使用对话团队合作从发起人到生物仿制人生长激素的转换:来自瑞典的单中心经验。

Biologics in therapy Pub Date : 2013-01-01 Epub Date: 2013-05-28 DOI:10.1007/s13554-013-0011-z
Carl-Erik Flodmark, Katarina Lilja, Heike Woehling, Kajsa Järvholm
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引用次数: 43

摘要

简介:sk大学医院基于经济考虑,对需要重组人生长激素(rhGH)治疗的儿童实施了一项新的治疗计划。这包括使用对话团队合作方法,将患者从原药rhGH治疗转换为生物仿制药rhGH,生长激素(Omnitrope®)治疗。评估采用该方法实施治疗切换的可行性,以及切换对治疗效果和治疗成本的影响。方法:作为对话团队合作方法的一部分,患者/家长获得了多次对话和信息来源的机会,包括与科室主任、负责医师和专业内分泌护士进行讨论。绘制每位患者的身高和身高标准差评分(HSDS)数据(N = 98)。还使用建模方法来预测切换到生物仿制药rhGH后的生长情况;然后将预测结果与转换后实际观察到的高度进行比较。计算2009年5 - 8月至2012年5 - 8月间rhGH治疗的临床费用。结果:102例患者中,98例接受了转换。高度和HSDS数据表明,切换到生物仿制药rhGH后,对生长速度没有负面影响。建模表明,转换后观察到的生长与基于患者转换前数据的预测生长一致。没有严重的或意外的药物不良反应的报告后,切换到生物仿制药rhGH。转换后,rhGH治疗的诊所费用从大约600万瑞典克朗(2009年5月至8月)下降到大约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:患者成功从原药切换到生物仿制药rhGH(生长激素),对生长无负面影响,未发生严重或意外的药物不良反应。从原料药到生物仿制药rhGH的转换与大量的成本节约有关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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

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 (N = 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.

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