Health technology assessment

Too often Health Technology Assessment (HTA) is still an insider concept in many fields of medicine. Access is often hindered by the wrong information or by none at all on this interdisciplinary concept, with its frequently different conceptual worlds and modes of work, fear of encroachment on personal professional freedom, the attempt to use HTA reports to enforce cost-cutting, and its origins in political science. This results in an immense loss of information, which runs counter to the very fears listed above. This contribution first clarifies the various concepts and then presents the goals of HTA. Finally, we describe the groups of interest in the medical sphere and discuss their positive and negative relationships to HTA. The aim is to show that HTA objectively evaluates medical procedures based on the health system in question and on the social structure, and that the fears of the various groups are unjustified. Far from being “cookbook” medicine, HTA provides valid information relevant to everyday life in a compact, evaluated form, thereby releasing resources to increase freedom of action by reducing cost pressures.     

Health technology assessment in Denmark

The Danish healthcare services are mainly provided by public sector institutions. The system is highly decentralized. The state has little direct influence on the provision of healthcare services. State influence is exercised through legislation and budget allocations. The main task of the state is to initiate, coordinate, and advise. Counties, which run the hospitals, also decide on the placement of services. The hospital sector is controlled within the framework of legislation and global budgets. General practitioners occupy a central position in the Danish healthcare sector, acting as gatekeepers to the rest of the system. The system works well, and its structure has resulted in steady costs of health care for a long period. There is no regulatory mechanism in the Danish health services requiring use of health technology assessment (HTA) as a basis for policy decisions, planning, or administrative procedures. However, since the late 1970s a number of comprehensive assessments of health technology have formed the basis for national health policy decisions. In 1997, after years of public criticism of the quality of hospital care and health technologies, and on the basis of a previously developed national HTA strategy, a national institute for HTA (DIHTA) was established. There seems to be a growing awareness of evidence-based healthcare among health professionals and a general acceptance of health economic analyses as a basis for health policy decision making. This progress is coupled with growing regional HTA activity in the health services. HTA seems to have a bright future in Denmark.     

Health technology assessment in Sweden

Sweden has a welfare system that is based on the fundamental principle that all citizens are entitled to good health and medical care, regardless of where they live or what their economic circumstances are. Health and medical care are considered to be public sector responsibilities. However, there is growing interest in establishing more private alternatives to public care. An important characteristic of the Swedish healthcare system is its decentralization, with a major role for county councils. County councils are now merging into larger administrative units (region). The whole Swedish system is in the process of reform, mainly because of perceptions that it was too rigid and had insufficient patient orientation. An important factor in the reforms is that power in the system will be even more decentralized and will have greater public input. This change is seen as calling for increased central follow-up and evaluation of matters such as social, ethical, and economic aspects. Although the state has decentralized control, it still attempts to control the general direction of the system through regulation, subsidy, recommendations, and guidelines. An important actor in the system is the Swedish Council on Technology Assessment in Health Care (SBU). SBU began in 1987 with assessments of health technologies, but its success has recently led policy makers to extend its coverage to dental care. Health technology assessment is increasingly visible to policy makers, who find it useful in decision making.     

Health technology assessment in Portugal

The Portuguese healthcare system is often portrayed as a National Health Service (NHS) model, characterized by universal coverage, comprehensive benefits, nearly free services, national tax financing, and public ownership or control of the factors of production. However, in reality the system fails to accomplish these features in a complete way. There coexist a number of occupation-related health insurance schemes that were originally intended to be integrated into the NHS. In addition, in key areas the NHS does not provide the wide range of services it promises. The public sector has a predominant role in the provision of hospital stays and general practitioner consultations, but the private sector provides a major portion of specialist consultations, dental consultations, and diagnostic services. Major problems in the system led to health reforms in the 1990s. New reform proposals include some specific steps concerning health technology, including standards for medical equipment based on quality, geographic distribution, sustainability, and cost-effectiveness. A new National Plan of Health Equipment was completed in 1998, aimed at improving the distribution of equipment. Despite reforms, healthcare expenditures continue to rise. There is general agreement that gains in efficiency could be made. This situation is beginning to encourage interest in health technology assessment (HTA) in Portugal, although these activities are not yet very developed. Recently, legislation requiring presentation of economic evaluations for new pharmaceutical products was enacted. Present plans also call for the creation in the future of a national agency for HTA.     

