Abstract
PURPOSE: Over 90% of people with hereditary cancer syndromes in the United States remain unidentified. The Genetic Cancer Risk Detector (GARDE) is an open-source, electronic health record (EHR)-integrated, digital health platform that can facilitate genetic cancer risk assessment and genetic testing. This study evaluates its budget impact on health care institutions. METHODS: A budget impact analysis was performed from the perspective of a US health care provider system over a 3-year horizon. Data from the BRIDGE randomized controlled trial data from the University of Utah Health (UHealth) were used, where eligible primary care patients were screened for genetic cancer risk via GARDE. Costs of GARDE were categorized across planning, implementation, and operational phases. Revenue projections were based on Centers for Medicare & Medicaid Services reimbursement rates. Scenario analyses varied uptake of interventions, surveillance intervals, reimbursement rates, and implementation scale. RESULTS: Of 1,444 patients identified by GARDE at UHealth and enrolled in the BRIDGE trial, 205 completed genetic testing, with 15 found to carry pathogenic variants. The total 3-year implementation cost was $29,217 US dollars (USD). Revenue from guideline-recommended procedures totaled $86,563 USD, yielding a net positive budget impact of $57,347 USD. Most revenue (76.4%) was generated by surgical risk-reduction procedures. Scenario analyses revealed high sensitivity to cancer risk-reducing surgery uptake and implementation scale. Modeling 100% uptake of risk-reducing surgeries increased revenue to $128,102 USD, while 20-fold scaling of the implementation population increased revenue to $1.7 million USD. Commercial insurance reimbursement assumptions further amplified revenue. CONCLUSION: GARDE enables scalable hereditary cancer risk assessment within a health care provider system. Even with modest uptake, it yields a positive financial return, and significantly greater revenue is achievable with broader implementation. These findings support adoption of EHR-integrated tools to enhance clinical outcomes in precision cancer prevention and risk management, in an economically viable manner.