Cost-Effectiveness of Immune Checkpoint Inhibitor Therapy Plus Bacillus Calmette-Guérin for High-Risk Nonmuscle-Invasive Bladder Cancer: Analyses of CREST, POTOMAC, and ALBAN.

PURPOSE: Three recent trials evaluated immune checkpoint inhibitors (ICIs) + bacillus Calmette-Guérin (BCG) for treatment of high-risk nonmuscle-invasive bladder cancer (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. In this article, 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 with 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 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 US 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 (incremental cost-effectiveness ratio = $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 UK 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.