OBJECTIVES: The importance of biosimilars is increasing as more and more biologicals with significant budget impact are going to lose market exclusivity in upcoming years. Due to expected price erosion, decision makers can improve the allocative efficiency of scarce resources by increasing the utilisation of biosimilars. This study aims to evaluate the impact of the Hungarian reimbursement policy on the uptake of biosimilar infliximab, the first monoclonal antibody (mAB) infliximab with patent expiry in 2013.

METHODS: The utilization of biologicals were analysed retrospectively on individual patient-level data between 2013-2016 provided by the National Institute of Health Insurance Fund Management (NIHIFM). We aggregated patient numbers on mABs, and analysed the initial therapy of new patients and switching rates between mABs in colitis ulcerosa (CU) and rheumatoid arthritis (RA).

RESULTS: Data shows that overall market share of biosimilar infliximab in CU increased after patent expiry (33.7%), while in RA it remained marginal (0.2%) by the end of 2016. Compared to other single source biologicals the proportion of new CU and RA patients on infliximab were 50.9% and 2.5%, respectively, all these patients were started on biosimilars. During the study period 25% of CU patients with therapy switch from adalimumab to infliximab were switched to the original product and 75% of the patients were switched to the biosimilar alternative. Majority of RA patients were switched between seven patented active substances and only few patients were switched to multisource infliximab (1.6%).

CONCLUSIONS: In Hungary the current biosimilar policy shows mixed results in incentivizing the increased uptake of multisource biologicals. Although new patients treated with infliximab started on biosimilars, but majority of RA patient started on other patented products. Policy tools and measures should be developed by the NIHIFM to facilitate biosimilar use, including single switch to biosimilars, and monitor outcomes.