Challenges to achieving value in drug spending in a decentralized country: the Spanish case.

OBJECTIVES This article presents an overview of the Spanish health sector variables and drug policies as well as highlights the perspectives of new reforms. METHODS Initially, the text frames the health sector in the sociodemographic context; it describes the past two decades of demographic changes noting particularly the very low birth rate and the growth in the proportion of the elderly. It also summarizes the main aggregate economic trends emphasizing the gross national product growth of near an annual 4% for the past 10 years and the decrease in the unemployment rate from high values of approximately 20% to half that rate in the same period, together with a stabilization of the inflation rate around 4%, still higher than EU average values. Second, this article describes the Spanish health sector organization and financing, underlining that it is mostly a publicly funded system (approximately 80% of total health-care expenditures are public) and that the universal coverage is financed out of general taxation after two decades of transition from social security-based premiums. Simultaneously to that universalization of the health-care rights, Spain started a political decentralization process in almost all the spheres of the public administration, health issues included. The article describes the changes in budgeting, management, and funding that nowadays fully belong to the regions. RESULTS An essential part of the text is devoted to the pharmaceutical sector and its policies. Drug budgets represent almost 25% of the total public health expenditures; this proportion is approximately 50% of primary care expenditures. The incentive payments to achieve a more efficient prescription are approximately 2% of primary care physicians' gross salary. Doctors in hospitals have scarce incentives related to this issue. Some examples are presented of how this decentralization process affects the pharmaceutical policies that are designed and implemented by both the central and the regional governments. Regions are currently developing health technology assessment departments that will also perform activities on the economic evaluation of drugs. CONCLUSIONS The planned reforms will still retain at the central government level the control of three major drug policies: authorization, pricing, and reimbursement. Several policies are currently focused on increasing the 6% share of generic drugs in the total drug market toward the EU average. The decentralization will allow the regions to modify some reimbursement policies and mainly to establish new incentives on prescription and purchasing procedures of drugs by the hospitals. The new drug agency is foreseen to assume the utilization of cost-effectiveness studies to provide economic information in the pricing and reimbursement processes.