The use of economic evaluation in decision making appears to have increased over the past few years and economic evaluation is looked upon as another measure to help contain costs and improve efficiency in an evidence-based decision-making environment. Following the examples of Australia and the Canadian Province of Ontario, four European Union (EU) countries (Finland, the Netherlands, Portugal, and the United Kingdom) have recently introduced economic evaluation guidelines. In addition to the Australian and Canadian guidelines, which constitute a hurdle to reimbursement, the paradigm that seems to be evolving in the four EU countries follows a similar route. Finland and the Netherlands seem to be moving toward the notion of a fourth hurdle to reimbursement, whereas the National Institute for Clinical Excellence in England and Wales was in principle meant to influence practice, although in reality this essentially acts as a hurdle to reimbursement, requiring a different data set to that used by regulatory authorities. Whereas the Portuguese guidelines were developed to assist in preparing economic submissions to support reimbursement decisions, they are unclear about when such evidence will be required and also discuss the dissemination of economic evidence to broader audiences. The introduction of these guidelines poses a number of challenges to policy makers, the implications of which are analyzed in the paper: a) to ensure that economic evaluations are carried out scientifically without industrial or political bias; b) to define an acceptable methodology that would increase their credibility; and c) to address certain practical issues ranging from deciding how to use economic evaluations in policy making to setting up new institutions or improving the coordination and dissemination of evidence. The variation in the use of economic evaluation guidelines in the four EU countries highlights the differences in national pharmaceutical policies and is in line with policy makers' continuous attempts to contain costs. While the paper critically discusses the guidelines, it also points out that a series of methodologic issues need to be addressed if economic criteria are to be introduced in policy making with the aim to improve resource allocation. The paper concludes that economic evaluation as a discipline is beginning to impact on policy, whereas the consistent use of economic evaluation results is, in principle, being adopted by policy makers but needs to go a step further to reach practitioners.

Objectives: To study the socioeconomic impact of rheumatic illness in Sweden and to discuss the consequences for technology assessment studies.

Methods: A cost-of-illness study based on data from official statistics and treatment studies.

Results: The total socioeconomic cost was 52 billion Swedish kronor (SEK) in 1994. The imbalance between direct (10% of total) and indirect costs (90effectiveness of the healthcare sector, the need for new treatment methods, appropriate information systems, and technology assessment studies as well as the institutional arrangements for rehabilitation and basic medical research.

Conclusions: A discussion of solutions for financial cooperation between county councils and regional social insurance offices should be considered. The new biotechnological pharmaceuticals will increase the cost for drugs in health care about 20 times, but the total socioeconomic cost for society may remain at the same level due to a decrease of inpatient costs and indirect costs for loss of production as well as a decrease of transfer payments from social insurance. It is unavoidable that the new pharmaceuticals require priority discussions and active resource allocation in health care and in other sectors of society.

There is a time delay between the final recruitment of patients to a randomized controlled trial and the publication of results. The practical options available to decision makers during this gap can be listed according to whether all treatments are already widely available or whether at least one has been restricted to the trial. When the treatments are already in widespread use, the options are simply either to stop randomizing or to continue. When one trial treatment is restricted, there are further options: a) withdraw the restricted treatment altogether, pending the final analysis; b) continue to offer randomization, with a view to providing further data should these be needed; or c) make the intervention widely available to patients who would have previously been eligible for the trial. In this paper, we discuss the relative advantages and disadvantages of each option and discuss their attendant ethical implications. In particular, we suggest that continuing randomization is an option worthy of serious consideration. Randomizing patients acts as a “hedge” against the need for more data, given that sample size calculation is an inexact science. However, patients must be made aware of the basis on which randomization is offered.

Objective: Our study aims to provide a practical contribution to the field of medical technology assessment within a new paradigm. This paradigm indicates the need for more comprehensive technology assessments in the development stage of a new technology.

Method: We introduce a method, based on Saaty's Analytic Hierarchy Process, which quantitatively supports discussions between the various actors that shape the technology's development and diffusion. These discussions focus on technical, medical, social, and economical requirements relevant to the design and diffusion of the new technology.

Discussion: In contrast to more traditional technology assessments, our method encompasses the perspectives of the diverse actors in the social context of technology development and diffusion. It influences their decision making on technology design and diffusion in order to improve this technology's later clinical as well as social effectiveness.

This paper considers the question of what ought to be valued in the context of measuring the outcomes of healthcare interventions. The answer is discrete health states in the case of the quality-adjusted life-year (QALY) model and an entire health profile in the case of the healthy-years equivalent (HYE) approach. How well the weighted average of values attached to the former approximates the overall value attached to the latter depends on the validity of the assumptions of the QALY model. The paper considers some of the empirical literature relating to them. One of the most important assumptions, which from the limited evidence available appears not to hold, is additive separability. However, it is argued that violation of this assumption does not in itself invalidate the QALY approach, since in some circumstances it might be more appropriate to elicit the value of a health state independently of the states that succeed it. Investigation into this issue is identified as one of the key areas where future research efforts should be directed.

Objective: The purpose of this study is to analyze the perception of the content of health technology assessment (HTA) among health professionals applying for a state grant of DKK 10 million.

Methods: A total of 113 applications were received and analyzed. When conducting the analysis, it was assumed that the applicants' maximum five-page project description would reflect: a) the applicants' perception of what an HTA is; b) how the assessment was to be conducted; and c) what the results were going to be used for.

Results: More than 40% of all applications focused on treatment; in 51% only one or two professional groups were to be involved (thus interdisciplinarity was questionable); only 22% of the HTA cases were intended to form the basis for political/administrative decisions; in general, the HTAs were planned far less comprehensively than was relevant; 76% of the projects did not include a formal synthesis phase; 41% intended to use diffusion as the only method for publication of the HTA result.

Conclusions: The analysis reveals several areas where DIHTA has to make an effort in order to secure that HTA in fact constitutes a comprehensive and well-documented basis for decision making. These areas concern the following topics: multidisciplinarity, the objective of HTA, comprehensiveness, the synthesis phase, and publication and utilization of the HTA result.