藥品價值評估框架的構(gòu)建作為藥物政策研究的一個新興領(lǐng)域已得到廣泛的關(guān)注。美國食品藥品管理局（FDA）從2009年開始組織專家構(gòu)建了以藥品風(fēng)險-效益評估框架為基礎(chǔ)的藥品價值評估體系，并將其用于人用藥品的管理決策中。從FDA風(fēng)險-效益評估框的構(gòu)成、每個價值維度的評估要點以及框架的特點等方面對其進行了深度的解析，并結(jié)合我國藥品價值評估工作開展的現(xiàn)狀，從我國建立藥品價值評估框架迫切性與必要性、以藥品發(fā)現(xiàn)階段為切入點構(gòu)建全生命周期動態(tài)評估框架和將定性與定量方法相結(jié)合的框架體系構(gòu)建等3個方面提出建議。

Construction of drug value assessment framework has gained extensive attention in the field of drug policy research. U.S FDA has been set out to establish the drug value assessment framework based on the benefit-risk evaluation since 2009. This paper systematically introduced the composition, basic elements and key assessment considerations of FDA benefit-risk evaluation framework, and also analyzed the characteristics of FDA framework. Moreover, we put forward three suggestions about the establishment of China drug value evaluation system, including (1) the necessity and urgency for establishment of drug value assessment system in China; (2) establishing a dynamic framework covering life-time evaluation beginning with drug discovery phase; (3) Combing qualitative and quantitative methods together to construct the drug value assessment framework.

R951

國家食品藥品監(jiān)督管理總局政策研究課題（G20150I）