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Moorkens E, Vulto AG, Huys I, et al. Policies for biosimilar uptake in Europe: An overview. PLoS One. 2017;12(12):e0190147doi: 10.1371/journal.pone.0190147.
Moorkens, E., Vulto, A. G., Huys, I., Dylst, P., Godman, B., Keuerleber, S., Claus, B., Dimitrova, M., Petrova, G., Sović-Brkičić, L., Slabý, J., Šebesta, R., Laius, O., Karr, A., Beck, M., Martikainen, J. E., Selke, G. W., Spillane, S., McCullagh, L., Trifirò, G., Vella Bonanno, P., Mack, A., Fogele, A., Viksna, A., Władysiuk, M., Mota-Filipe, H., Meshkov, D., Kalaba, M., Mencej Bedrač, S., Fürst, J., Zara, C., Skiöld, P., Magnússon, E., & Simoens, S. (2017). Policies for biosimilar uptake in Europe: An overview. PloS one, 12(12), e0190147. https://doi.org/10.1371/journal.pone.0190147
Moorkens, Evelien, et al. "Policies for biosimilar uptake in Europe: An overview." PloS one vol. 12,12 (2017): e0190147. doi: https://doi.org/10.1371/journal.pone.0190147
Moorkens E, Vulto AG, Huys I, Dylst P, Godman B, Keuerleber S, Claus B, Dimitrova M, Petrova G, Sović-Brkičić L, Slabý J, Šebesta R, Laius O, Karr A, Beck M, Martikainen JE, Selke GW, Spillane S, McCullagh L, Trifirò G, Vella Bonanno P, Mack A, Fogele A, Viksna A, Władysiuk M, Mota-Filipe H, Meshkov D, Kalaba M, Mencej Bedrač S, Fürst J, Zara C, Skiöld P, Magnússon E, Simoens S. Policies for biosimilar uptake in Europe: An overview. PLoS One. 2017 Dec 28;12(12):e0190147. doi: 10.1371/journal.pone.0190147. eCollection 2017. PMID: 29284064; PMCID: PMC5746224.
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PLoS One. 2017 Dec 28;12(12):e0190147. doi: 10.1371/journal.pone.0190147. eCollection 2017.

Policies for biosimilar uptake in Europe: An overview.

PloS one

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

Affiliations

  1. KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium.
  2. Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands.
  3. Medicines for Europe, Brussels, Belgium.
  4. Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
  5. Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.
  6. Main Association of Austrian Social Security Institutions, Vienna, Austria.
  7. Faculty of pharmaceutical sciences, Ghent University, Ghent, Belgium.
  8. Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria.
  9. Croatian Health Insurance Fund, Zagreb, Croatia.
  10. State Institute for Drug Control, Prague, Czech Republic.
  11. State Institute for Drug Control, Brno, Czech Republic.
  12. State Agency of Medicines, Tartu, Estonia.
  13. Department of Traumatology and Orthopedics, University of Tartu, Tartu, Estonia.
  14. Karr Consultancy Ltd, Hertfordshire, United Kingdom.
  15. OMEDIT Alsace, Agence Régionale de Santé du Grand Est, Strasbourg, France.
  16. Research Unit, Social Insurance Institution, Helsinki, Finland.
  17. Wissenschaftliches Institut der AOK (WIdO), Berlin, Germany.
  18. Department of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, Ireland.
  19. National Centre for Pharmacoeconomics, St James's Hospital, Dublin, Ireland.
  20. Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
  21. Division Pharmaceuticals, Norwegian Hospital Procurement Trust, Oslo, Norway.
  22. Department of Medicines and Medical Devices, The National Health Service, Riga, Latvia.
  23. HTA Consulting, Cracow, Poland.
  24. Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal.
  25. Semashko National Research Institute for Public Health, Moscow, Russia.
  26. Primary healthcare center Zemun, Belgrade, Serbia.
  27. Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Ljubljana, Slovenia.
  28. Health Insurance Institute, Ljubljana, Slovenia.
  29. Barcelona Health Region, Catalan Health Service, Barcelona, Spain.
  30. TLV, Stockholm, Sweden.
  31. Ministry of Welfare, Reykjavik, Iceland.

PMID: 29284064 PMCID: PMC5746224 DOI: 10.1371/journal.pone.0190147

Abstract

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.

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