Cost-effectiveness of nivolumab versus surveillance for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence: a US payer perspective

References

• Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2022. CA Cancer J Clin. 2022;72(1):7–33. doi: 10.3322/caac.21708.
   PubMed Web of Science ®Google Scholar
• Mossanen M, Gore JL. The burden of bladder cancer care: direct and indirect costs. Curr Opin Urol. 2014;24(5):487–491. doi: 10.1097/MOU.0000000000000078.
   PubMed Web of Science ®Google Scholar
• Aly A, Johnson C, Doleh Y, et al. The real-world lifetime economic burden of urothelial carcinoma by stage at diagnosis. J Clin Pathw. 2020;6(4):51–60.
   PubMedGoogle Scholar
• Saginala K, Barsouk A, Aluru JS, et al. Epidemiology of bladder cancer. Med Sci. 2020;8(1):15. doi: 10.3390/medsci8010015.
   Google Scholar
• NCCN. NCCN clinical practice guidelines in oncology (NCCN guidelines) for bladder cancer. National Comprehensive Cancer Network; V.1; 2020. Available from: http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
   Google Scholar
• Witjes JA, Bruins HM, Cathomas R, et al. European Association of Urology guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2020 guidelines. Eur Urol. 2021;79(1):82–104. doi: 10.1016/j.eururo.2020.03.055.
   PubMed Web of Science ®Google Scholar
• Rouprêt M, Babjuk M, Burger M, et al. European Association of Urology guidelines on upper urinary tract urothelial carcinoma: 2020 update. Eur Urol. 2021;79(1):62–79. doi: 10.1016/j.eururo.2020.05.042.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. FDA approves nivolumab for adjuvant treatment of urothelial carcinoma; 2021 [cited 2022 June]. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nivolumab-adjuvant-treatment-urothelial-carcinoma.
   Google Scholar
• Bajorin DF, Witjes JA, Gschwend JE, et al. Adjuvant nivolumab versus placebo in muscle-invasive urothelial carcinoma. N Engl J Med. 2021;384(22):2102–2114. doi: 10.1056/NEJMoa2034442.
   PubMed Web of Science ®Google Scholar
• Schnipper LE, Davidson NE, Wollins DS, et al. Updating the American Society of Clinical Oncology value framework: revisions and reflections in response to comments received. J Clin Oncol. 2016;34(24):2925–2934. doi: 10.1200/JCO.2016.68.2518.
   PubMed Web of Science ®Google Scholar
• Dubois RW, Westrich K. As value assessment frameworks evolve, are they finally ready for prime time? Value Health. 2019;22(9):977–980. doi: 10.1016/j.jval.2019.06.002.
   PubMed Web of Science ®Google Scholar
• Teitsson S, Brodtkorb T-H, Kurt M, et al. Challenges, considerations, and approaches for developing a cost-effectiveness model for the adjuvant treatment of muscle-invasive urothelial carcinoma: with a spotlight on nivolumab versus placebo. J Med Econ. 2024. doi: 10.1080/13696998.2024.2322394.
   Web of Science ®Google Scholar
• Institute for Clinical Economic Review. ICER’s reference case for economic evaluations: principles and rationale; 2020 [cited 2023 Sep 29. Available from: https://icer.org/wp-content/uploads/2020/10/ICER_Reference_Case_013120.pdf.
   Google Scholar
• Surveillance, Epidemiology, and End Results (SEER). Cancer of the urinary bladder – cancer stat facts [cited 2023 Sep 29]. Available from: https://seer.cancer.gov/statfacts/html/urinb.html.
   Google Scholar
• Bellmunt J, von der Maase H, Mead GM, et al. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC intergroup study 30987. J Clin Oncol. 2012;30(10):1107–1113. doi: 10.1200/JCO.2011.38.6979.
   PubMed Web of Science ®Google Scholar
• Jevdjevic M, Nickel K, Teitsson S, et al. CO153 survival analyses and indirect treatment comparisons (ITCS) in first-line metastatic urothelial carcinoma (1L MUC). Value Health. 2022;25(7):S333. doi: 10.1016/j.jval.2022.04.246.
   Web of Science ®Google Scholar
• Sternberg CN, Skoneczna I, Kerst JM, et al. Immediate versus deferred chemotherapy after radical cystectomy in patients with pT3-pT4 or N + M0 urothelial carcinoma of the bladder (EORTC 30994): an intergroup, open-label, randomised phase 3 trial. Lancet Oncol. 2015;16(1):76–86. doi: 10.1016/S1470-2045(14)71160-X.
   PubMed Web of Science ®Google Scholar
• IBM Watson Health. Micromedex RED BOOK (electronic version). Available from: https://www.micromedexsolutions.com/.
   Google Scholar
• Centers for Medicare and Medicaid Services. Cost reports; 2023 [cited 2023 Mar 21]. https://www.cms.gov/Research-Statistics-Data-and-Systems/Downloadable-Public-Use-Files/Cost-Reports.
   Google Scholar
• Cagiannos I, Morash C. Surveillance strategies after definitive therapy of invasive bladder cancer. Can Urol Assoc J. 2009;3(6 suppl 4):S237–S242. doi: 10.5489/cuaj.1205.
