Rapid health technology assessment of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia
- VernacularTitle:英克司兰治疗动脉粥样硬化性心血管疾病伴高胆固醇血症的快速卫生技术评估
- Author:
Xing GAO
1
;
Tianya LIU
2
;
Qian ZHANG
1
;
Bo ZHANG
1
;
Wei LI
1
;
Ling LIU
1
Author Information
1. Dept. of Pharmacy，the Affiliated Hospital of Xuzhou Medical University，Jiangsu Xuzhou 221004，China
2. Dept. of Anesthesiology，the Affiliated Hospital of Xuzhou Medical University，Jiangsu Xuzhou 221004，China
- Publication Type:Journal Article
- Keywords:
inclisiran;
atherosclerotic cardiovascular disease;
hypercholesterolemia;
rapid health technology assessment
- From:
China Pharmacy
2025;36(19):2460-2465
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To evaluate the efficacy， safety and economy of inclisiran in the treatment of atherosclerotic cardiovascular disease with hypercholesterolemia. METHODS A rapid health technology assessment （HTA） approach was employed. HTA reports， systematic reviews（SR）/meta-analyses， and pharmacoeconomic studies related to inclisiran were systematically identified through comprehensive searches of Chinese and English databases， including PubMed， Embase， the Cochrane Library， CNKI and Wanfang database， supplemented by HTA institutional repositories. The search timeframe spanned from database inception to April 2025. The results of the studies were descriptively analysed and summarized through literature screening， data extraction and literature quality assessment. RESULTS The final analysis included 22 studies， comprising one HTA report， 15 SR/meta-analyses， and 6 pharmacoeconomic evaluations. Regarding therapeutic efficacy， compared with control group， inclisiran could significantly reduce the levels of low-density lipoprotein cholesterol， proprotein convertase subtilisin/kexin type 9， total cholesterol， triacylglycerol， apolipoprotein B， and lipoprotein（a）， increase the level of high-density lipoprotein cholesterol， and reduce the risk of adverse cardiovascular events. In terms of safety， the inclisiran group showed no significant difference compared with the control group in the risk of total adverse events， serious adverse events， or non-serious adverse events； however， an increased incidence of injection site reactions was observed， most of which were mild. In terms of cost-effectiveness， there were discrepancies in research conclusions both domestically and internationally. More studies indicated that inclisiran did not demonstrate cost-effectiveness advantage and would require an appropriate price reduction to meet cost-effectiveness criteria. CONCLUSIONS Inclisiran demonstrates favorable efficacy and acceptable safety in treating atherosclerotic cardiovascular disease with hypercholesterolemia， though its economic profile requires improvement.
