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

Abstract

Objective: This study aimed to provide an overview of biosimilar policies in 10 EU MSs. Methods: Ten EU MS pharmaceutical markets (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK) were selected. A comprehensive literature review was performed to identify supply-side and demand-side policies in place in the selected countries. Results: Supply-side policies for biosimilars commonly include price linkage, price re-evaluation, and tendering; the use of internal or external reference pricing varies between countries; health technology assessment is conducted in six countries. Regarding demand-side policies, pharmaceutical prescription budgets or quotas and monitoring of prescriptions (with potential financial incentives or penalties) are in place in eight and in seven countries respectively. Switching is generally allowed, but is solely the physician's responsibility. Automatic substitution is not recommended, or even forbidden, in most EU MSs. Prescription conditions or guidelines that apply to biosimilars are established in nearly all surveyed EU MSs. Conclusions: Important heterogeneity in policies on biosimilars was seen between (and even within) selected countries, which may partly explain variations in biosimilar uptake. Supply-side policies targeting price have been reported to limit biosimilar penetration in the long term, despite short-term savings, while demand-side policies are considered to positively impact uptake. ARTICLE HISTORY

Effective tools to manage biosimilars prescription: The Italian experience

“…• biosimilar price discount over original biologic price, the number of analogues, and the distribution channel were not correlated with the biosimilar uptake; • average generic price discount over originator and the number of biosimilars show a trend toward statistical significance for correlation with biosimilar uptake, but do not reach the significance threshold; • incentive policies and the date of first biosimilar market entry were correlated with biosimilar uptake [17] , although other studies suggested that incentives might differently impact product classes [36] .…”

“…By considering one framework [17] , policies concerning biosimilars can be divided into "demand-side " and "supply-side " ones. Demand-side measures aim to steer the prescription of biological drugs towards the biosimilar alternative, while supply-side policies focus on the conditions associated with provision of the product.…”

key Drivers for Market Penetration of Biosimilars in Europe

“…The full description of the results for the literature review was presented elsewhere [25]. Incentive policies applied to biosimilars are heterogeneous across countries.…”

“…The search strategy used free search terms and was performed between October and November 2015. The full description of the methodology for the literature review was presented elsewhere [25]. The search strategy was performed in the following databases: MEDLINE; Embase; The Cochrane library; Generics and Biosimilars initiative (GaBi) journal and website; and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and Health Technology Assessment International (HTAi) websites for conference abstracts.…”