Economic Evaluation of Lutetium-177 (177Lu)–PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer in Italy

Vollständiger Abstract

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Introduction: The increasing costs of cancer care have raised the need for economic evaluations that integrate treatment efficacy and resource utilization. This study aimed to assess the economic value of Lutetium-177 (177Lu)–prostate-specific membrane antigen (PSMA)-617 in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) from an Italian healthcare perspective. Patients and Methods: A cost-effectiveness analysis was performed using clinical efficacy data from randomized controlled trials (RCTs) evaluating 177Lu-PSMA-617. Two scenarios were considered. Scenario 1 evaluated 177Lu-PSMA-617 plus standard care (SC) versus SC alone using pivotal phase III trial data. Scenario 2 compared 177Lu-PSMA-617 with chemotherapy and androgen receptor pathway inhibitors (ARPIs) using phase II and III RCTs. Drug costs were based on Italian ex-factory prices. In addition, an exploratory three-state Markov cost–utility model including progression-free survival (PFS), progressive disease, and death was developed using data from the VISION trial. Results: In Scenario 1, 730 patients were analyzed. The ESMO-MCBS grade was 3, and the incremental cost per month of PFS gained with 177Lu-PSMA-617 versus SC was €20,906. In Scenario 2, 651 patients were included. The monthly cost per PFS gained with 177Lu-PSMA-617 was €19,017 versus enzalutamide and €20,565 versus abiraterone. In the exploratory cost–utility model, estimated QALYs were 1.02 with 177Lu-PSMA-617 and 0.64 with SC, corresponding to an incremental gain of 0.38 QALYs. At an incremental cost of approximately €32,000 per patient, the resulting model-based ICER was approximately €85,000/QALY. Conclusions:177Lu-PSMA-617 provides meaningful clinical benefit in appropriately selected patients with PSMA-positive mCRPC, but this benefit is associated with substantial incremental treatment costs. The exploratory model-based ICER was sensitive to treatment duration and other model assumptions. These findings support careful assessment of the clinical value and economic sustainability of 177Lu-PSMA-617 in the Italian healthcare setting. Further studies incorporating real-world resource utilization, treatment-related costs, post-progression therapies, and prospectively collected quality-of-life data are warranted.