Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University, Haidian District, Xueyuan Road No. 38, Beijing, 100191, China.
State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, 999078, China.
Health Res Policy Syst. 2022 Jan 3;20(1):3. doi: 10.1186/s12961-021-00810-1.
In China, health technology assessment (HTA) has recently been adopted in pricing negotiation for medicine listing in the National Reimbursement Drug List. At present, how HTA is applied to inform the decision-making process remains underreported. In order to explore how the adoption of HTA was translated into listing and price negotiation results in light of the confidential nature of the negotiating process, this study aimed to compare the negotiated price and the clinical benefit of selected targeted anticancer medicines (TAMs) involved in the 2019 negotiation.
Among 16 TAMs successfully negotiated, only four TAMs representing four indication groups had appropriate reference medicines for comparison and were, therefore, included in the analysis. The price and clinical benefit of the four TAMs were compared against one or two reference medicines with the same initial indications. The sales prices for nine TAMs before and after the negotiation were extracted from the centralized medication procurement system. Clinical benefits were evaluated based on evidence from published articles and clinical guidelines. The results suggested that, despite the application of HTA, both rational and irrational decisions had been made about the reimbursement of TAMs in the 2019 negotiation, warranting further investigation.
While the development and adoption of HTA has seen significant progress in China, actions are needed to ensure that the adoption of HTA is effectively applied in decisions on the reimbursement of medicines.
在中国，卫生技术评估（HTA）最近已被用于国家医保药品目录药品上市定价谈判。目前，HTA 如何应用于为决策过程提供信息的相关研究还较少。由于谈判过程的保密性，本研究旨在探索如何将 HTA 的应用转化为谈判结果和列入目录的结果，选择了参与 2019 年谈判的部分抗肿瘤靶向药物（TAMs），比较其谈判价格和临床获益。
在成功谈判的 16 个 TAMs 中，仅有 4 个代表 4 个适应证组的 TAMs 有适当的对照药物进行比较，因此纳入了分析。对 4 个 TAMs 的价格和临床获益与相同初始适应证的 1 个或 2 个对照药物进行了比较。从集中采购系统中提取了 9 个 TAMs 谈判前后的销售价格。临床获益基于已发表文章和临床指南中的证据进行评估。结果表明，尽管应用了 HTA，但在 2019 年谈判中，TAMs 的报销决策仍存在合理和不合理的情况，需要进一步调查。
尽管中国在 HTA 的开发和应用方面取得了重大进展，但仍需要采取行动，确保 HTA 的应用能够有效地应用于药品报销决策中。
