Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia.
Department of Obstetrics and Gynecology, University of California, Davis, Sacramento.
JAMA Netw Open. 2020 Mar 2;3(3):e201594. doi: 10.1001/jamanetworkopen.2020.1594.
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.
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.
Mifepristone pretreatment plus misoprostol administration vs misoprostol alone.
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.
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, -$5 111 629 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.
This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone.
ClinicalTrials.gov Identifier: NCT02012491.
早期妊娠丢失（EPL）是妊娠最常见的并发症。一项多中心随机临床试验比较了两种医学管理策略，发现米非司酮预处理比单独使用米索前列醇的标准治疗方法更有效 25%。米非司酮的成本可能是实施该方案的一个障碍。
评估在美国使用米非司酮预处理加米索前列醇与单独使用米索前列醇治疗 EPL 的成本效益。
设计、地点和参与者：这是一项同时进行的前瞻性经济评估，于 2014 年 5 月 1 日至 2017 年 4 月 30 日在 3 个美国地点进行了一项随机临床试验。参与者包括 300 名胚胎发育或胚胎或胎儿死亡的女性。从医疗保健部门和社会角度计算了成本效益，时间范围为 30 天。数据分析于 2018 年 7 月 1 日至 2019 年 7 月 3 日进行。
米非司酮预处理加米索前列醇给药与单独使用米索前列醇。
2018 年美元成本、质量调整生命年（QALY）的有效性和治疗效果。计算了米非司酮和米索前列醇与单独使用米索前列醇的增量成本效益比（ICER），并生成了成本效益可接受性曲线。
在随机临床试验中纳入的 300 名女性中（平均[SD]年龄，30.4[6.2]岁），从医疗保健部门的角度来看，接受米非司酮预处理和单独使用米索前列醇的两组的平均成本相似（696.75 美元[95%CI，591.88 美元-801.62 美元]与 690.88 美元[95%CI，562.38 美元-819.38 美元]；P=0.94）和社会视角（3846.30 美元[95%CI，2783.01 美元-4909.58 美元]与 4845.62 美元[95%CI，3186.84 美元-6504.41 美元]；P=0.32）。米非司酮预处理组的 QALY 更高（0.0820 [95%CI，0.0815-0.0825]与 0.0806 [95%CI，0.0800-0.0812]；P=0.001），且第一次治疗后的完成率更高（83.8%与 67.1%；P<0.001），而单独使用米索前列醇组。从医疗保健部门的角度来看，米非司酮预处理与单独使用米索前列醇相比具有成本效益，其增量成本效益比为 4225.43 美元（95%CI，-195053.30 美元至 367625.10 美元）每获得一个质量调整生命年。从社会角度来看，米非司酮预处理优于单独使用米索前列醇（95%CI，-5111629 美元至 1801384 美元）。在从医疗保健部门和社会角度愿意支付每获得一个质量调整生命年 150000 美元的情况下，米非司酮预处理与单独使用米索前列醇相比具有成本效益的概率分别约为 90%和 80%。
这项研究发现，与单独使用米索前列醇相比，使用米非司酮预处理治疗 EPL 的成本效益更高。
ClinicalTrials.gov 标识符：NCT02012491。