   PubMedGoogle Scholar
• Karakiewicz PI, Palapattu GS, Lotan Y, et al. Outcomes of radical cystectomy for transitional cell carcinoma of the bladder: a contemporary series from the Bladder Cancer Research Consortium. J Urol. 2006;176(6 Pt 1):2414–2422; discussion 2422. doi: 10.1016/j.juro.2006.08.004.
   PubMed Web of Science ®Google Scholar
• Sternberg CN, Bellmunt J, Sonpavde G, et al. ICUD-EAU international consultation on bladder cancer 2012: chemotherapy for urothelial carcinoma—neoadjuvant and adjuvant settings. Eur Urol. 2013;63(1):58–66. doi: 10.1016/j.eururo.2012.08.010.
   PubMed Web of Science ®Google Scholar
• Latimer NR. Survival analysis for economic evaluations alongside clinical trials–extrapolation with patient-level data: inconsistencies, limitations, and a practical guide. Med Decis Making. 2013;33(6):743–754. doi: 10.1177/0272989X12472398.
   PubMed Web of Science ®Google Scholar
• Rutherford MJ, Lambert PC, National Institute for Health and Care Excellence Decision Support Unit., et al. NICE DSU technical support document 21: flexible methods for survival analysis. Decision Support Unit, University of Sheffield; 2020, 21. Available from: http://www.nicedsu.org.uk.
   Google Scholar
• Jackson C, Stevens J, Ren S, et al. Extrapolating survival from randomized trials using external data: a review of methods. Med Decis Making. 2017;37(4):377–390. doi: 10.1177/0272989X16639900.
   PubMed Web of Science ®Google Scholar
• Galsky MD, Witjes JA, Gschwend JE, et al. Disease-free survival with longer follow-up from the phase 3 CheckMate 274 trial of adjuvant nivolumab in patients who underwent surgery for high-risk muscle-invasive urothelial carcinoma. Society for Urologic Oncology 22nd Annual Meeting, Orlando, FL, USA; 2021.
   Google Scholar
• Mitra AP, Quinn DI, Dorff TB, et al. Factors influencing post-recurrence survival in bladder cancer following radical cystectomy. BJU Int. 2012;109(6):846–854. doi: 10.1111/j.1464-410X.2011.10455.x.
   PubMed Web of Science ®Google Scholar
• Ozbir S, Girgin C, Kara C, et al. Local and systemic recurrence patterns of urothelial cancer after radical cystectomy. Kaohsiung J Med Sci. 2014;30(10):504–509. doi: 10.1016/j.kjms.2014.03.011.
   PubMed Web of Science ®Google Scholar
• Geynisman DM, Broughton E, Hao Y, et al. Real-world treatment patterns and clinical outcomes among patients with advanced urothelial carcinoma in the United States. Urol Oncol. 2022;40(5):195 e191–195 e111.
   Web of Science ®Google Scholar
• De Santis M, Bellmunt J, Mead G, et al. Randomized phase II/III trial assessing gemcitabine/carboplatin and methotrexate/carboplatin/vinblastine in patients with advanced urothelial cancer who are unfit for cisplatin-based chemotherapy: EORTC study 30986. J Clin Oncol. 2012;30(2):191–199. doi: 10.1200/JCO.2011.37.3571.
   PubMed Web of Science ®Google Scholar
• Guyot P, Ades AE, Ouwens MJ, et al. Enhanced secondary analysis of survival data: reconstructing the data from published Kaplan–Meier survival curves. BMC Med Res Methodol. 2012;12(1):9. doi: 10.1186/1471-2288-12-9.
   PubMed Web of Science ®Google Scholar
• Witjes JA, Galsky MD, Gschwend JE, et al. Health-related quality of life with adjuvant nivolumab after radical resection for high-risk muscle-invasive urothelial carcinoma: results from the phase 3 CheckMate 274 trial. Eur Urol Oncol. 2022;5(5):553–563. doi: 10.1016/j.euo.2022.02.003.
   PubMed Web of Science ®Google Scholar
• Centers for Medicare and Medicaid Services. Physician fee schedule; 2023 [cited 2023 Mar 21]. https://www.cms.gov/medicare/physician-fee-schedule/search.
   Google Scholar
• Bureau of Labor Statistics. U.S. city average; item: medical care; base period: 1982–84 = 100. Not Seasonally Adjusted; February 2023 [cited 2023 Mar 21]. Available from: http://data.bls.gov/cgi-bin/surveymost?cu.
   Google Scholar
• Perrin A, Sherman S, Pal S, et al. Lifetime cost of everolimus vs. axitinib in patients with advanced renal cell carcinoma who failed prior sunitinib therapy in the US. J Med Econ. 2015;18(3):200–209. doi: 10.3111/13696998.2014.985789.
   PubMed Web of Science ®Google Scholar
• Briggs A, Claxton K, Sculpher MJ. Modelling methods for health economic evaluation. Oxford: Oxford University Press; 2006.
   Google Scholar