OBJECTIVES: Biologics are innovative drugs that changed the paradigm in the treatment of many autoimmune diseases. However, biologics 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. This study’s objective was to assess the budget impact of introducing an etanercept biosimilar, SB4, in Portugal for approved adult etanercept indications.

METHODS: A budget-impact model (BIM) was used to estimate the cost saving potential of introducing SB4 in Portugal 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 adoption rates of SB4 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 accumulated budget-savings of: €1.52m, €2.27m and €3.03m in the slow, moderate and rapid uptake scenario, respectively. This would allow for savings equivalent to 167-333 patient-years for the three uptake scenarios.

CONCLUSIONS: The introduction of SB4 represents substantial cost-saving potential for the healthcare system in Portugal. The budget impact was sensitive to SB4 market uptake rates. Mechanisms in place that can support the biosimilar uptake are essential in order to achieve these savings. These savings will contribute to healthcare system sustainability in Portugal, 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.