加拿大麦克马斯特大学Feng Xie团队研究了成本效益分析中的行业赞助偏倚。相关论文发表在2022年6月22日出版的《英国医学杂志》上。

为了在成本效益分析（CEA）中评估行业赞助（药品、医疗器械和生物技术公司）与成本效益之间的关联，研究组进行了一项基于注册表的分析。塔夫茨成本效益分析注册中心用于确定1976-2021年间在Medline发布的所有CEA，筛选出使用质量调整寿命年报告增量成本效益比（ICER）、并提供有关ICER大小或位置的充分信息的CEA。

描述性分析用于描述和比较有无行业赞助的CEA的特征。使用Logistic回归分析确定行业赞助与使用选定阈值（5万美元、10万美元、15万美元）得出的成本效益结论之间的关联。稳健线性回归用于评估行业赞助与ICER规模之间的关联。所有回归分析均根据疾病和研究设计特征进行了校正。

8192个CEA符合条件并纳入分析，其中2437个（29.7%）由行业赞助。行业赞助的CEA与非行业赞助研究相比，更有可能发布低于5万美元（校正后的优势比为2.06）、10万美元（2.95）和15万美元（3.34）的ICER。在5877个报告了正增量成本和质量调整寿命年的CEA中，来自行业赞助研究的ICER比来自非行业赞助研究低33%。

研究结果表明，CEA中的赞助偏倚是显著的、系统性的，并且存在于一系列疾病和研究设计中。独立机构使用CEA可以使付款人有更大的能力谈判更低的价格。

附：英文原文

Title: Industry sponsorship bias in cost effectiveness analysis: registry based analysis

Author: Feng Xie, Ting Zhou

Issue&Volume: 2022/06/22

Abstract:

Objective To assess the association between industry sponsorship (drug, medical device, and biotechnology companies) and cost effectiveness results in cost effectiveness analysis (CEA).

Design Registry based analysis

Data source The Tufts Cost-Effectiveness Analysis Registry was used to identify all CEAs published in Medline between 1976 and 2021.

Eligibility criteria for selecting studies CEAs that reported incremental cost effectiveness ratio (ICER) using quality adjusted life year and provided sufficient information about the magnitude or location of the ICER.

Methods Descriptive analyses were used to describe and compare the characteristics of CEAs with and without industry sponsorship. Logistic regression was used to identify the association between industry sponsorship and the cost effective conclusion using selected threshold values ($50000 (￡40511; €47405), $100000, and $150000). Robust linear regression was used to assess the association between industry sponsorship and the magnitude of ICER. All regression analyses were adjusted for disease and study design characteristics.

Results 8192 CEAs were eligible and included in the analysis, with 2437 (29.7%) sponsored by industry. Industry sponsored CEAs were more likely to publish ICERs below $50000 (adjusted odds ratio 2.06, 95% confidence interval 1.82 to 2.33), $100000 (2.95, 2.52 to 3.44), and $150000 (3.34, 2.80 to 3.99) than non-industry sponsored studies. Among 5877 CEAs that reported positive incremental costs and quality adjusted life years, ICERs from industry sponsored studies were 33% lower (95% confidence interval 40 to 26) than those from non-industry sponsored studies.

Conclusions Sponsorship bias in CEAs is significant, systemic, and present across a range of diseases and study designs. Use of CEAs conducted by independent bodies could provide payers with more ability to negotiate lower prices. This impartiality is especially important for countries that rely on published CEAs to inform policy making for insurance coverage because of limited capacity for independent economic analysis.

DOI: 10.1136/bmj-2021-069573

Source: https://www.bmj.com/content/377/bmj-2021-069573