Early HTA Initiatives

Sweden was one of the first countries to assess health technology. In fact, one of the first technology assessments was a study of the computed tomography scanner carried out in the early 1970s. Even before this study, the National Board of Health and Welfare had asked selected physicians, prominent in their specialties, to evaluate medical technology. Over the past 15 years, this informal and opinion-based approach has slowly been replaced by more evidence-based approaches. An early initiative involving economic aspects of evaluation was undertaken by the Swedish Medical Research Council (MFR), through a cost-benefit study of polio vaccinations (10). Another early initiative to conduct an economic evaluation as part of the policy-making process was undertaken in 1980 by a government committee, which carried out a cost-benefit analysis of water fluoridation. MFR was also an early player in setting up a limited research program for HTA; it also produced a review on HTA methodology in 1984 (4) and together with the Swedish Institute for Health Services Development (Spri) began a series of consensus conferences on controversial technologies or health-care practices in 1982. This series continued for over twenty years.

Those who advocated the idea of HTA in the late 1970s were greatly influenced by the work of the U.S. Office of Technology Assessment (OTA). The broad policy-oriented definition of HTA and its methodology was imported to Sweden, with representatives from the United States involved in the process of selling the concept to key people at seminars and conferences. A proposal to establish a national center for stimulating and coordinating research on medical technologies was raised in Linköping in 1982. The idea was to establish a university-based national institute for health technology assessment. This initiative failed, in part, because it was not possible at that time to obtain any financial support from the national government. However, 2 years later, the local county council in Östergötland decided, together with Linköping University, to establish the Center for Medical Technology Assessment (CMT). The center's very first project was to conduct a comprehensive assessment of the shock wave lithotriptor used to treat kidney stones (6), and its research profile continues to focus on health economic evaluations, and the evaluation of rehabilitation technologies. Ongoing projects concentrate on the evaluation of screening programs, for example, for prostate cancer, abdominal aorta aneurysm, and cervical cancer, as well as procedures related to treatment of cardiovascular diseases. Collaboration with, and financial support from, the local health-care authority are still substantial. The center is a member of the international network for HTA agencies (INAHTA).

Another active research organization, which undertakes the economic evaluation of health technologies and organizational studies, is the Institute of Health Economics (IHE) in Lund. It is a nonprofit research organization established in 1979. Today, IHE is owned by Apoteket AB (The National Corporation of Swedish Pharmacies) and conducts health-economic evaluations and analyses in the following areas:

• Evaluation of pharmaceuticals and medical technology.
• Organization and financing of health care.
• The provision of pharmaceuticals.
• Health care in developing countries.
• Traffic safety and health.

IHE also organizes courses such as health economic seminars for drug formulary committees.

Two university-based organizations with strong profiles in health economics are the Centre for Health Economics at the Stockholm School of Economics (CHE), established in 1991, and the Centre for Health Economics (LUCHE) at Lund University, founded in 1998. The research at CHE not only includes health-care economics, but also the interaction between the environment and health and the effects of income and wealth distribution on health. The research program currently includes four main areas: analysis of health-care systems, economic evaluation of health-care technologies, pharmaceutical economics, and measurement and management of efficiency and quality in health-care provision. LUCHE was established to develop the university's research capacity in the field of health economics; as early as 1980 Lund University's health economists had taken the initiative to set up a Nordic study group in health economics and in 1982, a symposium was held on pharmaceutical economics. The creation of a special center provided the network of people in the field of health economics with a stable organization that would enhance the development of health economics as an area of specialist knowledge at the university.

Establishment of SBU

In parallel with the planning of the university center in Linköping, a proposal was developed to set up a national agency for HTA. The Swedish Council on Technology Assessment in Health Care (SBU) was created in 1987 with the basic remit to continuously update the government and health-care providers with scientific information on the overall value of medical technologies. Some county councils have more formal links with the SBU and some finance local HTA units, for example in Östergötland and Stockholm. Recently, a formal agreement was established between the SBU, the National Board for Health and Welfare and the Medical Products Agency aimed at improving cooperation in the field of assessing health technologies, transforming results into guidelines and disseminating information. The SBU has actively supported international collaboration, and, since 1986, the secretariat of the International Network of Agencies for Health Technology Assessment (INAHTA) has been located at the SBU.

