Assessing the Impact on Health and Productivity Outcomes of Anti-PD-(L)1 Agents to Treat Early-Stage Cancers in Italy

Background: Anti-programmed cell death-(ligand) 1 (anti-PD-[L]1) agents are approved for advanced and early-stage cancers. While they may offer clinical and economic benefits in the neoadjuvant and/or adjuvant setting, their population-level impact in Italy has not been thoroughly evaluated. Objective: This study aims to estimate health and productivity outcomes of introducing anti‑PD‑(L)1 agents for neoadjuvant and/or adjuvant therapy in early‑stage cancers in Italy (melanoma Stage IIB/C, melanoma Stage III, renal cell carcinoma, triple‑negative breast cancer and resectable non‑small‑cell lung cancer) over a 10-year horizon. Methods: We developed a model synthesising outputs from five indication-specific Markov models comparing two worlds: one without anti-PD-(L)1 agents use in the neoadjuvant and/or adjuvant settings versus one with their use. Italian-specific population and incidence inputs were used, with clinical and quality-of-life data from individual trials, from a societal perspective with 3% annual discount. Outcomes included total life years (LYs), recurrence- free (RF)/event-free (EF)/disease-free (DF) LYs, quality-adjusted LYs (QALYs), number of recurrences/events, metastatic treatments, total deaths and deaths after first event/recurrence. Productivity gains were estimated using a human capital approach. Results: Between 2025 and 2034, 118,329 patients with early-stage cancer were estimated to be eligible for anti-PD-(L)1 agents in Italy. Compared with no early-stage use, neoadjuvant/adjuvant use was associated with increased total LYs (+ 20,458, + 5%), RF/EF/DF LYs (+ 60,631, + 19%), QALYs (+ 21,093, + 6%) and fewer recurrences/events (− 20,209, − 33%), metastatic treatments (− 25,220, − 38%), total deaths (− 7137, − 24%) and deaths after first event/recurrence (− 8021, − 32%). Productive years gained were 35,897 (+ 30%). Conclusions: Our study suggests that the use of anti-PD-(L)1 agents in early-stage cancers is associated with substantial health and societal gains in Italy. Expanding their use across approved indications translates trial benefits into fewer recurrences, deaths and productivity losses, informing national planning and access decision.