Cost-Effectiveness of Perioperative Durvalumab With Neoadjuvant Gemcitabine/Cisplatin in Muscle-Invasive Bladder Cancer Treatment.

[BACKGROUND] For patients with cisplatin-eligible clinically localized muscle-invasive bladder cancer (MIBC), cisplatin-based neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) has long been the standard of care. In recent years, immune checkpoint inhibitors have transformed this paradigm. Adjuvant nivolumab was shown to extend disease-free and overall survival compared with placebo for patients at high risk for disease recurrence after RC (CheckMate 274 trial) and has become established as the new standard treatment. More recently, adding durvalumab to neoadjuvant gemcitabine/cisplatin (GC) and as adjuvant monotherapy ("perioperative/sandwich" immunotherapy) in cisplatin-eligible MIBC was shown to improve event-free and overall survival (NIAGARA trial). Herein, we evaluated the cost-effectiveness of adopting upfront, perioperative durvalumab for treating cisplatin-eligible MIBC.

[METHODS] We developed a decision-analytic Markov model using efficacy and safety data from the NIAGARA trial comparing neoadjuvant GC + durvalumab followed by RC and adjuvant durvalumab ("durvalumab") versus neoadjuvant GC followed by RC alone ("comparison"). In the comparison arm, patients with residual disease after NAC were modeled to receive adjuvant nivolumab, with associated survival and quality-of-life benefits incorporated using efficacy data from the CheckMate 274 trial. We calculated life years, quality-adjusted life years (QALYs), and direct medical costs from a US Medicare payer perspective over a 5-year time horizon. Scenario, one-way sensitivity, and probabilistic sensitivity analyses were performed.

[RESULTS] The durvalumab arm achieved greater life years (3.85 vs 3.81) and QALYs (3.05 vs 3.01) than the comparison arm. Higher upfront treatment costs from adding perioperative durvalumab were offset by greater reductions in postprogression treatment costs, resulting in lower total costs ($567,215 vs $592,368). Therefore, the durvalumab arm dominated comparison. Results were highly robust across extensive sensitivity analyses.

[CONCLUSIONS] In the United States, adding perioperative durvalumab to neoadjuvant GC for cisplatin-eligible MIBC treatment is likely life-extending and cost-effective compared with the current standard treatment of cisplatin-based NAC followed by risk-adapted adjuvant nivolumab.