Fifth Department of Medicine, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.
Department of Personalized Oncology, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.
Clin Drug Investig. 2022 Aug;42(8):643-656. doi: 10.1007/s40261-022-01173-3. Epub 2022 Jul 11.
Despite treatment with statins, dyslipidaemia patients with elevated cholesterol- and triglyceride-levels remain at high residual risk for major adverse cardiovascular events (MACE). New lipid-lowering drugs must prevent the occurrence of MACE and exhibit cost-effectiveness for their successful adoption to clinical practice.
To assess the cost effectiveness of icosapent ethyl, fenofibrate, ezetimibe, evolocumab, and alirocumab in combination with statins compared to statin monotherapy for cardiovascular prevention from the perspective of UK's National Health Service.
A Markov model simulated the progression of cardiovascular disease and MACE, including myocardial infarction, stroke, angina pectoris, and coronary revascularisation, in dyslipidaemia patients. The model was populated with cardiovascular outcome trial data for each drug. Cost and utility data were extracted from peer-reviewed literature. The incremental cost-effectiveness ratio (ICER) is reported per quality-adjusted life years (QALY) gained in 2021 Great Britain Pounds (£).
For primary cardiovascular prevention, icosapent ethyl increased QALYs by 0.79 and costs by £15,421 compared to statin monotherapy (ICER = £19,485/QALY). Fenofibrate yielded 0.62 additional QALYs at cost-savings of - £6127 (ICER = - £9932/QALY). For secondary prevention, the omega-3 fatty acid icosapent ethyl extended QALYs by 0.98 at costs of £12,981 compared to statin monotherapy (ICER = £13,285/QALY). Fenofibrate added 0.85 QALYs whilst saving - £637 (ICER = - £7472/QALY). Ezetimibe increased QALYs by 0.60 at cost reductions of - £2529 (ICER = - £4231/QALY). PCSK9 inhibitors provided QALYs of 0.53 and 0.86 at costs of £45,279 and £46,375 for evolocumab (ICER = £85,193/QALY) and alirocumab (ICER = £54,211/QALY), respectively. At a willingness-to-pay threshold of £25,000/QALY, there is a probability of 100% for icosapent ethyl (98% in primary prevention) and 0% for PCSK9 inhibitors to be cost effective in secondary prevention.
Icosapent ethyl is cost effective for primary and secondary cardiovascular prevention at an annual price of £2064 in the UK. For PCSK9 inhibitors, price discounts or prescription restrictions are necessary to achieve cost effectiveness.
尽管使用了他汀类药物，胆固醇和甘油三酯水平升高的血脂异常患者在发生主要不良心血管事件（MACE）方面仍存在较高的残余风险。新的降脂药物必须预防 MACE 的发生，并在成本效益方面具有优势，才能成功应用于临床实践。
从英国国家医疗服务体系的角度评估埃扎替韦单抗、非诺贝特、依折麦布、依洛尤单抗和阿利西尤单抗与他汀类药物联合治疗与他汀类药物单药治疗在心血管预防方面的成本效益。
一个马尔可夫模型模拟了血脂异常患者心血管疾病和 MACE（包括心肌梗死、中风、心绞痛和冠状动脉血运重建）的进展。该模型使用了每种药物的心血管结局试验数据进行填充。成本和效用数据从同行评议的文献中提取。增量成本效益比（ICER）以 2021 年英国英镑（£）表示的每获得一个质量调整生命年（QALY）的增量成本进行报告。
对于一级心血管预防，与他汀类药物单药治疗相比，二十碳五烯酸乙酯增加了 0.79 个 QALYs，成本增加了 15,421 英镑（ICER = £19,485/QALY）。非诺贝特在节省成本 - £6127 的情况下增加了 0.62 个额外的 QALYs（ICER = - £9932/QALY）。对于二级预防，欧米伽-3 脂肪酸二十碳五烯酸乙酯与他汀类药物单药治疗相比，将 QALYs 延长了 0.98 个，成本增加了 12,981 英镑（ICER = £13,285/QALY）。非诺贝特增加了 0.85 个 QALYs，同时节省了 - £637（ICER = - £7472/QALY）。依折麦布降低成本 - £2529，增加了 0.60 个 QALYs（ICER = - £4231/QALY）。PCSK9 抑制剂在 Evolocumab （ICER = £85,193/QALY）和 Alirocumab （ICER = £54,211/QALY）的成本分别为 £45,279 和 £46,375 时，提供了 0.53 和 0.86 的 QALYs。在支付意愿阈值为 25,000 英镑/QALY 时，埃扎替韦单抗（98%在二级预防中）和 PCSK9 抑制剂有 100%的概率具有成本效益。
在英国，埃扎替韦单抗的年度价格为 2064 英镑时，在一级和二级心血管预防方面具有成本效益。对于 PCSK9 抑制剂，需要降低价格或限制处方，才能实现成本效益。
