The potential clinical and economic outcomes of pharmacogenomic approaches to EGFR-tyrosine kinase inhibitor therapy in non-small-cell lung cancer.

OBJECTIVES Pharmacogenomic applications in oncology offer significant promise, but the clinical and economic implications remain unclear. The objective of this study was to evaluate the potential cost-utility of implementing epidermal growth factor receptor (EGFR) testing before initiating second-line therapy for advanced refractory non-small-cell lung cancer (NSCLC). METHODS We developed a decision analytic model to evaluate the cost-utility of EGFR protein expression or gene copy number testing compared to standard care with erlotinib in refractory advanced NSCLC patients. Costs and utilities were obtained from publicly available sources. We performed sensitivity analyses to evaluate uncertainty in the results. RESULTS The quality-adjusted life expectancies for erlotinib, EGFR protein expression testing, and gene copy number testing were: 0.44, 0.48, and 0.50 quality-adjusted life years (QALYs); and the costs were: $57,238, $63,512, and $66,447, respectively. The most cost-effective testing option, EGFR gene copy number testing, produced an incremental cost-effectiveness ratio of $162,018/QALY compared to no testing (erlotinib). The results were most sensitive to the survival estimates, health state utilities, and cost of disease progression. In the probabilistic sensitivity analyses, erlotinib without testing was the optimal treatment strategy until the $150,000/QALY willingness-to-pay threshold, after which gene copy testing was optimal. The discounted expected value of perfect information at a $100,000/QALY threshold in the USA over 5 years was $31.4 million. CONCLUSIONS The study results suggest that EGFR pharmacogenomic testing has the potential to improve quality-adjusted life expectancy in the treatment of refractory NSCLC by a clinically meaningful margin at a value commensurate with the approved therapies in this setting. Additional research in this area is warranted.