加拿大卫生部通过Orbis项目批准的肿瘤药物的治疗价值：一项横断面研究

IF 2 Q3 HEALTH POLICY & SERVICES

Journal of Cancer Policy Pub Date : 2025-08-23 DOI:10.1016/j.jcpo.2025.100635

Joel Lexchin

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引用次数: 0

摘要

2019年5月，美国食品和药物管理局（FDA）启动了Orbis项目，旨在通过促进与包括加拿大卫生部在内的国际监管机构的协调，让患者更快地获得有希望的癌症治疗方法。这项研究评估了加拿大卫生部通过奥比斯项目批准的药物的附加治疗价值。方法下载FDA截止2024年底通过Orbis项目批准的药物清单，并对加拿大卫生部参与的药物进行鉴定。确定了加拿大卫生部批准这些药物的类型——标准、优先和符合条件通知（NOC/c，有条件批准）。根据四个国际组织的评级对药物（主要、中等和次要）的附加治疗价值进行评估。根据复习类型比较附加治疗价值（轻度、中度、重度）的分布，采用卡方检验。结果FDA批准了68种药物的112种适应症，其中49种（72.1 %）药物的78种（69.6% %）适应症获得了加拿大卫生部的审查（30种新药和48种现有药物的新适应症）。生产商从审批程序中撤回了一种药物，留下77种新药和新的适应症供分析。28种药物进行了标准审评，31种为优先审评，18种为NOC/c审评。不同复习类型的附加治疗价值分布差异有统计学意义，p = 0.0052（卡方检验）。在23种优先审查的药物中，有16种（69.6 %）提供了中等（10）或主要(6)的额外治疗效果。在剩余的40种具有其他类型批准的治疗评价的药物中，只有12种具有中等或主要的额外治疗价值。结论本研究的结果表明，加拿大卫生部参与奥比斯项目时应将重点放在有资格优先审查的药物上。

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Therapeutic value of oncology drugs approved by Health Canada through Project Orbis: a cross-sectional study

Background

In May 2019, the US Food and Drug Administration (FDA) initiated Project Orbis with the aim of providing patients faster access to promising cancer treatments by promoting coordination with international regulatory agencies, including Health Canada. This study evaluates the additional therapeutic value of drugs approved by Health Canada through Project Orbis.

Methods

The FDA list of drugs approved through Project Orbis until the end of 2024 was downloaded and drugs that Health Canada participated in were identified. The type of approval that Health Canada gave these drugs – standard, priority and Notice of Compliance with conditions (NOC/c, conditional approval) was identified. The additional therapeutic value of the drugs (major, moderate and minor) was assessed from the ratings of four international organizations. The distribution of additional therapeutic value (minor, moderate, major) according to review type was compared using a Chi-square test.

Results

The FDA approved 68 drugs for 112 indications of which 49 (72.1 %) drugs were reviewed by Health Canada for 78 (69.6 %) indications (30 new drugs and 48 new indications for existing drugs). The manufacturer withdrew one drug from the approval process leaving 77 new drugs and new indications for analysis. Twenty-eight drugs had a standard review, 31 a priority review and 18 a NOC/c review. The distribution of additional therapeutic value by review type was statistically significantly different, p = 0.0052 (Chi-square test). Sixteen (69.6 %) out of 23 drugs with a priority review offered either moderate (10) or major (6) additional therapeutic gains. Only 12 of the remaining 40 drugs with a therapeutic evaluation that had other types of approval had moderate or major additional therapeutic value.