Background
Dementia currently affects over 12 million people in Europe, with numbers projected to reach 20 million by 2050. Alzheimer’s disease is the leading cause of dementia, accounting for 60-80% of cases.
Prior to 2025, only a small number of symptomatic therapies were authorised for Alzheimer’s disease in Europe: the acetylcholinesterase inhibitors donepezil, rivastigmine and galantamine, and the NMDA receptor antagonist memantine, the last of which was authorised by the European Medicines Agency (EMA) in 2002. None of these medicines modify the underlying, biological causes of Alzheimer’s disease.
The European marketing authorisations for lecanemab in April 2025, and donanemab in September 2025, therefore marked a turning point for the Alzheimer’s disease community in Europe, ending a gap of over two decades without a new approved treatment. Alzheimer Europe welcomed the authorisation of lecanemab and donanemab, as the first disease-modifying therapies for Alzheimer’s disease. We acknowledged that these treatments carry very real safety risks, that their benefits are modest and confined to the earliest stages of the disease, and that healthcare systems must be well-resourced to deliver them safely. However, the organisation also stated that people living with early Alzheimer’s disease deserve the opportunity to discuss these treatments with their doctor and to make an informed choice with their families, based on their individual circumstances and preferences.
Alzheimer Europe therefore notes with growing concern the lack of coverage by national health services and insurers in Europe, which is restricting access to those who can afford to pay privately or travel abroad for treatment. At the time of writing, Health Technology Assessment (HTA) agencies in Denmark, Finland, France, Germany, the Netherlands, Sweden and the United Kingdom have concluded their initial assessments, issuing negative coverage recommendations on lecanemab. In Luxembourg, a controlled access programme was established in January 2026, with costs covered via hospital budgets pending a formal pricing and reimbursement application. Assessments are ongoing elsewhere, but the vast majority of patients in Europe are not currently able to access these authorised therapies through publicly funded mechanisms.
Experience from the United States and Japan, where lecanemab and donanemab have been available and reimbursed since 2023 and 2024, offers a useful counterpoint to some of the concerns that may have influenced European HTA deliberations. Side effects, including amyloid-related imaging abnormalities (ARIA), have occurred at rates consistent with clinical trial data, underscoring the importance of careful patient selection, shared decision-making, and robust safety monitoring. Real-world uptake has also been more modest than early projections suggested. To date, health systems in the US and Japan have not been overwhelmed with demand for treatment. Rather, treatment has been confined to a small, well-defined group of patients who are likely to benefit from anti-amyloid therapies. Treated patients, with biomarker-confirmed early Alzheimer’s disease and without contraindications, represent a small fraction of the broader dementia population.
Alzheimer Europe values and respects the rigorous health economic assessments that national HTA bodies conduct and recognises the difficult judgements they are asked to make in the interests of patients and health systems alike. However, the organisation is concerned that the current situation raises fundamental questions of equity, with access determined by financial means, geography and socioeconomic status. Alzheimer Europe also notes that without reimbursed access within national health systems, it will be hard to generate the real-world evidence on long term outcomes, patient selection and treatment delivery that is needed to refine clinical practice and prepare for future therapies. In addition, the organisation is concerned that HTA frameworks may not fully reflect the value these medicines may hold for patients, caregivers, clinicians and health systems, with insufficient consideration, involvement and weighting being given to the perspectives of people living with Alzheimer’s disease and their carers.
Alzheimer Europe recognises that anti-amyloid therapies, while a significant step forward, represent only one dimension of the unmet need faced by people with dementia and their carers. Across Europe, people living with dementia continue to experience difficulties in accessing the support, guidance, interventions, treatments and care they need. Investment in new treatments must not be at the expense of funding for these services, and for the health and social care workforce that delivers them. As the number of people living with dementia in Europe continues to grow, additional, protected and cross sectoral investment is urgently needed.
The following statement sets out five areas of concern for Alzheimer Europe and the wider dementia community.
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