Abstract
Objective
In 2017, China launched a new round of medical reform (NMR) to address the inaccessibility of high-priced drugs for patients with serious diseases. This study explored the impact of the NMR on the accessibility and affordability of high-priced monoclonal antibodies (mAbs), and the effective promotion policies after the NMR.
Methods
We used a standard method developed by the World Health Organization to conduct two surveys on the availability of mAbs and their prices before and after the NMR in the public hospitals in Hubei province, China. By interviewing hospital pharmacy experts, we identified the potential value of the current NMR in improving the access to therapeutic mAbs.
Results
The average availability of 13 mAbs increased by 8.1% in the surveyed hospitals of Hubei province after the NMR. The median unit price of 10 mAbs dropped by 34.3%. The average affordability of a treatment cycle of 10 mAbs dropped from 680 days to 298 days of the disposable daily income for a middle-income resident (56.2% reduction). The drug price negotiation of medical insurance inclusion and the promotion of consistent evaluation of generic and original drugs could effectively promote the accessibility of mAbs. However, the zero markup of drug pricing and the limit on the proportion of drug revenues in public hospitals showed certain negative effects on the availability of mAbs.
Conclusion
Not all current NMR policies play a positive role in promoting the accessibility of mAbs. To further improve the accessibility of mAbs in the future in China, it is therefore critical to increase the investment in independent research and development of high-quality mAbs, establish localized guidelines for the rational use of mAbs in clinical practice, and have a cost-sharing mechanism for high-priced drugs with multiple stakeholders.
Similar content being viewed by others
References
Posner J, Barrington P, Brier T, et al. Monoclonal Antibodies: Past, Present and Future. Handb Exp Pharmacol, 2019,260:81–141
Leavy O. Therapeutic antibodies: past, present and future. Nat Rev Immunol, 2010,10(5):297
Walsh G. Biopharmaceutical benchmarks 2018. Nat Botechnol, 2018,36(12):1136–1145
Jiang R, Sun Y, Ung C, et al. Research and development of mAb drugs in China: a look from policy perspectives. Hum Vaccin Immunother, 2019,15(11):2695–2705
Wellcome and IAVI. Expanding access to monoclonal antibody-based products: A global call to action. https://www.iavi.org/phocadownload/expanding/Expanding%20access%20to%20monoclonal%20antibody-based%20products.pdf. Accessed January 19 2021.
Schmier J, Ogden K, Nickman N, et al. Costs of Providing Infusion Therapy for Rheumatoid Arthritis in a Hospital-based Infusion Center Setting. Clin Ther, 2017,39(8):1600–1617
Upchurch G, Disco ME, Visco JL, et al. Medication Access in America and Medicare Part D: Prescription Shopping Saves but May Be Costly. J Am Geriatr Soc, 2018,66(1):33–40
Yazdany J, Dudley RA, Lin GA, et al. Out-of-Pocket Costs for Infliximab and Its Biosimilar for Rheumatoid Arthritis Under Medicare Part D. JAMA, 2018,320(9):931
The State Council of China. “Thirteenth Five-Year Plan” for deepening the medical reforms. http://www.gov.cn/zhengce/content/2017-01/09/content_5158053.htm. Accessed September 01 2019.
National Bureau of Statistics of China: 2019 China Household Survey Main Data. Beijing, China: China Statistics Press. 2019.
Ministry of Commerce of China. Statistical analysis report on the operation of China’s pharmaceutical distribution industry in 2016. http://images.mofcom.gov.cn/www/201706/20170614162924487.pdf. Accessed September 01 2019.
World Health Organization and Health Action International. Measuring medicine prices, availability, affordability and price components, 2nd edition. https://www.who.int/medicines/areas/access/OMS_Medicine_prices.pdf. Accessed January 01 2016.
National Catalogue Service for Geographic Information of China. 1:1 million national basic geographic database in China. http://www.webmap.cn/commres.do?method=result100W. Accessed September 10 2020.
National Medical Products Administration of China. Drug Search Database. http://qy1.sfda.gov.ex2.ipv6.nmpa.gov.cn/datasearchcnda/face3/base.jsp?tableId=25&tableName=TABLE25&title=%E5%9B%BD%E4%BA%A7%E8%8D%AF%E5%93%81&bcId=152904713761213296322795806604. Accessed September 30 2018.
Zhang M, Li J, Hu H, et al. Seizing the strategic opportunities of emerging technologies by building up innovation system: monoclonal antibody development in China. Health Res Policy Sy, 2015,13:64–75
Mendis S, Fukino K, Cameron A, et al. The availability and affordability of selected essential medicines for chronic diseases in six low- and middle-income countries. Bull World Health Organ, 2007, 85(4):279–288
Yang H, Dib HH, Zhu M, et al. Prices, availability and affordability of essential medicines in rural areas of Hubei Province, China. Health Policy Plan, 2010,25(3):219–229
World Health Organization. ATC/DDD Index 2019. https://www.whocc.no/atc_ddd_index/. Accessed April 01 2019.
World Health Organization. WHO Collaborating Centre for Drug Statistics Methodology. https://www.whocc.no/atc_ddd_methodology/who_collaborating_centre/. Accessed January 01 2019.
Human Resources and Social Security Department of Hubei Province of China. Notice of Drug List of Basic Medical Insurance, Work Injury Insurance and Maternity Insurance in Hubei Province. http://rst.hubei.gov.cn/fbjd/xxgkml/zcwj/zcfg/201711/t20171109_705503.shtml. Accessed March 01 2019.
Diao Y, Qian J, Liu Y, et al. How government insurance coverage changed the utilization and affordability of expensive targeted anti-cancer medicines in China: an interrupted time-series study. J Glob Health, 2019,9(2):20702
Elsevier. Daclizumab — an overview. https://www.sciencedirect.com/topics/agricultural-and-biological-sciences/daclizumab. Accessed March 28 2021.
National Institute For Health And Care Excellence of UK. Cetuximab, bevacizumab and panitumumab for the treatment of metastatic colorectal cancer after firstline chemotherapy. https://www.nice.org.uk/guidance/ta242/chapter/1-Guidance. Accessed January 19 2021.
Acknowledgments
The authors are grateful to the contribution made by all pharmacists, pharmacy experts, and managers from these hospitals surveyed in Hubei Province.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
The authors declare that they have no competing interests.
Additional information
This work was supported by the grants from the National Natural Science Foundation of China (No. 70903025, No. 71373089).
Supplementary data
Rights and permissions
About this article
Cite this article
Ding, Yf., Zhang, Jw., Xia, Mj. et al. Availability and Affordability of Therapeutic Monoclonal Antibodies After the New Medical Reform in Hubei Province, China. CURR MED SCI 42, 1325–1333 (2022). https://doi.org/10.1007/s11596-022-2677-2
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11596-022-2677-2