Oral misoprostol tablets (25 µg) for induction of labor: a targeted literature review and cost analysis

Abstract

Background

Various methods exist for the induction of labor (IOL), and there is limited consensus as to optimal methods. Off-label misoprostol is recommended by the World Health Organization (WHO) for IOL but preparing it into doses suitable for IOL lacks precision, with potential adverse outcomes if dosing is inaccurate. This study explores potential outcomes and costs associated with increased uptake of a low-dose (25 µg) oral misoprostol formulation (Angusta; Norgine BV, Amsterdam) approved for IOL, in France, Belgium, and the Netherlands.

Methods

A literature review was undertaken to derive probabilities of delivery outcomes (vaginal, instrumental, and cesarean sections) for IOL methods, from published meta-analyses. Outcomes for oral misoprostol tablets (25 µg) were unavailable in the meta-analyses, so were estimated using data from two published retrospective cohort studies. A model was developed to predict the frequency of IOL outcomes and associated costs at the national level, across multiple scenarios. Scenarios were tested using a moderate, medium, and high increase in oral misoprostol tablet (25 µg) uptake. Market shares, costs, and induction rates were defined for each country using multiple data sources.

Results

Increased uptake of oral misoprostol tablets (25 µg) was estimated to be associated with a slightly increased rate of routine vaginal deliveries, and concurrent decreases in instrumental vaginal deliveries and cesarean sections. Since routine vaginal deliveries are less costly than other delivery outcomes, increased uptake of oral misoprostol tablets (25 µg) within the IOL market has the potential to be cost-saving. These trends were predicted using 25 µg oral misoprostol tablet outcomes informed by both retrospective studies.

Conclusion

Preliminary outcomes suggest that oral misoprostol tablets at 25 µg per dose may improve outcomes in IOL and be cost-saving. Further study is required to validate these findings and assess the comparative efficacy of IOL methods, including oral misoprostol tablets (25 µg).

Keywords:

• Induction of labor
• misoprostol
• oral misoprostol
• obstetrics
• costs

JEL CLASSIFICATION CODES:

• I00
• I
• A10
• A1
• A

Transparency

Declaration of funding

This study was supported by Norgine Ltd.

Declaration of financial/other relationships

A.C.P. is an employee of Norgine Ltd. K.P. is an employee of Health Economics and Outcomes Research Ltd., which received fees from Norgine in relation to this study and development of the manuscript. R.H. received consulting fees from Norgine Ltd. for this article and reports no other potential conflict of interest relevant to this work. F.P. received consulting fees from Norgine Ltd. for this article, has received consulting fees from Roche Diagnostics France, and reports no other potential conflict of interest relevant to this work. R.D. received consulting fees from Norgine Ltd. for this article, has received research grants from Ferring and consulting fees from Metagenics, and reports no other potential conflict of interest relevant to this work.

Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.

Author contributions

All authors: study conception and design. KP: analysis of data. All authors: interpretation of data. K.P. and A.C.P.: drafting of the manuscript. All authors: critical revision of the manuscript and final approval of the manuscript. All authors agree to be accountable for all aspects of the work.

Acknowledgements

Editorial assistance was provided by Jo Whelan of Health Economics and Outcomes Research Ltd., funded by Norgine.