The Budget Impact of Biosimilar Infliximab (Remsima(A (R))) for the Treatment of Autoimmune Diseases in Five European Countries

Inflammatory autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis) have a considerable impact on patients' quality of life and healthcare budgets. Biosimilar infliximab (Remsima(A (R))) has been authorized by the European Medicines Agency for the management of inflammatory autoimmune diseases based on a data package demonstrating efficacy, safety, and quality comparable to the reference infliximab product (Remicade(A (R))). This analysis aims to estimate the 1-year budget impact of the introduction of Remsima in five European countries. A budget impact model for the introduction of Remsima in Germany, the UK, Italy, the Netherlands, and Belgium was developed over a 1-year time horizon. Infliximab-na < ve and switch patient groups were considered. Only direct drug costs were included. The model used the drug-acquisition cost of Remicade. The list price of Remsima was not known at the time of the analysis, and was assumed to be 10-30% less than that of Remicade. Key variables were tested in the sensitivity analysis. The annual cost savings resulting from the introduction of Remsima were projected to range from a,not sign2.89 million (Belgium, 10% discount) to a,not sign33.80 million (Germany, 30% discount). If any such savings made were used to treat additional patients with Remsima, 250 (Belgium, 10% discount) to 2602 (Germany, 30% discount) additional patients could be treated. The cumulative cost savings across the five included countries and the six licensed disease areas were projected to range from a,not sign25.79 million (10% discount) to a,not sign77.37 million (30% discount). Sensitivity analyses showed the number of patients treated with infliximab to be directly correlated with projected cost savings, with disease prevalence and patient weight having a smaller impact, and incidence the least impact. The introduction of Remsima could lead to considerable drug cost-related savings across the six licensed disease areas in the five European countries. Mundipharma International Ltd.