Purpose. Life Technologies has developed a 14-gene molecular assay that provides information about the risk of death in early stage non-squamous non-small cell lung cancer patients after surgery. The assay can be used to identify patients at highest risk of mortality, informing subsequent treatments. The objective of this study was to evaluate the costeffectiveness of this novel assay. Patients and Methods. We developed a Markov model to estimate life expectancy, quality-adjusted life years (QALYs), and costs for testing versus standard care. Risk-group classification was based on assay-validation studies, and chemotherapy uptake was based on pre-and post-testing recommendations from a study of 58 physicians.We evaluated three chemotherapy-benefit scenarios: moderately predictive (base case), nonpredictive (i.e., the same benefit for each risk group), and strongly predictive.We calculated the incremental cost-effectiveness ratio (ICER) and performed one-way and probabilistic sensitivity analyses. Results. In the base case, testing and standard-care strategies resulted in 6.81 and 6.66 life years, 3.76 and 3.68 QALYs, and $122,400 and $118,800 in costs, respectively. The ICER was $23,200 per QALY (stage I: $29,200 per QALY; stage II: $12,200 per QALY). The ICER ranged from "dominant" to $92,100 per QALY in the strongly predictive and nonpredictive scenarios. The model was most sensitive to the proportion of high-risk patients receiving chemotherapy and the high-risk hazard ratio. The 14-gene risk score assay strategy was cost-effective in 68% of simulations. Conclusion. Our results suggest that the 14-gene risk score assay may be a cost-effective alternative to standard guidelinebased adjuvant chemotherapy decision making in early stage non-small cell lung cancer. The Oncologist 2014;19:466-476 Implications for Practice: Gene-expression profiles, like the 14-gene risk score assay, provide prognostic information that may improve adjuvant chemotherapy decision making in early stage non-small cell lung cancer relative to standard stage-based approaches. We evaluated the clinical and economic impacts of the 14-gene risk score assay and report a testing strategy that is likely to result in additional quality-adjusted survival at an additional cost that is generally considered to be cost-effective in the United States. Our findings can be used to inform decisions about clinical implementation and payer considerations.
Our data show that the assay resulted in a significant impact on physician treatment decisions in early-stage NSCLC, and that the nature of treatment changes generally correlated with the test's assessment of risk.
ALK-positive, advanced NSCLC in Argentina. Methods: A budget impact model we developed to evaluate two separate scenarios from a payer's perspective. The model compared scenarios with and without crizotinib. In the crizotinib scenario all patients testing positive for the ALK mutation were given crizotinib. Comparators were platin-containing regimens (ex pemetrexed), platin/pemetrexed, erlotinib/gefitinib, and crizotinib. Epidemiology, market basket, adverse event costs, and drug costs were informed through ten local physician questionnaires and published literature. The survey was administered to oncologists in six different private and public hospitals of varying sizes and locations in Argentina. Costs are in 2013 USD (1 USD = 5.88 ARS). Results: Considering the population of Argentina (42,610,981) and applying age based incidence rates, the number of lung cancer patients was estimated to be 12,139. Of those patients 82.5% were estimated to be have metastatic NSCLC and 74% were likely to be treated, leaving 7,411 treated patients in the model. The estimated one-year cost for treating these patients without crizotinib was estimated to be $205,874,409. In the scenario including crizotinib, 154 patients (market uptake of 2.08%) were taken from other regimens and given crizotinib resulting in an estimated one-year cost of $224,651,145. The incremental total cost between these scenarios was $18,776,736 while the incremental costs per ALK+ patient and per member were $211 and $.04 respectively. These results were robust under standard parameter estimate variations. ConClusions: Adding crizotinib as a treatment option may have an acceptable budget impact under standard practices.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.