Abstract
Background and objectives: Demand for assisted reproduction technology (ART) in Germany is high, with 100,844 treatment cycles during 2016. Many ART procedures involve ovarian stimulation with follicle stimulating hormone (FSH). Recently, biosimilar FSH products have become available. The objective of this study was to evaluate the cost-effectiveness of the recombinant FSH Gonal-f® (Originator) in comparison to biosimilar follitropin alfa, Bemfola® (Biosimilar 1) and Ovaleap® (Biosimilar 2), from a German payer perspective in terms of cost per live birth.
Methods: A decision tree model was developed, based on one cycle of assisted reproduction, to compare the original product to biosimilars. Clinical inputs, including live birth rates and adverse event rates were obtained from published randomized trials. Cost inputs were obtained from publicly available German sources. Clinical inputs, model structure and methodology were based on previous publications and validated by a clinical expert.
Results: Results indicated that the live birth rate is higher for the Originator compared to Biosimilar 1 (40.7% vs 32.1% respectively), and Biosimilar 2 (32.2% vs 26.8%). The average cost per live birth for women treated with the Originator was estimated to be lower than those who were treated with biosimilars: Originator vs Biosimilar 1 (€10,510 vs €12,192), Originator vs Biosimilar 2 (€12,590 vs €13,606). The analysis also found that the Originator is associated with an incremental cost-effectiveness of €4,168 and €7,540 per additional live birth versus Biosimilar 1 and Biosimilar 2 respectively. Sensitivity analysis indicated probabilities of pregnancy, embryo transfer and live birth, were key drivers of model costs. Scenario analysis confirmed the robustness of the model outcomes.
Conclusion: This study suggests that treatment with the Originator could result in a lower cost per live birth in comparison to biosimilars. Further analysis using real-world data, when available, is recommended to validate the results of the present study.
Acknowledgment
This study was financially supported by Merck KGaA.
Author contributions
WX, AL and EF were responsible for the creation of study documents, data analysis, data interpretation, and writing of the manuscript. All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.
Disclosure
WX, AL and EF are employees of IQVIA, London, UK and CR and RP are employees of Merck KGaA. KB has received honoraria from Merck. WX reports personal fees from MSD, Teva, and Ferring, during the conduct of the study; AL reports grants from Merck KGaA, during the conduct of the study; grants from Merck Inc, Ferring, and Teva, outside the submitted work; EF reports personal fees from Merck KGaA, during the conduct of this study; CR is a consultant for Merck. The authors report no other conflicts of interest in this work.