PHP321 - Supply-Side and Demand-Side Policies for Biosimilars: An Overview in 10 European Member States

Abstract

The European Union Member States (EU MS) are seeking for effective cost-containment measures to ensure sustainability of health care systems. With growing budget impact of costly biologic medicines, biosimilar promises for health care cost-savings are thoroughly scrutinised by payers. This study aimed to provide an overview of biosimilar policies implemented in selected EU MS. Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden and UK) were selected. A comprehensive review of the literature was performed to identify publications describing 1) supply-side policies and 2) demand-side policies in place in the selected countries through Medline, Embase, Cochrane library databases, GaBi, ISPOR and HTAi websites, National Health Authorities websites and grey literature. 1) Supply-side policies for biosimilars: price linkage and tendering were common practices in almost all countries, while pricing through internal or external reference pricing was more scattered between countries; health technology assessment was reported to be conducted in six countries. 2) Demand-side policies for biosimilars: six countries reported different approaches to control biosimilar prescription through pharmaceutical prescription budgets and/or prescription quotas, sometimes applying financial incentives or penalties measures. Except for Poland, switching and automatic substitution are generally not recommended, and decisions lie with physician’s responsibility; despite not being enforced, France was the first EU MS which legislated biosimilar substitution for naïve patients. Patient co-payment system is in place in all countries; specific co-payment systems to favor use of the cheaper treatment are reported in some countries. Education and information tools retrieved for biosimilars did not generally target a specific audience. Important heterogeneity was seen between (even within) selected countries in policies towards biosimilars; information was generally scarce on educative measures implemented to enhance biosimilar adoption by different stakeholders. This heterogeneity might contribute to explain differences in biosimilar uptakes reported across EU MS.