国家医保谈判药品新型GLP-1RA司美格鲁肽注射液的数字化遴选评价

目的 积极推进国家医保谈判药品新型胰高血糖素样肽-1受体激动剂(glucagon-like peptide-1 receptor agonist，GLP-1RA)周制剂司美格鲁肽注射液的临床准入工作。方法 通过量化评价体系优化、证据收集、综合分析决策3步，对司美格鲁肽注射液进行有效性、药学特性、安全性、经济性、其他属性五大项内容进行数字化评价。结果 经评价后可知司美格鲁肽注射液通过结构优化使半衰期延长至7 d，为GLP-1RA周制剂中最长。与人GLP-1氨基酸序列同源性在GLP-1RA周制剂中同源性最高，过敏反应发生率最低。因其独特的心血管获益被《2022美国糖尿病医学诊疗标准》和《2020中国2型糖尿病防治指南》等多部指南推荐用于合并2型糖尿病的动脉粥样硬化性心血管疾病患者，并可作为初始治疗以及2型糖尿病患者心血管病的一级预防。评价结果显示，司美格鲁肽注射液有效性得分25分，药学特性得分17.4分，安全性得分7.6分，经济性得分17分，其他属性得分11.3分，总分78.3分，遴选推荐级别为“推荐”。结论 司美格鲁肽注射液前3项核心属性良好，经医保谈判后，价格处于GLP-1RA周制剂中游水平，大大提高该药对于2型糖尿病患者的可及性，数字化遴选评价为该药的调入提供决策支持。

Digital Selection and Evaluation of State Negotiates Drugs of New GLP-1RA Semaglutide Injection

OBJECTIVE To actively promote the state negotiates drugs of new glucagon-like peptide-1 receptor agonist (GLP-1RA) weekly preparation of semaglutide injection clinical admission work. METHODS The effectiveness, pharmaceutical properties, safety, economy and other properties of semaglutide injection were digitally evaluated by three steps of optimization of quantitative evaluation system, collection of evidence and comprehensive analysis and decision. RESULTS After evaluation, the half-life of semaglutide injection was prolonged to 7 d by structural optimization, which was the longest in GLP-1RA weekly preparations. The amino acid sequence homology with human GLP-1 was the highest in GLP-1RA weekly preparations, and the incidence of allergic reaction was the lowest. Because of its unique cardiovascular benefits, it was recommended in several guidelines such as 《American Standards of Medical Care in Diabetes(2022)》 and 《Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China(2020)》 for patients with atherosclerotic cardiovascular disease as an initial treatment and as a primary prevention of cardiovascular disease in patients with type 2 diabetes mellitus. After the evaluation system was optimized, the efficacy score of semaglutide injection was 25 points, the pharmaceutical property score was 17.4 points, the safety score was 7.6 points, the economic score was 17 points, and the other attributes score was 11.3 points, total score was 78.3. The selection recommendation level was “recommendation”. CONCLUSION The first three core attributes of semaglutide injection were good. The price was in the mid-range of GLP-1RA weekly preparations after be negotiated by Medicare, greatly increasing its accessibility to patients with type 2 diabetes mellitus. The digital selection and evaluation of semaglutide injection provided decision support for the drug’s admission implemented.