A Framework for the Administration of Anti-amyloid Monoclonal Antibody Treatments in Early-Stage Alzheimer's Disease.

IF 7.4 2区医学 Q1 CLINICAL NEUROLOGY CNS drugs Pub Date : 2024-07-01 Epub Date: 2024-06-05 DOI:10.1007/s40263-024-01097-w

Michael H Rosenbloom, Tricia O'Donohue, Domi Zhou-Clark, Deepashni Mala, Andrew Frazier, Michael Tarrant, Michelle Modrijan, Melora Riveira, Darla Chapman, Yvonne Griffin, Lauren Shakalis, Thomas J Grabowski

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Abstract

The US Food and Drug Administration (FDA) approval of lecanemab for early-stage Alzheimer's disease (AD) represents an exciting new chapter in the management of neurodegenerative disease, but likewise presents numerous clinical, technical, and financial logistical challenges for both academic and non-academic medical institutions hoping to administer this drug. Minimal resources exist that provide guidance for establishing and maintaining a lecanemab treatment program at the institutional level. The current report aims to provide healthcare institutions a framework for the planning, onboarding, and longitudinal treatment of AD with anti-amyloid monoclonal antibody treatments. We present an implementation study involving three stages: (1) feasibility assessment, (2) operations and going live, and (3) monitoring assessment. We found that implementation of lecanemab in clinical practice was feasible due to the assignment of an enterprise-wide project manager to facilitate the planning phase, a cost analysis showing that lecanemab was financially sustainable, and the development of electronic medical record tools to support operational efficiency.

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早期阿尔茨海默氏症抗淀粉样蛋白单克隆抗体治疗的管理框架。

美国食品和药物管理局（FDA）批准将莱卡尼单抗用于早期阿尔茨海默病（AD）的治疗，为神经退行性疾病的治疗揭开了激动人心的新篇章，但同时也给希望使用这种药物的学术和非学术医疗机构带来了许多临床、技术和财务后勤方面的挑战。目前只有极少的资源可为在机构层面建立和维护莱卡奈单抗治疗项目提供指导。本报告旨在为医疗机构提供一个框架，用于抗淀粉样蛋白单克隆抗体治疗的规划、入职和纵向治疗。我们介绍了一项实施研究，包括三个阶段：(1) 可行性评估；(2) 运行和上线；(3) 监测评估。我们发现，在临床实践中实施莱卡尼单抗是可行的，因为我们指派了一名企业级项目经理来推动规划阶段的工作，成本分析表明莱卡尼单抗在财务上是可持续的，而且还开发了电子病历工具来支持运营效率。

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来源期刊

CNS drugs 医学-精神病学

CiteScore

12.00

自引率

3.30%

发文量

审稿时长

6-12 weeks

期刊介绍： CNS Drugs promotes rational pharmacotherapy within the disciplines of clinical psychiatry and neurology. The Journal includes: - Overviews of contentious or emerging issues. - Comprehensive narrative reviews that provide an authoritative source of information on pharmacological approaches to managing neurological and psychiatric illnesses. - Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. - Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in neurology and psychiatry. - Original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in CNS Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.