Incorporating Biomarkers into the Primary Prostate Biopsy Setting: A Cost-Effectiveness Analysis
Abstract
Purpose:
We performed a cost-effectiveness analysis using the PHI (Prostate Health Index), 4Kscore®, SelectMDx™ and the EPI (ExoDx™ Prostate [IntelliScore]) in men with elevated prostate specific antigen to determine the need for biopsy.
Materials and Methods:
We developed a decision analytical model in men with elevated prostate specific antigen (3 ng/ml or greater) in which 1 biomarker test was used to determine which hypothetical individuals required biopsy. In the current standard of care strategy all individuals underwent biopsy. Model parameters were derived from a comprehensive review of the literature. Costs were calculated from a health sector perspective and converted into 2017 United States dollars.
Results:
The cost and QALYs (quality adjusted life-years) of the current standard of care, which was transrectal ultrasound guided biopsy, was $3,863 and 18.085, respectively. Applying any of the 3 biomarkers improved quality adjusted survival compared to the current standard of care. The cost of SelectMDx, the PHI and the EPI was lower than performing prostate biopsy in all patients. However, the PHI was more costly and less effective than the SelectMDx strategy. The 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% to 34% compared to the current standard of care.
Conclusions:
Applying biomarkers in men with elevated prostate specific antigen to determine the need for biopsy improved quality adjusted survival by decreasing the number of biopsies performed and the treatment of indolent disease. Using SelectMDx or the EPI following elevated prostate specific antigen but before proceeding to biopsy is a cost-effective strategy in this setting.
References
- 1 : Prostate specific antigen for early detection of prostate cancer: longitudinal study. BMJ2009; 339: b3537. Google Scholar
- 2 : Economic burden of cancer in the US: estimates, projections, and future research. Cancer Epidemiol Biomarkers Preven2011; 20: 2006. Google Scholar
- 3 : A multicenter study of [–2]pro-prostate specific antigen combined with prostate specific antigen and free prostate specific antigen for prostate cancer detection in the 2.0 to 10.0 ng/ml prostate specific antigen range. J Urol2011; 185: 1650. Link, Google Scholar
- 4 : Detection of high-grade prostate cancer using a urinary molecular biomarker-based risk score. Eur Urol2016; 70: 740. Google Scholar
- 5 : A novel urine exosome gene expression assay to predict high-grade prostate cancer at initial biopsy. JAMA Oncol2016; 2: 882. Google Scholar
- 6 : The 4Kscore® test reduces prostate biopsy rates in community and academic urology practices. Rev Urol2015; 17: 231. Google Scholar
- 7 : Multicenter evaluation of the prostate health index to detect aggressive prostate cancer in biopsy naïve men. J Urol2015; 194: 65. Link, Google Scholar
- 8 : Who to Biopsy?. Available at http://www.prostatemarkers.org/. Accessed May 27, 2018. Google Scholar
- 9 : Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet2017; 389: 815. Google Scholar
- 10 : The cost-effectiveness of prostate cancer detection with the use of Prostate Health Index. Value Health2016; 19: 153. Google Scholar
- 11 : Cost-effectiveness of a new urinary biomarker-based risk score compared to standard of care in prostate cancer diagnostic—a decision analytical model. BJU Int2017; 120: 659. Google Scholar
- 12 : Cost-effectiveness of Prostate Health Index for prostate cancer detection. BJU Int2012; 110: 353. Google Scholar
- 13 : Use of the 4Kscore test to predict the risk of aggressive prostate cancer prior to prostate biopsy: overall cost savings and improved quality of care to the us healthcare system. Rev Urol2017; 19: 1. Google Scholar
- 14 : Lead time and overdiagnosis in prostate-specific antigen screening: importance of methods and context. J Natl Cancer Inst2009; 101: 374. Google Scholar
- 15 : Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial. Lancet Oncol2011; 12: 891. Google Scholar
- 16 : MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med2018; 378: 1767. Google Scholar
- 17 : High prostate cancer gene 3 (PCA3) scores are associated with elevated Prostate Imaging Reporting and Data System (PI-RADS) grade and biopsy Gleason score, at magnetic resonance imaging/ultrasonography fusion software-based targeted prostate biopsy after a previous negative standard biopsy. BJU Int2016; 118: 723. Google Scholar