Health technology assessment in Finland

Finland has a long tradition of supporting social programs that promote equality and the welfare state. The healthcare system is financed mainly by taxation. Everyone is insured against illness. Each of Finland's five provinces is run by a provincial government that monitors the provision of social welfare and health care. However, the municipalities actually provide the services and regulate medical equipment and regionalization of services. During the early 1990s, gross domestic product (GDP) fell dramatically, and healthcare expenditure rose to 9.4% of GDP. Due to the economy's rapid recovery, the share of healthcare expenditure has again decreased and now matches the average level of OECD countries of approximately 7.7%. The former Finnish method of central planning and norm setting has guaranteed a fairly uniform development of necessary services throughout the country and free or low-cost access. Tight central planning did not, however, create incentives to contain costs. Therefore, in the beginning of the 1990s, decision-making power was largely decentralized to the municipalities, and the principles of state subsidies were reformed. In 1995, the Finnish Office for Health Care Technology Assessment (FinOHTA) was set up as a new unit of the National Research and Development Centre for Welfare and Health (STAKES). FinOHTA is intended to function as a national central body for advancing HTA-related work in Finland, with the ultimate goal of promoting the effectiveness and efficiency of Finnish health care. At present, the importance of HTA is widely recognized in Finland, especially in the face of rising healthcare costs.     

Health technology assessment in Italy

Italy has a national health service (SSN) dating to 1978. Italy's system of government is characterized by a rather high degree of decentralization of power, and the health system is likewise decentralized. Most of the responsibilities for health care have been ceded to the regions. The state retains only limited coordinating and supervisory powers. The state has a financial responsibility for the national health service, but state contributions are limited and expenditures in excess of this made by the region must be financed from other sources. Health reforms of 1992-93 aimed at making the regions more sensitive to the need to control aggregate expenditure and to monitor measures to promote efficiency, quality, and citizen-patient satisfaction. The diffusion of individual health technologies has been relatively uncontrolled in many regions in Italy, although tight central constraints on capital spending have contained diffusion of new technology. Regulation of placement of services is a planning function and is the responsibility of both the Ministry of Health and the regions. Health technology assessment (HTA) activities have been expanding since the early 1990s, but these activities tend to be untargeted, uncoordinated, and without priorities. Nonetheless, the principal actors in the SSN at national, regional, and local levels are becoming more sensitive to the need to apply criteria of clinical and cost-effectiveness and to be more rigorous in deciding what services to guarantee. There are reasons to be guardedly optimistic about the future of HTA in Italy.     

Health technology assessment in Belgium

The Belgian healthcare system has a Bismarck-type compulsory health insurance, covering almost the entire population, combined with private provision of care. Providers are public health services, independent pharmacists, independent ambulatory care professionals, and hospitals and geriatric care facilities. Healthcare responsibilities are shared between the national Ministries of Public Health and Social Affairs, and the Dutch-, French-, and German-speaking Community Ministries of Health. The national ministries are responsible for sickness and disability insurance, financing, determination of accreditation criteria for hospitals and heavy medical care units, and construction of new hospitals. The six sickness and disability insurance funds are responsible for reimbursing health service benefits and paying disability benefits. The system's strength is that care is highly accessible and responsive to patients. However, the healthcare system's size remained relatively uncontrolled until recently, there is an excess supply of certain types of care, and there is a large number of small hospitals. The national government created a legal framework to modernize the insurance system to control budgetary deficits. Measures for reducing healthcare expenditures include regulating healthcare supply, healthcare evaluation, medical practice organization, and hospital budgets. The need to control healthcare facilities and quality of care in hospitals led to formal procedures for opening hospitals, acquiring expensive medical equipment, and developing highly specialized services. Reforms in payment and regulation are being considered. Health technology assessment (HTA) has played little part in the reforms so far. Belgium has no formal national program for HTA. The future of HTA in Belgium depends on a changing perception by providers and policy makers that health care needs a stronger scientific base.     

