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Comparative Study
. 2025 Apr 1;43(1):202.
doi: 10.1007/s00345-025-05589-2.

Cost-effectiveness of nivolumab compared with surveillance for adjuvant treatment of muscle-invasive urothelial carcinoma at high risk of recurrence in France

Affiliations
Comparative Study

Cost-effectiveness of nivolumab compared with surveillance for adjuvant treatment of muscle-invasive urothelial carcinoma at high risk of recurrence in France

Sylvie Negrier et al. World J Urol. .

Abstract

Purpose: To evaluate the cost-effectiveness of nivolumab for adjuvant treatment of adults with muscle-invasive urothelial carcinoma at high risk of recurrence (MIUC-HR) and tumour cell expression PD-L1 ≥ 1% following radical resection from the payer perspective in France.

Methods: A four-state (disease-free, loco-regional recurrence, distant recurrence, death) semi-Markov model was developed to simulate health outcomes and costs in a cohort of patients with MIUC-HR and tumour cell expression PD-L1 ≥ 1% following radical resection. Health state-specific costs and quality of life-adjusted life years (QALYs) were compared between two treatment strategies (nivolumab, surveillance). The time horizon was 15 years. Clinical and utility inputs were modelled from the data obtained in the Phase III trial CheckMate 274 (#NCT02632409). Cost inputs were extracted from French sources (notably the French National Cost Study). Model outputs were life-years and QALYs overall and by health-state, total costs and cost components. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) between the two treatment strategies were calculated.

Results: Life-years were 7.3 for nivolumab and 5.2 for surveillance; QALYs were 4.7 for nivolumab and 3.3 for surveillance. The between-strategy difference in QALYs was essentially accrued in the disease-free state (nivolumab: 4.2, surveillance: 2.6). Total costs were €129,150 for nivolumab and €93,031 for surveillance. The principal cost components were nivolumab acquisition (€ 44,054) and disease management (nivolumab: €29,831; surveillance: €27,233). The estimated ICER was € 17,228/LY gained and the estimated ICUR was €25,806/QALY.

Conclusion: Nivolumab in the adjuvant setting is likely to be cost-effective compared to surveillance in France.

Keywords: Adjuvant treatment; Cost-effectiveness; Cost-utility; Economic evaluation; Immune checkpoint inhibitor; Nivolumab; Urothelial carcinoma.

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Conflict of interest statement

Declarations. Competing interests: SB, FC and ST are employees of Bristol Myers Squibb, who develop and market immunotherapies for the treatment of MIUC. JC was an employee of VYOO, a contract research organisation which received funding from Bristol Myers Squibb for carrying out this study. CK and LN are employees of RTI Health Solutions, a contract research organisation which received funding from Bristol Myers Squibb for carrying out this study. JB, SN and MR report consultancy fees from Bristol Myers Squibb in the context of this study. In addition, JB reports honoraria from Bristol Myers Squibb, Roche and MSD and grant (institution) from Bristol Myers Squibb. SN reports research funding (institution) from Pfizer and Ipsen and honoraria from Bristol Myers Squibb, Pfizer, Ipsen, Eisaï and Merck Sharpe and Dohme. MR reports serving on advisory boards for Astellas, Bristol Myers Squibb and Pfizer.

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