Merck & Co, Kenilworth, NJ, USA.
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Lawrenceville, NJ, USA.
Value Health Reg Issues. 2021 Dec;26:50-55. doi: 10.1016/j.vhri.2020.12.014. Epub 2021 May 6.
Using a taxonomy previously developed, we assessed the strengths and limitations of available value assessment frameworks (VAF) in Latin America.
Systematic review of peer-reviewed journals, gray literature review, and surveys to ISPOR Latin America Industry Committee members were done to identify and select current VAF. Once selected, independent reviewers, organized by pairs, assessed each framework's input, methodology, and outputs.
We assessed 7 of 9 VAF in the region, excluding 2 that were not currently in use. The review included 1 framework developed by a regional entity, and 6 country frameworks for either price assessment or to inform reimbursement. Most of these frameworks had a clear definition of the purpose (6 of 7) but could provide more details on the conceptual approach, including perspectives, methods for obtaining preferences, and the ability to incorporate multiple value dimensions (2 of 7). Most lacked information about inclusions/exclusions of elements included in the framework, and whether it assumes a base case comparator and how it is selected. The description of the evaluation of data sources and their scientific validity was inconsistently reported (3 of 7). Few included an assessment of the intervention's effect on total costs of treating a defined population (2 of 7), or a description of how uncertainty could be incorporated (3 of 7). Finally, potential conflicts of interest among those creating the framework are not sufficiently addressed (0 of 7).
In the 7 frameworks assessed in Latin America, there are opportunities to improve dimensions, methods, and scope. Addressing these issues will strengthen these VAF for policy and clinical decision making.
使用先前开发的分类法,我们评估了拉丁美洲现有价值评估框架(VAF)的优缺点。
对同行评议期刊、灰色文献综述以及对 ISPOR 拉丁美洲行业委员会成员的调查进行了系统审查,以确定并选择当前的 VAF。一旦选定,独立审查员将通过两两分组的方式,评估每个框架的投入、方法和产出。
我们评估了该地区 9 个 VAF 中的 7 个,不包括 2 个当前未使用的框架。该审查包括由一个地区实体开发的 1 个框架,以及 6 个用于价格评估或为报销提供信息的国家框架。这些框架大多对目的有明确的定义(7 个中有 6 个),但可以更详细地说明概念方法,包括观点、获得偏好的方法以及纳入多个价值维度的能力(7 个中有 2 个)。大多数框架缺乏有关框架中包含的要素的纳入/排除的信息,以及它是否假设了一个基础比较器以及如何选择它。对数据来源及其科学有效性的评估的描述不一致(7 个中有 3 个)。很少有框架评估干预措施对治疗特定人群的总成本的影响(7 个中有 2 个),或者描述如何纳入不确定性(7 个中有 3 个)。最后,创建框架的人之间的潜在利益冲突没有得到充分解决(7 个中有 0 个)。
在拉丁美洲评估的 7 个框架中,在维度、方法和范围方面都有改进的空间。解决这些问题将增强这些 VAF 在政策和临床决策制定方面的作用。