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

Abstract Background: In 2017, China launched a new round of medical reform (NMR) to solve the problems of "expensive and difficult to use drugs" for patients. The expensive and high-value therapeutic monoclonal antibodies (mAbs) have become the focus of attention. Promoting the availability and affordability of mAbs is an important way to improve the quality of life and health equity of patients. Methods: We used a standard method developed by the World Health Organization to conduct two surveys on mAbs’ availability and price before and after the NMR in the public general hospitals in Hubei province. By interviewing experts from these hospital pharmacies, we identified the factors that contributed to low accessibility and determined the effectiveness of NMR. Results: After the NMR, we found the average availability of 13 mAbs increased by 6.7% in the survey hospitals of Hubei Province. The median per unit price of 10 mAbs dropped by 34.3%. The average cost of a treatment cycle of 10 mAbs dropped from an equivalent of 529 days to 151 days of daily disposable income for a middle-income resident. Only trastuzumab and bevacizumab showed a significant decrease in price and a significant increase in availability, simultaneously. High price, lack of clinical demand and hospital drug procurement list, low income of patients, limited coverage and reimbursement of National Basic Medical Insurance (NBMI) for mAbs, and lack of incentives for generic mAbs were the main obstacles to the accessibility of mAbs. The drug negotiation mechanism of NBMI and the promotion of consistency evaluation of generic and original drugs can effectively promote the accessibility of mAbs. Conclusions: The availability and affordability of mAbs in Hubei Province have improved significantly, but still at a low level. There is currently no synergy between the policies of the NMR to promote the accessibility of the mAbs. In the future, we should implement R & D incentives for high-quality mAbs and generics, conduct medication evaluation and education of therapeutic mAbs, and design a special medical insurance payment method.