42 Incremental Economic Burden Associated With Major Bleeding among Atrial Fibrillation Patients Treated With Factor Xa Inhibitors

Abstract

Clinical trials have demonstrated that factor Xa (FXa) inhibitors are efficacious for reducing stroke and systemic embolism risk among patients with nonvalvular atrial fibrillation (AF). However, bleeding risk remains a concern and it is important to understand the magnitude of the burden of major bleeding (MB) events to better define the optimal continuum of care for AF patients treated with FXa inhibitors. The objectives of this study were to evaluate the health care resource utilization and costs incurred during, as well as following hospitalization for MB among AF patients treated with FXa inhibitors. Patients with an AF diagnosis and hospitalization for MB (index event), based on ICD-9-CM codes, were identified from the MarketScan Commercial and Medicare databases (1/1/2011-12/31/2014). Patients were required to have received ≥1 prescription for apixaban or rivaroxaban (FXa inhibitors) within 3 months prior to hospitalization for MB. AF patients treated with FXa inhibitors, but did not have any diagnosis of MB during the study period were identified and grouped as AF patients without MB. Random dates between the first and last prescription date of FXa inhibitor prescriptions were used as index dates for those without MB. Patient characteristics were evaluated during the 6-month period prior to the index date. Health care resource utilization and associated costs, measured as reimbursed payment amounts, were evaluated for inpatient and outpatient services and outpatient prescription claims, and compared between AF patients with and without MB. Of the overall patients with AF treated with FXa inhibitors, 3,090 (3.3%) were hospitalized for MB and 89,868 were not. Mean age was higher for patients with MB versus without MB (74.3 versus 70.0 years, p<0.001), as were mean Charlson Comorbidity Index score (3.2 versus 1.7, p<0.001), CHADS2 score (2.4 versus 1.8, p<0.001), CHADS-VASc score (4.0 versus 3.2, p<0.001), and HAS-BLED score (2.2 versus 1.6, p<0.001). Among AF patients with MB, 86.0% were previously treated with rivaroxaban and 14.4% with apixaban; among those with no MB, 72.5% were treated with rivaroxaban and 23.8% with apixaban. The mean total cost for index MB hospitalization was $28,054. Within 30 days of the index event, mean total all-cause healthcare costs were significantly greater for patients with MB versus without MB ($24,656 versus $14,352, p<0.001), with hospitalization costs ($9,363 versus $4,571, p<0.001) and outpatient medical service costs ($13,105 versus $7,336) both being higher for AF patients with MB. Bleeding-related hospitalization ($4,342 versus $145, p<0.001) and outpatient medical service costs ($1,841 versus $119, p<0.001) were significantly higher for patients with MB versus without MB within 30 days of the index date. Total health care costs for all causes remained higher during the 12 months of follow-up for AF patients with MB versus without MB ($63,967 versus $37,916, p<0.001). In the real-world setting, 3.3% of AF patients treated with FXa inhibitors experience a hospitalization for MB. The cost of hospitalizations for MB is substantial and the incremental burden of total health care costs within one year following MB hospitalization is high. Approaches to better manage the continuum of care of AF patients with MB may allow for savings in health care resource utilization and associated costs.