Health technology assessment in Ireland

Ireland's health system is primarily funded from general taxation and is publicly provided, although private health care retains a considerable role. It is a unique structure, a mixture of universal health service free at the point of consumption and a fee-based private system where individuals subscribe to private health insurance that covers some of their medical expenses. The recent history of the Irish health services saw consolidation of existing services and an expansion into new areas to adapt to changing practices and needs. There has also been a drive to extract maximum efficiency so as to maintain the volume and quality of patient services at a time of very tight financial constraints. Introduction of new health technologies continued to accelerate. New technologies tended to spread rapidly before systematic appraisal of their costs and benefits. When the state is involved in funding the public hospital system, acceptance of new technology is a matter for discussion between agencies and the Department of Health and Children. Decisions about spending annual "development funding" have generally not been based on careful assessment of proposals for new technology. In 1995, a healthcare reform put new Public Health Departments in Health Boards in a prime position in Ireland's health services organization. These departments now emphasize evidence-based medicine. While Ireland does not have a national health technology assessment (HTA) program, there are plans to form an advisory group on HTA in 1998. HTA is seen as a significant element of future health policy in Ireland.     

Health technology assessment in Luxembourg

Luxembourg's public health insurance is a compulsory insurance for all employees, self-employed professionals, farmers, and pensioners. It is financed through contributions of the insured people, as well as by state taxes. Providers of health care are mainly private nonprofit institutions and self-employed professionals. All healthcare procedures are defined in fee schedules determined by a common decision of the Ministers of Social Security and Health according to proposals of a board of experts. The relative value of a service is also determined by the corresponding fee schedule. Hospitals are financed by individual budgets negotiated between each hospital and the health insurance. These hospital budgets do not cover services provided in hospitals by medical specialists, who are reimbursed on a fee-for-service basis. A low on hospital planning and organization allows the government to restrict the installation in hospitals of very expensive equipment or of equipment for which there is only a limited need in Luxembourg hospitals. Until recently there has been limited interest in or use of health technology assessment (HTA). However, large hospital investments have provoked some interest in the last few years. The Ministry of Health has asked for some HTA studies when a concrete decision had to be taken. Luxembourg decision makers have become more aware that HTA may help them to become more informed about the short- and long-term consequences of the application of health technology.     

Health technology assessment in Spain

The Spanish Constitution of 1978 established a healthcare system available to everyone and free at the point of service. The General Health Law of 1986 also established the framework for a National Health System (NHS). The Constitution and the law form the regulatory framework for the devolution of healthcare services to the Autonomous Regions. All the 17 Autonomous Regions have complete power regarding public health and planning. However, responsibilities on healthcare financing, organization, provision, and management have devolved to only seven Autonomous Regions. Financial support for health services comes mostly from taxes. Global budgets are a mechanism used by hospitals to control the acquisition of medium and low health technology. Major capital investments for health technology are controlled by the central government in 10 Autonomous Regions (population coverage of 38%) and by the Regional Health Services in the seven remaining Autonomous Regions. In 1995 a regulation for basing the introduction of new procedures and medical equipment on the assessment of safety, efficacy, and efficiency was issued. Health technology assessment (HTA) has a long history in Spain, beginning with the Advisory Board on High Technology in the government of Catalonia in 1984. This board evolved into the Catalan Agency for HTA (CAHTA) in 1994. The Basque Country established a unit for HTA in 1992 (Osteba) and the Andalusian government created an agency in 1996 (AETSA). A national agency for HTA (AETS) was established in 1994. These different programs coordinate their work and together act as an Advisory Committee of the Interregional Council of the NHS.     

Health technology assessment in France

The French healthcare system combines freedom of medical practice with nationwide social security. It is compulsory for every legal resident. A range of public and private institutions provide care, and patients have free access to physicians. The health coverage system is characterized by solidarity and universal responsibility. Although the French system is highly regulated, funding of health-related expenses is a chronic social problem. Since the 1996 healthcare reform, the national objective for reimbursed healthcare expenditures is voted by the parliament, and the annual increase of hospital funding is controlled at the regional level. An agency for hospitals has been established in every region, and it quantifies needs indexes for future equipment and beds. However, establishing appropriate reference ratios based on objective assessment is difficult. The idea of basing policy and practice decisions on objective assessment grew for years, until the National Agency for the Development of Medical Evaluation was established in 1989. The 1996 healthcare reform expanded this agency to encompass hospital accreditation and renamed it the National Agency for Accreditation and Evaluation in Health. In March 1999, the National Agency for Health Products was established. It controls the safety of medical products and evaluates products' medical benefits before reimbursement decisions. Health technology assessment is now related to virtually every health policy process in France, and its role increases continually.     

