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通过对话式团队合作从原研药转换为生物类似物重组人生长激素:来自瑞典的单中心经验

Switching From Originator to Biosimilar Human Growth Hormone Using Dialogue Teamwork: Single-Center Experience From Sweden.

作者信息

Flodmark Carl-Erik, Lilja Katarina, Woehling Heike, Järvholm Kajsa

机构信息

Childhood Obesity Unit, Barn-och Ungdomsmedicinska Kliniken, Skånes Universitetssjukhus, Malmö, Sweden ; Department of Pediatrics, Skåne University Hospital, Malmö, Sweden.

Department of Medicines Management and Informatics, County of Skåne, Malmö, Sweden.

出版信息

Biol Ther. 2013;3(1):35-43. doi: 10.1007/s13554-013-0011-z. Epub 2013 May 28.

Abstract

INTRODUCTION

A new treatment plan was implemented at Skåne University Hospital, on economic grounds, for children requiring recombinant human growth hormone (rhGH) treatment. This involved switching patients from treatment with originator rhGHs to treatment with a biosimilar rhGH, somatropin (Omnitrope), using a Dialogue Teamwork approach. The feasibility of using this approach to implement the switch of treatment was assessed, as well as the impact of the switch on treatment efficacy and cost of therapy.

METHODS

As part of the Dialogue Teamwork approach, patients/parents received several opportunities for dialogue and sources of information, including discussions with the Head of Department, the responsible physician and a specialized endocrinology nurse. Height and height standard deviation score (HSDS) data were plotted for each individual patient ( = 98). A modeling approach was also used, to predict growth after switching to biosimilar rhGH; the predictions were then compared to the actual observed height after the switch. Costs to the clinic of rhGH therapy were calculated between May-August 2009 and May-August 2012.

RESULTS

Of the 102 patients offered the switch, 98 accepted. Height and HSDS data indicated there was no negative impact on growth velocity after the switch to biosimilar rhGH. Modeling demonstrated that observed growth following the switch was consistent with predicted growth based on data before patients were switched. There were no reports of serious or unexpected adverse drug reactions following the switch to biosimilar rhGH. Following the switch, the cost to the clinic of rhGH treatment decreased from approximately 6 million SEK (May-August 2009) to approximately 4 million SEK (May-August 2012). This corresponds to an annual saving of 6 million SEK (€650,000).

CONCLUSION

Patients were successfully switched from originator to biosimilar rhGH (somatropin), with no negative impact on growth, and no serious or unexpected adverse drug reactions. The switch from originator to biosimilar rhGH is associated with substantial cost savings.

摘要

引言

出于经济原因,斯坎纳大学医院为需要重组人生长激素(rhGH)治疗的儿童实施了一项新的治疗方案。这包括采用团队对话方法,将患者从使用原研rhGH治疗转换为使用生物类似物rhGH(生长激素[奥曲肽])治疗。评估了使用这种方法实施治疗转换的可行性,以及转换对治疗效果和治疗成本的影响。

方法

作为团队对话方法的一部分,患者/家长有多次对话和获取信息的机会,包括与科室主任、责任医师和专业内分泌护士进行讨论。为每位患者(n = 98)绘制身高和身高标准差评分(HSDS)数据。还采用了一种建模方法来预测转换为生物类似物rhGH后的生长情况;然后将预测结果与转换后实际观察到的身高进行比较。计算了2009年5月至8月和2012年5月至8月期间rhGH治疗的临床成本。

结果

在提供转换机会的102名患者中,98名接受了转换。身高和HSDS数据表明,转换为生物类似物rhGH后对生长速度没有负面影响。建模显示,转换后的观察到的生长情况与基于患者转换前数据的预测生长情况一致。转换为生物类似物rhGH后,没有严重或意外药物不良反应的报告。转换后,rhGH治疗的临床成本从约600万瑞典克朗(2009年5月至8月)降至约400万瑞典克朗(2012年5月至8月)。这相当于每年节省600万瑞典克朗(65万欧元)。

结论

患者成功地从使用原研rhGH转换为使用生物类似物rhGH(生长激素),对生长没有负面影响,也没有严重或意外药物不良反应。从原研rhGH转换为生物类似物rhGH可节省大量成本。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5ca2/4079097/e72bf02fcf43/13554_2013_11_Fig1_HTML.jpg

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