药物快速卫生技术评估方法学研究--以抗肿瘤用药为例

Methodological study of rapid health technology assessment of drugs:taking antitumor drugs as an example

目的建立适合中国国情的、基于证据整合与价值判断的药物快速卫生技术评估(rHTA)方法学。方法采用文献综述法对卫生技术评估(HTA)、多准则决策分析(MCDA)进行研究,以抗肿瘤用药为抓手,初步形成基于我国国情的rHTA方法;再通过专家咨询法对抗肿瘤药物rHTA方法进行论证;最后以治疗非小细胞肺癌的药物为例初步验证其可行性。结果所构建的rHTA方法结合了HTA和MCDA的理论与原则:应用HTA收集与整合文献证据和真实世界证据,同时运用MCDA由多个利益相关方从不同角度对可获取的药物信息进行价值测量,建立药物rHTA的操作流程、价值评估的维度和指标、评分系统,并经治疗非小细胞肺癌的药物实例验证该方法可行。结论建立了一套基于HTA与MCDA的药物rHTA方法学,能够实现数据的快速收集与证据的整合,在短时间内为决策者提供循证决策支持。

OBJECTIVE To develop a rapid health technology assessment(rHTA)methodology of drugs based on evidence integration and value judgment,which is suitable for China’s national conditions.METHODS The literature review was adopted to study health technology assessment(HTA)and multi-criteria decision analysis(MCDA),and then rHTA method based on China’s condition was formulated preliminarily with anti-tumor drugs;the method of rHTA was demonstrated by expert consultation;finally,the feasibility of rHTA was preliminarily verified taking the drugs for the treatment of non-small cell lung cancer as an example.RESULTS Established rHTA method combined the theory and principles of HTA and MCDA:HTA method was used to guide the collection and synthesis of literature and real-world evidence,while MCDA made the value measurements of achievable evidences by various stakeholders from different views;it established the working process,evaluation dimensions,evaluation indicators and scoring system of rHTA.The feasibility of this method was verified by the drug example of treating non-small cell lung cancer.CONCLUSIONS A set of drug-driven rHTA methodology guidance based on HTA and MCDA is established.It can quickly collect and integrate evidence,and provide evidence support for decision makers in a short time.