Evaluating the quality and use of economic data in decisions about essential medicines.

OBJECTIVE To evaluate the quality of economic data provided in applications to the World Health Organization (WHO) Model List of Essential Medicines and to evaluate the role of these data in decision-making by the expert committee that considers the applications. METHODS We analysed applications submitted to the WHO Expert Committee on the Selection and Use of Essential Medicines between 2002 and 2013. The completeness of data on the price and cost-effectiveness of medicines was extracted from application documents and coded using a four-point scale. We recorded whether or not the expert committee discussed economic information and the outcomes of each application. Associations between the completeness of economic data and application outcomes were assessed using χ2 tests. FINDINGS The expert committee received 134 applications. Only eight applications (6%) included complete price data and economic evaluation data. Many applicants omitted or misinterpreted the economic evaluation section of the application form. Despite the lack of economic data, all applications were reviewed by the committee. There was no significant association between the completeness of economic information and application outcomes. The expert committee tried to address information gaps in applications by further review and analysis of data related to the application. CONCLUSION The World Health Organization should revise the instructions to applicants on economic data requirements; develop new mechanisms to assist applicants in completing the application process; and define methods for the use of economic data in decision-making.