Olry de Labry Lima Antonio, Gimeno Ballester Vicente, Sierra Sánchez Jesús Francisco, Matas Hoces Antonio, González-Outón Julio, Alegre Del Rey Emilio Jesús
Área de Gestión de Servicios y Profesionales de la Salud, Escuela Andaluza de Salud Pública (EASP), Granada, Spain; Instituto de Investigación Biosanitaria (IBS), Hospitales Universitarios de Granada/Universidad de Granada, Granada, Spain; Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública (CIBERESP), Spain.
Servicio de Farmacia, Hospital Universitario Miguel Servet, Zaragoza, Spain.
Rev Esp Cardiol (Engl Ed). 2018 Dec;71(12):1027-1035. doi: 10.1016/j.rec.2018.05.003. Epub 2018 Jun 22.
To analyze the cost-effectiveness ratio and budget impact of treatment with evolocumab (PCSK9 inhibitor) for patients in secondary prevention in the Spanish National Health System.
A budget impact analysis, decision tree and Markov models were designed under the public health system perspective, based on the only study with morbidity and mortality data (FOURIER). The alternatives compared were evolocumab vs statins, and dual therapy with ezetimibe in 5% of the population. The measure of effectiveness used was the number of cardiovascular events avoided. Univariate and probabilistic sensitivity analyses were performed.
The average annual cost of patients receiving evolocumab was 11 134.78€ and 393.83€ for standard treatment (statins plus ezetimibe). The incremental cost-effectiveness ratio was > 600 000 € per avoided cardiovascular event for both assessed outcomes (first: cardiovascular death, myocardial infarction, stroke, and hospitalization due to unstable angina or coronary revascularization; second: includes the first 3 events). To perform the 10-year Markov model, the average cost of standard treatment was 13 948.45€ vs 471 417.37€ with evolocumab. Treatment with evolocumab for patients with familial hypercholesterolemia would cost between 3 and 6.1 million euros, assuming a difference of 2.5 and 5.1 million euros with the standard treatment (2017). This difference would be between 204.3 and 1364.7 million euros (2021) for those with nonfamiliar hypercholesterolemia (secondary prevention).
Treatment with evolocumab is associated with a lower frequency of cardiovascular events, but is inefficient for patients suitable to receive this drug in the Spanish National Health System.
分析在西班牙国家卫生系统中，使用依洛尤单抗（一种前蛋白转化酶枯草溶菌素9[PCSK9]抑制剂）对二级预防患者进行治疗的成本效益比和预算影响。
基于唯一一项包含发病率和死亡率数据的研究（FOURIER），从公共卫生系统角度设计了预算影响分析、决策树和马尔可夫模型。比较的方案为依洛尤单抗与他汀类药物，以及在5%的人群中联合使用依折麦布的双重疗法。使用的有效性衡量指标是避免发生的心血管事件数量。进行了单因素和概率敏感性分析。
接受依洛尤单抗治疗的患者平均每年费用为11134.78欧元，标准治疗（他汀类药物加依折麦布）为393.83欧元。对于两个评估结局（第一个：心血管死亡、心肌梗死、中风以及因不稳定型心绞痛或冠状动脉血运重建导致的住院；第二个：包括前三个事件），每避免一次心血管事件的增量成本效益比均>600000欧元。为进行10年马尔可夫模型分析，标准治疗的平均成本为13948.45欧元，而依洛尤单抗为471417.37欧元。假设与标准治疗相差250万欧元和510万欧元（2017年），对于家族性高胆固醇血症患者，使用依洛尤单抗治疗的费用在300万至610万欧元之间。对于非家族性高胆固醇血症（二级预防）患者，这一差异在2.043亿至13.647亿欧元之间（2021年）。
依洛尤单抗治疗与较低的心血管事件发生率相关，但在西班牙国家卫生系统中，对于适合使用该药物的患者而言，其治疗效率较低。
