Overview

• The European Commission authorized Eli Lilly’s donanemab for early-stage Alzheimer after data showing only a months-long slowing of decline, with Germany expecting availability in the coming months.
• Treatment is limited to biomarker-confirmed cases with zero or one ApoE4 copy because of risks of brain swelling and microbleeds requiring repeated MRI checks.
• Lecanemab has been available in Germany since September 1 and is infused every two weeks, whereas donanemab is given every four weeks under MRI surveillance.
• Experts estimate only about 1% of Germany’s 1.2 million Alzheimer patients qualify—fewer than 12,000—even though roughly 250,000 are in the early phase, and women may see less benefit with higher risk.
• Drug costs are expected at roughly €24,000 per patient annually plus about €10,000 for diagnostics and monitoring, with reimbursement talks with insurers ongoing.