<b>Cost-Effectiveness of Immune Checkpoint Inhibitor Therapy plus BCG for High-Risk Non-muscle Invasive Bladder Cancer: Analyses of CREST</b> , <b>POTOMAC, and ALBAN</b>

PURPOSE: 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. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.