Dutch Competition Authority Presents Findings of Sector Inquiry of TNF-Inhibitors
The Dutch Competition Authority “Autoriteit Consument & Markt” (“ACM”) published yesterday the findings that result from its sector inquiry of TNF-inhibitors on the hospital market (see attached press release and findings). ACM had started its sector inquiry in June 2018 over concerns that the significant costs of TNF-inhibitors may be caused in part by insufficient competition among suppliers (see, Van Bael & Bellis Life Sciences Newsflash of 28 June 2018).
TNF-inhibitors are biological medicines used to treat autoimmune and immune-mediated disorders such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and hidradenitis suppurativa. They attach to a substance in the body called tumour necrosis factor (“TNF”) which causes inflammation and is found at high levels in patients afflicted by these conditions. In blocking the activity of TNF, the TNF-inhibitors reduce inflammation and other symptoms of the diseases.
The inquiry of ACM focused on the five TNF-inhibitors on the Dutch market (namely infliximab; etanercept; adalimumab; certoluzimab pegol; and golimumab) but also considered possible therapeutic alternatives that present a different mechanism of action. At the same time, ACM expressly refrained from taking positions on issues such as relevant market or dominant position.
ACM observed a substantial decrease in prices following the expiry of the patents in three active substances (infliximab; etanercept; and adalimumab). According to ACM, the advent of biosimilars was an important factor, but the price reduction was facilitated by scientific studies showing no major obstacles to switching existing patients from one TNF-inhibitor to another.
Despite the inroads of biosimilars on the market, two originating active substances have succeeded in maintaining their leadership position in their category. ACM attributes the staying power of these medicines to a variety of organisational and educational factors but also cites the possible effects of what it refers to as “conditional discounts” which cause a hospital to lose the benefit of the price reduction if a group of patients are unwilling or unable to make a product switch.
ACM makes a number of policy recommendations for hospitals, insurers and the government and adds that it will not hesitate to enforce the competition rules if specific discounts used by suppliers have a foreclosure effect on the market.