Policies for biosimilar uptake in Europe: An overview
Language English Country United States Media electronic-ecollection
Document type Journal Article
PubMed
29284064
PubMed Central
PMC5746224
DOI
10.1371/journal.pone.0190147
PII: PONE-D-17-26394
Knihovny.cz E-resources
- MeSH
- Biosimilar Pharmaceuticals economics therapeutic use MeSH
- Humans MeSH
- Drug Costs MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Geographicals
- Europe MeSH
- Names of Substances
- Biosimilar Pharmaceuticals MeSH
BACKGROUND: Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. OBJECTIVES: The 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. METHODS: An 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. RESULTS: In 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. CONCLUSIONS: Most 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.
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia Ljubljana Slovenia
Barcelona Health Region Catalan Health Service Barcelona Spain
Croatian Health Insurance Fund Zagreb Croatia
Department of Laboratory Medicine Karolinska Institutet Stockholm Sweden
Department of Medicines and Medical Devices The National Health Service Riga Latvia
Department of Pharmacology and Therapeutics Trinity College Dublin Dublin Ireland
Department of Traumatology and Orthopedics University of Tartu Tartu Estonia
Division Pharmaceuticals Norwegian Hospital Procurement Trust Oslo Norway
Faculty of pharmaceutical sciences Ghent University Ghent Belgium
Faculty of Pharmacy Medical University of Sofia Sofia Bulgaria
Faculty of Pharmacy University of Lisbon Lisbon Portugal
Health Insurance Institute Ljubljana Slovenia
Hospital Pharmacy Erasmus University Medical Center Rotterdam The Netherlands
Karr Consultancy Ltd Hertfordshire United Kingdom
KU Leuven Department of Pharmaceutical and Pharmacological Sciences Leuven Belgium
Main Association of Austrian Social Security Institutions Vienna Austria
Medicines for Europe Brussels Belgium
Ministry of Welfare Reykjavik Iceland
National Centre for Pharmacoeconomics St James's Hospital Dublin Ireland
OMEDIT Alsace Agence Régionale de Santé du Grand Est Strasbourg France
Primary healthcare center Zemun Belgrade Serbia
Research Unit Social Insurance Institution Helsinki Finland
Semashko National Research Institute for Public Health Moscow Russia
State Agency of Medicines Tartu Estonia
State Institute for Drug Control Brno Czech Republic
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