Real-world ctDNA test utilization and associated costs in US patients with bladder cancer who underwent radical cystectomy

BACKGROUND: Circulating tumor DNA (ctDNA) can inform prognosis and treatment effectiveness in bladder cancer. We evaluated real-world utilization and costs of ctDNA testing among US patients with bladder cancer undergoing radical cystectomy following initiation of Medicare coverage for ctDNA testing. METHODS: Using claims data from Optum Clinformatics Data Mart Database (January 19, 2022-June 30, 2025) covering commercial and Medicare Advantage plans, we evaluated ctDNA testing incidence, testing rate, and costs in patients undergoing radical cystectomy. Total (paid by payers and patients) and out-of-pocket costs (sum of coinsurance, copays, and deductibles) were reported. Time to first and second tests was estimated using Kaplan-Meier methods. Patient characteristics were evaluated among those who received ≥1 ctDNA test vs. untested patients. RESULTS: Among 1,995 patients (76.4% male; 89.1% White), 17.1% (341/1995) received ≥1 ctDNA test before (4.7%) and/or after (14.7%) radical cystectomy (median of 2 tests among those tested; Q1-Q3: 1-5). Median testing cost was $4,178 (Q1-Q3: $1,756-$4,178), with $0 median out-of-pocket cost. Testing rate rose from 4.0 (second half of 2022) to 34.0 (first half of 2025) tests per 1,000 patient-months (P for trend <0.001). Tested and untested cohorts had similar age, sex, and race distributions. Tested patients were more likely to receive systemic treatment before (46.0% vs. 35.8%, P < 0.001) and after cystectomy (24.0% vs. 10.1%, P < 0.001) than untested patients. CONCLUSIONS: Since Medicare coverage approval, ctDNA testing among US radical cystectomy-treated patients with bladder cancer has increased steadily but remains modest. Total costs varied, yet patient out-of-pocket expenses were minimal.