Cost-effectiveness analysis in the era of systemic immunotherapy for BCG-naive high-risk non–muscle-invasive bladder cancer in the United States, the United Kingdom, and China.

4598 Background: Non–muscle-invasive bladder cancer (NMIBC) has entered the era of systemic immunotherapy, with randomized trials evaluating the addition of systemic immunotherapy to BCG to improve disease control. The cost-effectiveness of combining immune checkpoint inhibitor (ICI) with BCG in BCG-naive high-risk NMIBC (HR-NMIBC) remains unclear. We therefore conducted a multinational cost-effectiveness analysis in the United States, United Kingdom, and China based on the CREST and POTOMAC studies. Methods: We developed a Markov model to evaluate treatment strategies for patients with BCG-naive HR-NMIBC over a 5-year time horizon from healthcare payer perspectives, with health outcomes measured in quality-adjusted life-years (QALYs). Total costs, QALYs, and incremental cost-effectiveness ratios (ICERs) were calculated for each strategy. Model robustness was assessed using deterministic and probabilistic sensitivity analyses. Results: Health outcomes were comparable across strategies, with BCG, durvalumab plus BCG, and sasanlimab plus BCG yielding 4.11, 4.31, and 4.18 QALYs, respectively. In the US, durvalumab plus BCG increased costs by $159,021 compared with BCG, resulting in an ICER of $827,706 per QALY, exceeding the willingness-to-pay (WTP) threshold of $150,000 per QALY. In the UK, the corresponding ICER was £503,944 per QALY, far above the WTP threshold of £20,000 per QALY. In China, the ICER reached ¥3,860,692 per QALY, exceeding the threshold defined as three times the national per-capita GDP (¥257,145). Sasanlimab plus BCG was strictly dominated by durvalumab plus BCG in all settings. Consequently, neither systemic immunotherapy–based strategy was cost-effective under the evaluated WTP thresholds. BCG was optimal in all probabilistic simulations, and ICI prices were the primary drivers of cost-effectiveness for systemic immunotherapy–based strategies. Conclusions: Despite modest clinical benefits, the high cost of systemic immunotherapy plus BCG precludes cost-effectiveness across health care systems, with BCG alone remaining the preferred strategy under current pricing. Future efforts should focus on drug price reductions and precision patient selection to improve the value proposition of early systemic immunotherapy. Costs ($; US) Costs (£; UK) Costs (¥; China) Incremental costs ($; US) Incremental costs (£; UK) Incremental costs (¥; China) Effectiveness (QALYs) ICER ($/QALY; US) ICER (£/QALY; UK) ICER (¥/QALY; China) BCG 48,828 21,307 119,383 - - - 4.11 - - - Durvalumab + BCG 207,849 118,126 861,110 159,021 96,819 741,728 4.31 827,706 503,944 3,860,692 Sasanlimab + BCG* 309,654 138,329 932,331 260,826 117,023 812,948 4.18 3,726,091 1,671,751 1,1613,542 *The Sasanlimab plus BCG strategy is strictly dominated by the Durvalumab plus BCG strategy (higher cost and lower effectiveness).