Objective To conduct a rapid health technology assessment (rHTA) of donanemab in the treatment of Alzheimer's disease (AD).

Methods A comprehensive search of CNKI, WangFang, PubMed, and Embase, as well as the official websites of foreign HTA institutions, was conducted to collect HTA reports, systematic reviews (SR)/Meta-analyses, and pharmacoeconomic studies on donanemab for the treatment of early symptomatic AD up to May 31, 2026. Descriptive analysis was conducted after screening, data extraction, and quality evaluation of the included studies.

Results A total of 20 SR/Meta-analyses, 5 pharmacoeconomic studies and 2 HTA reports were included. In terms of efficacy, donanemab was significantly superior to placebo in improving Clinical Dementia Rating-Sum of Boxes, Alzheimer's Disease Assessment Scale-Cognitive Subscale, Alzheimer's Disease Cooperative Study-Activities of Daily Living, and Integrated Alzheimer's Disease Rating Scale scores, and reducing amyloid-beta positron emission tomography signals and plasma phosphorylated Tau protein 217 levels (P<0.05). In terms of safety, donanemab significantly increased the incidence of amyloid-related imaging abnormalities with edema, amyloid-related imaging abnormalities with hemosiderin deposition and infusion-related reactions (P<0.05), but there were no significant differences in total adverse events, severe adverse events, and mortality rates between the two groups (P>0.05). In terms of economy, although donanemab had potential cost-effectiveness under a reasonable price via its limited-treatment course, it was not economically viable at the current pricing.

Conclusion Donanemab had a clearly statistically significant therapeutic effect on patients with early-stage AD, but the effect sizes of some indicators were relatively small, resulting in limited clinical benefits accompanied by a risk of amyloid related imaging abnormalities. Its economic impact was greatly influenced by regional, pricing, and treatment duration factors. Domestic evaluations are needed to support medical insurance and clinical decision-making.

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