Availability and Affordability of Therapeutic Monoclonal Antibodies After the New Medical Reform in Hubei Province,China

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.