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Originator recombinant human follitropin alfa versus recombinant human follitropin alfa biosimilars in Spain: A cost-effectiveness analysis of assisted reproductive technology related to fresh embryo transfers
Affiliation:1. Merck Healthcare KGaA, Frankfurter Str. 250, 64293, Darmstadt, Germany;2. Centre for Big Data Research in Health & School of Women''s and Children''s Health, UNSW Medicine & Health, Sydney, NSW, 2052, Australia;3. IVF Australia, Level 3, 15 Bowden Street, Alexandria, NSW, 2015, Australia;4. Department of Obstetrics, Gynecology and Reproductive Medicine, La Paz University Hospital, Paseo de la Castellana, 261, 28046, Madrid, Spain;5. Department of Reproductive Medicine, Ruber Internacional Hospital, C/ La Maso, 38, Mirasierra, Madrid, 28034, Spain;6. IQVIA Real World Solutions, London, UK;7. IQVIA Real World Solutions, Herikerbergweg 314, 1101, CT, Amsterdam, Netherlands;8. Merck, S.L.U., C/ Maria de Molina 40, Madrid, Spain, an affiliate of Merck KGaA;9. Department of Development and Regeneration, Laboratory of Endometrium, Endometriosis & Reproductive Medicine, KU Leuven, Herestraat 49 – Box 805|B-3000, Leuven, Belgium;10. Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale University Medical School, New Haven, CT, 06510, USA;11. Pharma Value Consulting, Pilatusweg 6 Oberwil-Lieli, 8966, Switzerland;12. Department of Obstetrics and Gynecology, Human Reproduction Unit, Cruces University Hospital, Basque Country University, Plaza de Cruces, S/N 48903 Barakaldo, Bizkaia, Bilbao, Spain;13. Instituto Valenciano de Infertilidad, IVI Bilbao, IVIRMA, Landabarri Bidea, nº 3 – 2nd Floor, 48940, Leioa, Vizcaya, Bilbao, Spain
Abstract:This study compared the cost per live birth and cost-effectiveness of the originator recombinant human follicle-stimulating hormone follitropin alfa (r-hFSH-alfa) and r-hFSH-alfa biosimilars for ovarian stimulation prior to assisted reproductive technology treatment in Spain. A decision tree model was developed, comprising pregnancy and live birth for one treatment cycle with fresh embryo transfer. Clinical inputs were based on a recent meta-analysis by Chua et al. [4]. Cost inputs were extracted from publicly available Spanish sources. The costs per live birth were lower with originator r-hFSH-alfa (€18,138) versus r-hFSH-alfa biosimilars (€20,377). The incremental cost-effectiveness ratio was €7208 for originator r-hFSH-alfa versus biosimilars. Drug acquisition costs for originator r-hFSH-alfa represented 10.5% of total costs in the base case analysis, and 6.2% in a treatment cycle resulting in live birth with one fresh embryo transfer. Results from the sensitivity analyses confirmed the robustness of the findings.
Keywords:r-hFSH-alfa  Biosimilars  Medically assisted reproduction  Cost-effectiveness analysis
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