Abstract
Aim
To assess, from a United States (US) payer’s perspective, the cost-effectiveness of gels designed to separate the endometrial surfaces (intrauterine spacers) placed following intrauterine surgery.
Materials and methods
A decision tree model was developed to estimate the cost-effectiveness of intrauterine spacers used to facilitate endometrial repair and prevent the formation (primary prevention) and reformation (secondary prevention) of intrauterine adhesions (IUAs) and associated pregnancy- and birth-related adverse outcomes. Event rates and costs were extrapolated from data available in the existing literature. Sensitivity analyses were conducted to corroborate the base case results.
Results
In this model, using intrauterine spacers for adhesion prevention led to net cost savings for US payers of $2,905 per patient over a 3.5-year time horizon. These savings were driven by the direct benefit of preventing procedures associated with IUA formation ($2,162 net savings) and the indirect benefit of preventing pregnancy-related complications often associated with IUA formation ($3,002). These factors offset the incremental cost of intrauterine spacer use of $1,539 based on an assumed price of $1,800 and the related increase in normal deliveries of $931. Model outcomes were sensitive to the probability of preterm and normal deliveries. Budget impact analyses show overall cost savings of $19.96 per initial member within a US healthcare plan, translating to $20 million over a 5-year time horizon for a one-million-member plan.
Limitations
There are no available data on the effects of intrauterine spacers or IUAs on patients’ quality of life. Resultingly, the model could not evaluate patients’ utility related to treatment with or without intrauterine spacers and instead focused on costs and events avoided.
Conclusion
This analysis robustly demonstrated that intrauterine spacers would be cost-saving to healthcare payers, including both per-patient and per-plan member, through a reduction in IUAs and improvements to patients’ pregnancy-related outcomes.
PLAIN LANGUAGE SUMMARY
Every year, women in the United States (US) undergo surgery to treat intrauterine abnormalities to maintain or improve the uterus’ ability to support fetal development and result in a term delivery. Despite the benefits of these procedures, damage caused to the endometrium (uterine lining) is associated with a risk of adherence of the endometrial cavity surfaces with scar tissue known as intrauterine adhesions (IUAs).
Damage to the endometrium and the resulting IUAs may be associated with infertility, light or absent menstruation, pregnancy loss, and other pregnancy-related complications. Treating these conditions within the US healthcare system consumes resources and adds costs for healthcare payers (public and private insurance providers).
To facilitate endometrial repair and to reduce or prevent IUAs, researchers have developed materials to place within the endometrial cavity following surgery to separate the endometrial surfaces during the early healing period. These intrauterine “spacers” are intended to improve patients’ subsequent clinical outcomes and save money for healthcare payers. It is unknown whether these improved clinical outcomes offset the cost of the routine use of spacers following “at-risk” procedures that involve the endometrial cavity.
We developed a model designed to determine the cost-effectiveness of an intrauterine spacer by quantifying improvements in clinical outcomes and the resultant cost savings for patients undergoing uterine surgeries with or without spacers. Our model predicted that routinely using such spacers following at-risk procedures would improve patient outcomes and reduce costs to US payers.
Declaration of funding
This study was funded by Rejoni Inc., Bedford, Massachusetts, USA, who commissioned Axtria Inc. to work with MGM and other physician subject matter experts to review the literature, design, and develop the model described herein.
Declaration of financial/other relationships
DS, CM, AM, AKJ, LS, WCL, and JK are paid employees of Axtria Inc. MGM and IF are consultants for Rejoni Inc.
Author contributions
All authors participated in the design of this study. The analysis was performed by DS, CM, AM, AKJ, LS, and JK. The writing for this manuscript was reviewed and edited by all authors. All authors approve this as the final version of the manuscript to be published and agree to be accountable for all aspects of the work.
Acknowledgements
No assistance in the preparation of this article is to be declared. This article and the results herein have not been presented at any previous presentations.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Geolocation information
This work was conducted by employees of Axtria Inc., Berkeley Heights, New Jersey, USA, with funding from Rejoni Inc., Bedford, Massachusetts, USA, and is intended for global audiences, focusing on those within the USA.