Riccio Eleonora, Sabbatini Massimo, Capuano Ivana, Pellegrino Angela Maria, Petruzzelli Luigi Annicchiarico, Pisani Antonio
Department of Nephrology, University of Campania "Luigi Vanvitelli", via S. Pansini 5, 80131, Naples, Italy.
Chair of Nephrology, Department of Public Health, University Federico II of Naples, Naples, Italy.
BMC Nephrol. 2020 Feb 22;21(1):57. doi: 10.1186/s12882-020-01716-w.
Oral iron is recommended as first line treatment of anemia in non-dialysis chronic kidney disease (ND-CKD) patients. Sucrosomial® iron, a new generation oral iron with high absorption and bioavailability and a low incidence of side effects, has shown to be not inferior to intravenous (IV) iron in the replacement of iron deficiency anemia in patients with ND-CKD. Besides the clinical benefit, it is also important to determine the comparative total costs of oral versus IV iron administrations. The aim of this study was to perform a cost-minimization analysis of oral Sucrosomial iron, compared with IV iron gluconate from an Italian societal perspective.
Cost analysis was performed on the 99 patients with ND-CKD and iron-deficiency anemia of the randomized trial by Pisani et al. Human and material resources utilization was recorded during each iron administration. According to study perspective, direct and indirect costs were considered. Costs for each resource unit were taken from official Italian sources. Probabilistic sensitivity analyses were carried out to test the robustness of the results.
The base case analysis showed an average cost/cycle per patient of € 111 for oral iron and € 1302 for IV iron. Thus, the potential saving was equal to € 1191 per patient/cycle. The sensitivity analysis showed that the most sensitive driver is the time loss by patient and caregivers for the therapy and related-care, followed by the minutes of nursing care and the number of kilometres travelled to reach the referral centre.
This study showed that oral Sucrosomial® iron could offer specific advantages in terms of potential savings, and allowed identifying some implications for future research. Such advantages still persist with the new single dose IV iron formulation available in the market, although to a lesser extent.
口服铁剂被推荐作为非透析慢性肾脏病（ND-CKD）患者贫血的一线治疗方法。蔗糖铁，一种新一代口服铁剂，具有高吸收性、高生物利用度且副作用发生率低，已证明在治疗ND-CKD患者缺铁性贫血方面不劣于静脉注射（IV）铁剂。除了临床益处外，确定口服与静脉注射铁剂给药的相对总成本也很重要。本研究的目的是从意大利社会角度对口服蔗糖铁与葡萄糖酸铁静脉注射进行成本最小化分析。
对Pisani等人随机试验中的99例ND-CKD合并缺铁性贫血患者进行成本分析。在每次铁剂给药期间记录人力和物力资源的使用情况。根据研究角度，考虑直接成本和间接成本。成本取自意大利官方来源。进行概率敏感性分析以检验结果的稳健性。
基础病例分析显示，口服铁剂每位患者每个周期的平均成本为111欧元，静脉注射铁剂为1302欧元。因此，每位患者每个周期的潜在节省为1191欧元。敏感性分析表明，最敏感的驱动因素是患者和护理人员因治疗及相关护理而损失的时间，其次是护理时间和前往转诊中心的行程公里数。
本研究表明，口服蔗糖铁在潜在节省成本方面具有特定优势，并有助于确定对未来研究的一些启示。尽管程度较小，但市场上现有的新型单剂量静脉注射铁剂配方仍保留了这些优势。
