Lexchin Joel
Professor Emeritus, School of Health Policy and Management, York University, 4700 Keele St., Toronto, ON M3J 1P3, Canada; Associate Professor, Faculty of Medicine, University of Toronto, Canada.
Health Policy. 2023 Oct;136:104901. doi: 10.1016/j.healthpol.2023.104901. Epub 2023 Aug 26.
To examine whether there has been a change in the number of therapeutically important new medicines not being introduced into the Canadian market in light of the December 2017 announcement of regulatory changes to lower Canadian prices.
A list was compiled of medicines approved by the Food and Drug Administration (FDA) between 2014-2021 but not submitted to Health Canada. The therapeutic value of these medicines was assessed based on evaluations by two independent sources. If no evaluation was available, potential therapeutic value was determined based on the presence of one or more of three medicine characteristics. Interrupted time series was used to determine if there were changes in overall new medicine introductions and therapeutically important new medicines.
The FDA approved 364 new medicines of which 116 (31.9%) were not submitted to Health Canada. There was a decrease in overall annual number of submissions but that was not related to the announcement at the end of 2017. There was no change in the introduction of therapeutically important new medicines as a percent of all medicines not marketed in Canada but there was a decrease in the absolute number.
The number of therapeutically important medicines not being introduced into Canada is increasing but that is not related to the proposed price reforms.
鉴于2017年12月宣布的降低加拿大药品价格的监管变化，研究未进入加拿大市场的具有重要治疗意义的新药数量是否发生了变化。
编制一份2014年至2021年间美国食品药品监督管理局（FDA）批准但未提交给加拿大卫生部的药品清单。这些药品的治疗价值基于两个独立来源的评估。如果没有评估结果，则根据三种药品特性中的一种或多种来确定潜在治疗价值。采用中断时间序列分析来确定新药总体引入量和具有重要治疗意义的新药是否有变化。
FDA批准了364种新药，其中116种（31.9%）未提交给加拿大卫生部。每年提交的药品总数有所下降，但这与2017年底的公告无关。在未在加拿大上市的所有药品中，具有重要治疗意义的新药引入比例没有变化，但绝对数量有所下降。
未引入加拿大的具有重要治疗意义的药品数量在增加，但这与拟议的价格改革无关。
