Abstract

Background: The CheckMate 227 trial has indicated that nivolumab plus ipilimumab compared with chemotherapy significantly increases long-term survival in the first-line setting of advanced non-small-cell lung cancer (NSCLC).Methods: A Markov model was built to estimate the cost and effectiveness of nivolumab plus ipilimumab vs. chemotherapy as the first-line therapy in patients with advanced NSCLC based on outcomes data from the CheckMate 227 trial. We calculated the cost and health outcomes at a willingness-to-pay (WTP) threshold of $150,000 per quality adjusted life year (QALY) in populations with different programmed death ligand 1 (PD-L1) expression levels (≥50, ≥1, and <1%) or a high tumor mutational burden (TMB) (≥10 mutations per megabase). Sensitivity analysis were used to test the model stability.Results: The outcomes showed that the incremental costs and QALYs by using nivolumab plus ipilimumab were $124180.76 and 1.16, $70951.42 and 0.53, $144093.63 and 0.83 for the advanced NSCLC patients with a PD-L1 expression ≥50%, ≥1%, and <1%, which led to an incremental cost-effective ratio (ICER) of $107403.72, $133732.20, and $172589.15 per QALY, respectively. For patients with a high TMB, nivolumab plus ipilimumab contributed an extra 2.04 QALYs at a cost of $69182.50 per QALY.Conclusion: Nivolumab plus ipilimumab as first-line therapy makes a better cost-effective strategy than chemotherapy in advanced NSCLC patients with PD-L1 expression levels ≥50% and ≥1% or a high TMB, at a willingness-to-pay threshold of $150,000 per QALY, but not in the patients with a PD-L1 expression <1%.

Highlights

  • Around the globe, lung cancer is the leading cause of cancer incidence and mortality, with 2.1 million new lung cancer cases and 1.8 million deaths worldwide [1,2,3,4]

  • This study aims to evaluate the cost-effectiveness of nivolumab plus ipilimumab vs. chemotherapy in previous untreated advanced non-small-cell lung cancer (NSCLC) patients without driver alterations that can be targeted

  • For patients with a high tumor mutational burden (TMB), the use of nivolumab plus ipilimumab cost an additional $141255.72, provided an additional 2.04 quality adjusted life years (QALYs) and an incremental cost-effective ratios (ICERs) of $69182.50 per QALY compared with chemotherapy (Supplementary Table 4)

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Summary

Introduction

Lung cancer is the leading cause of cancer incidence and mortality, with 2.1 million new lung cancer cases and 1.8 million deaths worldwide [1,2,3,4]. In the pivotal phase three trial CheckMate 227, the first-line therapy using nivolumab plus ipilimumab brought about a longer duration of overall survival (OS) than that of patients with advanced NSCLC using chemotherapy, regardless of PD-L1 expression levels [17, 18]. Nivolumab plus ipilimumab was subsequently approved as the first-line treatment for patients with metastatic NSCLC, PD-L1 ≥ 1%, without EGFR or ALK genomic tumor aberrations by the United States (US) Food and Drug Administration (FDA) in May, 2020. The CheckMate 227 trial has indicated that nivolumab plus ipilimumab compared with chemotherapy significantly increases long-term survival in the first-line setting of advanced non-small-cell lung cancer (NSCLC)

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