DOI: 10.1136/bmjopen-2026-117595 ISSN: 2044-6055

Cost-effectiveness analysis of disitamab vedotin plus toripalimab versus chemotherapy as treatment for HER2-expressing advanced urothelial cancer in China

Yize Jia, Lin Zhu, Shuo Kang, Xiaohui Wang

Objective

HER2-expressing advanced urothelial cancer is associated with poor prognosis and substantial treatment burden, and the economic value of emerging combination therapies remains uncertain. This study aimed to evaluate whether disitamab vedotin combined with toripalimab is more cost-effective than chemotherapy for patients with HER2-expressing advanced urothelial cancer from the perspective of the Chinese healthcare system.

Design and setting

Based on the RC48-C016 trial ( NCT05302284 ), a partitioned survival model was developed to simulate lifetime health outcomes and economic costs. Data were obtained from the RC48-C016 trial and other publicly available published literature.

Participants

Patients with HER2-expressing advanced or metastatic urothelial carcinoma in China were included in this study. They were assigned to receive either disitamab vedotin plus toripalimab or chemotherapy based on the treatment arms defined in the RC48-C016 trial.

Primary and secondary outcome measures

Economic value was assessed using quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER). Model robustness was evaluated through deterministic sensitivity analysis and probabilistic sensitivity analysis.

Results

The base-case analysis showed that disitamab vedotin plus toripalimab resulted in an incremental cost of US$16 101.81 and an incremental QALY gain of 0.28, corresponding to an ICER of US$56 889.17 per QALY gained. This value exceeded China’s willingness-to-pay threshold of US$38 224 per QALY. Probabilistic sensitivity analysis showed that, at this threshold, disitamab vedotin plus toripalimab had a 38.5% probability of being cost-effective. These findings suggest that disitamab vedotin plus toripalimab is unlikely to be cost-effective under current pricing.

Conclusion

The cost-effectiveness analysis indicated that disitamab vedotin plus toripalimab is not a cost-effective treatment option for patients with HER2-expressing advanced urothelial cancer in China.

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