Abstract
ABSTRACTObjective: 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.
Highlights
Background and objectiveThe global economic crisis, which has affected Europe since mid-2007, forced the European Union (EU) member states (MSs) to implement several cost-containment measures to decrease or control healthcare expenditure, with major pressure exerted on pharmaceutical budgets [1,2]
In Hungary, there is a policy called ‘preferred reference pricing system’, applicable when more than two versions of a biologic medicine are available; this policy sets preferred price ranges based on the reference price for reimbursement, i.e. medicines priced up to 115% of the reference price are eligible for 100% reimbursement [26]
This study provides a comprehensive overview of biosimilar supply-side and demand-side policies implemented in selected EU MSs
Summary
Background and objectiveThe global economic crisis, which has affected Europe since mid-2007, forced the European Union (EU) member states (MSs) to implement several cost-containment measures to decrease or control healthcare expenditure, with major pressure exerted on pharmaceutical budgets [1,2]. Increasing the use of generics and biosimilars is considered an efficient way to improve patient health outcomes at a reduced cost, while sparing the budget for innovative medicines [6,7,8,9,10]. With the growing budget impact of costly biologic medicines – constituting about 27% of pharmaceutical sales in Europe [12] in 2014 – biosimilar promises for healthcare cost savings are thoroughly scrutinized by healthcare payers. In 2016, IMS Health estimated the cumulative potential savings in the top five EU markets (France, Germany, Italy, Spain, and the UK) and the USA at around 50–100 billion EUR over the 5 years [6]. The EU has the most developed regulated biosimilars market, with 21 medicines already authorized as of June 2016 [13] (Table 1)
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