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.