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

Sep 22, 2026

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Background: Anti-programmed cell death-(ligand) 1 (anti-PD-(L)1) agents are approved for advanced and early-stage cancers, but their population-level impact in Italy is not well evaluated. Objective: Estimate health and productivity outcomes from introducing anti-PD-(L)1 agents for neoadjuvant and/or adjuvant therapy in early-stage cancers in Italy over 10 years. Methods: A model compares scenarios without vs with anti-PD-(L)1 use using Italian-specific inputs, trial-based clinical/quality-of-life data, and a societal perspective. Results: Greater LYs, QALYs, and fewer recurrences/events, metastatic treatments, deaths, and productivity losses. Conclusions: Wide-scale adoption yields substantial health and societal gains in Italy.

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Abstract

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Introduction

Clinical Drug Investigation (2026) 46:869–881 [https://doi.org/10.1007/s40261-026-01567-7](https://doi.org/10.1007/s40261-026-01567-7) Assessing the Impact on Health and Productivity Outcomes of Anti‑PD‑(L)1 Agents to Treat Early‑Stage Cancers in Italy Andrea Marcellusi1 · Fabio Calabrò2 · Anna Maria Di Giacomo3 · Fabio Puglisi4,5 · Alessio Cortellini6,7,8 · Isobel Thornton9 · Yan Zhi Tan10 · Alessandro Catanzaro10 · Catarina Neves10 · Fabrizio Ascone11 · Matilde Franceschini11 · Mario Calandriello11 · Raquel Aguiar‑Ibáñez12 · Yizhen Lai13 Received: 9 December 2025 / Accepted: 14 May 2026 / Published online: 6 June 2026 © The Author(s) 2026 Abstract 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)/diseasefree (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. 1 Introduction There has been a notable increase in the incidence and prevalence of cancer across the EU over the past three decades. In Italy, the annual number of newly diagnosed cancers has risen by approximately 60% since 1995 [1], with at least 400,000 cases diagnosed each year [2] . In 2022 alone, an estimated 407,240 new cancer cases were recorded, with breast, colorectal, lung and prostate cancers accounting for almost half of these [3] . Between 2010 and 2020, cancer prevalence in Italy increased by 27%, likely reflecting both rising incidence and longer life expectancy [1]. Despite this, Extended author information available on the last page of the article Italy’s age-standardised cancer mortality was 6% lower than the EU average, largely due to medical advances [1] . With mortality falling but incidence and prevalence rising, the survivorship burden continues to grow in Italy, consistent with patterns reported across high-income nations [4] . Similar to other EU countries, cancer expenditure in Italy has steadily increased over the past decade, reaching an estimated €20 billion in 2022 wi

FAQs

What is the purpose of assessing anti-PD-(L)1 use in Italy’s early-stage cancers?

To estimate health and productivity outcomes from introducing anti-PD-(L)1 agents for neoadjuvant and/or adjuvant therapy in early-stage cancers over a 10-year horizon in Italy.

How did the study estimate health and productivity outcomes?

It built a model synthesizing outputs from five indication-specific Markov models, comparing scenarios without anti-PD-(L)1 use versus with use. It incorporated Italian-specific incidence and population inputs, trial-based clinical and quality-of-life data, and used a societal perspective with 3% annual discounting.

What overall benefits were reported with anti-PD-(L)1 agents in early-stage settings?

Compared with no early-stage use, the model estimated increases in total life years, recurrence-free/event-free/disease-free life years, and QALYs, alongside fewer recurrences/events, metastatic treatments, total deaths, and deaths after first event/recurrence. Productivity gains were also estimated.

Sep 22, 2026

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