Policies for biosimilar uptake in Europe: An overview.

Evelien Moorkens,Laura Mccullagh,Einar Magnússon,Antra Fogele,Pieter Dylst,Jurij Fürst,Barbara Claus,Juraj Slabý,Ljiljana Sović-Brkičić,Marija Kalaba,Patricia Vella Bonanno,Simona Mencej Bedrač,Robin Šebesta,Guenka Petrova,Isabelle Huys,Brian Godman,Corrine Zara,Gianluca Trifirò,Ott Laius,Jaana E Martikainen,Susan Spillane,Maria Dimitrova,Arnold G Vulto,Peter Skiöld,Simon Keuerleber,Dmitry Meshkov,Steven Simoens,Asbjørn Mack,Anita Viksna,Allan Karr,M Beck ,M Wladysiuk ,Gisbert Selke ,Hélder Mota-Filipe

doi:10.1371/journal.pone.0190147

Abstract

BackgroundAcross European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.ObjectivesThe aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake.MethodsAn overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake.ResultsIn all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution.ConclusionsMost countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Highlights

Biological medicinal products are widely used, e.g., in treatment of autoimmune diseases and cancer, targeting key disease mediators [1]
Most countries have put in place specific supply-side policies for promoting access to biosimilars
We propose that investments should be made to clearly communicate on biosimilars and educate stakeholders

Summary

Introduction

Biological medicinal products are widely used, e.g., in treatment of autoimmune diseases and cancer, targeting key disease mediators [1]. They are often expensive and continued growth in market share and expenditure is expected in the coming years [2]. This trend puts pressure on already restricted healthcare budgets and may lead to a decrease in patient access to treatment [3]. Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe

Objectives

Results

Discussion

Conclusion