ABSTRACT
OBJECTIVE: To provide reference for improving the purchase management policy of priority reviewed drugs in China. METHODS: Based on the purchase management policy of priority reviewed drugs in China, priority reviewed drugs approved for market by the end of 2017 were sorted out; the priority reviewed drugs that had been purchased in a clear way were selected and classified according to the reasons for their inclusion in the priority review. The procurement methods of different categories of priority reviewed drugs in different provinces were compared in order to find out the shortcomings of priority reviewed drug procurement management and put forward related suggestions. RESULTS & CONCLUSIONS: By the end of 2017, 56 priority reviewed drugs achieved marketing authorization, 16 of which were purchased through provincial drug procurement platforms. Among the 16 drugs mentioned above, there were 13 priority reviewed drugs of which purchase methods were specific, including direct online purchase, price-limited online purchase, bidding purchase, price-negotiated purchase, bidding purchase and record purchase. And the direct online purchase was used the most frequently. According to the reasons included in the priority review, above 13 drugs with specific purchase methods were divided into 5 categories such as new drugs with obvious clinical value, urgent medical needed drugs, pediatric drugs, first generic drugs, the drugs which had passed investigational new drug application. China’s purchase management policy of priority reviewed drugs still had shortcomings through three aspects, including the system design, purchase method and management procedure. There is no sufficient connection between the registration review policy and the procurement policy. In addition to the clinical badly-needed priority reviewed drugs, the procurement methods of priority reviewed drugs in the remaining categories was not uniform, and the regional difference was large. And the utilization degree of pharmacoeconomic evaluation during the drug purchasing process needed to be improved. It is suggested to make the category of drug purchase more detailed combining with the classification of drug registration, unify the method of drug purchase to make the purchase way of each kind of priority reviewed drugs explicit, standardize the management of drug purchase and improve the attention and utilization of pharmacoeconomic evaluation, so as to improve the accessibility of priority reviewed drugs in China.