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是否到了承诺重新评估肿瘤药物的过程的时候了?对 2017 年至 2021 年在加拿大审查的用于实体瘤适应证的系统疗法进行描述性分析。

Is It Time to Commit to a Process to Re-Evaluate Oncology Drugs? A Descriptive Analysis of Systemic Therapies for Solid Tumour Indications Reviewed in Canada from 2017 to 2021.

机构信息

Division of Medical Oncology, Department of Medicine, The Ottawa Hospital Cancer Centre and The University of Ottawa, Ottawa, ON K1N 6N5, Canada.

Novartis Pharmaceuticals Inc. Canada, Dorval, ON H9S 1A9, Canada.

出版信息

Curr Oncol. 2022 Mar 10;29(3):1919-1931. doi: 10.3390/curroncol29030156.

DOI:10.3390/curroncol29030156
PMID:35323356
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8947363/
Abstract

We undertook an analysis of the Canadian Agency for Drugs and Technologies in Health (CADTH)'s health technology assessments (HTAs) of systemic therapies for solid tumour indications to determine if a mechanism to re-evaluate HTA decisions is needed based on the level of certainty supporting the original recommendation. To measure the certainty in the evidence, we analysed if: (1) overall survival (OS) was the primary endpoint in the pivotal trial, (2) median OS was available at the time of the recommendation, and (3) the expert review committee explicitly identified gaps in the evidence. There were 96 drugs approved by Health Canada that met our eligibility criteria between 1 January 2017 and 31 October 2021. Median OS was not estimable at the time of the recommendation in 57% of the positive recommendations, and the uncertainty in the magnitude of clinical benefit was identified by the expert review committee in 21% of the positive recommendations. There is uncertainty at the time of the HTA recommendation for many drugs, and thus a need to implement a process to re-evaluate drugs in Canada to allow patients timely access to promising therapies while ensuring long-term value of therapies to patients and the healthcare system.

摘要

我们对加拿大药物和技术评估机构(CADTH)针对实体瘤适应症的系统治疗方法的健康技术评估(HTA)进行了分析,以确定是否需要根据原始推荐意见所支持的确信程度建立重新评估 HTA 决策的机制。为了衡量证据的确信度,我们分析了:(1)总生存期(OS)是否为关键试验的主要终点,(2)推荐时是否有可用的中位 OS,以及(3)专家审查委员会是否明确指出证据存在差距。在 2017 年 1 月 1 日至 2021 年 10 月 31 日期间,有 96 种符合我们入选标准的药物获得了加拿大卫生部的批准。在 57%的阳性推荐意见中,推荐时无法估计中位 OS,而在 21%的阳性推荐意见中,专家审查委员会确定了临床获益幅度的不确定性。在 HTA 推荐时,许多药物存在不确定性,因此需要在加拿大实施重新评估药物的流程,以确保患者能够及时获得有前途的治疗方法,同时确保治疗方法对患者和医疗保健系统的长期价值。

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