机构:[1]School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China,四川省人民医院[2]Department of Pharmacy, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chengdu, Sichuan, China,临床药学部临床药学部四川省人民医院四川省肿瘤医院[3]Department of Pharmacy, Chengdu Second People’s Hospital, Chengdu, Sichuan, China,[4]Department of Pharmacy, The Third People’s Hospital of Chengdu, Chengdu, Sichuan, China
BackgroundWhether the high cost of cancer drugs is commensurate with their value to patients, which has become the focus of public concern. We aimed to assess the value of new cancer drugs approved for solid cancer in China and to explore the association between price and value of drugs. MethodsWe identified all new drugs for solid tumor that approved by the China's National Medical Products Administration (NMPA) between 2016 and 2020. The value of these drugs was assessed according to the American Society of Clinical Oncology Value Framework (ASCO-VF) and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). We calculated Cohen's kappa statistic to describe agreement between the two frameworks. Spearman's correlation coefficient was used to evaluate the correlation between price and value of drugs. ResultsBetween 2016 and 2020, 37 new drugs were approved by the NMPA for solid tumor and we could evaluate the value of 28 drugs (76%). Eight (29%) of drugs were approved for non-small-cell lung cancer and 6 (21%) for breast cancer. ASCO-VF scores had a range of -20 to 110.1, and the median score was 43.3 (inter-quartile range 27.1-58.35). Only seven drugs (25%) met the ASCO-VF cutoff score. By the ESMO-MCBS, 13 drugs showed a meaningful value. Agreement between these two frameworks thresholds was only fair (kappa = 0.515, P < 0.05). We found no statistically significant correlation between launch price of drugs and clinical benefit according to both frameworks. ConclusionsNot all NMPA-approved new cancer drugs had meaningful value as measured by ASCO-VF or ESMO-MCBS. There was no significant correlation between drug price and the level of clinical benefit.
基金:
Youth of the Natural Science Foundation of China [72204039]; Fundamental Research Funds for the Central Universities of China [ZYGX2021J033]; Medical Science and Technology Project of the Sichuan Provincial Health Commission [21PJ115]
第一作者机构:[1]School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China,
通讯作者:
推荐引用方式(GB/T 7714):
Luo Jing,Ou Shunlong,Wei Hua,et al.Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020[J].FRONTIERS IN PUBLIC HEALTH.2023,11:doi:10.3389/fpubh.2023.1109668.
APA:
Luo, Jing,Ou, Shunlong,Wei, Hua,Qin, Xiaoli,Peng, Rui...&Jiang, Qian.(2023).Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020.FRONTIERS IN PUBLIC HEALTH,11,
MLA:
Luo, Jing,et al."Value assessment of NMPA-approved new cancer drugs for solid cancer in China, 2016-2020".FRONTIERS IN PUBLIC HEALTH 11.(2023)