The Centre for Assessment of Medical Technology in Örebro (CAMTÖ) was set up in 1999 and is financed by Örebro County Council. Its purpose is to promote health technology assessment and evidence-based medicine at the local-regional level. The center works as a network of clinicians, experienced practitioners and qualified researchers under the management of a small committee. Experts from different fields, such as epidemiology, biostatistics, health economics, health policy, and nursing have been attached to the center, serving as consultants on study design, and disseminating information to the members of the network. Examples of the topics that have been assessed include:

• Evaluation of the outcome of changes in practices, such as a higher percentage of day care, check-ups by nurses instead of doctors, referring procedures from hospitals to primary care, etc.
• Assessment of differences in practice between different health-care providers at all levels.
• The impact of systematic reviews for clinical practices at the local level.

This type of center can conduct primary research, disseminate HTA results locally, and propose new projects to the SBU.

From a Technology-Oriented to a Health Problem-Oriented Approach

During its first 5 years, assessments by SBU were technology and service-oriented. The first technology assessment addressed preoperative testing in elective surgery. Follow-up surveys in 1990 and 1991—undertaken to evaluate the impact of the first report—showed a significant decrease in routine preoperative testing, which had been recommended by the SBU. Other early reports were on dental implants, gastroscopy, and extracorporeal shock wave lithotripsy. During the 1990s, systematic literature review methodology became the fundamental method at the SBU. Increasingly, the scope of assessment came to focus on important health problems in society (e.g., back pain), and the assessment then covered all relevant preventive, diagnostic, and treatment methods. In one recent report, the SBU analyzed a great number of methods used in the management of neck and back pain, including their economic consequences, and concluded that most of the back pain methods used in Sweden were found to be either ineffective or unproven. However, this type of review takes 3–4 years from its start to the published report, a time period considered by some critics to be too long in that there is a risk that policy makers will not have the time to wait for assessment reports. On the other hand, there is a certain value in having project groups (usually approximately 7–12 people representing the clinical and research community as well as economists, epidemiologists, and other professions), working together over a long period of time on HTA. Such collaboration involves a learning process as well as a process of creating advocates for evidence-based medicine. In fact, approximately 1,000 experts have participated in SBU assessments and have become ambassadors of the results, thus playing an important role in the dissemination of the findings. It is obvious, however, that there is a conflict between being comprehensive, transparent, and evidence-based and being timely and relevant. To tackle the problem of people with limited time not being able to read reports in their entirety, the SBU has put much effort into producing short summaries of report findings for particular target groups, including the public.

A New Technology-Oriented Early Warning Program

As a response to the problem of time delay, SBU Alert—a mechanism for early identification and assessment—was established in 1997. The demand came primarily from health-care politicians. Relevant policy-oriented information on evidence and potential consequences, provided at the right time, is meant to aid health policy makers in understanding more accurately the potential impact of new technologies and to optimize their diffusion and assessment (5). To achieve this, the SBU Alert program acts as a “bridge” between medical experts, on the one hand, and policy makers and the public, on the other. It does this by identifying relevant medical technologies and producing timely information on the scientific basis of the medical effects and potential consequences for health services. The SBU produces, in cooperation with medical experts, brief assessments, which are published on the Internet and then considered for revision. The SBU Alert advisory board is composed of medical experts and is involved in assisting in the selection of new technologies to assess; supplementing the assessments undertaken by the medical expert consultants; and taking part in information dissemination. As of February 2004, sixty-two briefs have been published and another thirty technologies have been selected for assessment.

Other relevant Swedish organizations such as the Medical Product Agency, the National Board of Health and Welfare, and health-care providers are represented on the SBU Alert advisory board. Several similar initiatives to set up units for early warning have been undertaken in other countries, including the United Kingdom, The Netherlands, Canada, Spain, France, Denmark, Switzerland, Norway, and Israel. Together, they have established the international collaborative group, EuroScan.

Increasing Interest in Priority Setting

Increasing efficiency through HTA/evidence-based medicine is one approach to handling the growing gap between the demand for and the supply of resources. Another is explicit priority setting. The National Council on Care Policy (which is a forum for dialogue between the national government, the county councils and the municipalities on health-care issues) has initiated a national program for the development of priority setting. In January 2001, the National Centre for Priority Setting in Health Care was established in Linköping. The center's mission is to pursue and stimulate the theoretical and practical development of knowledge and methodologies for priority setting.

