Department of Cardiology, Medical Director Charité Cardiovascular Center (CC11), Campus Benjamin Franklin Charité - Universitätsmedizin Berlin, Hindenburgdamm 30, 12203, Berlin, Germany.
Department of Learning, Informatics, Management and Ethics, Karolinska Institutet, 171 77, Stockholm, Sweden.
Eur Heart J Qual Care Clin Outcomes. 2022 Jan 5;8(1):31-38. doi: 10.1093/ehjqcco/qcaa072.
To assess the cost-effectiveness of proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab added to standard-of-care lipid-lowering treatment [maximum tolerated dose (MTD) of statin and ezetimibe] in Swedish patients with a history of myocardial infarction (MI).
Cost-effectiveness was evaluated using a Markov model based on Swedish observational data on cardiovascular event rates and efficacy from the FOURIER trial. Three risk profiles were considered: recent MI in the previous year; history of MI with a risk factor; and history of MI with a second event within 2 years. For each population, three minimum baseline low-density lipoprotein cholesterol (LDL-C) levels were considered: 2.5 mmol/L (≈100 mg/dL), based on the current reimbursement recommendation in Sweden; 1.8 mmol/L (≈70 mg/dL), based on 2016 ESC/EAS guidelines; and 1.4 mmol/L (≈55 mg/dL), or 1.0 mmol/L (≈40 mg/dL) for MI with a second event, based on 2019 ESC/EAS guidelines. Proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab was associated with increased quality-adjusted life-years and costs vs. standard-of-care therapy. Incremental cost-effectiveness ratios (ICERs) were below SEK700 000 (∼€66 500), the generally accepted willingness-to-pay threshold in Sweden, for minimum LDL-C levels of 2.3 (recent MI), 1.7 (MI with a risk factor), and 1.7 mmol/L (MI with a second event). Sensitivity analyses demonstrated that base-case results were robust to changes in model parameters.
Proprotein convertase subtilisin/kexin type 9 inhibition with evolocumab added to MTD of statin and ezetimibe may be considered cost-effective at its list price for minimum LDL-C levels of 1.7-2.3 mmol/L, depending on risk profile, with ICERs below the accepted willingness-to-pay threshold in Sweden.
评估在瑞典有心肌梗死（MI）病史的患者中，与他汀类药物和依折麦布最大耐受剂量（MTD）的标准降脂治疗相比，添加前蛋白转化酶枯草溶菌素/糜蛋白酶 9 抑制剂（PCSK9i）依洛尤单抗的成本效益。
使用基于 FOURIER 试验中瑞典观察性心血管事件发生率和疗效数据的马尔可夫模型评估成本效益。考虑了三种风险状况：前一年有近期 MI；有 MI 危险因素的病史；以及 2 年内有第二次 MI 事件的病史。对于每个人群，考虑了三种最低基线低密度脂蛋白胆固醇（LDL-C）水平：2.5mmol/L（≈100mg/dL），基于瑞典目前的报销建议；1.8mmol/L（≈70mg/dL），基于 2016 年 ESC/EAS 指南；1.4mmol/L（≈55mg/dL）或 1.0mmol/L（≈40mg/dL），对于有第二次 MI 事件的患者，基于 2019 年 ESC/EAS 指南。与标准治疗相比，添加依洛尤单抗的 PCSK9i 治疗与增加的质量调整生命年和成本相关。在最低 LDL-C 水平分别为 2.3（近期 MI）、1.7（有危险因素的 MI）和 1.7mmol/L（有第二次 MI 事件的 MI）时，增量成本效益比（ICER）低于瑞典普遍接受的 70 万瑞典克朗（≈66500 欧元）支付意愿阈值。敏感性分析表明，基础案例结果对模型参数的变化具有稳健性。
对于最低 LDL-C 水平为 1.7-2.3mmol/L 的患者，添加依洛尤单抗的 PCSK9i 治疗可能被认为是具有成本效益的，具体取决于风险状况，ICER 低于瑞典普遍接受的支付意愿阈值。
