Kassenärztliche Vereinigung Bayerns, Elsenheimerstr. 39, 80687 Munich, Germany.
Eur J Clin Pharmacol. 2013 Apr;69(4):929-36. doi: 10.1007/s00228-012-1412-5. Epub 2012 Oct 2.
There are concerns that biosimilar erythropoiesis-stimulating agents (ESAs) are less effective than the originator ESAs. The objective of our study was to investigate differences between originator and biosimilar ESA utilisation based on defined daily doses (DDD), doses upon switching, differences between short- and long-acting ESAs and prescribed daily doses (PDD) of either ESA in ambulatory patients with renal anaemia undergoing chronic maintenance haemodialysis [chronic kidney disease (CKD) stage 5].
Patients with CKD stage 5 and specific pharmacotherapy with ESAs for at least six 3-month periods (accounting quarters) were selected from a population-based database of accounting information of Bavarian physicians and pharmacy claims data (January 2008 to December 2010). The DDD was used to determine mean ESA consumption. Descriptive statistics were used to describe the results.
In our study, 6,177 CKD stage 5 patients received ESAs for ≥6 accounting quarters, of whom 64.4 % received originator ESAs, 21.1 % received biosimilars and 14.6 % received any sequence originator and biosimilar (total of 35.7 % any biosimilar). Patients receiving either originator short-acting ESAs, long-acting darbepoetin-alfa or M-PEG epoetin-beta had a median DDD consumption of 0.77, 0.81 and 0.90, respectively. Patients receiving a biosimilar short-acting ESA had a median DDD consumption of 0.82. Doses were not increased when the therapy was switched from the originator to the biosimilar ESA. These results were confirmed in 1,886 patients receiving a continuous prescription over 12 accounting quarters, with patients receiving short-acting originator ESAs, long-acting darbepoetin-alfa and biosimilar ESAs having a median daily DDD consumption of 0.80, 0.86 and 0.81, respectively.
We conclude that, based on a population based analysis, ESA consumption of patients on chronic haemodialysis is similar for biosimilar and originator ESAs.
人们担心生物类似的红细胞生成刺激剂(ESA)不如原研 ESA 有效。本研究的目的是基于定义的每日剂量(DDD)、转换时的剂量、短效和长效 ESA 之间的差异以及接受慢性维持性血液透析的肾性贫血的门诊患者(慢性肾脏病[CKD]5 期)中任一 ESA 的每日规定剂量(PDD),调查原研和生物类似 ESA 利用之间的差异。
从巴伐利亚医生的人口基础会计信息数据库和药房报销数据中选择 CKD 5 期患者,并接受特定的 ESA 药物治疗至少 6 个 3 个月期(会计季度)(2008 年 1 月至 2010 年 12 月)。DDD 用于确定 ESA 的平均消耗量。采用描述性统计描述结果。
在我们的研究中,6177 名 CKD 5 期患者接受 ESA 治疗≥6 个会计季度,其中 64.4%接受原研 ESA,21.1%接受生物类似物,14.6%接受任何原研和生物类似物序贯治疗(共 35.7%接受任何生物类似物)。接受原研短效 ESA、长效达贝泊汀-α或 M-PEG 促红素-β的患者的中位 DDD 消耗量分别为 0.77、0.81 和 0.90。接受生物类似短效 ESA 的患者的中位 DDD 消耗量为 0.82。当从原研 ESA 转换为生物类似物 ESA 时,剂量并未增加。在 1886 名接受连续处方治疗 12 个会计季度的患者中,这些结果得到了证实,接受短效原研 ESA、长效达贝泊汀-α和生物类似物 ESA 的患者的中位每日 DDD 消耗量分别为 0.80、0.86 和 0.81。
我们的结论是,基于基于人群的分析,慢性血液透析患者的 ESA 消耗在生物类似物和原研 ESA 之间相似。