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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.

Author information

1
Yale School of Medicine, New Haven, USA.
2
Yale School of Public Health, New Haven, USA.
3
Cancer Outcomes Public Policy and Effectiveness Research (COPPER) Center, New Haven, USA.
4
Yale Cancer Center, Yale University, New Haven, USA.
5
San Raffaele Scientific Institute, Milan, Italy.
6
Yale School of Medicine, New Haven, USA. christos.hatzis@yale.edu.
7
Yale Cancer Center, Yale University, New Haven, USA. christos.hatzis@yale.edu.

Abstract

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 http://medicine.yale.edu/lab/pusztai/ticer/ .

KEYWORDS:

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

PMID:
26749360
DOI:
10.1007/s10549-016-3677-3
[Indexed for MEDLINE]
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