Back to Search Start Over

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

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

Authors :
Vasileios Kourafalos
Eleonora Allocati
Luka Voncina
Brian Godman
Arianit Jakupi
Robert Plisko
Evelien Moorkens
Kateřina Kohoutová
Nataša Grubiša
Gisbert Selke
Anita Viksna
Arnold G. Vulto
Jurij Fürst
Jaana E. Martikainen
Leona Popelková
Ileana Mardare
Patricia Vella Bonanno
Vincent Suttorp
Dorthe Bartels
Sarah Mörtenhuber
Ott Laius
Iris Hoxha
Gustaf Befrits
Isabelle Huys
Dmitry Meshkov
Gnosia Achniotou
Rannveig Einarsdóttir
Øyvind Melien
Juraj Slabý
Ieva Greičiūtė-Kuprijanov
Simon Keuerleber
Einar Magnusson
Corinne Zara
Admir Malaj
Robert Puckett
Silvia Stockinger
Vanda Marković-Peković
Maria Dimitrova
Vera Vlahović Palčevski
Konstantin Tachkov
Tanja Novakovic
Roisin Adams
Roberta Joppi
Erasmus MC other
Pharmacy
Source :
Frontiers in Pharmacology, Vol 11 (2021), Frontiers in Pharmacology, 11:591134. Frontiers Media S.A., Frontiers in Pharmacology, Volume 11
Publication Year :
2021
Publisher :
Frontiers Media S.A., 2021.

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.

Details

Language :
English
ISSN :
16639812
Volume :
11
Database :
OpenAIRE
Journal :
Frontiers in Pharmacology
Accession number :
edsair.doi.dedup.....faa4da2fb244fd6ae5a4663168b042ca
Full Text :
https://doi.org/10.3389/fphar.2020.591134/full