Restelli Umberto, Croce Davide, Bonizzoni Erminio, Marzanatti Mario, Andreini Angelo, Sorio Marco, Tecchio Cristina, Barison Erika, Benedetti Fabio
School of Public Health, Faculty of Health Sciences, University of Witwatersrand, Johannesburg, South Africa.
Center for Health Economics, Social and Health Care Management, LIUC Università Cattaneo, Castellanza, VA, Italy.
J Blood Med. 2020 Apr 2;11:123-130. doi: 10.2147/JBM.S224173. eCollection 2020.
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.
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.
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.
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.
粒细胞集落刺激因子（G-CSFs）被广泛用于动员CD34干细胞，并支持造血干细胞移植（HSCT）后的植入。我们进行了一项预算影响分析以及一项针对两种G-CSF（来格司亭和非格司亭生物类似药）的增量成本效益研究，考量了植入情况、住院天数以及使用的G-CSF瓶数。
2009年至2016年期间，对248例接受自体HSCT的患者进行了评估，并根据造血干细胞动员和移植后造血干细胞恢复所使用的G-CSF类型分为三组（100例来格司亭-来格司亭组、93例来格司亭-非格司亭组、55例非格司亭-非格司亭组）。
来格司亭-来格司亭组、来格司亭-非格司亭组、非格司亭-非格司亭组之间观察到以下具有统计学意义的差异：用于全骨髓恢复的采集到的CD34细胞数量更多（分别为10.56 vs 8.00 vs 7.20；p = 0.0003），且使用的G-CSF瓶数更少（分别为8 vs 8 vs 9；p = 0.00020），来格司亭更具优势。在用于动员的G-CSF瓶数、单采次数和CD34细胞峰值方面未发现具有统计学意义的差异。来格司亭组移植后的血液学恢复比非格司亭组更快：中性粒细胞计数植入（>500/mmc）的中位时间为12天对13天；血小板恢复（>20,000/mmc）的中位时间为12天对15天（p = 0.0001）。与非格司亭生物类似药相比，使用来格司亭使每位患者节省成本566欧元，这与住院天数减少（分别为16天对17天；p = 0.00012）、不良事件、实验室检查、出院后血小板恢复输血的总体发生率较低有关。
根据我们的经验，来格司亭在有效性和成本更低方面优于非格司亭。本研究显示出来格司亭相对于非格司亭的临床优势，表明来格司亭可能具有成本节约优势。
