Promoting China's model of innovative drug pricing rules
Objective To introduce the contents,significance of the policy on"Notice on Establishing Initial Launching Market Price Formation for Newly Original Chemicals and Encouraging High-Quality Innovation"issued by the China Healthcare Security Administration in 2024 and put forward suggestions for improvement.Methods The contents and requirements of economic analysis of new drugs with high,middle and low innovative degrees were summarized through policies analysis and literature review,the classification of added benefits of innovative drugs in America,Germany,France and Canada was compared.Results Great progress has been made in the research and development of innovative drugs in China in recent years.We should adhere to the basic principle that drug prices should be determined by the market,and give full play to the role of the government in supporting and guiding the prices of newly listed drugs.The innovation degree of new drugs is evaluated from three dimensions:pharmaceutical basis,clinical value and evidence-based information.The evaluation system consists of 3 first-grade indexes,13 second-grade indexes and 34 third-grade indexes,which are classified into high(90-150 scores),middle(50-90 scores)and low(below 50 scores)categories according to the scores value,to guide pharmaceutical companies to self-evaluating the innovation degree of newly listed chemicals.Conclusion The new policy encourages the development of high-quality innovative drugs,and takes the clinical value as the priority,paying attention on the added therapeutic benefit assessment.The new policy clarifies the composition of the"basket"and"initial price"of countries and regions of external reference pricing that has been established in China.The composition including 5 parts,the manufacturing costs,production period costs,sales profits,taxes,and distributor/wholesaler's mark-up.It should fully mobilize the initiative of free-pricing system by the pharmaceutical enterprises,recommendation from trade associations,clinical professional opinions issued by medical institutions,mobilize the enthusiasm of health technology assessment agencies and multi-disciplinary experts,finally conduct the social co-governance of drug prices in China.
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