IPM Take
Europe’s anti-amyloid pathway is precision medicine in its most operational form. The label itself creates access gates: early symptomatic disease, confirmed amyloid pathology, ApoE status, infusion delivery, ARIA monitoring and MRI availability. The political issue is obvious. If only major memory centres can deliver that pathway safely, approval may widen the gap between patients who are biologically eligible and patients whose local system is actually ready.
Executive Summary
EMA lists both Leqembi, lecanemab, and Kisunla, donanemab, as authorised in the EU for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease, with confirmed amyloid pathology and only one or no ApoE4 copy. Both medicines require specialist supervision and MRI monitoring for amyloid-related imaging abnormalities, ARIA. Leqembi is given every two weeks, while Kisunla is given every four weeks and should not be used for more than 18 months.
Why it matters
- Regulators: Need to ensure that risk minimisation measures, controlled access and monitoring requirements are realistic in routine Alzheimer’s care.
- HTA bodies / payers: Must assess not only drug value, but also the cost and feasibility of amyloid confirmation, ApoE testing, infusion delivery and repeated MRI monitoring.
- Hospitals / providers: Need memory services, imaging capacity, infusion teams and trained multidisciplinary staff before approval can translate into safe access.
Before anti-amyloid therapies, Alzheimer’s care was largely built around diagnosis, symptomatic treatment, care planning and support. The arrival of disease-modifying therapies changes the access pathway, but not in a simple way.
What has changed is that treatment eligibility now depends on a chain of requirements. Patients need early symptomatic disease, confirmed amyloid pathology and ApoE status. They also need infusion services, specialist supervision and repeated MRI capacity to monitor ARIA, a known risk involving swelling or bleeding in the brain.
The eligible group is therefore narrow, and the system burden is high. These medicines are not general dementia treatments, nor are they suitable for all people with Alzheimer’s disease. They are intended for patients at an early symptomatic stage who meet biological and genetic criteria and can be monitored safely.
For IPM, the message is direct: Alzheimer’s innovation will not be judged only by regulatory approval or HTA decisions. It will be judged by whether health systems can build safe, timely and equitable diagnostic and monitoring pathways for the patients most likely to benefit.
