Document Type : Original Article

Authors

1 HEOA Group, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, China

2 Institute for Healthy Cities and West China Research Center for Rural Health Development, Sichuan University, Chengdu, China

3 School of Public Health, Imperial College London, London, UK

4 School of Public Administration, Sichuan University, Chengdu, China

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).
 
Conclusion 
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. 

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