Independent Researcher, 158 Front Street E, Toronto, ON M5A 0K9, Canada.
Macdonald-Laurier Institute, Ottawa, ON K1N 7Z2, Canada.
Curr Oncol. 2024 Sep 18;31(9):5599-5607. doi: 10.3390/curroncol31090414.
Canada is known to have a complex pathway for new drug approval and reimbursement, resulting in delayed access for patients with serious and life-threatening diseases, such as cancer. Several recent publications from key stakeholders, including patients, physicians and policymakers, highlight patient helplessness, physician frustrations and policymakers entangled in a massive network of bureaucracy unable to make headway. Several quantitative and qualitative assessments using time from regulatory approvals to successful reimbursements confirm long review times and high rejection rates for oncology drugs, especially those receiving conditional approvals. A consensus forum of 18 Canadian oncology clinicians recently voiced frustration with the process and inability to deliver guideline-supported efficacious therapies to their patients. This manuscript compares data extracted from publicly available data sources from 2019 to June 2024 to previous publications. Public databases from Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH), which is in the process of changing to Canada's Drug Agency, and the pan-Canadian Pharmaceutical Alliance (pCPA) were reviewed and the data collected were analyzed with descriptive statistics. From the data, three trends emerge, (i) an increasing number of oncology drugs are receiving conditional approvals from Health Canada, (ii) the percentage of conditionally approved oncology drugs receiving positive reimbursement recommendations from CADTH is still low but appears to be improving, but delays in access are now contingent upon pCPA deciding whether to negotiate price and then the duration of any negotiation, and (iii) real-world evidence is no longer part of the decision-making for conditional approvals. A slight increase in the positive endorsement of RWE used to support CADTH recommendations was observed. The lack of timely access to oncology drugs hurts Canadian patients. While a small trend of improvement appears to be emerging, longer-term data collection is required to ensure sustained patient benefits.
加拿大新药审批和报销途径复杂，导致癌症等严重危及生命的疾病患者获得治疗的时间延迟。最近，包括患者、医生和政策制定者在内的一些关键利益相关者发表了几篇文章，强调了患者的无助、医生的沮丧以及政策制定者陷入庞大的官僚主义网络中无法取得进展。几项使用从监管批准到成功报销的时间进行的定量和定性评估证实，肿瘤药物的审查时间长，拒绝率高，特别是那些获得有条件批准的药物。最近，一个由 18 名加拿大肿瘤临床医生组成的共识论坛对这一过程表示不满，并表示无法为其患者提供符合指南的有效治疗方法。本文比较了从 2019 年 6 月至 2024 年 6 月从公开数据来源提取的数据与之前的出版物。审查了加拿大卫生部、加拿大药品和技术评估机构（CADTH）——该机构正在更名为加拿大药品管理局——以及泛加拿大制药联盟（pCPA）的公共数据库，使用描述性统计方法对收集的数据进行了分析。从数据中得出了三个趋势，（i）越来越多的肿瘤药物获得了加拿大卫生部的有条件批准，（ii）CADTH 对有条件批准的肿瘤药物的正面报销建议的百分比仍然较低，但似乎在提高，但获得批准的时间现在取决于 pCPA 是否决定协商价格以及任何谈判的持续时间，（iii）现实世界的证据不再是有条件批准决策的一部分。观察到用于支持 CADTH 建议的条件性批准的真实世界证据的使用略有增加。及时获得肿瘤药物的机会不足，会对加拿大患者造成伤害。虽然出现了一个略微改善的趋势，但需要进行更长期的数据收集，以确保患者持续受益。