Health technology assessment in Switzerland

Switzerland has a mixed public and private healthcare system. All citizens are enrolled in compulsory basic health insurance. A 1996 law allows people to choose among different sickness funds and managed care plans. The federal government is empowered to act on important health issues, but the 26 cantons have prime responsibility in health care and social welfare. They have their own laws on health care, hygiene, hospitals, and social welfare. These laws are not harmonized. The system is complex, with a mix of public (mainly hospitals) and private (mainly doctors' offices) providers. The health services are decentralized. Ambulatory care was traditionally provided in doctors' offices, but the last decade has seen the development of centers for day surgery, group practices, and managed care plans. Decisions on placement, location, and extension of services are decentralized. The payment system is very complex. Current trends include global budgets, cost analyses, and prices related to patient categories. However, coverage policy is developed centrally and includes both traditionally established services and new technologies. New technologies are added to the list only after evaluation by the Federal Coverage Committee. The coverage process integrates health technology assessment (HTA). Coverage can be granted in stages, including limited coverage and temporary coverage. Technologies and coverage can be reevaluated on the basis of registries or assessment information. The structure of the Swiss healthcare system does not lend itself to the establishment of a national HTA program. However, recent moves include the development of a coordinating mechanism for HTA in Switzerland.     

Health technology assessment in Greece

In 1983 a health reform aimed to assure universal coverage and equity in the distribution of services in Greece. The reform implied state responsibility for the financing and delivery of services and a reduction of the private sector. The model was a Bismarckian scheme for social insurance. However, healthcare delivery remains fragmented and uncoordinated and the private sector is getting stronger. The dominant payment system is fee-for-service for the private sector and administered prices and salaries for public hospitals and social insurance funds. The many insurers have their own eligibility requirements, validation procedures, etc. Coverage of services by social security funds, probably among the most comprehensive in Europe, is determined more on historical and political grounds than on efficiency or cost-effectiveness. The system is plagued by problems, including geographical inequalities, overcentralization, bureaucratic management, poor incentives in the public sector, open-ended financing, inefficient use of hospital beds, and lack of cost-effectiveness. There are no specific legal provisions for the control of health technology. Technologies are introduced without standards or formal consideration of needs. There are no current efforts to control health technology in Greece. However, health technology assessment (HTA) has gained increasing visibility. In 1997 a law provided for a new government agency responsible for quality control, economic evaluation of health services, and HTA. The hope is that the new law may introduce evaluation and assessment elements into health policy formulation and assure that cost effectiveness, quality, and appropriate use of health technology will receive more attention.     

Health technology assessment in The Netherlands

The Dutch healthcare system is not a single overall plan, but has evolved from a constantly changing mix of institutions, regulations, and responsibilities. The resulting system provides high-quality care with reasonable efficiency and equal distribution over the population. Every Dutch citizen is entitled to health care. Health insurance is provided by a mix of compulsory national insurance and public and private insurance schemes. Hospitals generally have a private legal basis but are heavily regulated. Supraregional planning of high-tech medical services is also regulated. Hospitals function under fixed, prospective budgets with regulation of capital investments. Independent general practitioners serve a gatekeeper role for specialist and hospital services and are paid by capitation or fee for service. Specialists are paid by fee for service. All physicians' fees are controlled by the Ministry of Economic Affairs. Coverage of benefits is an important method of controlling the cost of services. There is increasing concern about health care quality. Health technology assessment (HTA) has become increasingly visible during the last 15 years. A special national fund for HTA, set up in 1988, has led to many formal and informal changes. HTA has evolved from a research activity into policy research for improving health care on the national level. In 1993 the government stated formally that enhancing effectiveness in health care was one of its prime targets and that HTA would be a prime tool for this purpose. The most important current issue is coordination of HTA activities, which is now undertaken by a new platform representing the important actors in health care and HTA.     

