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

Anton Safonov, Shiyi Wang, Cary P. Gross, Divyansh Agarwal, Giampaolo Bianchini, Lajos Pusztai, Christos Hatzis

Research output: Contribution to journalArticlepeer-review


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

Original languageEnglish
Pages (from-to)223-234
Number of pages12
JournalBreast Cancer Research and Treatment
Issue number2
Publication statusPublished - Jan 1 2016


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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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