Department of Clinical and Experimental Medicine and Pharmacology, Unit of Pharmacology, University of Messina, Messina, Italy.
BioDrugs. 2012 Apr 1;26(2):113-20. doi: 10.2165/11630770-000000000-00000.
Epoetins are one of the three biologics for which biosimilars are available in Italy. So far, there is a lack of Italian national/regional longitudinal data about epoetin use.
The aim of this study was to evaluate the prescribing pattern of epoetins (reference products and biosimilars) in a Local Health Unit (LHU) of Southern Italy in recent years.
A retrospective drug utilization study was conducted during the period 1 January 2010 - 31 May 2011. The data source was the dispensing database of the Messina LHU, which contains anonymized data about dispensed drugs (including epoetins) that are prescribed by specialists to the residents in the catchment area. Indication of use and prescribed dosage of epoetins were derived by the therapeutic plans filled in by specialists and linked to drug dispensing records. Prevalence of epoetin use in the province of Messina (653 810 inhabitants) in 2010 was calculated. Furthermore, frequency analyses by sex, age, indication of use of epoetin users, as well as measurement of volume of use (defined daily dose [DDD]/1000/day) and expenditure of epoetins in 2010 were also performed. Analysis of the switching pattern between different reference products and biosimilar epoetins was performed.
Overall, 4288 patients were treated with epoetins during the study period (mean age ± SD: 74.2 ± 13.7; females: 52%). Darbepoetin alpha and reference product epoetin alpha accounted overall for 79.8% of epoetin users, while biosimilars of epoetin alpha accounted for 0.9%. Among 1247 epoetin users for whom the therapeutic plan was revised, 1065 (85.4%) were treated because of anemia due to chronic kidney disease and 158 (12.6%) because of chemotherapy-induced anemia. In 2010, prevalence of epoetin use was 5.5 (95% CI 5.3, 5.7) per 1000 inhabitants in the province of Messina. The volume of use and related expenditure for epoetins was 3.58 DDD/1000 inhabitants/day and Euro 5 572 457 (about Euro 8.50 per capita/day) in 2010. Switching between different epoetins was very frequent (21.8% of users) but switching from reference products to biosimilars was very rare.
Epoetins are frequently dispensed to residents in the province of Messina, mainly for the treatment of chronic kidney disease-related anemia, with a relevant impact on the pharmaceutical expenditure covered by the National Health System. Use of biosimilar products is very low in both naïve patients and in those who switch from other reference product epoetins.
促红细胞生成素是意大利可获得生物类似药的三种生物制剂之一。到目前为止，意大利还缺乏关于促红细胞生成素使用的国家/地区纵向数据。
本研究旨在评估意大利南部一个地方卫生单位（LHU）近年来促红细胞生成素（参照产品和生物类似药）的处方模式。
这是一项回顾性药物利用研究，于 2010 年 1 月 1 日至 2011 年 5 月 31 日期间进行。数据来源是墨西拿 LHU 的配药数据库，其中包含了由专家为该地区居民开出处方药物（包括促红细胞生成素）的匿名数据。通过专家填写的治疗计划得出促红细胞生成素的使用指征和规定剂量，并与药物配药记录相关联。计算了 2010 年墨西拿省（653810 名居民）促红细胞生成素的使用率。此外，还对 2010 年按性别、年龄、促红细胞生成素使用者的使用指征、用量（定义日剂量[DDD]/1000 人/天）和促红细胞生成素支出进行了频率分析。还分析了不同参照产品和生物类似药促红细胞生成素之间的转换模式。
研究期间，共有 4288 名患者接受了促红细胞生成素治疗（平均年龄±标准差：74.2±13.7；女性：52%）。达贝泊汀α和参照产品促红细胞生成素α总体上占促红细胞生成素使用者的 79.8%，而促红细胞生成素α的生物类似药占 0.9%。在 1247 名接受治疗计划修订的促红细胞生成素使用者中，1065 名（85.4%）因慢性肾脏病相关贫血而接受治疗，158 名（12.6%）因化疗引起的贫血而接受治疗。2010 年，墨西拿省促红细胞生成素使用率为 5.5（95%置信区间 5.3，5.7）/1000 人。2010 年，促红细胞生成素的用量和相关支出为 3.58 DDD/1000 人/天和 5572457 欧元（约 8.50 欧元/人/天）。不同促红细胞生成素之间的转换非常频繁（21.8%的使用者），但从参照产品转换为生物类似药的情况非常罕见。
促红细胞生成素在墨西拿省的居民中经常被开出，主要用于治疗慢性肾脏病相关贫血，这对国家卫生系统覆盖的药物支出有重大影响。生物类似药的使用在初治患者和从其他参照产品促红细胞生成素转换过来的患者中都非常低。
