Optimizing CAR-T therapy delivery in the Italian healthcare system: economic and organizational insights in follicular lymphoma

Introduction: Follicular Lymphoma (FL) is the second most common lymphoid malignancy, with 20% of patients progressing within 24 months of first-line therapy. Chimeric antigen receptor T-cell (CAR-T) therapies have improved outcomes in relapsed or refractory FL, yet their use requires significant resources and complex care pathways. Although outpatient CAR-T programs have shown promising safety and feasibility, limited evidence exists on their organizational, economic, and ethical implications in the Italian healthcare setting. This study compares the current CAR-T pathway for FL patients with a virtual optimized scenario incorporating outpatient management in selected phases. Methods: A multidimensional framework was applied to assess differences between standard in-hospital care (Standard Pathway) across three Italian public hospitals (Genoa, Rome, Perugia) and a partially outpatient model (Efficient Pathway). Literature review and expert consultations validated existing practices and informed optimization criteria. Structured surveys provided quantitative and qualitative inputs. Economic modelling estimated three-year full costs using patient-level data, while organizational and ethical aspects were evaluated through Likert scales. Results: Efficient Pathway shifted bridging therapy, post-infusion monitoring, and follow-up to outpatient settings, reducing total costs from € 611,070 (As-Is) to € 497,421 (To-Be). Organizational benefits included increased bed capacity (average score: 4.9/6) and consumable utilization (average score: 4.3/6), while ethical gains were observed in treatment accessibility (average score: 4.3/6). Conclusions: Introducing outpatient management into CAR-T phases may provide economic, organizational, and ethical advantages when supported by clear eligibility criteria and structured monitoring. As CAR-T indications expand, pathway redesign will be essential to ensure equitable access and sustain healthcare system resources.