Evelien Moorkens1, Brian Godman2,3,4, Isabelle Huys1, Iris Hoxha5, Admir Malaj5, Simon Keuerleber6, Silvia Stockinger6, Sarah Mörtenhuber6, Maria Dimitrova7, Konstantin Tachkov7, Luka Vončina8, Vera Vlahović Palčevski8, Gnosia Achniotou9, Juraj Slabý10, Leona Popelková10, Kateřina Kohoutová10, Dorthe Bartels11, Ott Laius12, Jaana E Martikainen13, Gisbert W Selke14, Vasileios Kourafalos15, Einar Magnússon16, Rannveig Einarsdóttir17, Roisín Adams18, Roberta Joppi19, Eleonora Allocati20, Arianit Jakupi21, Anita Viksna22, Ieva Greičiūtė-Kuprijanov23, Patricia Vella Bonanno2, Vincent Suttorp24, Øyvind Melien25, Robert Plisko26, Ileana Mardare27, Dmitry Meshkov28, Tanja Novakovic29, Jurij Fürst30, Corinne Zara31, Vanda Marković-Peković32, Nataša Grubiša33, Gustaf Befrits34, Robert Puckett35, Arnold G Vulto1,24. 1. Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium. 2. Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom. 3. Division of Public Health Pharmacy and Management, School of Pharmacy, Faculty of Health Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa. 4. Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden. 5. Department of Pharmacy, University of Medicine Tirana, Tirana, Albania. 6. Austrian Social Insurance, Vienna, Austria. 7. Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria. 8. Faculty of Health Studies, University of Rijeka, Rijeka, Croatia. 9. Health Insurance Organization (HIO), Nicosia, Cyprus. 10. State Institute for Drug Control, Prague, Czechia. 11. Amgros, Copenhagen, Denmark. 12. State Agency of Medicines, Tartu, Estonia. 13. Pharmaceuticals Pricing Board, Ministry of Social Affairs and Health, Helsinki, Finland. 14. AOK Research Institute (WIdO), Berlin, Germany. 15. National Organization for the Provision of Healthcare Services (EOPYY), Athens, Greece. 16. Ministry of Welfare, Reykjavik, Iceland. 17. The National University Hospital of Iceland, Reykjavik, Iceland. 18. St James's Hospital, Dublin, Ireland. 19. Clinical Research and Drug Evaluation Unit, Local Health Authority of Verona, Verona, Italy. 20. Mario Negri Institute for Pharmacological Research (IRCCS), Milan, Italy. 21. UBT - Higher Education Institute, Prishtina, Kosovo. 22. Department of Medicines and Medical Devices, The National Health Service, Riga, Latvia. 23. Ministry of Health of the Republic of Lithuania, Vilnius, Lithuania. 24. Erasmus University Medical Center, Rotterdam, Netherlands. 25. Reviews and Health Technology Assessments, Norwegian Institute of Public Health, Oslo, Norway. 26. HTA Consulting, Cracow, Poland. 27. Public Health and Management Department, Faculty of Medicine, "Carol Davila", University of Medicine and Pharmacy Bucharest, Bucharest, Romania. 28. V. A. Trapeznikov Institute of Control Sciences of Russian Academy of Sciences, Moscow, Russia. 29. ZEM Solutions, Belgrade, Serbia. 30. Health Insurance Institute, Ljubljana, Slovenia. 31. Drug Area, Catalan Health Service, Barcelona, Spain. 32. Department of Social Pharmacy and Pharmacy Practice, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina. 33. Health Insurance Fund, Banja Luka, Bosnia and Herzegovina. 34. Stockholm County Council, Stockholm, Sweden. 35. NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom.
Abstract
Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.
Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries.
Authors: Yannick Vandenplas; Steven Simoens; Philippe Van Wilder; Arnold G Vulto; Isabelle Huys Journal: Front Pharmacol Date: 2021-04-19 Impact factor: 5.810
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