OBJECTIVES: Biologics are very effective medicines for the treatment of a broad spectrum of autoimmune diseases, but represent a substantial cost in the healthcare systems. Etanercept is one of the preferred biologics in the treatment of autoimmune diseases due to its well established safety and efficacy profile in the approved indications. The study objective study was to assess the budget impact of introducing an etanercept biosimilar, SB4, in Belgium for approved adult etanercept indications.

METHODS: A budget-impact model (BIM) was used to estimate the cost saving potential of introducing SB4 in Belgium over a three-year horizon from the payer’s perspective. Annual sales (€) of the reference product in the year prior to biosimilar entry were used assuming these to remain constant over the 3-year horizon.

Three model scenarios with different SB4adoption rates vs the reference product were developed: slow (10%; 20%; and 30% of total etanercept sales at year 1; 2; and 3), moderate (15%; 30%; 45%) and rapid (20%; 40%; 60%). Prices were obtained from published sources.

RESULTS: introduction of SB4 in the biologic treatment setting over a three-year horizon resulted in projected budget-savings of: €4.97m, €7.45m and €9.93m in the slow, moderate and rapid uptake scenario, respectively. This would allow for savings equivalent to 634, 951 and 1,268 patient-years for the slow, moderate and rapid uptake scenario, respectively.

CONCLUSIONS: Introduction of SB4 represents substantial cost-saving potential for the healthcare system in Belgium. Mechanisms that can support the biosimilar uptake are essential in order to achieve these savings, which are currently not in place in Belgium. These savings will contribute to healthcare system sustainability in Belgium, as these could be used to treat additional patients within the same therapeutic area, fund novel therapies for other disease areas and/or potentially fund other hospital or medical department needs.