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Estimating demand for potential disease-modifying therapies for Alzheimer's disease in the UK
The British Journal of Psychiatry ( IF 10.5 ) Pub Date : 2024-01-18 , DOI: 10.1192/bjp.2023.166
Axel A. S. Laurell , Ashwin V. Venkataraman , Tatjana Schmidt , Marcella Montagnese , Christoph Mueller , Robert Stewart , Jonathan Lewis , Clare Mundell , Jeremy D. Isaacs , Mani S. Krishnan , Robert Barber , Timothy Rittman , Benjamin R. Underwood

Background

Phase three trials of the monoclonal antibodies lecanemab and donanemab, which target brain amyloid, have reported statistically significant differences in clinical end-points in early Alzheimer's disease. These drugs are already in use in some countries and are going through the regulatory approval process for use in the UK. Concerns have been raised about the ability of healthcare systems, including those in the UK, to deliver these treatments, considering the resources required for their administration and monitoring.

Aims

To estimate the scale of real-world demand for monoclonal antibodies for Alzheimer's disease in the UK.

Method

We used anonymised patient record databases from two National Health Service trusts for the year 2019 to collect clinical, demographic, cognitive and neuroimaging data for these cohorts. Eligibility for treatment was assessed using the inclusion criteria from the clinical trials of donanemab and lecanemab, with consideration given to diagnosis, cognitive performance, cerebrovascular disease and willingness to receive treatment.

Results

We examined the records of 82 386 people referred to services covering around 2.2 million people. After applying the trial criteria, we estimate that a maximum of 906 people per year would start treatment with monoclonal antibodies in the two services, equating to 30 200 people if extrapolated nationally.

Conclusions

Monoclonal antibody treatments for Alzheimer's disease are likely to present a significant challenge for healthcare services to deliver in terms of the neuroimaging and treatment delivery. The data provided here allows health services to understand the potential demand and plan accordingly.



中文翻译:

估计英国对阿尔茨海默病潜在疾病缓解疗法的需求

背景

针对脑淀粉样蛋白的单克隆抗体 lecanemab 和 donanemab 的三期试验报告称,早期阿尔茨海默病的临床终点存在统计学上的显着差异。这些药物已经在一些国家使用,并且正在通过在英国使用的监管审批程序。考虑到管理和监测所需的资源,人们对医疗保健系统(包括英国的医疗保健系统)提供这些治疗的能力表示担忧。

目标

估计英国现实世界对阿尔茨海默病单克隆抗体的需求规模。

方法

我们使用两个国家卫生服务信托机构 2019 年的匿名患者记录数据库来收集这些人群的临床、人口统计、认知和神经影像数据。使用多纳奈单抗和乐卡奈单抗临床试验的纳入标准评估治疗资格,并考虑诊断、认知表现、脑血管疾病和接受治疗的意愿。

结果

我们检查了 82 386 人转介服务的记录,覆盖约 220 万人。应用试验标准后,我们​​估计每年最多有 906 人在这两项服务中开始接受单克隆抗体治疗,如果在全国范围内推算,则相当于 30 200 人。

结论

阿尔茨海默病的单克隆抗体治疗可能会对医疗保健服务在神经影像和治疗方面提出重大挑战。此处提供的数据使卫生服务机构能够了解潜在需求并做出相应的计划。

更新日期:2024-01-18
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