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Breast Cancer Res Treat. 2016 Jan;155(2):223-34. doi: 10.1007/s10549-016-3677-3. Epub 2016 Jan 9.

Assessing cost-utility of predictive biomarkers in oncology: a streamlined approach.

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Yale School of Medicine, New Haven, USA.
Yale School of Public Health, New Haven, USA.
Cancer Outcomes Public Policy and Effectiveness Research (COPPER) Center, New Haven, USA.
Yale Cancer Center, Yale University, New Haven, USA.
San Raffaele Scientific Institute, Milan, Italy.
Yale School of Medicine, New Haven, USA.
Yale Cancer Center, Yale University, New Haven, USA.


Evaluation of cost-utility is critical in assessing the medical utility of predictive or prognostic biomarkers. Current methods involve complex state-transition models, requiring comprehensive data inputs. We propose a simplified decision-analytic tool to explore the relative effect of factors contributing to the cost-utility of a biomarker. We derived a cost-utility metric, the "test incremental cost-effectiveness ratio" (TICER) for biomarker-guided treatment compared to no biomarker use. This method uses data inputs readily accessible through clinical literature. We compared our results with traditional cost-effectiveness analysis of predictive biomarkers for established (HER2-guided trastuzumab, ALK-guided crizotinib, OncotypeDX-guided adjuvant chemotherapy) and emerging (ROS1-guided crizotinib) targeted treatments. We conducted sensitivity analysis to determine which factors had the greatest impact on TICER estimates. Base case TICER for HER2 was $149,600/quality-adjusted life year (QALY), for ALK was $22,200/QALY, and for OncotypeDX was $11,600/QALY, consistent with literature-reported estimates ($180,000/QALY, $202,800/QALY, $8900/QALY, respectively). Base case TICER for ROS1-guided crizotinib was $205,900/QALY. Generally, when treatment cost is considerably greater than biomarker testing costs, TICER is driven by clinical outcomes and health-related quality of life, while biomarker prevalence and treatment cost have a lesser effect. Our simplified decision-analytic approach produces values consistent with existing cost-effectiveness analyses. Our results suggest that biomarker value is mostly driven by the clinical efficacy of the targeted agent. A user-friendly web tool for complete TICER analysis has been made available for open use at .


Breast cancer; Comparative effectiveness; Decision analysis; OncotypeDX; Outcomes; Research

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