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.
Highlights
Biological medicines represent a multi-billion-dollar medicines’ industry used in the treatment of cancer and autoimmune diseases
Results from part 2 and 3 of the survey on the availability of biosimilars and pricing, reimbursement and policy measures related to adalimumab are discussed
Countries with no adalimumab biosimilars on the market at that time were Cyprus, Greece, Kosovo, Malta, Serbia and the Republic of Srpska; with Greece at the time waiting for approval of reimbursement
Summary
Biological medicines represent a multi-billion-dollar medicines’ industry used in the treatment of cancer and autoimmune diseases. They represent a challenge for healthcare budgets due to their often high prices and increasing use (Moorkens et al, 2016; Godman et al, 2018; La Merie, 2018; IQVIA, 2019). With sales of US$20 billion in 2018, Humira® is the highest selling product in the world and generates 60% of AbbVie’s revenue (AbbVie News Center, 2019). AbbVie has used an extensive strategy (related to patent filing, marketing, and pricing) to protect the sales and revenue of. On October 16, 2018, product-specific patent protection on. In some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
