Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy Secondary Analysis of a Randomized Clinical Trial

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 life-years (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 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815-0.0825] vs 0.0806 [95% CI, 0.0800-0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, -$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, -$5 & x202f;111 & x202f;629 to $1 & x202f;801 & x202f;384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingness-to-pay of $150 & x202f;000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively. Conclusions and Relevance This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone. Question Is pretreatment with mifepristone a cost-effective regimen for the medical management of early pregnancy loss? Findings In this planned economic evaluation including 300 women from a randomized clinical trial, pretreatment with mifepristone plus misoprostol had fewer treatment failures and an incremental cost-effectiveness ratio of $4225.43 per quality-adjusted life year gained in the United States, compared with the standard regimen of misoprostol alone. Meaning These findings suggest that pretreatment with mifepristone is of clinical and economic value when compared with misoprostol alone for the medical management of early pregnancy loss. This economic evaluation assesses the cost-effectiveness of medical management of early pregnancy loss with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States.