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.