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Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer.
JAMA Oncol 2018; 4(8):1080-1084JO

Abstract

Importance

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.

Objective

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.

Results

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.

Authors+Show Affiliations

Centro de Estudos e Pesquisa de Hematologia e Oncologia, Faculdade de Medicina do ABC, Santo André, Brazil.Department of Population Health Sciences, Huntsman Cancer Institute, University of Utah, Salt Lake City. Department of Internal Medicine, University of Utah, Salt Lake City.Sylvester Comprehensive Cancer Center at the University of Miami, Miami, Florida.Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, England.Centro de Estudos e Pesquisa de Hematologia e Oncologia, Faculdade de Medicina do ABC, Santo André, Brazil.Sylvester Comprehensive Cancer Center at the University of Miami, Miami, Florida.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29852038

Citation

Aguiar, Pedro N., et al. "Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer." JAMA Oncology, vol. 4, no. 8, 2018, pp. 1080-1084.
Aguiar PN, Haaland B, Park W, et al. Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer. JAMA Oncol. 2018;4(8):1080-1084.
Aguiar, P. N., Haaland, B., Park, W., San Tan, P., Del Giglio, A., & de Lima Lopes, G. (2018). Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer. JAMA Oncology, 4(8), pp. 1080-1084. doi:10.1001/jamaoncol.2018.1395.
Aguiar PN, et al. Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer. JAMA Oncol. 2018 08 1;4(8):1080-1084. PubMed PMID: 29852038.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cost-effectiveness of Osimertinib in the First-Line Treatment of Patients With EGFR-Mutated Advanced Non-Small Cell Lung Cancer. AU - Aguiar,Pedro N,Jr AU - Haaland,Benjamin, AU - Park,Wungki, AU - San Tan,Pui, AU - Del Giglio,Auro, AU - de Lima Lopes,Gilberto,Jr PY - 2018/6/1/pubmed PY - 2019/10/1/medline PY - 2018/6/1/entrez SP - 1080 EP - 1084 JF - JAMA oncology JO - JAMA Oncol VL - 4 IS - 8 N2 - Importance: 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. Objective: 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. Results: 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. SN - 2374-2445 UR - https://www.unboundmedicine.com/medline/citation/29852038/Cost_effectiveness_of_Osimertinib_in_the_First_Line_Treatment_of_Patients_With_EGFR_Mutated_Advanced_Non_Small_Cell_Lung_Cancer_ L2 - https://jamanetwork.com/journals/jamaoncology/fullarticle/10.1001/jamaoncol.2018.1395 DB - PRIME DP - Unbound Medicine ER -