Abstract

363 Background: Limited information on costs related to incident AEs in pts with aUC in the real-world setting is available. Methods: Pts with aUC treated with 1L systemic therapy (94% chemotherapy, 6% immune checkpoint inhibitor) between 1/2012-9/2017 (first therapy administration defined the index date) were identified using IQVIA Real-World Data Adjudicated Claims – US database. Pts with continuous enrollment for ≥6 months pre- and ≥3 months post-index and ≥1 UC diagnosis code were included. Proportions of pts with febrile neutropenia (FN), dehydration, acute kidney injury (AKI), sepsis, colitis, hepatitis, adrenal insufficiency, and pneumonitis (select AEs), and per-pt-per month (PPPM) healthcare costs were assessed. Incident AEs during 1L therapy were identified using outpatient/inpatient claims and a subgroup of severe AEs (identified using only inpatient claims) was analyzed separately. Incremental costs of AEs were calculated as cost differences (CDs) between pts with and without AEs using multivariate linear regression to adjust for baseline differences. Results: Pts with (n = 666) and without (n = 569) select AEs had similar median age of 62 years; pts with select AE had more women (34.4% vs. 29.0%) and chemotherapy-treated pts than pts without select AEs (96.1% vs. 91.0%) (both p < 0.05). Baseline characteristics were similar in pts with (n = 290) and without (n = 1,290) severe AEs. FN (28.0%; severe 6.3%), dehydration (26.5%; severe 8.3%), AKI (11.3%; severe 8.8%), and sepsis (8.8%; severe 8.0%) occurred most frequently during 1L therapy (median duration: 15 weeks). Adjusted PPPM CDs between pts with and without AEs were $1,716 overall and $6,130 for severe AEs, with the greatest CDs observed for pneumonitis ($14,400; severe $20,242), sepsis ($8,581; severe $9,490) and AKI ($7,977; severe $8,843) (all p < 0.05). Inpatient costs had the largest impact on CDs. Conclusions: Costs of AEs, especially severe, during 1L treatment of aUC can cause substantial burden to healthcare system. Biomarker-based therapy selection, education/awareness early recognition and management of AEs may reduce hospitalizations and healthcare costs, and may impact care quality.

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