Fifth Department of Medicine, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.
Department of Personalized Oncology, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.
Cardiovasc Drugs Ther. 2023 Aug;37(4):683-694. doi: 10.1007/s10557-021-07310-y. Epub 2022 Jan 11.
Novel pharmaceutical treatments reducing cardiovascular events in dyslipidaemia patients must demonstrate clinical efficacy and cost-effectiveness to promote long-term adoption by patients, physicians, and insurers.
To assess the cost-effectiveness of statin monotherapy compared to additive lipid-lowering therapies for primary and secondary cardiovascular prevention from the perspective of Germany's healthcare system.
Transition probabilities and hazard ratios were derived from cardiovascular outcome trials for statin combinations with icosapent ethyl (REDUCE-IT), evolocumab (FOURIER), alirocumab (ODYSSEY), ezetimibe (IMPROVE-IT), and fibrate (ACCORD). Costs and utilities were retrieved from previous literature. The incidence of major adverse cardiovascular events was simulated with a Markov cohort model. The main outcomes were the incremental cost-effectiveness ratios (ICER) per quality adjusted life year (QALY) gained.
For primary prevention, the addition of icosapent ethyl to statin generated 0.81 QALY and €14,732 costs (ICER: 18,133), whereas fibrates yielded 0.63 QALY and € - 10,516 costs (ICER: - 16,632). For secondary prevention, the addition of ezetimibe to statin provided 0.61 QALY at savings of € - 5,796 (ICER: - 9,555) and icosapent ethyl yielded 0.99 QALY and €14,333 costs (ICER: 14,485). PCSK9 inhibitors offered 0.55 and 0.87 QALY at costs of €62,722 and €87,002 for evolocumab (ICER: 114,639) and alirocumab (ICER: 100,532), respectively. A 95% probability of cost-effectiveness was surpassed at €20,000 for icosapent ethyl (primary and secondary prevention), €119,000 for alirocumab, and €149,000 for evolocumab.
For primary cardiovascular prevention, a combination therapy of icosapent ethyl plus statin is a cost-effective use of resources compared to statin monotherapy. For secondary prevention, icosapent ethyl, ezetimibe, evolocumab, and alirocumab increase patient benefit at different economic costs.
新型降脂药物在血脂异常患者中降低心血管事件的效果必须具有临床疗效和成本效益,才能促进患者、医生和保险公司的长期采用。
从德国医疗保健系统的角度评估他汀类药物单药治疗与原发性和继发性心血管预防的附加降脂治疗相比的成本效益。
从他汀类药物联合依折麦布(IMPROVE-IT)、依洛尤单抗(FOURIER)、阿利西尤单抗(ODYSSEY)、二十碳五烯酸乙酯(REDUCE-IT)和贝特类药物(ACCORD)的心血管结局试验中得出转移概率和风险比。成本和效用从以前的文献中检索得到。主要不良心血管事件的发生率通过马尔可夫队列模型进行模拟。主要结局是每获得一个质量调整生命年(QALY)的增量成本效益比(ICER)。
对于一级预防,依折麦布与他汀类药物联合使用可获得 0.81 QALY 和 14732 欧元的成本(ICER:18133),而贝特类药物则可获得 0.63 QALY 和 -10516 欧元的成本(ICER:-16632)。对于二级预防,依折麦布与他汀类药物联合使用可提供 0.61 QALY,并节省 5796 欧元(ICER:-9555),而依洛尤单抗则可提供 0.99 QALY 和 14333 欧元的成本(ICER:14485)。依洛尤单抗和阿利西尤单抗的 PCSK9 抑制剂分别提供 0.55 和 0.87 QALY,成本分别为 62722 欧元和 87002 欧元(ICER:114639 和 100532)。在 20000 欧元时,依折麦布(一级和二级预防)、阿利西尤单抗超过了 95%的成本效益概率,而依洛尤单抗则超过了 149000 欧元。
对于一级心血管预防,与他汀类药物单药治疗相比,依折麦布联合他汀类药物的联合治疗是一种具有成本效益的资源利用方式。对于二级预防,依折麦布、依洛尤单抗、阿利西尤单抗和贝特类药物以不同的经济成本增加了患者的获益。