Seijas-Amigo José, Mauriz-Montero Maria José, Suarez-Artime Pedro, Gayoso-Rey Mónica, Reyes-Santías Francisco, Estany-Gestal Ana, Casas-Martínez Antonia, González-Freire Lara, Rodriguez-Vazquez Ana, Pérez-Rodriguez Natalia, Villaverde-Piñeiro Laura, Castro-Rubinos Concepción, Espino-Paisán Esther, Cordova-Arevalo Octavio, Rodriguez-Penas Diego, Cardeso-Paredes Begoña, Ribeiro-Ferreiro Marta, Rodríguez-Mañero Moisés, Cordero Alberto, González-Juanatey José R
Cardiology Department, Complejo Hospitalario Universidad de Santiago de Compostela, Santiago de Compostela, 15706 Santiago de Compostela, Spain.
Fundación Instituto de Investigación Sanitaria de Santiago de Compostela (FIDIS), 15706 Santiago de Compostela, Spain.
Diseases. 2024 Oct 5;12(10):244. doi: 10.3390/diseases12100244.
The primary objective of this study was to conduct a cost-utility analysis of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in real-world, comparing their use with standard care for managing cardiovascular disease. A multicenter prospective study was conducted across 12 Spanish hospitals from May 2020 to April 2022, involving 158 patients with hypercholesterolemia or atherosclerotic cardiovascular disease. This study assessed health-related quality of life (QoL) using the EQ-5D-3L questionnaire. The cost-utility analysis evaluated the economic impact of PCSK9 inhibitors when used with standard care compared to standard care alone, calculating the incremental cost-effectiveness ratio (ICER). This study included 158 patients with an average age of 61 years, male (66.5%). For patients initiating PCSK9 inhibitors, the treatment cost was EUR 13,633.39, while standard therapy cost EUR 3638.25 over two years. QoL for PCSK9 inhibitors stood at 1.6489 over two years, compared to 1.4548 for standard therapy. The results revealed favorable cost-utility outcomes, with an ICER of EUR 51,427.72. Significant improvements were observed in the domains of mobility, self-care, daily activities, pain/discomfort, and anxiety/depression ( < 0.001). This study presents the first real-world cost-utility analysis of PCSK9 inhibitors, supporting their economic rationale and highlighting their benefits in clinical practice. Healthcare decision-makers can use these results to inform their decisions and reimbursement policies concerning PCSK9 inhibitors. Trial Registration clinicaltrials.gov Identifier: NCT04319081.
本研究的主要目的是在现实世界中对前蛋白转化酶枯草溶菌素/克新9型（PCSK9）抑制剂进行成本效用分析，将其使用情况与管理心血管疾病的标准治疗方法进行比较。2020年5月至2022年4月，在西班牙的12家医院开展了一项多中心前瞻性研究，纳入了158例高胆固醇血症或动脉粥样硬化性心血管疾病患者。本研究使用EQ-5D-3L问卷评估健康相关生活质量（QoL）。成本效用分析评估了PCSK9抑制剂与标准治疗联合使用时相对于单独使用标准治疗的经济影响，计算了增量成本效益比（ICER）。本研究纳入了158例患者，平均年龄61岁，男性占66.5%。对于开始使用PCSK9抑制剂的患者，两年的治疗成本为13,633.39欧元，而标准治疗的成本为3638.25欧元。PCSK9抑制剂的两年QoL为1.6489，而标准治疗为1.4548。结果显示成本效用结果良好，ICER为51,427.72欧元。在行动能力、自我护理、日常活动、疼痛/不适和焦虑/抑郁等领域观察到显著改善（<0.001）。本研究首次对PCSK9抑制剂进行了现实世界的成本效用分析，支持了其经济合理性，并突出了其在临床实践中的益处。医疗保健决策者可利用这些结果为有关PCSK9抑制剂的决策和报销政策提供参考。试验注册 clinicaltrials.gov标识符：NCT04319081。
