Is osimertinib, a third-generation tyrosine kinase inhibitor (TKI), a cost-effective first-line therapy for treatment-naive, epidermal growth factor receptor gene (EGFR)-mutated, non–small cell lung cancer?
In this cost-effectiveness analysis of data from the FLAURA randomized clinical trial, the number of incremental quality-adjusted life-years (QALYs) gained in the base case by using osimertinib was 0.594 compared with using first- and second-generation EGFR-TKIs. In the United States, the incremental cost per QALY was approximately $225 000, and in Brazil, approximately $172 000.
At current costs, by World Health Organization cost-effectiveness threshold criteria, osimertinib is not cost-effective as a first-line therapy of EGFR-mutated NSCLC.
The survival of patients with advanced non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene mutations has improved substantially in the last decade with the development of targeted tyrosine kinase inhibitors (TKIs). Osimertinib, a third-generation TKI that is approved by the US Food and Drug Administration for the treatment of patients who develop EGFR T790M mutations, has recently shown improved clinical outcomes compared with gefitinib and erlotinib for treatment-naive patients.
The aim of this study was to assess the cost-effectiveness of osimertinib for the first-line treatment of patients with EGFR-mutated NSCLC.
Design, Setting, and Participants
For this cost-effectiveness analysis, we extracted individual patient data from the FLAURA randomized clinical trial and used findings of our earlier meta-analysis to develop a decision-analytic model and determine the cost-effectiveness of osimertinib (AZD9291) compared with first- and second-generation EGFR-TKIs over a 10-year time horizon. All direct costs were based on US and Brazilian payer perspectives.
Main Outcomes and Measures
The main outcome of this study was the incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life-year (QALY) gained by using osimertinib compared with first- or second-generation EGFR-TKIs in previously untreated EGFR-mutated NSCLC.
In the base case using the data as reported in the FLAURA trial, the incremental QALY for osimertinib was 0.594 compared with the first- and second-generation EGFR-TKIs. In the United States, the osimertinib ICERs were $226 527 vs erlotinib, $231 123 vs gefitinib, and $219 874 vs afatinib. In Brazil, the ICERs were $162 329, $180 804, and $175 432, respectively. The overall survival (95% CI) reported in the FLAURA trial (hazard ratio, 0.63; 95% CI, 0.45-0.88) had the strongest association with the ICER (ranging from $84 342 to $859 771). Osimertinib price adjustments to the FLAURA trial data improved cost-effectiveness. For example, a discount of 10% on osimertinib acquisition cost was associated with a 20% decreased ICER compared with the base case ICER, and a discount of 20% on osimertinib acquisition cost was associated with a 40% decreased ICER compared with the base case ICER.
Conclusions and Relevance
At current costs, by World Health Organization cost-effectiveness threshold criteria, osimertinib is not cost-effective for first-line therapy of EGFR-mutated NSCLC in either the United States or Brazil.
Aguiar PN, Haaland B, Park W, San Tan P, del Giglio A, de Lima Lopes G. Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non–Small Cell Lung Cancer. JAMA Oncol. Published online May 31, 2018. doi:10.1001/jamaoncol.2018.1395
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