RESUMO
INTRODUCTION: The irreversible ErbB family blocker afatinib and the reversible EGFR tyrosine kinase inhibitor gefitinib were compared in the multicenter, international, randomized, head-to-head phase 2b LUX-Lung 7 trial for first-line treatment of advanced EGFR mutation-positive NSCLCs. Afatinib and gefitinib costs and patients' outcomes in France were assessed. METHODS: A partitioned survival model was designed to assess the cost-effectiveness of afatinib versus gefitinib for EGFR mutation-positive NSCLCs. Outcomes and safety were taken primarily from the LUX-Lung 7 trial. Resource use and utilities were derived from that trial, an expert-panel questionnaire, and published literature, limiting expenditures to direct costs. Incremental cost-effectiveness ratios (ICERs) were calculated over a 10-year time horizon for the entire population, and EGFR exon 19 deletion or exon 21 L858R mutation (L858R) subgroups. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: For all EGFR mutation-positive NSCLCs, the afatinib-versus-gefitinib ICER of was 45,211 per quality-adjusted life-year (QALY) (0.170 QALY gain for an incremental cost of 7697). ICERs for EGFR exon 19 deletion and L858R populations were 38,970 and 52,518, respectively. Afatinib had 100% probability to be cost-effective at a willingness-to-pay threshold of 70,000/QALY for patients with common EGFR mutations. CONCLUSION: First-line afatinib appears cost-effective compared with gefitinib for patients with EGFR mutation-positive NSCLCs.