Department of Medical Oncology, BC Cancer, Vancouver, BC V5Z 4E6, Canada.
Department of Medicine, University of British Columbia, Vancouver, BC V6T 1Z4, Canada.
Curr Oncol. 2022 Jan 18;29(2):402-410. doi: 10.3390/curroncol29020036.
Accelerated approval (AA) by the FDA enables earlier access to promising new therapies. Health Canada has a similar process. Canada implemented a national health technology assessment (HTA) for reimbursement decisions in 2011. This study evaluated regulatory and funding timelines and decisions for FDA AA cancer therapies in Canada. The FDA's AA of malignant hematology and oncology from January 2000-December 2019 was reviewed. Dates from Health Canada, HTA decisions and provincial listings were collected. There were 94 FDA AAs, two of which were subsequently withdrawn. Of the 92 AAs, 70 received full (46)/conditional (24) Health Canada approval, and 22 were not filed. Since the introduction of HTA, 31 out of 45 of Health Canada's approved indications underwent HTA review: 18 received a positive recommendation conditional on cost-effectiveness, 8 were not recommended and 5 were withdrawn/suspended. The median time from the AA to any Health Canada approval is 9.4 months, from any Health Canada approval to HTA decision is 5.8 months and from HTA decision to the first formulary listing is 12.0 months. The access and timeline for the first formulary listing differences were observed between the USA and Canada due to the decision of pharmaceutical companies to submit (or not) to regulatory/HTA bodies, national procedural delays with different healthcare delivery models and submission timelines. This study demonstrates that there is delayed access to promising new therapies in Canada.
加速审批（AA）使 FDA 能够更早地获得有前途的新疗法。加拿大卫生部也有类似的程序。加拿大在 2011 年实施了国家卫生技术评估（HTA）用于报销决策。本研究评估了加拿大 FDA AA 癌症疗法的监管和资金时间表和决策。审查了 2000 年 1 月至 2019 年 12 月 FDA 对恶性血液学和肿瘤学的 AA。收集了来自加拿大卫生部、HTA 决策和省级上市的日期。有 94 项 FDA AA，其中两项随后被撤回。在 92 项 AA 中，70 项获得了完整（46）/有条件（24）加拿大卫生部批准，22 项未提交。自 HTA 推出以来，加拿大卫生部批准的 45 个适应症中有 31 个接受了 HTA 审查：18 个根据成本效益有条件推荐，8 个不推荐，5 个撤回/暂停。从 AA 到任何加拿大卫生部批准的中位数时间为 9.4 个月，从任何加拿大卫生部批准到 HTA 决定的中位数时间为 5.8 个月，从 HTA 决定到第一个处方清单的中位数时间为 12.0 个月。由于制药公司决定向监管/HTA 机构提交（或不提交）、不同医疗保健提供模式和提交时间表的国家程序延迟，观察到了美国和加拿大之间在第一个处方清单获取和时间线上的差异。本研究表明，加拿大获得有前途的新疗法的机会延迟。
