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Abstract：
BACKGROUND: The potential role played by launch price and clinical value in reimbursement decisions has not been sufficiently established in China. This study aimed to investigate the association of launch price and clinical value with reimbursement decisions for anticancer drugs after the implementation of reimbursement-linked price negotiation in China.
METHODS: Anticancer drugs approved by the National Medical Products Administration (NMPA) of China from January 2017 to June 2022 were eligible for inclusion. Approval and reimbursement dates of included drug indications were retrieved from publicly available resources. We collected measures of clinical value, including survival, quality of life (QoL), and overall response rate from pivotal clinical trials and calculated treatment price at launch. Univariate and multivariate Cox proportional hazards models were employed to estimate the association between launch price, clinical value, and reimbursement decisions of anticancer drugs in China.
RESULTS: The median reimbursement lag was 579 days (interquartile range [IQR]: 402-936) for 93 indications supported by randomized controlled trials and 637 days (IQR: 373-858) for 42 indications supported by single-arm clinical trials. Reimbursement was granted to 60 (65%) and 23 (55%) indications supported by randomized controlled and single-arm clinical trials, respectively. The launch price of anticancer drugs was not associated with reimbursement decisions in multivariate regression analyses. Indications supported by randomized controlled trials with higher clinical value were more likely to be reimbursed (hazard ratio [HR] for survival=1.07, 95% CI: 1.00-1.15, P=.037), while the overall response rate of indications supported by single-arm clinical trials was not associated with the likelihood of being reimbursed (HR=2.09, 95% CI: 0.14-32.28, P=.595).
CONCLUSIONS: The launch price of anticancer drugs may not have a significant impact on reimbursement decisions, while the implementation of reimbursement-linked price negotiation in China has prioritized anticancer drugs with higher clinical value, but only for indications supported by randomized controlled trials. Efforts are needed to prioritize indications supported by single-arm clinical trials that have higher value during the process of price negotiation.
METHODS: Anticancer drugs approved by the National Medical Products Administration (NMPA) of China from January 2017 to June 2022 were eligible for inclusion. Approval and reimbursement dates of included drug indications were retrieved from publicly available resources. We collected measures of clinical value, including survival, quality of life (QoL), and overall response rate from pivotal clinical trials and calculated treatment price at launch. Univariate and multivariate Cox proportional hazards models were employed to estimate the association between launch price, clinical value, and reimbursement decisions of anticancer drugs in China.
RESULTS: The median reimbursement lag was 579 days (interquartile range [IQR]: 402-936) for 93 indications supported by randomized controlled trials and 637 days (IQR: 373-858) for 42 indications supported by single-arm clinical trials. Reimbursement was granted to 60 (65%) and 23 (55%) indications supported by randomized controlled and single-arm clinical trials, respectively. The launch price of anticancer drugs was not associated with reimbursement decisions in multivariate regression analyses. Indications supported by randomized controlled trials with higher clinical value were more likely to be reimbursed (hazard ratio [HR] for survival=1.07, 95% CI: 1.00-1.15, P=.037), while the overall response rate of indications supported by single-arm clinical trials was not associated with the likelihood of being reimbursed (HR=2.09, 95% CI: 0.14-32.28, P=.595).
CONCLUSIONS: The launch price of anticancer drugs may not have a significant impact on reimbursement decisions, while the implementation of reimbursement-linked price negotiation in China has prioritized anticancer drugs with higher clinical value, but only for indications supported by randomized controlled trials. Efforts are needed to prioritize indications supported by single-arm clinical trials that have higher value during the process of price negotiation.
摘要：
背景：在中国实施与报销挂钩的价格谈判后，研究抗癌药物的上市价格和临床价值与报销决策的关系。
方法：2017年1月至2022年6月中国国家药监局批准的抗癌药物符合纳入条件。所包括的药物适应症的批准和报销日期是从公开可用的资源中检索的。我们收集了临床价值的测量，包括生存,生活质量,以及关键临床试验的总体反应率和启动时计算的治疗价格。单变量和多变量Cox比例风险模型被用来估计发射价格之间的关联，临床价值，和中国抗癌药物的报销决定。
结果：对于随机对照试验支持的93种适应症，中位补偿滞后为579天（IQR：402-936），对于单组临床试验支持的42种适应症，中位补偿滞后为637天（IQR373-858）。60（65％）和23（55％）的适应症得到了随机对照和单臂临床试验的支持，分别。在多元回归分析中，抗癌药物的上市价格与报销决定无关。临床价值较高的随机对照试验支持的适应症更有可能获得报销（生存率HR=1.07，95CI：1.00-1.15，p=0.037），而单组临床试验支持的适应症的总体缓解率与获得报销的可能性无关(HR=2.09,95CI:0.14~32.28,p=0.595).
结论：抗癌药的上市价格可能不会对报销决定产生重大影响，虽然在中国实施与报销挂钩的价格谈判，但优先考虑了具有较高临床价值的抗癌药物，但仅限于随机对照试验支持的适应症。需要努力优先考虑在价格谈判过程中具有更高价值的单臂临床试验支持的适应症。
方法：2017年1月至2022年6月中国国家药监局批准的抗癌药物符合纳入条件。所包括的药物适应症的批准和报销日期是从公开可用的资源中检索的。我们收集了临床价值的测量，包括生存,生活质量,以及关键临床试验的总体反应率和启动时计算的治疗价格。单变量和多变量Cox比例风险模型被用来估计发射价格之间的关联，临床价值，和中国抗癌药物的报销决定。
结果：对于随机对照试验支持的93种适应症，中位补偿滞后为579天（IQR：402-936），对于单组临床试验支持的42种适应症，中位补偿滞后为637天（IQR373-858）。60（65％）和23（55％）的适应症得到了随机对照和单臂临床试验的支持，分别。在多元回归分析中，抗癌药物的上市价格与报销决定无关。临床价值较高的随机对照试验支持的适应症更有可能获得报销（生存率HR=1.07，95CI：1.00-1.15，p=0.037），而单组临床试验支持的适应症的总体缓解率与获得报销的可能性无关(HR=2.09,95CI:0.14~32.28,p=0.595).
结论：抗癌药的上市价格可能不会对报销决定产生重大影响，虽然在中国实施与报销挂钩的价格谈判，但优先考虑了具有较高临床价值的抗癌药物，但仅限于随机对照试验支持的适应症。需要努力优先考虑在价格谈判过程中具有更高价值的单臂临床试验支持的适应症。
