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加拿大新癌症药物准入途径。

The Pathway for New Cancer Drug Access in Canada.

机构信息

Division of Medical Oncology, Department of Medicine, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1H 8L6, Canada.

Ottawa Hospital Research Institute, Ottawa, ON K1Y 4E9, Canada.

出版信息

Curr Oncol. 2022 Jan 21;29(2):455-464. doi: 10.3390/curroncol29020041.

DOI:10.3390/curroncol29020041
PMID:35200541
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8870298/
Abstract

Cancer treatment has evolved significantly over the past decade with the emergence of a multitude of new treatments across cancer types. Alongside the pace of drug discovery, the cost of cancer drugs has also increased. In the face of this growth in development and spending, it is crucial to have an understanding of the processes and pressures new drugs navigate to get to the market in Canada. This paper is a review of the complex, multi-step regulatory and funding process undertaken by cancer drugs in Canada. It reviews the role of Health Canada, the Patented Medicine Prices Review Board, the Health Technology Assessment, the pan-Canadian Pharmaceutical Alliance, and finally, the provincial, territorial, and federal payers. Recent developments are highlighted. Strategies to minimize duplication of effort, improve timeliness, and increase efficiency are explored. The cancer drug regulatory and funding process in Canada is complex, and an understanding of the current system and ongoing evolution is essential.

摘要

过去十年,癌症治疗取得了显著进展,各种癌症类型出现了大量新的治疗方法。随着药物发现的步伐,癌症药物的成本也在增加。面对这种发展和支出的增长,了解新药在加拿大进入市场所经历的过程和面临的压力至关重要。本文综述了加拿大癌症药物所经历的复杂的、多步骤的监管和资金审批过程。文中回顾了加拿大卫生部、专利药品价格审查委员会、卫生技术评估机构、加拿大全药网、以及最后省级、地区和联邦支付方的作用。本文还强调了最近的发展情况。探讨了最小化重复工作、提高及时性和提高效率的策略。加拿大的癌症药物监管和资金审批过程复杂,了解当前的系统和正在进行的演变是必不可少的。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd1d/8870298/2e52f986422b/curroncol-29-00041-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd1d/8870298/2e52f986422b/curroncol-29-00041-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd1d/8870298/2e52f986422b/curroncol-29-00041-g001.jpg

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Oncologist. 2020 Jan;25(1):e130-e137. doi: 10.1634/theoncologist.2019-0314. Epub 2019 Sep 10.
3
Pan-Canadian Pharmaceutical Alliance (pCPA): Timelines Analysis and Policy Implications.泛加拿大药品联盟(pCPA):时间线分析及政策影响
肿瘤临床研究的症结在哪里?我们能解决吗?
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Timeliness of Health Technology Assessments and Price Negotiations for Oncology Drugs in Canada.加拿大肿瘤药物卫生技术评估与价格谈判的及时性
Clinicoecon Outcomes Res. 2024 May 25;16:437-445. doi: 10.2147/CEOR.S462872. eCollection 2024.
5
New Anticancer Drugs: Reliably Assessing "Value" While Addressing High Prices.新型抗癌药物:在解决高价问题的同时,可靠地评估“价值”。
Curr Oncol. 2024 Apr 28;31(5):2453-2480. doi: 10.3390/curroncol31050184.
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Access to Oncology Medicines in Canada: Consensus Forum for Recommendations for Improvement.加拿大肿瘤药物的可及性:改进建议共识论坛。
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