IMPORTANCE Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen. OBJECTIVE To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States. DESIGN, SETTING, AND PARTICIPANTS This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019. INTERVENTIONS Mifepristone pretreatment plus misoprostol administration vs misoprostol alone. MAIN OUTCOMES AND MEASURES Costs in 2018 US dollars, effectiveness in quality-adjusted lifeyears (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated. RESULTS Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4

INTRODUCTION: To compare the cost effectiveness of pretreatment with mifepristone to misoprostol alone in women seeking medical management of nonviable early pregnancy. METHODS: This within-trial comparison included 300 women with anembryonic gestation or embryonic/fetal demise randomized to off-label misoprostol 800 mcg vaginally or off-label mifepristone 200 mg followed 24 hours later by misoprostol. The primary outcome was gestational sac expulsion with one dose of misoprostol. Both healthcare and societal sector perspectives were adopted to calculate the incremental cost effectiveness ratio (ICER), expressed as cost per quality-adjusted life-year (QALY) gained. Costs included medical treatment and complications, patient and caregiver time, transportation, and lost productivity over the 30-day study period. Results are in 2018 US dollars. QALYs were based on a modified utility score, with successful medical therapy defined as 1 and need for uterine aspiration defined as 0.95. This study was approved by the University of Pennsylvania Institutional Review Board. RESULTS: Complete expulsion rate after one misoprostol dose was 124/148 (83.8%) with mifepristone pretreatment versus 100/149 (67.1%) after misoprostol alone. Uterine aspiration was required for 13 (8.8%) women after mifepristone pretreatment and 35 (23.5%) women after misoprostol alone. In the healthcare sector analysis mifepristone pretreatment was less expensive ($657 vs. $658 mean per-person cost) and more effective (0.08 vs. 0.07 QALYs gained) than misoprostol alone. Analysis from the societal perspective again demonstrated that mifepristone pretreatment was both less expensive ($3,807 vs. $4,819) and more effective than misoprostol alone. CONCLUSION: Pretreatment with mifepristone is the economically dominant strategy as it is both cost saving and more effective.

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