Incorporating biomarkers into the primary prostate biopsy setting: a cost-effectiveness analysis.

Abstract

To perform a cost-effectiveness analysis of using Prostate Health Index (PHI), 4Kscore, SelectMDx and ExoDx Prostate IntelliScore (EPI) in men with an elevated PSA value to determine the need for biopsy. We developed a decision-analytic model for men with an elevated PSA values (≥ 3ng/mL) where one of the biomarker tests was to determine which hypothetical individuals required a biopsy. In the current standard of care strategy, all individuals underwent a biopsy. Model parameters were derived from a comprehensive review of the literature. Costs were calculated from a health sector perspective and converted into 2017 US dollars. The cost and QALYs of the current standard of care (transrectal ultrasound guided biopsy) was $3,863 and 18.085, respectively. The use of any of the three biomarkers improved quality-adjusted survival compared to the current standard of care. The cost of SelectMDx, PHI and EPI was lower than performing a prostate biopsy on all patients. However, PHI was more costly and less effective than the SelectMDx strategy. EPI provided the highest QALY with an incremental cost-effectiveness ratio of $58,404 per QALY. The use of biomarkers could reduce the number of unnecessary biopsies by 24-34% compared to the current standard of care. The use of biomarkers in men with an elevated PSA to determine the need for biopsy improves quality-adjusted survival by decreasing the number of biopsies performed and treatment of indolent disease. Obtaining a SelectMDx or EPI following an elevated PSA but before proceeding to a biopsy are cost-effective strategies in this setting.