On November 28 th , 2019, the National Healthcare Security Administration (NHSA) and the Ministry of Human Resources and Social Security (MOHRSS) of China announced the results of drug pricing negotiations. Seventy first-negotiated drugs with 60.7% average price decrease and twenty-seven re-negotiated medicines with 26.4% average price fall, involving 11 disease categories, were successfully incorporated into National Reimbursement Drug List (NRDL). Medicines that successfully get accessed to NRDL are mostly new listings with high clinical value, and more than half of them are manufactured by Chinese enterprises. Compared to the negotiated drug list of 2017, the biggest increase in western medicines is the alimentary tract and metabolism (10 drugs added), and the traditional Chinese medicine is internal medicine (17 drugs added). The negotiation follows the process including preparation, examination, negotiation, and announcement. There are several innovations in the procedure, such as the parallel calculation of the floor price, the introduction of competitive negotiations, allowing companies to apply for price confidentiality, and increasing government-enterprise communication before negotiations. Incorporating patented drugs into NRDL by negotiation not only helps patients reduce the economic burden, but also encourages pharmaceutical companies to innovate.

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In order to ascertain the current status of and challenges posed by the incidence and prevalence of rare diseases in China, this study teases out data on the incidence and prevalence of 121 rare diseases listed in China's First List of Rare Disease to provide rationales and references for the development and promotion of rare-disease-related policies. The National Health Commission of the People's Republic of China issued the Rare Disease Diagnosis and Treatment Guide (2019) (denoted here as China's Rare Disease Diagnosis and Treatment Guide), which cited data on the incidence/prevalence of 21 rare diseases (21 of 121 rare diseases, 17.36%). Data on 68 diseases (56.20%) were found in monographs, literature databases, and official websites. Data on the incidence/prevalence of 70 diseases were compiled, though no data were available for the 51 remaining diseases. There are published data on the incidence/prevalence of only 14 diseases at the national level. Sources of data on the incidence and prevalence of rare diseases mainly include cases counts from hospitals (40.56%), other sources of data (24.48%), screening (20.98%), cross-sectional studies (8.39%), and estimates from models (7.69%). Data on the incidence/prevalence of rare diseases in China are limited and typically lack accuracy, uniformity, and timeliness. Epidemiological data at the national level are greatly lacking, and data are not amenable to comparison. China recently initiated epidemiological studies of rare diseases at the national and regional level. The country will continue to promote, use, and update its list of common rare diseases, actively encourage the coding and registration of cases of rare diseases, and take actions to collect, share, and use that information.