REAL-WORLD CTDNA TEST UTILIZATION AND ASSOCIATED COSTS IN US PATIENTS WITH BLADDER CANCER WHO UNDERWENT RADICAL CYSTECTOMY
Author(s)
Ching-Yu Wang, BS, MS, PhD1, Hal Yapici, MBA, MPH, MD2, Jonathan Lilley, BS2, Weiqi Jiao, Sc.M.2, Kunal J. Lodaya, MD2, Haojie Li, PhD1, Todd M. Morgan, MD3;
1Merck & Co. Inc., Rahway, NJ, USA, 2Boston Strategic Partners, Inc., Boston, MA, USA, 3University of Michigan, Department of Urology, Ann Arbor, MI, USA
1Merck & Co. Inc., Rahway, NJ, USA, 2Boston Strategic Partners, Inc., Boston, MA, USA, 3University of Michigan, Department of Urology, Ann Arbor, MI, USA
OBJECTIVES: Circulating tumor DNA (ctDNA) can detect minimal residual disease and monitor treatment effectiveness in bladder cancer (BC) management. We assessed real-world ctDNA test utilization and costs among US BC patients undergoing radical cystectomy (RC) following Medicare coverage approval (April 2022) of ctDNA testing.
METHODS: Claims from Optum’s de-identified Clinformatics® Data Mart Database (01/19/2022-06/30/2025) were used to identify adult patients who had ≥2 BC diagnosis-related claims within 6 months of each other, and an RC procedure code post-Medicare ctDNA testing coverage (04/19/2022). Continuous insurance coverage was required ≥3 months pre-RC and ≥6 months post-RC (except for deaths ≤6 months). Test prevalence, testing rate, and costs were assessed. Patient characteristics were evaluated among those who received ≥1 ctDNA test (CPT codes 81479 and 0340U) versus not (“ctDNA-tested” vs. “untested” cohorts). Comparisons were assessed using chi-square or z-tests with Wilson confidence intervals.
RESULTS: Of 1,995 RC-treated BC patients identified, majority were male (76.4%) and White (75.7%). Overall, 17.1% (341/1995) had 1 or more ctDNA test post-MIBC diagnosis (median of 2 tests among tested; Q1-Q3: 1-5); 4.7% (94/1995) and 14.7% (293/1995) were tested pre-RC and post-RC, respectively. The median ctDNA testing cost was $4,178 [Q1-Q3: $1,756-$4,178], with an out-of-pocket cost of $0. Following Medicare coverage approval, ctDNA testing rate increased from 4.0 (second half of 2022) to 34.0 (first half of 2025) per 1000 patient-months (p for trend <0.001). The ctDNA-tested and untested cohorts had similar characteristics, including comparable age, sex, and race distributions. ctDNA-tested patients (vs. untested) were more likely to receive systemic treatment before (46.0% vs. 35.8%, p<0.001) and after RC (24.0% vs. 10.1%, p<0.001).
CONCLUSIONS: Since Medicare began covering ctDNA testing, the overall utilization among US RC-treated BC patients has been modest but rising significantly. Although total costs varied, out-of-pocket expenses appeared minimal.
METHODS: Claims from Optum’s de-identified Clinformatics® Data Mart Database (01/19/2022-06/30/2025) were used to identify adult patients who had ≥2 BC diagnosis-related claims within 6 months of each other, and an RC procedure code post-Medicare ctDNA testing coverage (04/19/2022). Continuous insurance coverage was required ≥3 months pre-RC and ≥6 months post-RC (except for deaths ≤6 months). Test prevalence, testing rate, and costs were assessed. Patient characteristics were evaluated among those who received ≥1 ctDNA test (CPT codes 81479 and 0340U) versus not (“ctDNA-tested” vs. “untested” cohorts). Comparisons were assessed using chi-square or z-tests with Wilson confidence intervals.
RESULTS: Of 1,995 RC-treated BC patients identified, majority were male (76.4%) and White (75.7%). Overall, 17.1% (341/1995) had 1 or more ctDNA test post-MIBC diagnosis (median of 2 tests among tested; Q1-Q3: 1-5); 4.7% (94/1995) and 14.7% (293/1995) were tested pre-RC and post-RC, respectively. The median ctDNA testing cost was $4,178 [Q1-Q3: $1,756-$4,178], with an out-of-pocket cost of $0. Following Medicare coverage approval, ctDNA testing rate increased from 4.0 (second half of 2022) to 34.0 (first half of 2025) per 1000 patient-months (p for trend <0.001). The ctDNA-tested and untested cohorts had similar characteristics, including comparable age, sex, and race distributions. ctDNA-tested patients (vs. untested) were more likely to receive systemic treatment before (46.0% vs. 35.8%, p<0.001) and after RC (24.0% vs. 10.1%, p<0.001).
CONCLUSIONS: Since Medicare began covering ctDNA testing, the overall utilization among US RC-treated BC patients has been modest but rising significantly. Although total costs varied, out-of-pocket expenses appeared minimal.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
EE361
Topic
Economic Evaluation
Topic Subcategory
Cost/Cost of Illness/Resource Use Studies
Disease
SDC: Oncology, SDC: Urinary/Kidney Disorders, STA: Personalized & Precision Medicine