Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.
Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA.
J Manag Care Spec Pharm. 2024 Dec;30(12):1349-1354. doi: 10.18553/jmcp.2024.30.12.1349.
Per capita spending on drugs in the United States is double that of Canada. One commonly debated point when comparing the 2 countries is whether this additional spending allows residents of the United States access to valuable therapies not available in Canada.
To characterize the therapeutic value of prescription drugs used in the United States that are not marketed in Canada.
This cross-sectional study used IQVIA Multinational Integrated Data Analysis System data to identify drugs purchased in the United States but not in Canada from 2017 to 2021. Drug listing and regulatory review statuses were obtained. We categorized the drugs into 8 mutually exclusive groups: listing status in Canada ("cancelled post-market" or "dormant; approved but not marketed; cancelled pre-market"), other alternatives available ("formulation unavailable," "existing drug class," or "therapeutically similar"), "pre-approval," "atypical access available," or "unavailable without alternatives marketed" in Canada. Therapeutic value assessments of drugs in the last category were obtained from 3 international organizations.
2,084 products were purchased in the United States but not in Canada from 2017 to 2021; 1,685 were excluded because they were not prescription drugs, were combinations in which each active pharmaceutical ingredient was already available in the United States as a separate drug, had been discontinued in the United States by August 30, 2023, or were marketed in Canada by August 30, 2023. After exclusions, there were 399 drugs; 120 (30%) were "cancelled post-market," 38 (10%) were "dormant; approved but not marketed; cancelled pre-market," 49 (12%) were "formulation unavailable," 130 (33%) were "existing drug class," 35 (9%) were "therapeutically similar," 3 (1%) were "preapproval," 15 (4%) were "atypical access available," and 9 (2%) were "unavailable" in Canada. 6 of the 9 drugs had been evaluated by 1 or more independent organizations, and all 6 were rated as offering minor to no additional therapeutic value compared with existing drugs.
There was similar access to important prescription drug therapies in the United States and Canada. Overall, the additional spending in the United States may not have necessarily translated into access to important therapeutic innovations.
美国的人均药品支出是加拿大的两倍。在比较这两个国家时，人们经常争论的一点是，这种额外的支出是否让美国居民能够获得在加拿大无法获得的有价值的疗法。
描述在美国使用但未在加拿大上市的处方药物的治疗价值。
本横断面研究使用 IQVIA 多国综合数据分析系统的数据，确定了 2017 年至 2021 年期间在美国购买但在加拿大未购买的药物。获取了药物上市和监管审查状况。我们将药物分为 8 个互斥组：加拿大的上市状况（“上市后取消”或“休眠；批准但未上市；上市前取消”）、其他可用替代药物（“制剂不可用”、“现有药物类别”或“治疗上相似”）、“预批准”、“非典型准入可用”或“在加拿大无替代药物可用”。对最后一类药物的治疗价值评估来自 3 个国际组织。
2017 年至 2021 年期间，在美国购买但在加拿大未购买的产品有 2084 种；由于它们不是处方药、是每种活性药物成分在美国都已作为单独药物上市的组合、已在美国于 2023 年 8 月 30 日之前停产、或在加拿大于 2023 年 8 月 30 日之前上市，因此排除了 1685 种产品。排除后，有 399 种药物；120 种（30%）为“上市后取消”，38 种（10%）为“休眠；批准但未上市；上市前取消”，49 种（12%）为“制剂不可用”，130 种（33%）为“现有药物类别”，35 种（9%）为“治疗上相似”，3 种（1%）为“预批准”，15 种（4%）为“非典型准入可用”，9 种（2%）在加拿大“不可用”。其中 9 种药物中的 6 种已被 1 个或多个独立组织评估，所有 6 种药物均被评为与现有药物相比提供的治疗价值较小或没有额外价值。
美国和加拿大的重要处方药物治疗方法可获得性相似。总体而言，美国的额外支出不一定转化为获得重要治疗创新的机会。
