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加拿大癌症药物资助决策中临床医生投入的特点:基于 CADTH 报销建议的横断面研究。

Characteristics of clinician input in Canadian funding decisions for cancer drugs: a cross-sectional study based on CADTH reimbursement recommendations.

机构信息

Department of Health Policy, The London School of Economics and Political Science, London, UK

Department of Medicine, University of Calgary, Calgary, Alberta, Canada.

出版信息

BMJ Open. 2023 Oct 16;13(10):e066378. doi: 10.1136/bmjopen-2022-066378.

Abstract

OBJECTIVE

To examine characteristics of clinician input to the pan-Canadian Oncology Drug Review (pCODR) for cancer drug funding recommendations from 2016 to 2020.

DESIGN, SETTING AND PARTICIPANTS: Descriptive, cross-sectional study including 62 reimbursement decisions from pCODR from 2016 to 2020.

INTERVENTIONS

pCODR recommendations were analysed for the number of clinicians consulted on each submission, affiliation, number of submissions per clinician, declared financial conflicts of interest (FCOIs), randomisation, type of blinding, primary endpoint, study phase, and whether the study demonstrated improvement in overall survival (OS) and progression-free survival (PFS).

MAIN OUTCOME MEASURES

The main outcome was clinician support for the initial funding recommendation. Secondary outcome measures were the association between clinician FCOIs and clinical benefit in positive recommendations.

RESULTS

The study consisted of 62 submissions, in which 48 included clinician input. A total of 129 unique clinicians provided 342 consultations. The majority (59%) provided input on less than 5 submissions; however, a small proportion (4%) consulted on over 10. Nearly all clinicians were physicians (125; 96%). From the 342 consultations, 228 declared financial conflicts (67%). The most common conflicts were payments for advisory roles (51%) and honorariums (23%). Of the 48 cancer drugs under review, clinicians recommended funding 46 (96%). Only 12 (25%) demonstrated substantial benefit, according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale score. Drugs recommended for funding were more likely to have improved PFS and OS data. However, most cancer drugs supported by clinicians demonstrated no change in health-related quality of life (HRQoL), including one that demonstrated worsened HRQoL. There was no statistically significant difference between FCOI status and recommending drugs with health gains.

CONCLUSION

Clinicians offer crucial information on funding decisions. However, we found clinicians strongly supported funding nearly all cancer drugs under review, despite most not offering substantial benefit to patients nor gains in quality of life. While these drugs might be helpful options in clinical practice, funding numerous cancer drugs may be unsustainable for public health systems.

摘要

目的

考察 2016 年至 2020 年期间,加拿大肿瘤药物审查机构(pCODR)对癌症药物资助建议的临床医生输入特征。

设计、设置和参与者:包括 2016 年至 2020 年期间 pCODR 的 62 项报销决策的描述性、横断面研究。

干预措施

对每一份提交的 pCODR 建议进行了分析,包括咨询的临床医生人数、所属机构、每位临床医生的提交次数、申报的财务利益冲突(FCOI)、随机化、盲法类型、主要终点、研究阶段,以及研究是否显示出总生存(OS)和无进展生存期(PFS)的改善。

主要结果测量

主要结果是临床医生对初始资助建议的支持程度。次要结果测量是临床医生 FCOI 与阳性推荐中临床获益之间的关联。

结果

该研究共包括 62 项提交,其中 48 项包含临床医生的意见。共有 129 名独特的临床医生提供了 342 次咨询。大多数(59%)提供的意见不到 5 份提交;然而,一小部分(4%)提供的意见超过 10 份。几乎所有的临床医生都是医生(125 名;96%)。在 342 次咨询中,有 228 次申报了财务利益冲突(67%)。最常见的冲突是担任咨询角色的报酬(51%)和酬金(23%)。在审查的 48 种癌症药物中,临床医生建议资助 46 种(96%)。根据欧洲肿瘤内科学会临床获益量表评分,只有 12 种(25%)显示出实质性获益。推荐资助的药物更有可能改善 PFS 和 OS 数据。然而,大多数得到临床医生支持的癌症药物并未改善健康相关生活质量(HRQoL),包括一种药物显示 HRQoL 恶化。在 FCOI 状况和推荐具有健康获益的药物之间没有统计学上的显著差异。

结论

临床医生为资助决策提供了重要信息。然而,我们发现临床医生强烈支持审查中的几乎所有癌症药物的资助,尽管大多数药物对患者没有实质性益处,也没有改善生活质量。虽然这些药物在临床实践中可能是有帮助的选择,但为众多癌症药物提供资金可能对公共卫生系统是不可持续的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0713/10583055/7264a460c05d/bmjopen-2022-066378f01.jpg

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