Descriptive Analysis of Idarucizumab (Praxbind^®) Use in a National Hospital Database

Study Objectives:

Based on clinical data including the REVERSE AD study, idarucizumab (Praxbind^®), the first reversal agent specific for dabigatran (Pradaxa^®) users, received approval for indications of life threatening bleeding and emergency surgery/urgent procedures in patients treated with dabigatran when reversal of the anticoagulant effects of dabigatran is needed. The objectives of this analysis were to identify the number of idarucizumab encounters in a large national hospital database; describe indications and patient characteristics of those encounters; and, extrapolate the number of national uses.

Methods:

This is a retrospective analysis of the Premier Healthcare Database (PHD) among adult patients (age >18 years) with a hospital encounter between October 16, 2015 and September 30, 2016 and a billing charge for idarucizumab. For this analysis, idarucizumab indication was defined using ICD 9 and 10 diagnosis and procedures codes and Admission Type from the CMS UB04 Billing Form. Life threatening bleed was defined as intracranial hemorrhage or gastrointestinal bleed with admission type of emergent, urgent, or trauma; Emergency Surgery/Urgent Procedure was defined as procedure on the day of or day after admission with admission type of emergent, urgent, or trauma. Categorical variables were presented as counts and percentages (N, %) and continuous variables were summarized as means (standard deviations), medians and interquartiles. National volume projections were estimated using Premier's proprietary methodology that includes weighting according to hospital characteristics.

Results:

During the identification period, there were 558 encounters requiring idarucizumab. The mean patient age at encounter was 76 years (± 12), 53% were male, 88% were white, and the mean Charlson Comorbidity Index score was 2.4 (± 2.2). Among 494 patients, 60% were admitted with a life threatening bleed, 36% with an emergency surgery/urgent procedure and 4% fit both indication definitions; 64 (12%) could not be categorized. Among those admitted with life threatening bleeds, 61% were gastrointestinal and 36% were intracranial. The most common emergency surgery/urgent procedures were gastrointestinal surgeries for inspection, resection, excision, and/or repair (21%), bone repositioning (8%), drainage/repair of anatomical site (7%), joint replacement (7%) and hepatobiliary system/pancreas resection (6%). Overall, ninety-six percent of the initial dose administered was according to the label (5g/100mL). The estimated number of idarucizumab administrations nationally over the 1-year period was 2,225.

Conclusion:

This is the first real world descriptive analysis to characterize the utilization of idarucizumab in U.S. hospitals. From this analysis, withstanding the limitation of a retrospective analysis, the pattern of use for idarucizumb is consistent with what was observed in the REVERSE AD clinical trial. Further study is required to understand the implications of use on clinical and economic outcomes in a real-world setting.