Villa Guillermo, Lothgren Mickael, Kutikova Lucie, Lindgren Peter, Gandra Shravanthi R, Fonarow Gregg C, Sorio Francesc, Masana Lluis, Bayes-Genis Antoni, Hout Ben van
Economic Modeling CoE, Amgen, Zug, Switzerland.
Economic Modeling CoE, Amgen, Zug, Switzerland.
Clin Ther. 2017 Apr;39(4):771-786.e3. doi: 10.1016/j.clinthera.2017.02.011. Epub 2017 Mar 31.
Our objective was to assess the cost-effectiveness of evolocumab in patients at high risk of cardiovascular (CV) events from the Spanish National Health System perspective.
A Markov model was used to assess the cost-effectiveness (incremental [∆] cost per ∆ quality-adjusted life-year [QALY]; or cost utility) of evolocumab plus standard of care (SoC; statins) versus SoC, assuming lifetime treatment. Cohorts with baseline LDL-C >100 mg/dL and familial hypercholesterolemia (FH) or CV event history (secondary prevention [SP]) were considered. Lifetime CV event rates were predicted either (1) using risk equations considering local risk factors (Spanish Familial Hypercholesterolemia Cohort Study) adjusted to reflect the increased risk of FH patients or (2) using CV event rates from local registries (Information System for the Development of Research in Primary Care) for SP patients. LDL-C relative reductions from evolocumab trials (Evolocumab 140 mg Q2W (bi-weekly) and 420 mg QM (monthly)) were converted into CV event reductions using rate ratios per millimole per liter (mmol/L; 38.67 mg/dL) from a meta-analysis of statin trials (Cholesterol Treatment Trialists' Collaboration).
Predicted 10-year/lifetime CV risks were 50%/95% (FH) and 62%/82% (SP) for SoC and 27%/83% (FH) and 44%/69% (SP) for evolocumab plus SoC. Predicted 10-year/lifetime major CV event risks were 42%/86% (FH) and 47%/67% (SP) for SoC and 21%/68% (FH) and 31%/52% (SP) for evolocumab plus SoC. Predicted per patient-year rates of non-fatal/fatal CV events were 2.2/0.8 (FH) and 1.1/0.6 (SP) for SoC and 1.2/0.6 (FH) and 0.7/0.5 (SP) for evolocumab plus SoC. Predicted CV event reductions per mmol/L were 17% (FH) and 15% (SP). Evolocumab treatment was associated with increased QALYs and costs compared with SoC (FH: ∆cost, €65,369; ∆QALY, 2.12; incremental cost-effectiveness ratio [ICER], €30,893; SP: ∆cost, €42,266; ∆QALY, 0.93; ICER, €45,340).
Evolocumab plus to SoC may provide a cost-effective option for LDL-C lowering in FH and SP patients in Spain.
我们的目标是从西班牙国家卫生系统的角度评估依洛尤单抗在心血管（CV）事件高危患者中的成本效益。
采用马尔可夫模型评估依洛尤单抗联合标准治疗（SoC；他汀类药物）与SoC相比的成本效益（每质量调整生命年[QALY]的增量[∆]成本；或成本效用），假设进行终身治疗。考虑基线低密度脂蛋白胆固醇（LDL-C）>100mg/dL且患有家族性高胆固醇血症（FH）或有CV事件病史（二级预防[SP]）的队列。终身CV事件发生率的预测方法为：（1）使用考虑当地风险因素（西班牙家族性高胆固醇血症队列研究）的风险方程，并进行调整以反映FH患者增加的风险；或（2）使用来自当地登记处（初级保健研究发展信息系统）的SP患者的CV事件发生率。将依洛尤单抗试验（依洛尤单抗140mg每2周一次和420mg每月一次）中LDL-C的相对降低率，通过他汀类药物试验的荟萃分析（胆固醇治疗试验者协作组）中每毫摩尔每升（mmol/L；38.67mg/dL）对应的率比，转换为CV事件降低率。
对于SoC，预测的10年/终身CV风险分别为50%/95%（FH）和62%/82%（SP）；对于依洛尤单抗联合SoC，分别为27%/83%（FH）和44%/69%（SP）。对于SoC，预测的10年/终身主要CV事件风险分别为42%/86%（FH）和47%/67%（SP）；对于依洛尤单抗联合SoC，分别为21%/68%（FH）和31%/52%（SP）。预测的每患者年非致命/致命CV事件发生率，对于SoC分别为2.2/0.8（FH）和1.1/0.6（SP）；对于依洛尤单抗联合SoC分别为1.2/0.6（FH）和0.7/0.5（SP）。每降低1mmol/L预测的CV事件减少率为17%（FH）和15%（SP）。与SoC相比，依洛尤单抗治疗与QALY增加和成本增加相关（FH：∆成本，65369欧元；∆QALY，2.12；增量成本效益比[ICER]，30893欧元；SP：∆成本，42266欧元；∆QALY，0.93；ICER，45340欧元）。
在西班牙，依洛尤单抗联合SoC可能为FH和SP患者降低LDL-C提供一种具有成本效益的选择。
