Cost-Effectiveness of Circulating Tumor DNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer Based on IMvigor011 Trial.

The optimal adjuvant treatment approach for muscle-invasive bladder cancer (MIBC) remains unsettled. The IMvigor011 trial demonstrated that circulating tumor DNA (ctDNA)-guided adjuvant atezolizumab improves outcomes and advances precision oncology in this setting. However, the socioeconomic value of this biomarker-driven strategy is unclear. We therefore assessed the economic value of ctDNA-guided therapy in this postoperative setting.

We constructed a three-state Markov model to estimate costs, quality-adjusted life-years (QALYs), incremental net monetary benefit (INMB), and incremental cost-effectiveness ratios (ICERs) in patients with MIBC. The model compared a ctDNA-guided adjuvant atezolizumab strategy with the standard of care (SOC) from a US health care payer perspective. Cost-effectiveness was assessed across willingness-to-pay (WTP) thresholds of $50,000-$150,000 in US dollars (USD) per QALY, and model robustness was examined through comprehensive sensitivity analyses.

Over a 5-year horizon, the ctDNA-guided strategy yielded 3.05 QALYs at a cost of $78,796 USD, compared with 2.92 QALYs and $131,601 USD for SOC. This corresponded to an ICER of -$397,163 USD per QALY gained, demonstrating dominance through greater benefit at lower cost. Sensitivity analyses confirmed that the ctDNA-guided approach was consistently cost-effective across all WTP thresholds.

ctDNA-guided atezolizumab adjuvant therapy proves to be a cost-effective strategy for MIBC, optimizing health care resource allocation and reducing overtreatment while improving patient outcomes. More standardized ctDNA testing protocols and transparent reporting of ctDNA status distributions are essential.

JCO oncology practice. 2026 Mar 26 [Epub ahead of print]

Zihan Xue, Yunkai Qie, Shan Liang, Rongjiang Li, Chong Shen, Zhouliang Wu, Houyuan Chen, Yuda Lin, Peng Li, Hailong Hu

Department of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.