Overview

• Germany and Austria will be the first EU countries to offer the anti-amyloid Alzheimer therapy starting 1 September, according to Biogen and Eisai.
• The approval covers mild cognitive impairment or early Alzheimer’s, roughly the first three years of disease, with use generally limited to patients with zero or one ApoE4 allele.
• Manufacturer pricing implies about €24,000 per patient per year for the drug, with roughly €10,000 more for testing, administration and monitoring, while insurers initially cover costs pending a G-BA benefit assessment and price talks.
• Treatment is given as an intravenous infusion every two weeks and requires biomarker confirmation of Alzheimer pathology plus mandatory ApoE4 genotyping and MRI-based monitoring.
• Risks of brain swelling and microbleeds led to a conditional authorization that includes an EU-wide patient registry and a safety study, and some clinics may delay starts due to capacity limits and unresolved reimbursement arrangements.