Abstract

Anti-TNFs are the most commonly used biologics in rheumatologic and dermatologic immune diseases all over Italy; however, biosimilar penetration varies across the different Italian regions. Infliximab biosimilar market shares (MS) at 12 months from launch varied from 7% to 14% in Campania and Sicily up to 52% in Tuscany. The study’s objective was to assess the budget impact of introducing Benepali®, an etanercept biosimilar, in 3 Italian regions for all licensed adult etanercept indications. A budget-impact model was used to estimate the cost saving potential of introducing Benepali vs. Enbrel®in 3 Italian regions, Campania, Sicily & Tuscany over a two-year time horizon from regional payer’s perspective. Current etanercept treated population has been estimated through IMS sales data and projected over 2 years using the trends observed in the past 2 years in each region. Benepali MS in year 1 was assumed to be the same reached by the infliximab biosimilars in each region. A logarithmic function was used to model uptake in the whole year 2 based on the available 3 months sales data of year 2 of the infliximab biosimilars in each region. Prices of both etanercept products are from published sources and 10% price erosion per year has been modeled. Benepali introduction in the biologic treatment setting resulted over the two-year horizon in projected budget-savings of: €1.3m in Campania, €1.7m in Sicily and €5.9m in Tuscany. Budget impact was sensitive to Benepali market penetration given that all regions had similar etanercept population and same prices. Benepali introduction represents a cost-saving opportunity for all studied regions. In Tuscany, with mechanisms in place to support the biosimilar adoption, the saving potential was greater than the other 2 regions. Collaborative agreements at regional level between payers and prescribers can support biosimilar adoption generating savings while achieving better outcomes for patients.

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