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PPTA Executive Summary of FDA’s U.S. Immunoglobulin Utilization Study Report

PPTA Executive Summary of FDA’s U.S. Immunoglobulin Utilization Study Report

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The CBER Surveillance Program BEST Initiative recently posted its Assessment of Immune Globulin Utilization in Commercially insured and Medicare Populations study report. The aim of the study is to provide a better picture of the evolution of Ig use over a 10-year longitudinal period in the context of emerging scientific evidence and clinical trends. PPTA developed an Executive Summary of the study report, highlighting key observations, findings, and conclusions.

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Results from the study confirm that Ig use increased between 2009 and 2019, in both the commercially-insured and Medicare populations. Increases were observed in:

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  • the number of Ig administrations
  • the number of enrollees receiving Ig
  • the annual number of administrations per recipient
  • the average aggregate annual dose
  • the average dose per administration (to a lesser extent)

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To read the full Executive Summary, click here.