Decision-making in priority setting for medicines--a review of empirical studies.

Rising pharmaceutical expenditure leads to an increased need for priority setting in medicinal care. The objective of this paper is to review studies that empirically analyse a macro- and meso-level decision-making process for including drugs in and/or excluding drugs from reimbursement lists and drug formularies in industrialized countries. We identified six separate studies analysing a decision-making process as a whole. According to them, the most important groups in decision-making were experts and administrative persons. The decision-makers had an explicitly or implicitly defined set of criteria that were considered in decision-making, with clinical evidence on the benefit and the costs being the main criteria used. However, formal pharmacoeconomic analyses were given a rather small role. The criteria used varied between studies, and also between decisions. The decisions seemed inevitably to be partly value-based in their nature, as the scientific or other exact evidence did not give a firm foundation on which the decisions could be solely based. The majority of the studies concentrated on descriptive analysis on how things are rather than on explicitly analysing how decision-making processes perform against defined principles or goals. To facilitate decision-making by clearly defined principles and methods, more analytic studies on decision-making are especially needed.