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新药经济评估中的挑战:匈牙利利妥昔单抗的经验。

Challenges in economic evaluation of new drugs: experience with rituximab in Hungary.

机构信息

Health Economics and Technology Assessment Research Centre, Corvinus University of Budapest, Budapest, Hungary.

出版信息

Med Sci Monit. 2010 Jan;16(1):SR1-5.

PMID:20037504
Abstract

BACKGROUND

Implementation of a new therapy into clinical practice is a complex process. Various countries have different requirements for information but most often focus on economic evaluation, which often plays a stronger role in healthcare decision making than does clinical evidence.

MATERIAL/METHODS: To identify all potential challenges in economic evaluation, the case of a new biological drug, rituximab, used to treat rheumatoid arthritis, has been taken as an example. We present methods and results of economic assessment, highlighting the specific issues that should be considered in countries with economic and health care conditions similar to those of Hungary.

RESULTS

In principle, economic evaluation requires data on characteristics of target population, disease progression, treatment impact, preferences, resource utilization and unit prices. Treatment effect/relative risk reduction and clinical practice patterns (resource use) may be more generalizable, whereas prices and baseline risk need to be jurisdiction specific. In order to address issues of transferability, investments need to be made in the collection of epidemiological and demographic data, plus data on clinical practice patterns, resource use, costs and health state valuation. In Hungary this problem has been solved through conducting a well designed 255 patient cross-sectional study.

CONCLUSIONS

The Hungarian example shows that there should be more investment in data collection for those parameters that are thought to differ most from place to place. Owing to the similarities between Central and Eastern Europe countries in health care systems, clinical practice patterns and economic indicators, they may be able to develop partnerships to develop relevant regional databases and registries.

摘要

背景

将一种新疗法应用于临床实践是一个复杂的过程。不同国家对信息有不同的要求,但通常侧重于经济评估,而经济评估在医疗保健决策中的作用往往比临床证据更为重要。

材料/方法:为了确定经济评估中所有潜在的挑战,以一种用于治疗类风湿关节炎的新型生物药物利妥昔单抗为例。我们介绍了经济评估的方法和结果,强调了在与匈牙利的经济和医疗保健条件相似的国家中应考虑的具体问题。

结果

原则上,经济评估需要有关目标人群特征、疾病进展、治疗影响、偏好、资源利用和单位价格的数据。治疗效果/相对风险降低和临床实践模式(资源利用)可能更具普遍性,而价格和基线风险需要具体到管辖范围。为了解决可转移性问题,需要在收集流行病学和人口统计学数据以及临床实践模式、资源利用、成本和健康状态估值方面进行投资。在匈牙利,通过对 255 名患者进行横断面研究,解决了这个问题。

结论

匈牙利的例子表明,应该在那些被认为与地点差异最大的参数上投入更多的数据收集。由于中东欧国家在医疗保健系统、临床实践模式和经济指标方面存在相似性,它们可以建立合作伙伴关系,开发相关的区域数据库和登记处。

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Challenges in economic evaluation of new drugs: experience with rituximab in Hungary.新药经济评估中的挑战:匈牙利利妥昔单抗的经验。
Med Sci Monit. 2010 Jan;16(1):SR1-5.
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Arthritis Rheum. 2004 Dec 15;51(6):964-73. doi: 10.1002/art.20843.

引用本文的文献

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The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review.生物制剂治疗类风湿关节炎的成本效益:一项系统评价。
PLoS One. 2015 Mar 17;10(3):e0119683. doi: 10.1371/journal.pone.0119683. eCollection 2015.
2
Economic burden of long-term care of rheumatoid arthritis patients in Hungary.匈牙利类风湿性关节炎患者长期护理的经济负担。
Eur J Health Econ. 2014 May;15 Suppl 1:S131-5. doi: 10.1007/s10198-014-0601-9. Epub 2014 May 16.
3
Transferability of results of cost utility analyses for biologicals in inflammatory conditions for Central and Eastern European countries.
中东欧国家炎症性疾病生物制剂成本效用分析结果的可转移性。
Eur J Health Econ. 2014 May;15 Suppl 1:S27-34. doi: 10.1007/s10198-014-0591-7. Epub 2014 May 16.
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Role of centralized review processes for making reimbursement decisions on new health technologies in Europe.集中审查程序在欧洲新医疗技术报销决策中的作用。
Clinicoecon Outcomes Res. 2011;3:117-86. doi: 10.2147/CEOR.S14407. Epub 2011 Aug 30.