Cost-Effectiveness and Clinical Utility of Pancreatic Cancer Non-Invasive Test in New-Onset Diabetes.

[IMPORTANCE] Most pancreatic cancer (PC) cases are diagnosed at a late stage, leading to poor prognosis. New-onset diabetes (NOD) increases the risk of PC by 6- to 8-fold within the first 3 years of diagnosis. This study aims to assess the clinical utility and economic benefits of early detection of PC in patients with NOD using a cell-free DNA (cfDNA) epigenomic blood test (Avantect; ClearNote Health, CA).

[DESIGN] A Markov model compares two primary strategies: no testing and testing higher-risk NOD patients using the cfDNA epigenomic test. Using the enriching new-onset diabetes for pancreatic cancer (END-PAC) criteria ≥3, approximately 20% of the NOD patients were at higher risk for PC. The cfDNA epigenomic test has a sensitivity of 68% and a specificity of 97%.

[RESULTS] The cfDNA test is robustly cost-effective in NOD high-risk patients, with an Incremental Cost-Effectiveness Ratio (ICER) of $56,564 at a Willingness-to-Pay (WTP) threshold of $100,000; its cost-effectiveness is superior to the standard of care, ie, no testing. In a modeled cohort of 10,000 NOD patients, the no-testing strategy would result in 1% of PC cases, with only 7.1% being eligible for potentially curative surgery. By contrast, cfDNA testing identified 71 cases of PC, with 32.4% of these cases being eligible for surgical resection. Early-stage detection through this approach more than quadruples surgical eligibility and significantly enhances the chances of a cure.

[CONCLUSIONS AND RELEVANCE] These findings underscore the transformative clinical and economic value of early PC detection in high-risk patients with NOD. Implementing cfDNA testing during the first three years following diabetes onset has the potential to shift the diagnosis paradigm, leading to early interventions and meaningful improvements in expected survival, while remaining cost-effective.