Follitropin Alpha for assisted reproduction: an analysis based on a non-interventional study in Greece

Abstract

Objective

To conduct an economic evaluation estimating the cost per live birth after controlled ovarian stimulation (COS) using Follitropin Alpha (Gonal-F), in the Greek National Health System setting. A secondary objective was to predict the live birth rateof the In Vitro Fertilization (IVF) procedure.

Methods

A single arm, multi-center, prospective, non-interventional study was conducted on which economic, efficacy and safety data were collected by six of the largest IVF centers. The participants were 350 female patients. Three statistical methods were employed for the analysis of the study outcomes, namely (a) Generalized Linear Modeling for the estimation of the costs of IVF treatment, (b) multivariable logistic regression and (c) an Artificial Neural Network (ANN) model for live birth prediction.

Results

The mean total cost of IVF therapy per patient was estimated at €3728 (95% CI: €3679–€3780), while the total cost per live birth was €14,872 (95% CI: €12,441–€17,951). The live birth rate after 3 complete IVF cycles was estimated at 22.9%, while the percentage of those suffering from OHSS was limited at 0.57%. In logistic regression, the Ovarian Sensitivity Index (OSI) was a factor found to be positively associated with live birth (OR 7.39, 95% CI: 1.84–29.71). For the ANN, important predictors included number of gestational sacs and the duration of infertility.

Conclusion

The present study constitutes the largest single-arm study based on real data in Greece to date. The cost of IVF treatment and the cost per live birth are not insignificant in this NHS setting. The live birth rate, cost per oocyte, and the cost per live birth are in line with literature. OSI was a main contributing factor to the accurate prediction of the live birth rate, while age and BMI were found to be negatively correlated.

Keywords:

• economic evaluation
• Gonal-F
• highly purified human menopausal gonadotropin
• economic analysis

Transparency

Declaration of financial/other relationships

FV and MA received financial support for the authorship of this paper. FV had received consultation fees by Merck Greece in the past. DS and SD are full time employees in Merck Greece. CN, DD, LT, ME, PA and ME (last author) received no financial support for this paper. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

AM wrote the manuscript and analyzed the data. DS and DS reviewed and edited the manuscript. CN, DD, LT, ME, PA contributed to the data collection. ME (last author) conceived, designed and supervised the clinical part of this study as the Principal Investigator. FV wrote the manuscript, analyzed the data, prepared the tables, reviewed and edited the manuscript and is the guarantor of the whole work. All authors listed have reviewed and approved the manuscript for publication.

Acknowledgements

The authors would like to thank the staff of “Merck Healthcare KGaA” for their dedicated involvement in this study. No other assistance in the preparation of this article is to be declared.

Notes

i Gonal-f is a registered trademark of MERCK KGaA, Frankfurter, Darmstadt, Germany.

Additional information

Funding

This study was funded by Merck Greece an affiliate of “Merck Healthcare KGaA” (CrossRef Funder ID: 10.13039/100009945), who participated in the design of the study, in the analysis and interpretation of the data and in the writing of this manuscript.