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A cost-effectiveness modeling evaluation comparing a biosimilar follitropin alfa preparation with its reference product for live birth outcome in Germany,Italy and Spain
Authors:Salvatore Gizzo  Marcos Ferrando  Monica Lispi  Claudio Ripellino  Nazarena Cataldo  Klaus Bühler
Affiliation:1. Department of Women and Children’s Health SDB, Policlinico Abano Terme, Padova, Italy;2. salvatore.gizzo@gmail.com;4. Department of Reproductive and Gynaecological Medicine, Instituto Valenciano de Infertilidad (IVI–RMA), Bilbao, Spain;5. Regional Medical Affairs Fertility, Merck Serono SpA, Rome, Italy, an affiliate of Merck KGaA, Darmstadt, Germany;6. Quintiles IMS, Milan, Italy;7. Centre for Gynaecology, Endocrinology, and Reproductive Medicine, Ulm and Stuttgart, Germany;8. Department of Gynaecology, Jena-University Hospital-Friedrich Schiller University, Jena, Germany
Abstract: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.
Keywords:Cost per live birth  incremental cost-effectiveness ratio  ICER  follitropin alfa  Spain  Italy  Germany  recombinant human follicle-stimulating hormone
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