Three recent trials evaluated immune checkpoint inhibitors (ICI)+BCG for treatment of high-risk non-muscle invasive bladder cancer (HR-NMIBC). Two of these trials (CREST, POTOMAC) demonstrated that ICI+BCG improved event-free survival compared with BCG alone but resulted in higher rates of treatment-related adverse events. Herein, we evaluated the cost-effectiveness of ICI+BCG compared with BCG alone. We then created a publicly available cost-effectiveness calculator to facilitate future NMIBC drug value comparisons.
We used a Markov model to compare sansalimab+BCG to induction and maintenance BCG alone for BCG-naïve high-risk NMIBC. Efficacy and toxicity probabilities were extracted from the CREST trial. One-way and probabilistic sensitivity analyses were performed. Incremental cost-effectiveness ratios (ICERs) were compared using a willingness-to-pay threshold of $100,000/quality-adjusted life year (QALY). Analyses were repeated using POTOMAC and ALBAN data.
From a U.S. Medicare payer's perspective, the combination of sasanlimab+BCG resulted in 0.03 additional QALYs (6.12 vs 6.09) at an additional cost of $145,940 relative to BCG alone. Combination therapy was found not to be cost-effective over a lifetime horizon (ICER = $6,316,217/QALY). On one-way sensitivity analysis, the combination of sasanlimab+BCG became cost-effective only if the cost of sasanlimab was reduced by > 94% (to $1399/treatment). Similar findings were found from a U.K. perspective and with data from POTOMAC/ALBAN.
ICI+BCG is not cost-effective as a combination therapy relative to BCG alone. Further efforts are needed to improve the efficacy/toxicity profile of novel therapies, while continued scrutiny of the health system cost implications of new agents remains warranted.
The Journal of urology. 2026 May 18 [Epub ahead of print]
Daniel D Joyce, Vidit Sharma, Grace E Ratcliff, Daniel A Barocas, Sam S Chang, David F Penson, Vignesh T Packiam, Girish Kulkarni, Kevin M Wymer, Stephen A Boorjian
Department of Urology, Vanderbilt University Medical Center, Nashville, TN, USA., Department of Urology, Mayo Clinic, Rochester, MN, USA., Department of Health Policy, Vanderbilt University Medical Center, Nashville, TN, USA., Division of Urology, Rutgers Cancer Institute, New Brunswick, NJ, USA., Department of Surgery, University of Toronto, Toronto, ON, CANADA.