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

Abstract

Aim

To evaluate the cost-effectiveness of adjuvant nivolumab compared with surveillance for the treatment of patients with high-risk muscle-invasive urothelial carcinoma (MIUC) after radical resection from a US healthcare payer perspective and to investigate the impact of alternative modeling approaches on the cost-effectiveness results.

Material and methods

A four-state, semi-Markov model consisting of disease free, local recurrence, distant recurrence, and death health states was developed to investigate the cost-effectiveness of nivolumab compared with surveillance over a 30-year time horizon. The model used data from the randomized CheckMate 274 trial (NCT02632409) and published literature to inform transitions among health states, and inputs on cost, utility, adverse event, and disease management. Scenario analyses were conducted to investigate the impact of model structure and key assumptions on the results. One-way deterministic and probabilistic sensitivity analysis were conducted to investigate the robustness of the results.

Results

Total expected costs were higher with nivolumab ($162,278) compared with surveillance ($63,027). Nivolumab was associated with improved survival (1.61 life-years gained compared with surveillance) and an incremental gain of 0.98 quality-adjusted life-years (QALYs). Although total treatment costs were higher for nivolumab, cost offsets were observed because of delayed or avoided recurrences and deaths experienced with nivolumab compared with observation. The incremental cost-effectiveness and cost-utility ratios were $61,462/life-year and $100,930/QALY.

Limitations

At the time of analysis, CheckMate 274 had limited follow-up on disease-free survival and no overall survival data. The limited evidence necessitated assumptions on modeling survival after each type of recurrence.

Conclusions

Nivolumab is estimated to be a life-extending and cost-effective option for adjuvant treatment of MIUC for patients who are at high risk of recurrence after undergoing radical resection in the United States. Using a threshold of $150,000/QALY, the cost-effectiveness conclusions remained consistent across the scenario and sensitivity analyses conducted.

Keywords:

• Adjuvant treatment
• incremental cost-effectiveness ratio
• incremental cost-utility ratio
• muscle-invasive urothelial carcinoma
• nivolumab
• decision analysis
• Markov model

JEL CLASSIFICATION CODES:

• C10
• C1
• C
• C18

This article is related to:

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

Transparency

     

Declaration of financial/other interests

ST, MK, and MYP are employees of Bristol Myers Squibb (BMS); TP was an employee of BMS at the time of the study. THB, CK, and FK are employees of RTI Health Solutions, which received payment from Bristol Myers Squibb for contracted analyses. SP received personal payment from Bristol Myers Squibb for attendance at an advisory board meeting.

Author contributions

All authors contributed to the study design. ST, FK, and THB performed the analysis. ST and THB developed the first draft of the manuscript. All authors reviewed and contributed critical revisions to the manuscript. All authors agree to be held accountable for the manuscript content and approve the final version for publication.

Acknowledgements

Bristol Myers Squibb (Princeton, NJ, USA) and Ono Pharmaceutical Company Ltd. (Osaka, Japan). Editorial assistance was provided by Parexel, funded by Bristol Myers Squibb.

Data availability statement

Data are available upon reasonable request. Bristol Myers Squibb’s policy on data sharing may be found online at https://www.bms.com/researchers-and-partners/independent-research/data-sharing-request-process.html.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Previous presentation

A version of this analysis was previously presented at Virtual ISPOR, May 15–18, 2022.

Additional information

Funding

This study was sponsored by Bristol Myers Squibb.