Analisi di impatto sul budget sanitario italiano di enzalutamide per il trattamento del carcinoma prostatico metastatico ormono-sensibile.

ABSTRACT Budget impact analysis of enzalutamide for the treatment of hormone-sensitive metastatic prostate cancer in Italy Backgroud: After demonstrating additional benefit versus standard of care in ARCHES and ENZAMET studies, enzalutamide was reimbursed in Italy in May 2022 by the National Health Service (NHS) for the treatment of hormone-sensitive metastatic prostate cancer (mHSPC). Objective: This study estimates the financial impact associated to the introduction of enzalutamide for patients with mHSPC. Methods: A budget impact model was developed with a dynamic cost calculator approach, in which the impact on subsequent lines of therapy was considered. The analysis considered the NHS perspective and a 3-year time horizon. Included costs were related to drug acquisition and administration, monitoring, patient follow-up and adverse events. Eligible population was estimated based on published literature, real-world data and experts’ opinion while market shares were assessed considering real-world data and assumptions. National tariffs and published literature were considered for unit costs. Results: Eligible population was estimated at 6,200, 6,206 and 6,212 in years 1, 2 and 3 respectively. The introduction of enzalutamide, considering a progressive increase of market shares of 10%, 18% and 25%, is expected to overall increase NHS healthcare expenditure by € 688 thousands and € 2.6 and € 5.6 million in years 1, 2 and 3 respectively, corresponding on average to 1.55% of the overall prostate cancer expenditure. Results are robust across one-way sensitivity analyses, while confidential discount agreements of on-patent drugs might significantly impact the estimates. Conclusion: The introduction of enzalutamide for the treatment of adult patients with mHSPC is expected to increase patients’ health with a moderate impact on costs for the Italian NHS.