来卡尼单抗的疗效太小且不确定

The BMJ Pub Date : 2024-09-19 DOI:10.1136/bmj.q2044
Robert Howard
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引用次数: 0

摘要

对治疗效果的期望值提高并不能证明成本的合理性 英国药品和保健品管理局(MHRA)已批准将单克隆抗体莱卡奈单抗用于治疗有一个或没有载脂蛋白 E4(APOE4)基因拷贝的阿尔茨海默病患者。2 NICE 的结论是治疗效果 "小但有意义",但长期效果和实际应用的经济模型仍存在不确定性。NICE 正在向莱卡尼单抗的生产商卫材和英国国家医疗服务系统(NHS England)寻求更多有关不确定性的信息,并将在第二次会议上对这些信息和其他利益相关者的意见进行审议:"4 这在很大程度上反映了人们对该类药物的期望值过高,而该类药物的治疗效果却微乎其微,存在严重的安全风险,且用药成本高昂。试图传达治疗效果的真实程度............
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Lecanemab’s benefits are too small and uncertain
Raised expectations of treatment effect do not justify the cost The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the monoclonal antibody lecanemab for treatment of patients in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 (APOE4) gene.1 However, at the same time, the National Institute for Health and Care Excellence (NICE) issued draft guidance against using the drug in the NHS.2 NICE concluded that the treatment effect was “small but meaningful” but that uncertainty remains about long term effects and the economic model for use in practice. NICE is seeking additional information from lecanemab’s manufacturer, Eisai, and NHS England on identified uncertainties and will consider this information together with other stakeholder comments at a second meeting.3 The decision was met with outraged headlines: “Alzheimer’s wonder drug blocked for use on NHS.”4 These largely reflect the collision between raised expectations around this class of drugs and the tiny treatment benefits, serious safety risks, and high costs of the drug and its administration. Attempts to communicate the true magnitude of treatment …
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