i3 Innovus, Uxbridge, Middlesex, UK.
Value Health. 2010 Dec;13(8):1028-37. doi: 10.1111/j.1524-4733.2010.00771.x.
The objectives of this article were to assess the positions of the various national pharmacoeconomic guidelines on the transferability (or lack of transferability) of clinical and economic data and to review the methods suggested in the guidelines for addressing issues of transferability.
A review of existing national pharmacoeconomic guidelines was conducted to assess recommendations on the transferability of clinical and economic data, whether there are important differences between countries, and whether common methodologies have been suggested to address key transferability issues. Pharmacoeconomic guidelines were initially identified through the ISPOR Web site. In addition, those national guidelines not included in the ISPOR Web site, but known to us, were also considered.
Across 27 sets of guidelines, baseline risk and unit costs were uniformly considered to be of low transferability, while treatment effect was classified as highly transferable. Results were more variable for resource use and utilities, which were considered to have low transferability in 63% and 45% of cases, respectively. There were some differences between older and more recent guidelines in the treatment of transferability issues.
A growing number of jurisdictions are using guidelines for the economic evaluation of pharmaceuticals. The recommendations in existing guidelines regarding the transferability of clinical and economic data are quite diverse. There is a case for standardization in dealing with transferability issues. One important step would be to update guidelines more frequently.
本文旨在评估各国药物经济学指南对临床和经济数据可转移性(或不可转移性)的立场,并回顾指南中提出的用于解决可转移性问题的方法。
对现有的国家药物经济学指南进行了审查,以评估关于临床和经济数据可转移性的建议、国家之间是否存在重要差异,以及是否提出了共同的方法来解决关键的可转移性问题。药物经济学指南最初是通过 ISPOR 网站确定的。此外,还考虑了那些未包含在 ISPOR 网站上但我们已知的国家指南。
在 27 套指南中,基线风险和单位成本被一致认为具有较低的可转移性,而治疗效果被归类为高度可转移性。资源利用和效用的结果则更为多变,分别有 63%和 45%的情况认为它们具有较低的可转移性。在处理可转移性问题方面,新旧指南之间存在一些差异。
越来越多的司法管辖区正在使用指南来评估药品的经济性。现有指南中关于临床和经济数据可转移性的建议差异很大。在处理可转移性问题方面需要标准化。一个重要步骤是更频繁地更新指南。