Organizational impacts of fixed-duration therapies for the management of patients with chronic lymphocytic leukemia in Italy

Background: Chronic Lymphocytic Leukemia (CLL) is a common adult leukemia characterized by the progressive accumulation of dysfunctional lymphocytes. Recently introduced fixed-duration targeted therapies for previously untreated patients have demonstrated superior efficacy compared to chemotherapy, while offering time-limited treatment that improves patient quality of life and reduces the burden on healthcare systems compared to continuous therapies. This analysis examines the organizational impact of implementing first-line, fixed-duration CLL therapies, with focus on healthcare resource allocation, costs, and patient management. Methods: The regimens analyzed included ibrutinib + venetoclax (I + V, oral), venetoclax + obinutuzumab (Ven-Obi, oral/infusion), bendamustine + rituximab (BR, infusion), chlorambucil + obinutuzumab (Clb-Obi, oral/infusion), and fludarabine + cyclophosphamide + rituximab (FCR, infusion). Data were defined through product characteristics, published literature, expert opinion, and standard hospital procedures for drug administration, adverse event management, and treatment duration. A questionnaire administered in four Italian centers captured organizational aspects such as healthcare personnel time, patient assessment, treatment preparation and administration, and follow-up. Results: Personnel time and costs varied substantially across regimens, with administration mode (oral vs. infusion) emerging as a key driver. Time ranged from 4,899 min (81.6 h) for BR to 8,019 min (133.7 h) for Ven-Obi. Organizational costs ranged from €3,942 (BR) to €8,631 (Ven-Obi). The all-oral I + V combination showed a lower cost profile (€5,724) than Ven-Obi and was comparable to Clb-Obi, despite additional monitoring requirements. Conclusions: Treatment selection should balance efficacy with organizational and economic considerations. Findings highlight that oral therapies improve efficiency and patient convenience while reducing delivery costs.