(360) Real-World Clinical Outcomes and Disease Management Costs among High-Risk Non-Muscle Invasive Bladder Cancer Patients Treated with Bacillus Calmette-Guérin: A SEER-Medicare Analysis

Background: : High-risk (HR) non–muscle invasive bladder cancer (NMIBC) is typically managed with transurethral resection of the bladder tumor followed by Bacillus Calmette-Guérin (BCG), with novel treatments under investigation. Understanding the clinical outcomes and associated disease management costs (DMC) under current standard of care is essential for guiding the adoption of emerging treatments.

Objective: : To estimate real-world recurrence, survival, post-recurrence cystectomy, and DMC among HR-NMIBC patients treated with BCG.

Methods: : Adult patients with HR-NMIBC who received BCG were identified using SEER-Medicare data (2007–2020). Recurrence was categorized as NMIBC recurrence, muscle-invasive bladder cancer (MIBC) progression, and distant metastasis (DM) based on diagnosis and treatment records. Recurrence-free survival (RFS; from BCG initiation to any recurrence or all-cause death) and overall survival (OS; from BCG initiation to all-cause death) were assessed via Kaplan-Meier analysis. Post-recurrence cystectomy was described. Bladder cancer-related DMC by health state (excluding costs of procedures, pharmacological treatments and adverse events) were summarized: recurrence-free (RF; in years 1–2, 3–5 and 6+), NMIBC recurrence, MIBC progression, and terminal care (30 days before death). Radical and partial cystectomy costs were also estimated.

Results: : A total of 5,490 patients (median follow-up: 2.9 years) were included in this study, with a median age of 76 years, 80% male, and 91% White. Approximately 40% of patients experienced recurrence (1,528 NMIBC recurrence; 372 MIBC progression; 278 DM) and additional 14% died. Median RFS and OS were 2.8 (95% CI: 2.7–3.1) years and 8.2 (95% CI: 7.9–8.9) years, respectively. Among those with recurrence, 14% underwent cystectomy. Mean (standard deviation [SD]) monthly DMC substantially increased from NMIBC recurrence ($378 [1,167]) to MIBC progression ($1,195 [2,789]); in contrast, the costs declined over time in the RF state ($286 [939] in years 1–2, $171 [1,058] in years 3–5, and $105 [472] in years 6+). Mean (SD) costs per procedure for radical and partial cystectomy were $18,985 (15,463) and $15,367 (11,896), respectively. Terminal care costs were $2,823 (7,466).

Conclusions: : Patients with HR-NMIBC experienced high rates of recurrence with significant proportion undergoing subsequent cystectomy. Disease recurrence was associated with substantial economic burden, which increased with the stage of recurrence. Novel treatments that delay recurrence may help reduce the clinical and economic burden for patients with HR-NMIBC.

Sponsorship:: Merck & Co., Inc.