Rates of genetic testing in patients prescribed drugs with pharmacogenomic information in FDA-approved labeling

Pharmacogenomics J. 2021 Jun;21(3):318-325. doi: 10.1038/s41397-021-00211-1. Epub 2021 Feb 15.

Abstract

This study examined rates of genetic testing in two cohorts of publicly insured individuals who have newly prescribed medication with FDA pharmacogenomic labeling guidance. Genetic testing was rare (4.4% and 10.5% in Medicaid and Medicare cohorts, respectively) despite the fact that all participants selected were taking medications that contained pharmacogenomic labeling information. When testing was conducted it was typically done before the initial use of a target medication. Factors that emerged as predictors of the likelihood of undergoing genetic testing included White ethnicity (vs. Black), female gender, and age. Cost analyses indicated higher expenditures in groups receiving genetic testing vs. matched comparators with no genetic testing, as well as disparities between proactively and reactively tested groups (albeit in opposite directions across cohorts). Results are discussed in terms of the possible reasons for the low base rate of testing, mechanisms of increased cost, and barriers to dissemination and implementation of these tests.

MeSH terms

  • Adult
  • Age Factors
  • Aged
  • Black People
  • Cohort Studies
  • Costs and Cost Analysis
  • Databases, Factual
  • Drug Approval
  • Drug Labeling / economics
  • Drug Labeling / standards*
  • Ethnicity
  • Female
  • Humans
  • Male
  • Medicaid
  • Medicare
  • Middle Aged
  • Mississippi
  • Pharmacogenetics / economics
  • Pharmacogenetics / statistics & numerical data*
  • Pharmacogenomic Testing / economics
  • Pharmacogenomic Testing / statistics & numerical data*
  • Prescription Drugs
  • Sex Factors
  • United States
  • United States Food and Drug Administration
  • White People

Substances

  • Prescription Drugs