| Summary: | Umberto Restelli,1,2 Davide Croce,1,2 Erminio Bonizzoni,3 Mario Marzanatti,3 Angelo Andreini,4 Marco Sorio,4 Cristina Tecchio,4 Erika Barison,4 Fabio Benedetti4 1School of Public Health, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa; 2Center for Health Economics, Social and Health Care Management, LIUC Università Cattaneo, Castellanza, VA, Italy; 3Section of Medical Statistics and Biometry “GA Maccacaro”, Department of Clinica Science and Community, University of Milan, Milan, Italy; 4Bone Marrow Transplant Unit- Hematology, University of Verona, Verona, ItalyCorrespondence: Fabio BenedettiBone Marrow Transplant Unit- Hematology, University of Verona, Piazza L.A. Scuro, 10, Verona 37134, ItalyTel + 39 45 812 4647Fax + 39 45 8027488Email fabio.benedetti@univr.itPurpose: Granulocyte-colony stimulating factors (G-CSFs) are widely used to mobilize CD34+ stem cells and to support the engraftment after hematopoietic stem cell transplantation (HSCT). A budget impact analysis and an incremental cost-effectiveness study of two G-CSFs (Lenograstim and Filgrastim biosimilar), considering engraftment, number of hospitalization days and number of G-CSF vials administered were performed.Patients and Methods: Between 2009 and 2016, 248 patients undergoing autologous HSCT have been evaluated and divided into three groups (100 Leno-Leno, 93 Leno-Fil, 55 Fil-Fil) according to the type of G-CSF used for hematopoietic stem cell mobilization and hematopoietic stem cell recovery after transplant.Results: The following statistically significant differences have been observed between Leno-Leno, Leno-Fil, Fil-Fil groups: a higher number of harvested CD34+ cells (10.56 vs 8.00 vs 7.20; p=0.0003) and a lower number of G-CSF vials (8 vs 8 vs 9; p=0.00020) used for full bone marrow recovery favoring Lenograstim. No statistically significant differences were found regarding the number of G-CSF vials used for mobilization, apheresis number and CD34+ cell peak. The post-transplant hematological recovery was faster in Lenograstim group than Filgrastim group: median time to neutrophil count engraftment (> 500/mmc) was 12 vs 13 days; median time for platelets recovery (> 20.000/mmc) was 12 vs 15 days (p=0.0001). The use of Lenograstim achieved cost savings of € 566/patient over Filgrastim biosimilar, related to a decreased number of days of hospitalization (16 vs 17 days; p=0.00012), a lower overall incidence of adverse events, laboratory tests, transfusions for platelet recovery following discharge.Conclusion: In our experience, Lenograstim outperforms Filgrastim in terms of effectiveness and lower cost. This study shows a clinical superiority of Lenograstim over Filgrastim suggesting a potential cost savings favoring Lenograstim.Keywords: lenograstim, filgrastim, mobilization, cost-effectiveness, G-CSF, HSCT
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