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

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

2016 Value in Health

Rémuzat, C. | Kapuśniak, A. | Caban, A. | Ionescu, D. | Radière, G. | Mendoza, C. | Toumi, M. | Volume: 19, Issue: 7, Pages: A496,

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

https://www.doi.org/10.1016/j.jval.2016.09.869