OP0310 IMPLEMENTATION OF TNF-BIOSIMILARS (INFLIXIMAB AND ETANERCEPT) IN DANISH DEPARTMENTS OF RHEUMATOLOGY
Authors: Thomas Bo Jensen, Dorthe Bartels, Eva Aggerholm Sædder, Birgitte Klindt Poulsen, Stig Ejdrup Andersen, Mette MarieH.Christensen, Lars Nielsen, Hanne Rolighed Christensen
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> The use of expensive biological drugs in rheumatology is rapidly increasing and has led to substantial increases in drug expenditures. A considerable reduction of drug costs is possible by using biosimilars as soon as they become available and carrying out non-medical shifts to biosimilars (i.e. switching a patient well treated on a biooriginator to the biosimilar). Research on biosimilars has focused on interchangeability and safety outcomes, but little focus has been on nationwide implementation and the direct economic consequences on drug expenses. In Denmark, TNF-inhibitors are solely given in an in-hospital setting and bought through national tenders. The Danish in-hospital organization includes Regional Drug and Therapeutics Committees that ensures regional implementation of treatment guidelines and close collaboration between hospital pharmacies and regional clinical pharmacologists. Furthermore, the implementation of TNF-inhibitor biosimilars was preceded by careful preparations from among others a newly established national biosimilar task force. <h3>Objectives</h3> The aim of this study was to describe the implementation of the two first TNF-inhibitor biosimilars (infliximab and etanercept) in Danish departments of rheumatology. <h3>Methods</h3> Monthly data on drug sales to Danish rheumatology departments were used to assess the biosimilar uptake rate and subsequent changes in the drug expenditures during the implementation in Denmark. <h3>Results</h3> Shifts to biosimilars were begun within a few months following end of biooriginator patent, vertical lines in the figure. Use of the infliximab biosimilar was begun in April 2015, and in August 2015 biosimilar uptake was 92.9% of total infliximab use. Similarly use of etanercept biosimilar was begun in April 2016, and in June 2016 the biosimilar uptake was 91.6% of total etanercept use. In January 2015 the total use in Defined Daily Doses (DDD) were 42.4 thousand DDD's for infliximab and 37.3 thousand DDD's for etanercept. The use increased steadily and was in January 2018 138.4 thousand DDD's for infliximab and 62.1 thousand DDD's for etanercept (equivalent to increases of 226.6% and 66.8%). The increases in DDD's were not reflected in total drug costs due to the shift to biosimilars. The total drug cost for infliximab in January 2015 was 6.7 million DKK but was reduced to 5.4 million DKK in January 2018 (-19.4%). A corresponding cost reduction was seen for etanercept (11.3 million DKK in January 2015, 8.1 million DKK in January 2018, -28.7%). <h3>Conclusion</h3> Danish departments of rheumatology experienced a fast and near-complete switch of infliximab and etanercept biooriginators to biosimilars. At the same time the use of the drugs increased substantially, but due to large price reductions the total drug cost decreased despite the increasing use. We believe that a thorough preparation and an organizational setting supporting the implementation was crucial for the successful implementation. The Danish structure, with its national tendering, probably contributed to the substantial drug discounts obtained. The implementation will be used for future biosimilars in Denmark. <h3>Disclosure of Interests</h3> None declared