OBJECTIVES: EMPOWER-Lung 1 trial demonstrated that cemiplimab as monotherapy significantly improved overall survival (OS) and progression-free survival (PFS) compared with chemotherapy in patients with advanced non-small-cell lung carcinoma (NSCLC) with PD-L1 of at least 50%, providing a potential new treatment option for this patient population. This study aimed to evaluate the cost-effectiveness of cemiplimab versus pembrolizumab in the first line treatment for patients with advanced NSCLC expressing PD-L1 in ≥50% of tumor cells in Spain.

METHODS: A partitioned survival model was adapted considering the Spanish National Healthcare System perspective, over a lifetime horizon. OS and PFS were estimated from the studies EMPOWER-Lung 1 (cemiplimab) and KEYNOTE-024 (pembrolizumab). Time-varying hazard ratios from a network meta-analysis of randomized clinical trials were considered for survival outcomes. Direct health care costs (euros 2021) obtained from national databases and literature were considered. Utilities were derived from the EMPOWER-Lung 1 trial and disutility were derived from literature. A 3% annual discount rate was applied to effects and costs. Results were expressed in life years gained (LYG) and quality-adjusted life years (QALY) gained, costs and incremental cost-effectiveness ratio (ICER). Sensitivity analyses were performed to explore uncertainties.

RESULTS: After the patient's lifetime, the cost differential was €-6,301 compared to pembrolizumab (€61,893 vs €68,194). In terms of health outcomes, treatment with cemiplimab provided 0.93 LYG versus pembrolizumab (3.70 vs 2.77). Therefore, the ICER of cemiplimab was dominant versus pembrolizumab. Expressing health outcomes in QALYs, cemiplimab was associated with a gain of 0.64 QALYs vs. pembrolizumab (2.65 vs. 2.01). The resulting cost-utility ratio was also dominant over pembrolizumab. Sensitivity analysis confirmed the robustness of the model.

CONCLUSIONS: Findings suggest that cemiplimab versus pembrolizumab is a cost-effective first-line treatment option for advanced NSCLC with PD-L1 expression ≥50% in Spain.