{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T15:28:11Z","timestamp":1787239691293,"version":"build-2736575974"},"reference-count":36,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T00:00:00Z","timestamp":1787184000000},"content-version":"unspecified","delay-in-days":19,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,7,31]]},"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design and setting<\/jats:title>\n                    <jats:p>\n                      Based on the RC48-C016 trial (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05302284\">NCT05302284<\/jats:ext-link>\n                      ), 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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-117595","type":"journal-article","created":{"date-parts":[[2026,8,20]],"date-time":"2026-08-20T14:45:33Z","timestamp":1787237133000},"page":"e117595","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Cost-effectiveness analysis of disitamab vedotin plus toripalimab versus chemotherapy as treatment for HER2-expressing advanced urothelial cancer in China"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct05302284","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct05302284","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-1372-663X","authenticated-orcid":false,"given":"Yize","family":"Jia","sequence":"first","affiliation":[{"name":"School of Pharmacy, Hebei Medical University, Shijiazhuang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Zhu","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Hebei Medical University, Shijiazhuang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuo","family":"Kang","sequence":"additional","affiliation":[{"name":"Medical Insurance Office, The Second Hospital of Hebei Medical University, Shijiazhuang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-4968-2561","authenticated-orcid":false,"given":"Xiaohui","family":"Wang","sequence":"additional","affiliation":[{"name":"School of Pharmacy, Hebei Medical University, Shijiazhuang, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,8,20]]},"reference":[{"key":"2026082007452711000_16.8.e117595.1","doi-asserted-by":"crossref","DOI":"10.1186\/s13045-022-01291-7","article-title":"Integrated proteogenomic characterization of urothelial carcinoma of the bladder","volume":"15","author":"Xu","year":"2022","journal-title":"J Hematol Oncol"},{"key":"2026082007452711000_16.8.e117595.2","doi-asserted-by":"publisher","DOI":"10.3322\/CAAC.21834"},{"key":"2026082007452711000_16.8.e117595.3","doi-asserted-by":"publisher","DOI":"10.1016\/j.jncc.2024.01.006"},{"key":"2026082007452711000_16.8.e117595.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2016.06.010"},{"key":"2026082007452711000_16.8.e117595.5","doi-asserted-by":"crossref","first-page":"1003","DOI":"10.1093\/oncolo\/oyae215","article-title":"Reevaluating the role of platinum-based chemotherapy in the evolving treatment landscape for patients with advanced urothelial carcinoma","volume":"29","author":"Zhang","year":"2024","journal-title":"Oncologist"},{"key":"2026082007452711000_16.8.e117595.6","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2020.0011"},{"key":"2026082007452711000_16.8.e117595.7","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2011.37.3571"},{"key":"2026082007452711000_16.8.e117595.8","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1992.10.7.1066"},{"key":"2026082007452711000_16.8.e117595.9","doi-asserted-by":"crossref","DOI":"10.1200\/PO-24-00879","article-title":"Testing and Interpretation of Human Epidermal Growth Factor Receptor 2 Protein Expression and ERBB2 Gene Amplification in Advanced Urothelial Carcinoma","volume":"9","author":"Koshkin","year":"2025","journal-title":"JCO Precis Oncol"},{"key":"2026082007452711000_16.8.e117595.10","doi-asserted-by":"crossref","first-page":"e617","DOI":"10.1093\/oncolo\/oyad070","article-title":"HER2 Expression Associated with Clinical Characteristics and Prognosis of Urothelial Carcinoma in a Chinese Population","volume":"28","author":"Zhou","year":"2023","journal-title":"Oncologist"},{"key":"2026082007452711000_16.8.e117595.11","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.08.005"},{"key":"2026082007452711000_16.8.e117595.12","doi-asserted-by":"crossref","first-page":"e1094","DOI":"10.1093\/oncolo\/oyae127","article-title":"HER2 overexpression in urothelial carcinoma with GATA3 and PPARG copy number gains","volume":"29","author":"Zhu","year":"2024","journal-title":"Oncologist"},{"key":"2026082007452711000_16.8.e117595.13","doi-asserted-by":"crossref","first-page":"675","DOI":"10.1038\/s41571-024-00924-9","article-title":"HER2-targeted therapies beyond breast cancer - 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