Program

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In-person registration included the full virtual experience, and virtual-only attendees will be able to tune into live in-person sessions and/or watch captured in-person sessions on-demand in addition to having a variety of virtual-only sessions to attend.

Budget Impact Analysis of Sentinel Prostate Test Versus Current Diagnostic Strategy for Men with Suspicion of Prostate Cancer in the US

Speaker(s)

Meng Y1, Tenniswood M2, Elsea D1, Kowalski J1
1BresMed, Sheffield, UK, 2miR Scientific, New York, NY, USA

Presentation Documents

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.

Code

EE299

Topic

Clinical Outcomes, Economic Evaluation, Medical Technologies, Study Approaches

Topic Subcategory

Budget Impact Analysis, Clinical Outcomes Assessment, Diagnostics & Imaging

Disease

Medical Devices, Oncology, Reproductive and Sexual Health