In addition to the activities run by the center, an increasing number of projects and trials to establish systems for explicit priority setting are under way in Sweden. Such activities are currently taking place at both the national level (e.g., the National Board of Health and Welfare and the Swedish Society of Medicine), and at the local-regional level (e.g., the Östergötland county council and the West Region [Västra Götalandregionen]).

Examples from the National Level

In Sweden, with its decentralized health-care system, the decision-making process on medical technology takes place on several levels. First, one can identify the central (national) and local levels. At the central level are several organizations (i.e., government, government agencies, professional federations, and associations) that use evaluations in their policy work and recommendations. The clearest example of where a review of medical data and cost-effectiveness has been used in the process of policy making is in the case of the National Board of Health and Welfare's national guidelines for the treatment of coronary heart conditions.

The Department of Health and Social Affairs is regularly briefed on the work produced by the SBU. All reports are also sent to key politicians and administrators in county councils, and often, local meetings are arranged as part of the implementation process. However, it is difficult to discern how this information is actually used in the political process. There are findings that show that the SBU reports on moderately elevated blood pressure, use of neuroleptics, stomach pain, smoking cessation, and preoperative routines have had an impact on clinical practice (3). SBU staff have actively spread results through conferences, lectures, and publications. A newsletter is produced and distributed free of charge and has a circulation of 100,000 copies. In 1996, the SBU, together with four county councils in northern Sweden, developed a structure of locally based informants. Similar initiatives have subsequently been undertaken in other parts of Sweden. The network has now grown to include thirty-five informants throughout the country. The Stockholm County Council, for example, has established a local “SBU” office. A survey of clinicians and policy makers in Sweden in 1997 shows that 72 percent of politicians and 78 percent of clinicians are familiar with at least one report from SBU, while 66 percent of politicians and 78 percent of doctors have found at least one SBU report useful (13). A study in three county councils on the implementation of four SBU studies shows examples of several local activities aiming at implementing the results of the reports (13). It also shows that the implementation of results in systematic reviews is extremely complex as the results are not always clear from a policy perspective.

The effect of HTA on coverage policy decisions was studied as part of the EUR-ASSESS project. The introduction and diffusion of invasive cardiology therapy (ICT) was investigated in five countries including Sweden (2). In Sweden, several evaluations by national agencies were produced between 1983 and 1994. These were undertaken during a period of rapid expansion of by-pass surgery. For example, a consensus conference in 1983 led to improved discussions between doctors and policy makers and was used as a basis for policy decisions, while an expert opinion report in 1986 from the National Board of Health and Welfare resulted in an expansion of open-heart surgery. The EUR-ASSESS study concluded that, in Sweden and Catalonia, recent assessment studies have influenced coverage decisions for new ICT procedures.

Examples from the Local Level

On the local level, there are political, intermediate, and individual/clinical spheres. Politicians must decide on the allocation of resources between sectors and medical specialties. At the intermediate level (e.g., hospital or health center), decisions about particular technology and treatment guidelines are made. At the clinical level, priorities are set between individual patients and particular patient groups, respectively. However, in practice, the system is less well defined and more complicated than this account suggests.

At the local level, there are users of nationally produced assessments and guidelines. There are also other organizations, which produce assessments and local guidelines. Sometimes the national actors like the SBU communicate directly with individual clinicians, as in the case of the report on the treatment of mild and moderate hypertension. This report was used by individuals but was also used as a basis for work on local guidelines. One of the few examples where the politicians took account of scientific evaluation occurred in the case of Östergötland County Council, when they linked their decision on a contract with private chiropractors to the scientific evidence. The CMT at Linköping University was asked to investigate whether chiropractic care, as an alternative to physiotherapy in primary health care, is cost-effective. A randomized study was carried out comparing the costs and effectiveness in the treatment of back pain through chiropractic care or physiotherapy as the primary treatment. Before the study, politicians had agreed only to a short-term contract with the chiropractors and awaited the results from the trial before making a final decision. The results, which showed that no strategy was more cost-effective in all cases, were then reported in the scientific literature (14).

Assessment of Nonpharmaceutical Technologies

Compared with other countries, decision making on investments in expensive and complicated technology is more decentralized in Sweden. This makes the influence of HTA less obvious. Despite decentralized decision making, however, there is some evidence of the impact of the assessments that have been carried out. Examples include the introduction of “high-tech” procedures such as extracorporeal lithotripsy for kidney stones, heart transplantations, and liver transplantations. These technologies, together with four different prenatal screening tests, were investigated in terms of diffusion in a European study in the early 1990s. The aim of the project was to analyze factors affecting the diffusion of innovative medical technologies (17). The study indicates that evaluations in general have had a minor role in decision making, although in Sweden, the most thorough evaluation of lithotripsy did have a clear impact on decision making (7). For transplantations, several governments as well as professional groups were willing to support the need for assessment: “The effects of the results on policies and the diffusion pattern are less easy to determine, but certainly seem to have been influential in The Netherlands and Sweden” (17).

