title: Cost-effectiveness of a new urinary biomarker-based risk score compared to standard of care in prostate cancer diagnostics - a decision analytical model.
abstract: To assess the cost-effectiveness of a new urinary biomarker-based risk score (SelectMDx; MDxHealth, Inc., Irvine, CA, USA) to identify patients for transrectal ultrasonography (TRUS)-guided biopsy and to compare this with the current standard of care (SOC), using only prostate-specific antigen (PSA) to select for TRUS-guided biopsy.
  
  
  
  A decision tree and Markov model were developed to evaluate the cost-effectiveness of SelectMDx as a reflex test vs SOC in men with a PSA level of >3 ng/mL. Transition probabilities, utilities and costs were derived from the literature and expert opinion. Cost-effectiveness was expressed in quality-adjusted life years (QALYs) and healthcare costs of both diagnostic strategies, simulating the course of patients over a time horizon representing 18 years. Deterministic sensitivity analyses were performed to address uncertainty in assumptions.
  
  
  
  A diagnostic strategy including SelectMDx with a cut-off chosen at a sensitivity of 95.7% for high-grade prostate cancer resulted in savings of €128 and a gain of 0.025 QALY per patient compared to the SOC strategy. The sensitivity analyses showed that the disutility assigned to active surveillance had a high impact on the QALYs gained and the disutility attributed to TRUS-guided biopsy only slightly influenced the outcome of the model.
  
  
  
  Based on the currently available evidence, the reduction of over diagnosis and overtreatment due to the use of the SelectMDx test in men with PSA levels of >3 ng/mL may lead to a reduction in total costs per patient and a gain in QALYs.
authors.affiliation: Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Siebren
authors.initials: S
authors.lastname: Dijkstra
authors.affiliation: Department of Operating Rooms, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Tim M
authors.initials: TM
authors.lastname: Govers
authors.affiliation: Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Rianne J
authors.initials: RJ
authors.lastname: Hendriks
authors.affiliation: Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Jack A
authors.initials: JA
authors.lastname: Schalken
authors.affiliation: Department of Mathematical Modelling, Statistics and Bioinformatics, Ghent University, Ghent, Belgium.
authors.forename: Wim
authors.initials: W
authors.lastname: Van Criekinge
authors.affiliation: Department of Pathology, Maastricht University Medical Center, Maastricht, The Netherlands.
authors.forename: Leander
authors.initials: L
authors.lastname: Van Neste
authors.affiliation: Department of Operating Rooms, Radboud University Medical Center, Nijmegen, The Netherlands.|Department of Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Janneke P C
authors.initials: JPC
authors.lastname: Grutters
authors.affiliation: Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: John P Michiel
authors.initials: JPM
authors.lastname: Sedelaar
authors.affiliation: Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Inge M
authors.identifier: 0000-0002-8002-1869
authors.initials: IM
authors.lastname: van Oort
mesh_terms: D000368:Aged; D014408:Biomarkers, Tumor / Q000652:urine*; D001706:Biopsy; D003362:Cost-Benefit Analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000191:economics* / Q000453:epidemiology / Q000473:pathology; D012306:Risk
chemical_list: D014408:Biomarkers, Tumor
keywords: SelectMDx; biomarker; cost-effectiveness analysis; prostate biopsy; prostate cancer