摘要
目的系统评价前蛋白转化酶枯草溶菌素9(PCSK9)抑制剂预防高胆固醇血症患者心血管疾病的药物经济学评价研究,为优化临床治疗方案、制定相关政策及开展后续药物经济学评价研究提供参考。方法检索PubMed、中国知网等中英文数据库,收集建库至2023年10月8日发表的PCSK9抑制剂(依洛尤单抗、阿利西尤单抗)预防高胆固醇血症患者心血管疾病的药物经济学评价文献,使用2022版卫生经济学评价报告标准共识(CHEERS2022)量表进行文献质量评价,对纳入文献的基本信息、模型结构及相关参数、敏感性分析、结果等进行描述性分析。结果与结论共纳入29篇文献,总体质量较好。研究视角包括卫生体系、支付方、全社会等,均采用了Markov模型;效果和效用值数据主要来自既往研究,成本主要测算了直接成本,贴现率为每年1.5%~5.0%,意愿支付阈值多设定为1~3倍人均国内生产总值,健康产出指标大部分采用生存年和质量调整生命年;大部分研究的敏感性分析显示,基础评价结果具有稳健性,主要影响因素为药品价格。大部分的中国研究发现,急性冠脉综合征、心肌梗死、动脉粥样硬化性心血管疾病患者使用PCSK9抑制剂预防心血管疾病不具有经济学优势,仅部分特定群体(如三支病变患者、新发急性冠脉综合征且低密度脂蛋白胆固醇≥100 mg/dL的患者等)使用PCSK9抑制剂预防心血管疾病有经济性。建议后续研究参考CHEERS2022量表完善设计方案,尽量选择本土大样本、高质量数据,以提高报告质量和卫生决策的透明度,从而更准确地评价PCSK9抑制剂的经济性。
OBJECTIVE To systematically review the pharmacoeconomic evaluation literature about proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitors for the prevention of cardiovascular disease in patients with hypercholesterolemia,and to provide a reference for clinical treatment,health decision-making and future follow-up research.METHODS Retrieved from English and Chinese databases such as PubMed and CNKI,the pharmacoeconomic literature about PCSK9 inhibitors(evolocumab and alirocumab)for the prevention of cardiovascular disease in patients with hypercholesterolemia was collected from the establishment of the database to October 8,2023.The quality of the included literature was assessed with Consolidated Health Economic Evaluation Reporting Standards 2022(CHEERS 2022)scale.The descriptive analysis was performed for basic information,model structure,related parameters,sensitivity analysis and the results of included studies.RESULTS&CONCLUSIONS A total of 29 literature were included,with overall good quality.The evaluation mainly adopted the Markov model from the healthcare system,payer and societal perspective.The effectiveness and utility data mainly came from the previous studies;the direct cost was mainly considered with a discount rate of 1.5%-5.0%per year,while the willingness-to-pay threshold was often set at 1-3 times the gross domestic product per capita.Most health output indicators were measured in life years and quality-adjusted life years.The sensitivity analysis of most studies demonstrated the robustness and the main influential factor was the drug cost.Most Chinese studies showed that PCSK9 inhibitor was not cost-effective for the prevention of cardiovascular disease in patients with acute coronary syndrome,myocardial infarction and atherosclerotic cardiovascular disease.It was cost-effective to use PCSK9 inhibitors for the prevention of cardiovascular disease only in specific groups,such as patients with triple vessel disease,patients with newly diagnosed acute coronary syndrome and low-density li
作者
傅源源
周建成
邹颖
王璐颖
陈平钰
王永庆
FU Yuanyuan;ZHOU Jiancheng;ZOU Ying;WANG Luying;CHEN Pingyu;WANG Yongqing(Dept.of Pharmacy,the First Affiliated Hospital of Nanjing Medical University,Nanjing 210029,China;School of Pharmacy,Nanjing Medical University,Nanjing 211166,China;School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China)
出处
《中国药房》
CAS
北大核心
2024年第8期972-979,共8页
China Pharmacy
基金
江苏省卫生健康委员会药品临床综合评价项目(No.苏卫办药政〔2022〕1号)。
