Temporal trends and geographic differences of insurance coverage for cancer drug trials in mainland China
Huiyao Huang1*, Yu Tang1*, Qi Fan1, Dawei Wu1, Jun Wang2, Shuhang Wang1, Hong Fang1, Yue Yu1, Yuan Fang1, Ying Bai1, Chao Sun1, Anqi Yu1, Zhu Qi3, Tao Wei3, Zhao Yan4, Ye Cao5, Min Jiang6, Yanfei Liu7, Kunyan Li8, Ning Li1
1Department of Clinical Trial Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
2National Center for Drug Evaluation, China Food and Drug Administration, Beijing, China.
3School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing, China.
4Department of Clinical Trial Center, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
5Department of Clinical Trial Center, Sun Yat-sen University Cancer Center, Guangzhou, China.
6Department of Clinical Trial Center, Peking University Cancer Hospital & Institute, Beijing, China.
7Department of Clinical Trial Center, Fudan University Shanghai Cancer Center, Shanghai, China.
8Department of Clinical Trial Center, Hunan Cancer Hospital, Changsha, China.
Correspondence: Ning Li (Director of Clinical Trial Office, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, 17 South Panjiayuan Lane, Chaoyang District, Beijing, 100021, People’s Republic of China; E-mail: firstname.lastname@example.org).
*These authors contributed equally to this work.
Asia-Pacific Journal of Oncology 2020, https://doi.org/10.32948/ajo.2020.10.11
Background Data on insurance coverage of cancer drug trials in mainland China was of paucity, especially for its time trend and regional difference.
Methods Based on the national authoritative database, time trend analysis of insurance coverage of cancer drug trials was conducted, from both the perspectives of trials and participants. Meanwhile, group comparisons by region, drug type and study phase, were also performed. Mann-Kendall test was used for trend analysis, and chi-square test was used to conduct group comparisons.
Results A total of 1889 clinical trials were included, with 333 being international trials. In average, the insurance rate of trials was 79.8%, and it was steadily increased by 6.8% annually from 2010 to 2019. While the insurance coverage of Chinese participants was 67.6%, and it showed a wavy upward trend. Compared with international trials (91.9%), insurance rate of domestic trials (77.2%) was significantly lower (P < 0.001), but the rate gap decreased gradually. The comparisons by region showed that, the insurance rate in Northeast China (86.6%) was the highest, while that for Northwest China (40.0%) was lowest. Additionally, traditional Chinese medicine trials, and BE studies had significantly lower rate of insurance.
Conclusion The insurance coverage of cancer drug trials in mainland China has been increasing steadily over the past decade. However, the regional differences are significant. To promote insurance coverage emphatically in underdeveloped areas could be our work emphasis. Although this study specially included cancer drug trials, the results could also provide reference for trials in all other fields.
Key words Neoplasms, clinical trial, insurance, time trend, regional difference