Lexchin Joel
School of Health Policy and Management, York University, Toronto, Canada.
Department of Family and Community Medicine, University of Toronto, Toronto, Canada.
PLoS One. 2024 Aug 1;19(8):e0308118. doi: 10.1371/journal.pone.0308118. eCollection 2024.
The independent French drug bulletin Prescrire International rates the therapeutic innovation of new drug-indications approved for marketing in France using an ordinal scale with the lowest rating being "not acceptable". This study investigates whether these drugs were approved by Health Canada.
A list of "not acceptable" drug-indications was generated by handsearching all issues of Prescrire International between January 2013 and December 2022. The generic names, indications and reasons why Prescrire labeled them not acceptable were recorded. The approval date was determined by consulting the website of the European Medicines Agency (EMA). The status of these drug-indications in Canada was determined by searching multiple Health Canada websites. Therapeutic Evaluations for new drug-indications done by the Patented Medicine Prices Review Board (PMPRB) were recorded.
Prescrire rated 57 new drug-indications and 42 new indications for existing drugs as not acceptable. Seventy of these drug-indications were available in Canada- 42 new drug-indications and 28 new indications for existing drugs. Twenty (90.9%) of the 22 new drugs evaluated by the PMPRB were rated as slight/no therapeutic improvement and 2 as moderate therapeutic improvement. The median difference, in days, between approval times by the EMA/ANSM and Health Canada was 129 (interquartile range -102, 341) in favour of the former.
The majority of the not acceptable drug-indications were approved by Health Canada. The difference between when Prescrire and Health Canada examined the evidence for these drug-indications is unlikely to explain the difference in their evaluations. A change in regulatory standards at Health Canada may be one factor behind the presence of these drugs. To what degree those drugs led to more harms than benefits for patients who are taking them needs to be urgently investigated. Finally, the reasoning behind Health Canada's approval of these drugs should be interrogated.
法国独立药品公报《国际处方》使用一种序数尺度对在法国获批上市的新药适应症的治疗创新性进行评级，最低评级为“不可接受”。本研究调查了这些药物是否获得加拿大卫生部的批准。
通过人工查阅2013年1月至2022年12月期间的所有《国际处方》期刊，生成一份“不可接受”的药品适应症清单。记录通用名、适应症以及《国际处方》将其列为不可接受的原因。通过查询欧洲药品管理局（EMA）的网站确定批准日期。通过搜索加拿大卫生部的多个网站确定这些药品适应症在加拿大的情况。记录专利药品价格评审委员会（PMPRB）对新药适应症的治疗评估。
《国际处方》将57种新药适应症和42种现有药物的新适应症评为不可接受。其中70种药品适应症在加拿大有供应——42种新药适应症和28种现有药物的新适应症。PMPRB评估的22种新药中，有20种（90.9%）被评为轻微/无治疗改善，2种被评为中度治疗改善。EMA/法国国家药品安全局（ANSM）与加拿大卫生部批准时间的中位数差异为129天（四分位间距为-102, 341），EMA/ANSM的批准时间更早。
大多数不可接受的药品适应症获得了加拿大卫生部的批准。《国际处方》和加拿大卫生部审查这些药品适应症证据的时间差异不太可能解释它们评估结果的差异。加拿大卫生部监管标准的变化可能是这些药物存在的一个因素。迫切需要调查这些药物对服用它们的患者造成的危害是否大于益处。最后，应该审视加拿大卫生部批准这些药物的背后原因。
