Objectives

miR Sentinel™ Prostate Cancer Test (Sentinel) is a small non-coding RNA-based, non-invasive urine test designed to detect and risk-classify prostate cancer (PCa) with predictive accuracy over 90%. Current care for men suspected for PCa with prostate-specific antigen (PSA)>3ng/mL involves transrectal ultrasound-guided biopsy (TRUSB) with/without magnetic resonance imaging (MRI). Due to poor PSA accuracy, unnecessary biopsies are performed leading to increased costs and biopsy-related complications. MRI further increases costs, access to equipment is limited, and performance varies. This analysis assessed the clincial and budget effects of using Sentinel in biopsy-naïve men 45 and older with elevated PSA.

Methods

We developed a budget impact model representing the diagnostic pathways and PCa management. For current care, a proportion of eligible men receive MRI and biopsy. For Sentinel strategy, eligible men receive Sentinel and those with positive results are managed by Sentinel and TRUSB. Clinical and cost/resource inputs were based on Sentinel data, medical claims analysis, and literature. Unit costs for Sentinel, TRUSB and MRI were $1,200, $1,104 and $1,227 respectively. Rate and unit cost of managing biopsy complication were 23% and $4,683.

Results

For a 1-million-member plan, 7,064 biopsy naïve men 45 and older have elevated PSA>3ng/mL in a year. Following the cohort over 3 years, the Sentinel strategy reduces unnecessary biopsies by 98%, reduces undetected PCa cases by 59% and increases correct diagnosis by 128% compared to current care. The Sentinel strategy also yields cost saving with overall budget savings of $2.3m and a per-member-per-month savings of $0.06. The Sentinel test costs of $8.5m are offset by savings in MRI and biopsy ($5.4m) and biopsy related complications ($2.9m) costs.

Conclusion

Sentinel identifies and risk classifies PCa non-invasively, substantially reduces unnecessary biopsies, provides overall budget savings over a 3-year period, and resolves the uncertainty from suspicious PSA more effectively than Current Care.