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.

Tendering and biosimilars: what role for value-added services?

“…A 2017 policy overview of 31 European countries conducted by Medicines for Europe revealed similar findings regarding tendering for biosimilars [24]. In a separate literature review concerning 10 countries (Belgium, France, Germany, Greece, Hungary, Italy, Poland, Spain, Sweden, and the UK), tenders for biosimilars were reported to operate in all countries except Greece [25]. Tenders generally operate at the hospital level (except in Germany).…”

“…Criteria other than price alone may be considered in Belgium, France, Spain, and the UK, including additional services (e.g. medicine training or delivery service) [25]. Non-exclusive tenders (i.e.…”

“…Non-exclusive tenders (i.e. those that result in the inclusion of the originator product and the biosimilar in the formulary) are widespread, although exclusive tenders operate in Poland [25].…”

Biosimilars and patient care

“…The expectation that biosimilars will result in substantially reduced drug costs per treated individual has met with mixed success, as price reductions of biosimilars relative to the originator vary between countries (reviewed in ). So far, the strongest relative price difference for antipsoriatic biosimilars as given in the ‘Rote Liste’ in Germany is 25 % for the infliximab biosimilar Inflectra ® as compared to the originator product Remicade ® , while in Sweden, the cost reduction of Inflectra ® relative to Remicade ® in 2016 was approximately 58 % .…”

Biosimilars und Patientenversorgung

“…Die Erwartung, dass Biosimilars zu einer deutlichen Senkung der Arzneimittelkosten pro behandeltem Individuum führen werden, ist nicht immer erfüllt worden, da die Preisdifferenzen zwischen Biosimilars und den Originatoren von Land zu Land variieren (Übersicht in ). Bislang beträgt der größte relative Preisunterschied für antipsoriatische Biosimilars in der Bundesrepublik Deutschland Roten Liste angegeben ist, 25 % für das Infliximab‐Biosimilar Inflectra ® gegenüber dem Originalpräparat Remicade ® , während in Schweden die Kostenreduktion von Inflectra ® gegenüber Remicade ® im Jahr 2016 bei etwa 58 % lag .…”