OBJECTIVES: To assess the cost-effectiveness of pembrolizumab versus Standard-of-Care (SoC) chemotherapy for first-line treatment of PD-L1-positive (≥50%) metastatic Non-Small Cell Lung Cancer (NSCLC) patients with no EGFR mutations or ALK translocations, from the French healthcare system perspective.

METHODS: A three-state partitioned-survival model was developed to project outcomes and costs of squamous and non-squamous patients respectively, over a 10-year time horizon. Efficacy, safety and utility data were derived from KEYNOTE-024 (cut-off: May 9, 2016), a randomized phase III trial comparing pembrolizumab versus platinum-based doublets. Network meta-analysis was performed to consider platinum-based triplets used for non-squamous NSCLC. Progression-Free survival and overall survival estimates from the trial were extrapolated using a piecewise modelling approach based on parametric functions. Costs (in 2017 Euros) included drug acquisition, treatment administration, transportation, adverse events management, PD-L1 test, progression disease management and end of life. Costs and outcomes were discounted at 4% per year. The incremental cost-effectiveness ratio (ICER) was calculated as cost per Quality-Adjusted Life Year (QALY) and cost per Life Year (LY). One-way, probabilistic sensitivity and scenario analyses were performed to assess robustness of the results.

RESULTS: In squamous NSCLC, the ICER of pembrolizumab versus platinum-based doublets was €84,097/QALY and €66,825/LY (expected gain: 0.74 QALYs (9 months), 0.93 LYs (11 months); incremental cost: €62,032). In non-squamous NSCLC, the ICER of pembrolizumab versus platinum-based chemotherapy with paclitaxel plus bevacizumab was €78,729/QALY and €62,846/LY (expected gain: 0.68 QALYs (8 months), 0.85 LYs (10 months); incremental cost: €53,636); €28,448/QALY and €22,601/LY for platinum-based chemotherapy with paclitaxel plus bevacizumab versus doublet without pemetrexed; regimens including pemetrexed were dominated. Pembrolizumab had more than 80% probability of being cost-effective at willingness-to-pay (WTP) of €170,000/QALY in squamous NSCLC and 130,000€/QALY in non-squamous NSCLC.

CONCLUSIONS: Pembrolizumab appears cost-effective versus SoC chemotherapy for first-line treatment of PD-L1-positive (≥50%) metastatic NSCLC patients in France, assuming a WTP under €170,000/QALY.