matter for healthcare reform.

Objective: To analyze evolution of the health technology assessment (HTA) at the national level in South Korea.

Methods: Analysis of public documents, personal communication, and literative review.

Results: HTA in South Korea has been developed since 1990s, first introduced by academia and institutionalized within the National Health Insurance (NHI). Rapidly increasing expenditure had been a challenge of the NHI, which considered health technology management as a cost controlling measure. An amendment was made to the NHI Law in 2000, and provision was made to regulate the process of determining new insurance benefits including procedures, drugs, and equipment. This requirement made the NHI agencies to promote HTA approaches in connection with the government and professional organizations. Also the Healthcare Act was revised in October 2006 ruling that HTA focusing on safety and effectiveness be responsible for new health technologies. Currently, the HTA process is governed by a governmental committee comprising twenty members and technically supported by the HTA center created in the NHI structure.

Conclusions: Institutionalized HTA in Korea has been driven mainly by the requirements of the NHI and manifested strengths as well as weaknesses. The government is establishing a new organization for HTA, independent from the NHI.

Objectives: Malaysia, as a rapidly developing country, has been facing tremendous pressures in its attempts to maximize scarce resources. Despite this problem, Malaysia has made great strides in developing its health services, and has successfully provided good access to the population to healthcare services, reduced the incidence of many communicable diseases, and improved life expectancies and other global indices of health care, some of which are comparable to that of developed countries.

Methods: The Health Technology Assessment (HTA) Unit was set up in Malaysia in August 1995 in the Ministry of Health Malaysia and has since grown tremendously in size and resources. To date, forty-three in-depth assessments have been carried out, and the recommendations of these assessments were subsequently implemented. In addition, approximately 140 rapid assessment reports were produced in response to requests from policy and decision makers. HTA has been able to provide input into formulation of national and Ministry of Health Malaysia policies, and provide a basis for clinical practice guidelines development, input into purchasing decisions, regulation of drugs, as well as advertisements related to health.

Results: A major challenge is sustainability of the program, to be able to have trained personnel competent to take on the demanding tasks of assessments and the sustained efforts that are required. In addition, there need to be constant efforts to create awareness of the utility of HTA so that its services are used and its full potential realized. The scope of services may also need to be expanded to include an early warning system.

Conclusions: Malaysia has successfully implemented a health technology program that has had major impact on policy formulation and decision making at various levels. Challenges may be faced in sustaining and developing the program further.

Objectives: The aim of this study was to discuss the development of health technology assessment (HTA) in the Philippines.

Methods: A new national health insurance program began to be implemented in the Philippines in 1995 after passage of the Health Insurance Act.

Results: The program is known as the Philippine Health Insurance Corporation (PhilHealth). HTA was introduced to the Philippines in 1998. PhilHealth began to develop an HTA program subsequently.

Conclusions: As a developing country struggling to provide comprehensive health care to all citizens, PhilHealth sees HTA as an essential part of assuring that only effective and cost-effective care is provided for the public sector.

The Republic of Singapore is an island city-state in Southeast Asia. Its population enjoys good health and the Singapore Ministry of Health's mission is to promote good health and reduce illness, ensure access to good and affordable health care, and pursue medical excellence. This is achieved through a healthcare system that includes both private and public sector elements. The financing philosophy of Singapore's healthcare delivery system is based on individual responsibility and community support. Health care in Singapore is financed by a combination of taxes, employee medical benefits, compulsory health savings, insurance, and out-of-pocket payment. The capability for health technology assessment in Singapore was developed concurrently with its medical device regulation system in the 1990s. The first formal unit with health technology assessment (HTA) functions was established in September 1995. Today, HTA features in decision making for the Standard Drug List, licensing of medical clinics, the Health Service Development Programme, healthcare subsidies, and policy development. The public sector healthcare delivery clusters have also recently started health services research units with HTA functions. Singapore is organizing the 6th Health Technology Assessment International (HTAi) Annual Meeting in June 2009. Bringing this prestigious international conference to Asia for the first time will help raise awareness of HTA in the region.

Objectives: This study aims to review the development of health technology assessment (HTA), including the socioeconomic context, outputs, and policy utilization in the Thai setting.

Methods: This study was conducted through extensive document reviews including these published in both domestic and international literature.

Results: Evidence suggests that contextual elements of the health system, especially the country's economic status and health financing reforms, as well as their effects on government budgeting for medical and public health services, played an important role in the increasing needs and demands for HTA information among policy makers. In the midst of substantial economic growth during the years 1982 to 1996, several studies reported the rapid diffusion and poor distribution of health technologies, and inequitable access to high-cost technology in public and private hospitals. At the same time, economic analysis and its underpinning concept of efficiency were suggested by groups of scholars and health officials to guide national policy on the investment in health technology equipment. Related research and training programs were subsequently launched. However, none of these HTA units could be institutionalized into national bodies. From 1997 to 2005, an economic recession, followed by the introduction of a universal health coverage plan, triggered the demands for effective measures for cost containment and prioritization of health interventions. This made policy makers and researchers at the Ministry of Public Health (MOPH) pay increasing attention to economic appraisals, and several HTA programs were established in the Ministry. Despite the rising number of Thai health economic publications, a major problem at that period involved the poor quality of studies. Since 2006, economic recovery and demands from different interests to include expensive technologies in the public health benefit package have been crucial factors promoting the role of HTA in national policy decisions. Meanwhile, HTA capacity has been strengthened through the establishment of many health economic and HTA initiatives. An illustration of the work and contributions of the Health Intervention and Technology Assessment Program (HITAP) is provided. In this phase, HTA policy integration has been enhanced through different mechanisms and organizations.

Conclusion: Over the past two decades a notable progression has been made in relation to the capacity building of HTA research and its policy utility in Thailand. Such development has been shaped by multiple factors. It is anticipated that experience gained among academics, health officials, and civil society organizations will be helpful not only in sustaining the momentum but also in improving formal HTA systems in the future.

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.

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.