Résumé
OBJECTIVE To provide insights for enhancing the supply assurance capability of drugs in shortage in China. METHODS By sorting out top-level design ideas for Japan’s stable supply system for pharmaceuticals， this study elaborates on its current policies for stabilizing drug supply. Policy suggestions were proposed for existing challenges in the supply of drugs in shortage in China. RESULTS & CONCLUSIONS To stabilize drug supply， Japan formulated a systematic 3-tier policy framework that ran through pre-prevention， early risk monitoring， and response mechanisms for supply problems. Pre-prevention measures included establishing a graded classification system for stable supply lists， strengthening government control over the drug production process， and implementing a continuous supply system and cessation reporting system for post-market drugs. Early risk monitoring included self-assessing risks in enterprises， disclosing information concerning supply assurance of enterprises， and providing enterprises with price protection and incentives measures. Response mechanisms for supply problems included establishing the mechanism of increasing production and coordinated supply in enterprises， opening fast-track review and approval channels for changes in raw materials， and establishing emergency systems of transferring drugs to supply. To balance supply assurance and strong regulation of drugs in shortage through refining the incentive and regulatory policies for them， it is recommended to refine the criteria for selecting drugs in shortage， strengthen the circulation of information， optimize price management methods， and clarify problem feedback and solving.
Résumé
The cost-effectiveness analysis policy for drugs was institutionalized in Japan since 2019， realizing quantitative adjustment of price across varieties. A hierarchical categorization approach was adopted to select medicines with high expected annual sales. For selected medicines， adjustments were made to the premium and profit components within the existing price structure based on a pre-defined incremental cost-effectiveness ratio （ICER） threshold， effectively resolving the issue of inconsistent criteria and magnitudes caused by subjective judgment. Meanwhile， incentive measures like evaluation exemption or threshold enhancement were granted for specific medicines. Besides， a price adjustment mechanism， which was allowed for upward and downward adjustments， involving tiered ICER threshold and quantified formulas， had been established for the premium and profit components of drug price. In China’s National Reimbursement Drug List （NRDL） access， certain issues remained to be addressed： insufficient clarity in the quantitative mechanism of price formation， incomplete price adjustment measures， and lagging in the communication channels. It is recommended that the following measures could be referred to when further improving the scientificity and fairness of drug pricing during China’s NRDL access， such as enhancing the ICER threshold for medicines catering to special populations， quantifying criteria and extents for price adjustment， granting preferential pricing policies to pharmaceutical companies that present high-quality evidence of effectiveness， preceding communication channels with pharmaceutical companies， as well as exploring a price floor mechanism for the drugs with excessive price reduction.