Health technology assessment in the United Kingdom

The National Health Service (NHS) provides universal health coverage for all British citizens. Most services are free of charge, although modest copayments are sometimes applied. About 11% of the population also has private insurance. General practitioners, generally the first point of contact for accessing the system, are independent contractors who serve as gatekeepers for specialist and hospital services and enjoy substantial clinical autonomy. Hospitals are public and are regionalized, but the 1990 reforms made them self-governing trusts that contract with local purchasers (health authorities and general practitioner fundholders). Reforms beginning in 1990 moved the NHS away from a centralized administrative structure to more pluralistic arrangements in which competition, as well as management, influences how services develop. Health technology and health technology assessment (HTA) have gained increasing attention in the NHS during this period, as part of a wider NHS Research and Development (R&D) Strategy. The strategy promotes a knowledge-based health service with a strong research infrastructure and the capacity to critically review its own needs. HTA is the largest and most developed of the programs within the strategy. It has a formal system for setting assessment priorities involving widespread consultation within the NHS, and a National Co-ordinating Centre for Health Technology Assessment. The strategy supports related centers such as the U.K. Cochrane Centre and the NHS Centre for Reviews and Dissemination. A hallmark of the HTA program is strong public participation. The United Kingdom has made a major commitment to HTA and to seeking effective means of reviewing and disseminating evidence.     

Health technology assessment and screening in Sweden

OBJECTIVES: To describe health technology assessment (HTA) and policies concerning three screening procedures in Sweden. METHODS: The main source of information was reports from the Swedish Council for Technology Assessment in Health Care (SBU) and other governmental reports, supplemented by the professional literature. RESULTS: Prevention is emphasized in the healthcare services of Sweden. Specifically, screening is encouraged and supported when it is deemed beneficial. Sweden has a strong orientation toward evidence-based health care and HTA. Since its inauguration in 1987, SBU has fostered the use of HTA in making policy and clinical decisions in Sweden. Government policy in Sweden is to encourage services that are beneficial and cost-effective and discourages services that are not. Screening is no exception to this general rule. The three cases examined in this paper-mammography screening, PSA screening, and routine ultrasound screening in pregnancy-have all been formally assessed in Sweden. Assessments have been an integral part of policy making concerning these and other preventive measures. Mammography screening has been widely implemented. However, as in other countries, screening is often carried out in an opportunistic fashion, so that PSA screening, in particular, is carried out more in Sweden than can be justified by the evidence. CONCLUSIONS: Mammography screening is promoted and is completely available to the target group. PSA screening is discouraged, but not with complete success. Ultrasound in pregnancy is widely used, not because of good evidence of impact on mortality and morbidity among newborns, but because it increases the detection rate of congenitally malformed fetuses and because of evidence of positive effects on the management and planning of deliveries, as well as because of psychological and ethical implications of the technology. HTA is an important part of health policy making in Sweden.     

Health technology assessment in England and Wales

In this study, we describe the current state of the Health Technology Assessment (HTA) system in England and Wales. This system rests on a distinction between assessment and appraisal and has three main strands: researcher-led HTA, the research and development program, and the HTA-NICE (National Institute for Clinical Excellence) process. We outline the pressures for HTA and how it has evolved in the British National Health Service. We discuss how HTA priorities are chosen, how HTA information is collected and assessed, how HTA evidence is used, and we make some observations about its impact. In our discussion, we consider some limitations of the HTA system, its possible divergence from evidence-based health care, its centralization, and some of the key challenges for managing HTA-driven policy. But we remain hopeful that HTA can contribute to better and more explicit decision-making within England and Wales.     

Health technology assessment with risk aversion in health

Standard cost-effectiveness models compare incremental cost increases to incremental average gains in health, commonly expressed in Quality-Adjusted Life Years (QALYs). Our research generalizes earlier models in several ways. We introduce risk aversion in Quality of Life (QoL), which leads to “willingness-to-pay” thresholds that rise with illness severity, potentially by an order of magnitude. Unlike traditional CEA analyses, which discriminate against persons with disabilities, our analysis implies that the marginal value of improving QoL rises for disabled individuals. Our model can also value the uncertain benefits of medical interventions by employing well-established analytic methods from finance. Finally, we show that traditional QALYs no longer serve as a single index of health, when consumers are risk-averse. To address this problem, we derive a generalized single-index of health outcomes—the Generalized Risk-Adjusted QALY (GRA-QALY). Earlier models of CEA that abstract from risk-aversion nest as special cases of our more general model.