[Controversies around QALYs].

The paper summarizes the criticisms of the QALY concept utilization in health-economic evaluations that has been growing stronger in the last years. Despite of its limitations, the QALY concept has been routinely used in many countries incl. the Czech Republic. However, some states disapproved QALYs as an optimizing criterion at the level of their political decisions. The critical reflection concerns both the theoretical and the experimental issues. Based on a literary review, fundamental arguments against the concept are summarized, and a synthesis of material objections is presented. The critical arguments focus on the foundations of the QALY concept in the economic theory, some ethical principles, inconsistencies and technical imperfections of the quality-of-life measurement tools used in QALY calculations, the substitution rule, differences between various diagnoses, and disregarding some other important parameters. As a whole, the critics´ arguments can be judged as quite strong. The future will show whether the critical arguments summarized in this paper will lead to a development of alternative tools that have a potential of eliminating imperfections in QALYs, and consequently provide more complex data for the decision process.Key words: cost-effectiveness - health technology assessment - HTA - QALY - utility measure for medical interventions.