OBJECTIVES: United States (US) pre-adjudicated medical and institutional administrative claims are processed through large clearinghouses that contain large amounts of near real-time patient-level data across insurers. Our objective was to evaluate the utility of a pre-adjudicated, “payor agnostic” (open-source) commercial insurance claims database for active pharmaco-surveillance of rare adverse events of special interest (AESI).

METHODS: Using an open-source Observational Health Data Sciences and Informatics (OHDSI) R package, we compared age and sex stratified background incidence rates for eight AESI’s from 2017-2019 in IQVIA OpenClaims data to published data from a US adjudicated claims database and a US EHR database. We also calculated months until sample size achieved 80% power across relative risk (RR) thresholds (2.00, 1.50, and 1.25) for each of the AESIs.

RESULTS: Compared to the claims and EHR databases, OpenClaims had generally lower background rates for AESIs across age groups, most notably for the older age groups. Overall, time to statistical (80%) power was shorter for OpenClaims data for all tested RR thresholds compared to the other databases, with the greatest differences for more rare outcomes like Guillian-Barre syndrome (RR=1.25: 3.4 months sooner than claims and 2.2 months sooner than EHR) and encephalomyelitis (RR=1.25: 1.8 months sooner than claims and 1.4 months sooner than EHR). When looking across age groups and AESIs, OpenClaims had shorter times to statistical power for the youngest (0-5, 6-17 years old) and oldest age groups (65-74, 75-84 years old); differences in time were not as large for RR of 2.0.

CONCLUSIONS: Pre-adjudicated, open-source medical claims data would capture statistically significant increases in the rate of rare AESI’s versus background rates faster than other large claims or EHR databases. With its expansive data and shorter claims processing delays, using IQVIA’s OpenClaims in active pharmaco-surveillance may increase the efficiency of signal detection of rare outcomes.