The Expiry of Humira ® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.

Autor:	Moorkens E; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium., Godman B; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.; Division of Public Health Pharmacy and Management, School of Pharmacy, Faculty of Health Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa.; Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden., Huys I; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium., Hoxha I; Department of Pharmacy, University of Medicine Tirana, Tirana, Albania., Malaj A; Department of Pharmacy, University of Medicine Tirana, Tirana, Albania., Keuerleber S; Austrian Social Insurance, Vienna, Austria., Stockinger S; Austrian Social Insurance, Vienna, Austria., Mörtenhuber S; Austrian Social Insurance, Vienna, Austria., Dimitrova M; Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria., Tachkov K; Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria., Vončina L; Faculty of Health Studies, University of Rijeka, Rijeka, Croatia., Palčevski VV; Faculty of Health Studies, University of Rijeka, Rijeka, Croatia., Achniotou G; Health Insurance Organization (HIO), Nicosia, Cyprus., Slabý J; State Institute for Drug Control, Prague, Czechia., Popelková L; State Institute for Drug Control, Prague, Czechia., Kohoutová K; State Institute for Drug Control, Prague, Czechia., Bartels D; Amgros, Copenhagen, Denmark., Laius O; State Agency of Medicines, Tartu, Estonia., Martikainen JE; Pharmaceuticals Pricing Board, Ministry of Social Affairs and Health, Helsinki, Finland., Selke GW; AOK Research Institute (WIdO), Berlin, Germany., Kourafalos V; National Organization for the Provision of Healthcare Services (EOPYY), Athens, Greece., Magnússon E; Ministry of Welfare, Reykjavik, Iceland., Einarsdóttir R; The National University Hospital of Iceland, Reykjavik, Iceland., Adams R; St James's Hospital, Dublin, Ireland., Joppi R; Clinical Research and Drug Evaluation Unit, Local Health Authority of Verona, Verona, Italy., Allocati E; Mario Negri Institute for Pharmacological Research (IRCCS), Milan, Italy., Jakupi A; UBT - Higher Education Institute, Prishtina, Kosovo., Viksna A; Department of Medicines and Medical Devices, The National Health Service, Riga, Latvia., Greičiūtė-Kuprijanov I; Ministry of Health of the Republic of Lithuania, Vilnius, Lithuania., Vella Bonanno P; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom., Suttorp V; Erasmus University Medical Center, Rotterdam, Netherlands., Melien Ø; Reviews and Health Technology Assessments, Norwegian Institute of Public Health, Oslo, Norway., Plisko R; HTA Consulting, Cracow, Poland., Mardare I; Public Health and Management Department, Faculty of Medicine, 'Carol Davila', University of Medicine and Pharmacy Bucharest, Bucharest, Romania., Meshkov D; V. A. Trapeznikov Institute of Control Sciences of Russian Academy of Sciences, Moscow, Russia., Novakovic T; ZEM Solutions, Belgrade, Serbia., Fürst J; Health Insurance Institute, Ljubljana, Slovenia., Zara C; Drug Area, Catalan Health Service, Barcelona, Spain., Marković-Peković V; Department of Social Pharmacy and Pharmacy Practice, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina., Grubiša N; Health Insurance Fund, Banja Luka, Bosnia and Herzegovina., Befrits G; Stockholm County Council, Stockholm, Sweden., Puckett R; NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom., Vulto AG; Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.; Erasmus University Medical Center, Rotterdam, Netherlands.
Jazyk:	angličtina
Zdroj:	Frontiers in pharmacology [Front Pharmacol] 2021 Jan 08; Vol. 11, pp. 591134. Date of Electronic Publication: 2021 Jan 08 (Print Publication: 2020).
DOI:	10.3389/fphar.2020.591134
Abstrakt:	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. Competing Interests: AGV is involved in consulting, advisory work and speaking engagements for a number of companies, a.o. AbbVie, Accord, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Sandoz. RP runs a consulting company and previously worked with, a.o., Abbvie, Biogen, Sandoz, Pfizer, MSD, Roche, GSK, Sanofi. IM is involved in consulting and advisory work and recently worked with I&S Hungary, Ewopharma, Genesis Pharma, GSK. RP was employed by HTA Consulting at the time of the study. TN was employed by ZEM Solutions at the time of the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Moorkens, Godman, Huys, Hoxha, Malaj, Keuerleber, Stockinger, Mörtenhuber, Dimitrova, Tachkov, Vončina, Palčevski, Achniotou, Slabý, Popelková, Kohoutová, Bartels, Laius, Martikainen, Selke, Kourafalos, Magnússon, Einarsdóttir, Adams, Joppi, Allocati, Jakupi, Viksna, Greičiūtė-Kuprijanov, Vella Bonanno, Suttorp, Melien, Plisko, Mardare, Meshkov, Novakovuc, Fürst, Zara, Marković-Peković, Grubiša, Befrits, Puckett and Vulto.)
Databáze:	MEDLINE
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