Clinical value assessment of innovative drugs in Canada’s health insurance access
- VernacularTitle:加拿大创新药医保准入临床价值评估研究
- Author:
Tianyi SHENG
1
;
Rong JIANG
1
;
Rong SHAO
2
Author Information
1. The Research Center of National Drug Policy & Ecosystem，China Pharmaceutical University，Nanjing 211198，China;NMPA Key Laboratory for Drug Regulatory Innovation and Evaluation，Nanjing 211198，China
2. The Research Center of National Drug Policy & Ecosystem，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
innovative drugs;
clinical value;
health insurance access;
Canada
- From:
China Pharmacy
2024;35(24):2972-2976
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To introduce the clinical value assessment model for innovative drugs in Canada’s health insurance access， providing a reference for improving the clinical value assessment system for innovative drugs in China. METHODS The clinical value assessment system for innovative drugs in Canada’s health insurance access was organized from four aspects： the assessment body， the assessment process， the assessment dimensions， and the application of assessment results. A deep analysis was also conducted with the clinical value assessment of health insurance access for blinatumomab as an example. Then the suggestions were proposed for the improvement of relevant work in China. RESULTS & CONCLUSIONS Canada has established an independent clinical value assessment agency， the Canadian Agency for Drug and Technologies in Health （CADTH）， which is responsible for the health technology assessment of innovative drugs. The health insurance access to clinical value assessment system for innovative drugs is built with patient needs as the guide， and the review process includes stages such as opinion review and expert assessment. Different evaluation dimensions are set for oncology and non-oncology drugs， and the assessment is based on sufficient evidence and a transparent process. The assessment results include four types： reimbursement， conditional reimbursement， time-limited reimbursement， and non-reimbursement， balancing efficacy and accessibility. It is suggested that China should strengthen the clinical value assessment system for innovative drugs in health insurance access from four aspects： establishing a specialized institution for the clinical value assessment of innovative drugs， increasing the clarity of policy expectations， including patient benefit assessment indicators， and adding special reimbursement pathways for drugs.
