Trends in Mifepristone Dispensing in the United States: 2016–2023

Background: Use of mifepristone, a progesterone antagonist used for termination of early pregnancy, may have been recently impacted by clinical recommendations, judicial decisions, and changes to the U.S. Food and Drug Administration’s Risk Evaluation and Mitigation Strategies (REMS) program.

Objectives: To examine trends in mifepristone dispensing over time and by indication from January 2016 through June 2023 in a large, U.S.-based administrative claims database.

Methods: Within the Optum Research Database, we examined the frequency of mifepristone dispensing relative to the following events: 1) the American College of Obstetricians and Gynecologists (ACOG) recommendation to use of mifepristone in conjunction with misoprostol for management of early pregnancy loss (June 2018); 2) the U.S. Supreme Court ruling in Dobbs v. Jackson Women’s Health Organization that there is no constitutional right to abortion (June 2022); and 3) the modification of the REMS to allow mifepristone to be dispensed from retail pharmacies (January 2023). We created the following analytic time periods: 1) January 2016–May 2018 (baseline); 2) June 2018–May 2022 (ACOG); 3) June 2022–December 2022 (Dobbs); and 4) January 2023–June 2023 (REMS). We also examined dispensings by indications for mifepristone (i.e., induced abortion, missed abortion, Cushing’s syndrome, uterine fibroids, and emergency contraception) based on presence of a diagnosis or procedure code on the same claim as the mifepristone dispensing. We present data as counts or proportions or as mean rates of dispensings per 30 days (Rx/30d) standardized per 10,000,000 women aged 12-50 years enrolled during the period of interest.

Results: We identified 18,878 mifepristone dispensings during the study period, of which nearly 90% were associated with a diagnosis code for induced abortion. The rate of dispensing was lowest in the baseline period (257 Rx/30d) and increased 6% (273 Rx/30d), 199% (769 Rx/30d), and 289% (999 Rx/30d) compared to baseline in the ACOG, Dobbs, and REMS periods, respectively. While the rate of dispensing increased over time for all indications, the largest increase was observed for dispensings associated with a code for missed abortion, for which the rate increased 328% (12.4 Rx/30d), 2,310% (69.9 Rx/30d), and 2,700% (81.2 Rx/30d) in the ACOG, Dobbs, and REMS periods, respectively, relative to baseline (2.9 Rx/30d). The increases for induced abortion relative to baseline (242 Rx/30d) were 0% (241 Rx/30d), 164% (638 Rx/30d), and 248% (842 Rx/30d), respectively.

Conclusions: The rate of mifepristone dispensing in the U.S. increased between 2016 and 2023, with increases observed after each event of interest and among all indications for mifepristone.