OBJECTIVES: More than 1.4 million cases of prostate cancer (PCa), the second most common cancer in men, are diagnosed each year worldwide.

Patient’s risk stratification is a crucial decision-making tool to identify clinically significant PCa, to avoid unnecessary biopsies, overdiagnosis and overtreatment. European Guidelines indicate the need for new and improved biomarkers based in blood, urine or tissue.

A cost analysis of ProsTAV®, a new in vitro blood test for the early detection of PCa authorized in Europe, has been performed to determine economic impact of its introduction in the European healthcare systems.

METHODS: The analysis was developed from the perspective of the Spanish National Healthcare System, considering a cohort of approximately 9.3 million (men >50 years), to estimate direct costs (€, 2023) derived from the consumption of resources required for the diagnosis of PCa (PSA determinations, visits to urology, biopsies, as well as the complications arising from the performance of biopsies), in a time horizon of one year. Model considered ProsTAV® parameters (90% sensitivity and 33% specificity) and a number of annual biopsies of 57,568.

RESULTS: The introduction of ProsTAV® into the PCa diagnostic process in Spain represents a maximum difference of 0.21% (range: -0.18% to 0.21%) compared to current costs. It is associated with a reduction in the number Urologist visits, avoiding 21.28% of patients with suspected PCa having to undergo a biopsy and 33% reduction in the number of biopsies that would end up confirming the absence of PCa.

CONCLUSIONS: ProsTAV®, without increase in the costs associated with diagnosis of PCa, is linked with a reduction in the number of biopsies and the visits to the Urology Department, the avoidance of biopsies in patients without risk of PCa, and therefore, with evident benefits for patients. The use of this biomarker could be a very useful innovation for European healthcare systems.