Definition，Measurement and Evaluation of Drug Clinical Comprehensive Value from a Perspective of the Public Decision-making / 中国药房

ABSTRACT

OBJECTIVE：To provide reference for scientific decision-making of evaluation and application of clinical comprehensive value of drugs from the perspective of the public decision-making in China. METHODS ：Based on relevant documents and literatures ，drug clinical comprehensive value in other countries and areas ，the core indicators of drug clinical comprehensive value evaluation in China were confirmed. The concept and evaluation methods of each indicator were evaluated ， and relevant suggestions were put forward. RESULTS & CONCLUSIONS ：It’s suggested that the core indicators of China ’s drug clinical comprehensive value evaluation are safety and efficacy ，economy and affordability ，accessibility and fairness adherence ， suitability. The concepts of safety ，efficacy，economy，affordability and adherence indexes are clearly defined ，evaluation methods are systematic ，data sources are sufficient ，and international consensus exists in research design. There is no uniform definition of accessibility which composed of availability ，deliverability，availability，affordability and timeliness. The concept of equity is clearly defined and the evaluation method is systematic ，but the data source is insufficient. Appropriateness is evaluated by drug suitability index but there is no clear definition. Taking efficacy as an example ，efficacy includes intermediate indicators ，outcome indicators and quality of life indicators ，which are often confirmed by epidemiological research ，systematic evaluation and expert consensus. It ’s suggested that the Real World Study data should be used as much as possible when selecting or formulating the clinical comprehensive value indicators of drugs. With the help of multi-criteria decision-making analysis ，technical support should be provided by professional evaluation institutions ，and with the support of experts and researchers ，the above indicators should be empowered to form the clinical comprehensive value judgment of a drug by different public decision-making departments ，so as to decide whether to purchase ，use clinically ，or incorporate medical insurance reimbursement.