School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.
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.
Front Public Health. 2023 Feb 24;11:1109668. doi: 10.3389/fpubh.2023.1109668. eCollection 2023.
Whether 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.
We 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 κ statistic to describe agreement between the two frameworks. Spearman's correlation coefficient was used to evaluate the correlation between price and value of drugs.
Between 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 (κ = 0.515, < 0.05). We found no statistically significant correlation between launch price of drugs and clinical benefit according to both frameworks.
Not 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.
癌症药物的高成本是否与其对患者的价值相称，已成为公众关注的焦点。本研究旨在评估中国批准的实体瘤新药的价值，并探讨药物价格与价值之间的关系。
我们确定了 2016 年至 2020 年期间中国国家药品监督管理局（NMPA）批准的所有用于实体瘤的新药。根据美国临床肿瘤学会价值框架（ASCO-VF）和欧洲肿瘤内科学会临床获益量表（ESMO-MCBS）评估这些药物的价值。我们计算了 κ 统计量来描述两种框架之间的一致性。采用 Spearman 相关系数评估药物价格与价值之间的相关性。
2016 年至 2020 年期间，NMPA 批准了 37 种用于实体瘤的新药，我们可以评估 28 种药物（76%）的价值。8 种（29%）药物用于非小细胞肺癌，6 种（21%）用于乳腺癌。ASCO-VF 评分为-20 至 110.1，中位数为 43.3（四分位间距 27.1-58.35）。只有 7 种药物（25%）符合 ASCO-VF 截止值。根据 ESMO-MCBS，有 13 种药物具有有意义的价值。这两种框架阈值之间的一致性仅为中等（κ=0.515， < 0.05）。根据这两种框架，我们未发现药物上市价格与临床获益之间存在统计学显著相关性。
并非所有 NMPA 批准的新型癌症药物都具有 ASCO-VF 或 ESMO-MCBS 所衡量的有意义的价值。药物价格与临床获益水平之间没有显著相关性。
