Comparison of costs incurred by patients treated with adjuvant nivolumab versus placebo for high-risk muscle-invasive urothelial carcinoma.

Abstract

500 Background: The global, phase 3 CheckMate 274 trial showed significant and clinically meaningful benefit of adjuvant nivolumab (NIVO) treatment versus placebo (PBO) in reducing risk of disease recurrence or death in patients with muscle-invasive urothelial carcinoma (MIUC) at a high risk of recurrence after radical cystectomy. The implications of these benefits on costs associated with the treatment are unknown. Here, we estimate and compare per-patient medical and subsequent therapy costs in the United States for patients with high-risk MIUC initiating treatment with adjuvant NIVO or PBO. Methods: This analysis used individual data from all randomized patients for healthcare resources utilized (HCRU) from the CheckMate 274 trial. Medical (inpatient, lab, office visits, procedures, concomitant drugs) and subsequent treatment (surgery, radiotherapy, systemic therapy) resources were included, while the costs of NIVO were not included. US-based unit costs were applied to these resources and were obtained from Healthcare Cost and Utilization Project, Micromedex RED BOOK, and CMS databases, supplemented by inputs from published literature. HCRU was only captured on 2 follow-up visits after discontinuation of study therapy: follow-up 1 occurred approximately 35 days after the last dose or coinciding with the date of discontinuation, and follow-up 2 occurred approximately 80 days after follow-up 1. To align with data captured at follow-up visits, HCRU and related costs were analyzed from randomization to 12 months and 16 months. Costs were adjusted for censoring using the Kaplan–Meier sampling average estimator. Results: Total per-patient costs incurred by the NIVO-treated cohort (n = 353) were 6% lower than the PBO cohort (n = 356) over the 12-month period from randomization ($36K vs $38K) and 13% lower over the 16-month period from randomization ($41K vs $47K) (Table). The NIVO cohort, compared with placebo, had lower subsequent treatment costs ($2K vs $11K over 12 months, and $3K vs $18K over 16 months) despite higher medical costs ($34K vs $27K over 12 months, and $37K vs $29K over 16 months). Conclusions: Patients treated with adjuvant NIVO incurred lower total costs versus PBO, with the differential increasing over time. The slightly higher medical costs incurred by the NIVO cohort were offset by the substantially lower subsequent therapy costs. [Table: see text]