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Abstract
Background/objective: Although biosimilar drugs may be cheaper to purchase than reference biological products, they may not be the most cost-effective treatment to achieve a desired outcome. The analysis reported here compared the overall costs to achieve live birth using the reference follitropin alfa (GONAL-f) or a biosimilar (Ovaleap) in Spain, Italy and Germany.
Methods: Patient and treatment data was obtained from published sources; assisted-reproductive technology, gonadotropin, follow-up and adverse-event-related costs were calculated from tariffs and reimbursement frameworks for each country. Incremental cost-effectiveness ratios (ICERs) were calculated from the difference in costs between reference and biosimilar in each country, divided by the difference in live-birth rates. Mean cost per live birth was calculated as total costs divided by the live-birth rate.
Results: The published live birth rates were 32.2% (reference) and 26.8% (biosimilar). Drug costs per patient were higher for the reference recombinant human follicle-stimulating hormone in all three countries, with larger cost differences in Germany (€157.38) and Italy (€141.50) than in Spain (€22.41). The ICER for the reference product compared with the biosimilar was €2917.47 in Germany, €415.43 in Spain and €2623.09 in Italy. However, the overall cost per live birth was higher for the biosimilar in all three countries (Germany €8135.04 vs. €9185.34; Italy €8545.22 vs. €9733.37; Spain €14,859.53 vs. €17,767.19). Uncertainty in efficacy, mean gonadotropin dose and costs did not have a strong effect on the ICERs.
Conclusions: When considering live birth outcomes, treatment with the reference follitropin alfa was more cost effective than treatment with the biosimilar follitropin alfa.
Transparency
Declaration of funding
This analysis was funded by Merck KGaA, Darmstadt, Germany.
Author contributions: S.G. contributed to the data evaluation and the critical revision of the manuscript. M.F. and K.B. contributed to the design, inception and performance of the study, and the critical revision of the manuscript. M.L. contributed to the design of the study and the critical revision of the manuscript. C.R. and N.C. designed and developed the models for Italy and Spain, retrieved the data for the analysis, analyzed the results and contributed to the critical revision of the manuscript.
Declaration of financial/other relationships
S.G. and C.R. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. M.F. has disclosed that he has previously received funding from Merck KGaA, Darmstadt, Germany. M.L. has disclosed that she is an employee of Merck Serono SpA, an affiliate of Merck KGaA, Darmstadt, Germany. N.C. has disclosed that she is an employee of Quintiles IMS, Milan, Italy. K.B. has disclosed that he has received honoraria from Merck KGaA, Takeda and Stiftung Endometriose Forschung.
A peer reviewer on this manuscript received research grants from Merck. The remaining peer reviewers have no relevant financial or other relationships to disclose.
Medical writing support was provided by Steven Goodrick of inScience Communications, Springer Healthcare, UK, and funded by Merck KGaA, Darmstadt, Germany.
Acknowledgements
The authors would like to thank Dirk Eheberg for his contribution to the cost-effective analysis.
Notes
Notes
a GONAL-f is a registered trade name of Merck KGaA, Darmstadt, Germany
b Ovaleap is a registered trade name of Teva, Petah Tikva, Israel
c Bemfola is a registered trade name of Gedeon Richter UK Ltd, Budapest, Hungary