Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy
Authors: Divyah Nagendra, Nathanael Koelper, Sandra E. Loza-Avalos, Sarita Sonalkar, Melissa Chen, Jessica Atrio, Courtney A. Schreiber, Heidi S. Harvie
Journal: JAMA Network Open (2020)

<h3>Importance</h3> 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. <h3>Objective</h3> To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States. <h3>Design, Setting, and Participants</h3> 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. <h3>Interventions</h3> Mifepristone pretreatment plus misoprostol administration vs misoprostol alone. <h3>Main Outcomes and Measures</h3> 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. <h3>Results</h3> 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];<i>P</i> = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41];<i>P</i> = .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];<i>P</i> = .001) and a higher completion rate after first treatment (83.8% vs 67.1%;<i>P</i> &lt; .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, −$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingness-to-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively. <h3>Conclusions and Relevance</h3> This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone. <h3>Trial Registration</h3> ClinicalTrials.gov Identifier:NCT02012491