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, Isabelle Huys, Iris Hoxha, Admir Malaj, Simon Keuerleber, Silvia Stockinger, Sarah Mörtenhuber, Maria Dimitrova, Konstantin Tachkov, Luka Vončina, Vera V. Palčevski, Gnosia Achniotou, Juraj Slabý, Leona Popelková, Kateřina Kohoutová, Dorthe Bartels, Ott Laius, Jaana E. Martikainen, Gisbert W. SelkeVasileios Kourafalos, Einar Magnusson, 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. G. Vulto

Research output: Contribution to journalArticlepeer-review

Abstract

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as the 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: i) general financing/co-payment of medicines, ii) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and iii) 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% to 90% (the Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 to €99 (the 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.
Original languageEnglish
Article number591134
Number of pages17
JournalFrontiers in Pharmacology
Volume11
DOIs
Publication statusPublished - 8 Jan 2021

Keywords

  • adalimumab
  • biosimilars
  • humira
  • prices
  • Europe
  • competition
  • health policy

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