Impact of Economic Studies

A field of increasing interest in Sweden is the introduction of new drugs. All county councils have at least one drug committee. These committees are now expected not only to consider effectiveness but also economic aspects in their recommendations. However, committees have few resources for research of their own and are dependent on other parties instead. In 1998, the Swedish Institute for Health Economics investigated attitudes toward using health economic information as a basis for their recommendations (1). The most important sources were reports from the SBU, articles in scientific journals, and recommendations from the Medical Product Agency, in that order. The most important decision criteria for the committees were (i) the therapeutic effect, (ii) the relationship between effect and costs, (iii) the relationship between effect and side effects. A 1997 review article by Jönsson on the economic evaluation of medical technologies in Sweden concluded that cost-effectiveness studies have had a limited impact on the outcomes of decisions: “This is hardly surprising since methodology and data for such studies have only recently been available and efficient use of resources just recently has risen to the top of the health policy agenda” (9). Attitudes to economic information have been investigated by Jönsson and Karlsson in a survey of 600 randomly selected decision makers in Swedish health care, of which, 70 were administrators, 70 were politicians, and the remainder were doctors in leading positions (Unpublished data, 2002). Sixty percent of those surveyed responded and 23 percent of the respondents have used economic evaluations in decision making. Over 90 percent of the respondents agree that economic aspects should influence clinical practice to some, or to a large, extent. The impact of two well-known health economic evaluations was investigated. The so-called 4-S study of cholesterol lowering was known by 47 percent of respondents, while the SBU report on hypertension treatment was known by 50 percent. Those who were familiar with these two studies found measures on cost-effectiveness more relevant than cost-impact.

Integration of Cost-Effectiveness Information in Priority Setting

The National Board for Health and Welfare has initiated several projects on priority setting. The aim of one of the projects is to produce guidelines on heart diseases for the county councils to support local discussions on the allocation of resources and on clinical recommendations. These guidelines will include a ranked list of established health-care activities. Preliminary work in line with this plan was published in 2001 on coronary heart diseases (15). Data on cost-effectiveness played a clear role in these discussions and probably affected the outcome of the prioritization process. More comprehensive national guidelines, including priority setting for all heart-related conditions, were published during 2003. These were followed by guidelines on vertical priority setting on chronic obstructive lung disease and asthma and on venous thrombosis.

Besides this type of limited trial of explicit prioritization, not very much has happened in practice—with one exception. The drastic escalating cost of new drugs during the 1990s has, for the first time, drawn political attention to new technologies, and action is now being taken to increase the role of health economic evaluation in priority setting and decision making concerning drugs. In view of this, the Swedish Parliament passed a law in April 2002 to establish a new government agency (Pharmaceutical Benefit Board) for negotiating prices and making decisions on the reimbursement of drugs. The new agency has been operating since October 1, 2002. In the directives from Parliament, it is clear that incremental effectiveness and cost-effectiveness must be central criteria in decisions concerning the reimbursement of drugs. The new agency is now responsible for both price negotiations and decisions about a drug's inclusion in the benefit package. The agency has a staff of approximately twenty people, including health economists, who also support a decision-making committee that contains people with broad competence and experience in health care. There are two health economists among the committee's eleven members as well as two patient/public representatives. The committee meets once a month and makes decisions that are independent of the Ministry of Health and Social Affairs. All new drugs will be assessed on their clinical relevance and cost-effectiveness, based on applications from pharmaceutical companies. The committee assesses all material presented by the pharmaceutical company in its application. All relevant aspects, such as the severity of the condition, evidence of effectiveness, cost-effectiveness, and price are considered. If the company is dissatisfied with the decision made, there is an appeal mechanism. After a preliminary decision is made, representatives from the company have the opportunity to present their arguments directly to the committee. If the company is still dissatisfied with the final decision, it can appeal to an independent court. The agency will also evaluate old drugs already on the market on the same basis as new ones. Given the large number of older drugs in existence, it is uncertain how long this retrospective assessment will take.