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Statins, Tumor Necrosis Factor (TNF) Alpha Inhibitors, Granulocyte Colony Stimulating Factors, Intravenous (IV) Iron, Beta Blockers, and Angiotensin-Converting Enzyme (ACE) Inhibitors & Utilization

    Basic Details
    Last Updated
    Friday, March 15, 2024
    Original Posting Date
    Health Outcome(s)
    Drug Use
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    Regulatory Determination / Use

    In an earlier FDA study of intravenous (IV) iron products, differences in the market share of specific IV iron products were detected between patient-level administrative claims data from Sentinel and national manufacturer sales data. To examine whether the differences were due to challenges in estimating utilization for products with a non-oral route of administration, such as those involving injections, FDA assessed the agreement between data sources and utilization metrics by evaluating market share for selected drug classes. Six classes of drugs were selected, three orally administered drugs and three drugs with more complicated routes of administration. The study included data from January 1, 2011 to December 31, 2015. Agreement between patient-level data and national manufacturer sales data varied across different metrics, in part driven by product characteristics. The study helped FDA staff to understand the importance of comparing different utilization metrics when assessing medication use across multiple data sources and selecting the utilization metric that best aligns with how products are used and what is intended to be measured.