Frontiers in Pharmacology (Jan 2021)
The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures
- Evelien Moorkens,
- Brian Godman,
- Brian Godman,
- Brian Godman,
- Isabelle Huys,
- Iris Hoxha,
- Admir Malaj,
- Simon Keuerleber,
- Silvia Stockinger,
- Sarah Mörtenhuber,
- Maria Dimitrova,
- Konstantin Tachkov,
- Luka Vončina,
- Vera Vlahović Palčevski,
- Gnosia Achniotou,
- Juraj Slabý,
- Leona Popelková,
- Kateřina Kohoutová,
- Dorthe Bartels,
- Ott Laius,
- Jaana E. Martikainen,
- Gisbert W. Selke,
- Vasileios Kourafalos,
- Einar Magnússon,
- Rannveig Einarsdóttir,
- Roisín Adams,
- Roberta Joppi,
- Eleonora Allocati,
- Arianit Jakupi,
- Anita Viksna,
- Ieva Greičiūtė-Kuprijanov,
- Patricia Vella Bonanno,
- Vincent Suttorp,
- Øyvind Melien,
- Robert Plisko,
- Ileana Mardare,
- Dmitry Meshkov,
- Tanja Novakovic,
- Jurij Fürst,
- Corinne Zara,
- Vanda Marković-Peković,
- Nataša Grubiša,
- Gustaf Befrits,
- Robert Puckett,
- Arnold G. Vulto,
- Arnold G. Vulto
Affiliations
- Evelien Moorkens
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
- Brian Godman
- Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom
- Brian Godman
- Division of Public Health Pharmacy and Management, School of Pharmacy, Faculty of Health Sciences, Sefako Makgatho Health Sciences University, Pretoria, South Africa
- Brian Godman
- Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska Institutet, Karolinska University Hospital Huddinge, Stockholm, Sweden
- Isabelle Huys
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
- Iris Hoxha
- Department of Pharmacy, University of Medicine Tirana, Tirana, Albania
- Admir Malaj
- Department of Pharmacy, University of Medicine Tirana, Tirana, Albania
- Simon Keuerleber
- Austrian Social Insurance, Vienna, Austria
- Silvia Stockinger
- Austrian Social Insurance, Vienna, Austria
- Sarah Mörtenhuber
- Austrian Social Insurance, Vienna, Austria
- Maria Dimitrova
- Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria
- Konstantin Tachkov
- Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria
- Luka Vončina
- Faculty of Health Studies, University of Rijeka, Rijeka, Croatia
- Vera Vlahović Palčevski
- Faculty of Health Studies, University of Rijeka, Rijeka, Croatia
- Gnosia Achniotou
- Health Insurance Organization (HIO), Nicosia, Cyprus
- Juraj Slabý
- 0State Institute for Drug Control, Prague, Czechia
- Leona Popelková
- 0State Institute for Drug Control, Prague, Czechia
- Kateřina Kohoutová
- 0State Institute for Drug Control, Prague, Czechia
- Dorthe Bartels
- 1Amgros, Copenhagen, Denmark
- Ott Laius
- 2State Agency of Medicines, Tartu, Estonia
- Jaana E. Martikainen
- 3Pharmaceuticals Pricing Board, Ministry of Social Affairs and Health, Helsinki, Finland
- Gisbert W. Selke
- 4AOK Research Institute (WIdO), Berlin, Germany
- Vasileios Kourafalos
- 5National Organization for the Provision of Healthcare Services (EOPYY), Athens, Greece
- Einar Magnússon
- 6Ministry of Welfare, Reykjavik, Iceland
- Rannveig Einarsdóttir
- 7The National University Hospital of Iceland, Reykjavik, Iceland
- Roisín Adams
- 8St James’s Hospital, Dublin, Ireland
- Roberta Joppi
- 9Clinical Research and Drug Evaluation Unit, Local Health Authority of Verona, Verona, Italy
- Eleonora Allocati
- 0Mario Negri Institute for Pharmacological Research (IRCCS), Milan, Italy
- Arianit Jakupi
- 1UBT – Higher Education Institute, Prishtina, Kosovo
- Anita Viksna
- 2Department of Medicines and Medical Devices, The National Health Service, Riga, Latvia
- Ieva Greičiūtė-Kuprijanov
- 3Ministry of Health of the Republic of Lithuania, Vilnius, Lithuania
- Patricia Vella Bonanno
- Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom
- Vincent Suttorp
- 4Erasmus University Medical Center, Rotterdam, Netherlands
- Øyvind Melien
- 5Reviews and Health Technology Assessments, Norwegian Institute of Public Health, Oslo, Norway
- Robert Plisko
- 6HTA Consulting, Cracow, Poland
- Ileana Mardare
- 7Public Health and Management Department, Faculty of Medicine, “Carol Davila”, University of Medicine and Pharmacy Bucharest, Bucharest, Romania
- Dmitry Meshkov
- 8V. A. Trapeznikov Institute of Control Sciences of Russian Academy of Sciences, Moscow, Russia
- Tanja Novakovic
- 9ZEM Solutions, Belgrade, Serbia
- Jurij Fürst
- 0Health Insurance Institute, Ljubljana, Slovenia
- Corinne Zara
- 1Drug Area, Catalan Health Service, Barcelona, Spain
- Vanda Marković-Peković
- 2Department of Social Pharmacy and Pharmacy Practice, Faculty of Medicine, University of Banja Luka, Banja Luka, Bosnia and Herzegovina
- Nataša Grubiša
- 3Health Insurance Fund, Banja Luka, Bosnia and Herzegovina
- Gustaf Befrits
- 4Stockholm County Council, Stockholm, Sweden
- Robert Puckett
- 5NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital, Glasgow, United Kingdom
- Arnold G. Vulto
- Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium
- Arnold G. Vulto
- 4Erasmus University Medical Center, Rotterdam, Netherlands
- DOI
- https://doi.org/10.3389/fphar.2020.591134
- Journal volume & issue
-
Vol. 11
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.
Keywords