Effective tools to manage biosimilars prescription: the Italian experience

Abstract Introduction Biosimilars represent both a clinical and a financial opportunity. However, low biosimilar penetration has been observed across Europe. Italy has registered a high and increasing biosimilars uptake, but not uniform across regions. Objectives The paper aims to describe different managerial tools that can be leveraged to exploit the biosimilars’ potential. A focus on Italy and the Tuscany region will be specifically carried out. Furthermore, this research is intended to propose some preliminary considerations about the most effective measures to support biosimilars’ uptake. Methods This article is based on both desk research and on action research. A desk research was carried out to explore the existing international and national literature on the measures implemented to promote biosimilars’ penetration. The action research concerned a longitudinal cooperation project between the Management and Health Laboratory of Scuola Superiore Sant'Anna of Pisa and the Drugs and Appropriateness Policy Sector of Tuscany Region. The activity saw the direct involvement of the Management and Health Laboratory in supporting the regional pharmaceutical governance in managing biosimilars’ penetration. Results Several demand and supply side policies to foster biosimilar penetration have been implemented both at national and regional levels. In Italy, most regions have adopted specific biosimilar policies at different moments and with heterogeneous contents. The Tuscan Regional Health System implemented three main measures: formal top-down, bottom-up and “mixed” measures. The strategy was effective in increasing biosimilar uptake. The success is probably associated with its comprehensive approach and to the coherence of the different measures it was composed of.