临床与经济审查研究所的比较效益评估与德国联邦联合委员会的附加效益评估相比如何?定性研究。

IF 4.9 2区 医学 Q1 ECONOMICS Value in Health Pub Date : 2024-08-01 DOI:10.1016/j.jval.2024.04.015
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引用次数: 0

摘要

目的:我们比较了美国临床与经济研究所(ICER)的比较临床有效性评级和德国联邦联合委员会(G-BA)的附加效益评级,并探讨了哪些因素可能导致两个机构之间出现分歧:如果 ICER 在其 2020-2023 年价值评估框架下对药物进行了评估,且 G-BA 在 2024 年 1 月对相同适应症、患者人群和对比药物进行了相应评估,则我们将这些药物纳入评估范围。为了比较评估结果,我们修改了 ICER 提出的 G-BA 和 ICER 效益评级之间的交叉关系,以考虑 G-BA 的确定性评级。我们还确定了每对评估是否基于相似的证据。尽管有相似的证据基础,但根据修改后的交叉线对出现分歧的评估对进行了定性分析,以确定出现分歧的原因:结果:在根据适应症、患者亚群和参照物进行匹配的 15 对药物评估中,没有一对在基于相似证据的评估中表现出一致。分歧归因于证据评估的不同,包括对安全性、可推广性和研究设计的评估,以及G-BA在四个案例中认为现有证据不合适而拒绝接受:研究结果表明,即使在人群和比较对象相同、证据基础一致的情况下,不同的评估者也可能得出不同的比较效果结论,从而强调了临床效果评估中价值判断的存在。为了支持旨在促进国家间价值评估交流的倡议,这些价值判断应始终在评估摘要中以透明的方式呈现并说明理由。
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How Do the Institute for Clinical and Economic Review’s Assessments of Comparative Effectiveness Compare With the German Federal Joint Committee’s Assessments of Added Benefit? A Qualitative Study

Objectives

We compared the Institute for Clinical and Economic Review’s (ICER) ratings of comparative clinical effectiveness with the German Federal Joint Committee’s (G-BA) added benefit ratings, and explored what factors may explain the disagreement between the 2 organizations.

Methods

We included drugs if they were assessed by ICER under its 2020 to 2023 Value Assessment Framework and had a corresponding assessment by G-BA as of January 2024 for the same indication, patient population, and comparator drug. To compare assessments, we modified ICER’s proposed crosswalk between G-BA and ICER benefit ratings to account for G-BA’s certainty ratings. We also determined whether each pair was based on similar evidence. Assessment pairs exhibiting disagreement based on the modified crosswalk despite a similar evidence base were qualitatively analyzed to identify reasons for disagreement.

Results

Out of 15 drug assessment pairs matched on indication, patient subgroup, and comparator, none showed agreement in their assessments when based on similar evidence. Disagreement was attributed to differences in evidence evaluation, including evaluations of safety, generalizability, and study design, as well as G-BA’s rejection of the available evidence in 4 cases as unsuitable.

Conclusions

The findings demonstrate that even under conditions where populations and comparators are identical and the evidence base is consistent, different assessors may arrive at divergent conclusions about comparative effectiveness, thus underscoring the presence of value judgments within assessments of clinical effectiveness. To support initiatives that seek to facilitate the exchange of value assessments between countries, these value judgments should always be transparently presented and justified in assessment summaries.

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来源期刊
Value in Health
Value in Health 医学-卫生保健
CiteScore
6.90
自引率
6.70%
发文量
3064
审稿时长
3-8 weeks
期刊介绍: Value in Health contains original research articles for pharmacoeconomics, health economics, and outcomes research (clinical, economic, and patient-reported outcomes/preference-based research), as well as conceptual and health policy articles that provide valuable information for health care decision-makers as well as the research community. As the official journal of ISPOR, Value in Health provides a forum for researchers, as well as health care decision-makers to translate outcomes research into health care decisions.
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