Infliximab reference product versus biosimilar for the treatment of rheumatoid arthritis

Background: In Switzerland, relatively low biosimilar prescription rates have prompted the interest of the authorities. A health technology assessment (HTA) was requested to compare the available evidence of the infliximab reference product and its biosimilar for treating rheumatoid arthritis (RA). Objective: This HTA examines the efficacy, effectiveness and safety of the infliximab biosimilar compared to its reference product in RA and presents the health economic impact of a potentially increased biosimilar utilization in Switzerland. Furthermore, ethical, legal, social and organisational aspects of treatment initiation with biosimilars or switching to biosimilars are analysed. Research questions: Is it safe, efficacious and effective 1) to initiate treatment with infliximab biosimilar instead of the infliximab reference product, 2) to switch treatment from the infliximab reference product to infliximab biosimilar and 3) to switch treatment from infliximab biosimilar to the infliximab reference product in patients with RA? Methods: A systematic literature search for evidence on efficacy, effectiveness, safety and health economic outcomes of the infliximab reference product compared to biosimilars in RA was conducted. Meta-analysis was performed for outcomes with sufficient available evidence. The certainty of evidence for relevant outcomes was assessed by applying the GRADE approach. A de novo health economic model was built to assess cost differences between a RA patient treated with infliximab reference product and a patient treated with its biosimilar using a lifetime time horizon. The potential budget impact for Switzerland was estimated over the next five years. The health economic analysis focused on drug costs. Additional physician time and lab tests that may be required related to the switch were also considered. Furthermore, a targeted search for evidence on biosimilar-related ethical, legal, social and organisational aspects was conducted and findings we