PCV58 DEFINING THROMBOEMBOLIC EVENTS USING ADMINISTRATIVE CLAIMS DATA

Abstract

Through the Center for Biologics Evaluation and Research Biologics Effectiveness and Safety (BEST) Initiative, we sought to develop administrative claims-based definitions, referred to as algorithms, to facilitate identification of adverse events potentially associated with exposure to biologic products. The objectives of this study were to (1) develop algorithms for a series of thromboembolic events (TEEs), including pulmonary embolism (PE), deep vein thrombosis (DVT), and acute myocardial infarction (AMI), and (2) determine whether the 2015 transition to the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) affected the frequency of TEE reporting. Authors conducted a literature review using PubMed. Findings were leveraged to develop initial algorithms that were mapped from the International Classification of Diseases, Ninth Revision, Clinical Modification to ICD-10-CM via forward–backward mapping using General Equivalence Mappings. Clinical subject matter experts reviewed draft algorithms. Each algorithm was characterized in the IBM® MarketScan® Research Databases using the IBM MarketScan Treatment Pathways tool. Descriptive statistics, including the annual frequency of diagnosis for each algorithm, were generated for 2014–2017. DVT was the most common TEE, with the annual number of individuals with a relevant diagnosis code ranging from 4.36 to 4.96/1,000 enrolled/year; this was followed by AMI (2.83–3.16 individuals/1,000 enrolled/year) and PE (2.26–2.41 individuals/1,000 enrolled/year). A qualitative assessment of annual reporting frequency suggests that the transition to ICD-10-CM did not substantially affect the proportion of the enrolled population receiving an AMI, DVT, or PE diagnosis. Three new ICD-based TEE algorithms were developed and—though not subject to validation—were applied to generate statistics on the frequency of reporting for each category for 2014–2017. Annual proportions showed no indication that the ICD-10-CM transition meaningfully affected the frequency of TEE reporting. This effort is intended to support subsequent epidemiologic safety and effectiveness studies of biologics.