Cost-effectiveness analysis of expectant vs active management for treatment of persistent pregnancies of unknown location - 25/04/24

Doi : 10.1016/j.ajog.2024.03.035

Jessica R. Walter, MD ^a,^⁎ , Kurt T. Barnhart, MD, MSCE ^b, Nathanael C. Koelper, MPH ^b, Nanette F. Santoro, MD ^c, Heping Zhang, PhD ^d, Tracey R. Thomas, MPH ^b, Hao Huang, MD ^d, Heidi S. Harvie, MD, MSCE, MBA ^e,^f
On behalf of the
Eunice Kennedy Shriver National Institute of Child Health and Human Development Reproductive Medicine Network
^a Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, Northwestern University, Chicago, IL
^b Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA
^c Divisions of Reproductive Endocrinology and Infertility and Reproductive Sciences, Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO
^d Department of Biostatistics, Yale University School of Public Health, New Haven, CT
^e Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA
^f Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA

^∗Corresponding author: Jessica R. Walter, MD.

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Abstract

Background

Persistent pregnancies of unknown location are defined by abnormally trending serum human chorionic gonadotropin with nondiagnostic ultrasound. There is no consensus on optimal management.

Objective

This study aimed to assess the cost-effectiveness of 3 primary management strategies for persistent pregnancies of unknown location: (1) expectant management, (2) empirical 2-dose methotrexate, and (3) uterine evacuation followed by methotrexate, if indicated.

Study Design

This was a prospective economic evaluation performed concurrently with the Expectant versus Active Management for Treatment of Persistent Pregnancies of Unknown Location multicenter randomized trial that was conducted from July 2014 to June 2019. Participants were randomized 1:1:1 to expectant management, 2-dose methotrexate, or uterine evacuation. The analysis was from the healthcare sector perspective with a 6-week time horizon after randomization. Costs were expressed in 2018 US dollars. Effectiveness was measured in quality-adjusted life years and the rate of salpingectomy. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were generated. Sensitivity analyses were performed to assess the robustness of the analysis.

Results

Methotrexate had the lowest mean cost ($875), followed by expectant management ($1085) and uterine evacuation ($1902) (P=.001). Expectant management had the highest mean quality-adjusted life years (0.1043), followed by methotrexate (0.1031) and uterine evacuation (0.0992) (P=.0001). The salpingectomy rate was higher for expectant management than for methotrexate (9.4% vs 1.2%, respectively; P=.02) and for expectant management than for uterine evacuation (9.4% vs 8.1%, respectively; P=.04). Uterine evacuation, with the highest costs and the lowest quality-adjusted life years, was dominated by both expectant management and methotrexate. In the base case analysis, expectant management was not cost-effective compared with methotrexate at a willingness to pay of $150,000 per quality-adjusted life year given an incremental cost-effectiveness ratio of $175,083 per quality-adjusted life year gained (95% confidence interval, −$1,666,825 to $2,676,375). Threshold analysis demonstrated that methotrexate administration would have to cost $214 (an increase of $16 or 8%) to favor expectant management. Moreover, expectant management would be favorable in lower-risk patient populations with rates of laparoscopic surgical management for ectopic pregnancy not exceeding 4% of pregnancies of unknown location. Based on the cost-effectiveness acceptability curves, the probability of expectant management being cost-effective compared with methotrexate at a willingness to pay of $150,000 per quality-adjusted life year gained was 50%. The results were dependent on the cost of surgical intervention and the expected rate of methotrexate failure.

Conclusion

The management of pregnancies of unknown location with a 2-dose methotrexate protocol may be cost-effective compared with expectant management and uterine evacuation. Although uterine evacuation was dominated, expectant management vs methotrexate results were sensitive to modest changes in treatment costs of both methotrexate and surgical management.

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Key words : cost-effectiveness analysis, early pregnancy, methotrexate, pregnancy of unknown location

Plan

	The authors report no conflict of interest.
	This study was registered on ClinicalTrials.gov (clinical trial identification number: NCT02152696; NCT02152696?term=NCT02152696&rank=1) on May 28, 2014. Initial enrollment was on July 25, 2014.
	This work was supported by the National Institutes of Health (NIH)/Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (grant numbers: U10 HD27049 [to Christos Coutifaris], U10HD077680, U10HD055925 [to H.Z.], U10 HD39005, and U10 HD077844), a General Clinical Research Center grant (grant number: MO1RR10732), and construction grants (grant numbers: C06 RR016499 [to Pennsylvania State University], UL1 TR001863 [to Yale University], and HD076279 [to K.T.B.]). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NICHD or NIH.
	An earlier version of this work was presented at the 77th American Society for Reproductive Medicine Scientific Congress & Expo, Baltimore, MD, October 19, 2021.
	Cite this article as: Walter JR, Barnhart KT, Koelper NC, et al. Cost-effectiveness analysis of expectant vs active management for treatment of persistent pregnancies of unknown location. Am J Obstet Gynecol 2024;XX:x.ex–x.ex.