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Leqembi Launches in Germany on Sept. 1 Under Tight EU Conditions

Access hinges on strict eligibility under intensive monitoring, with reimbursement at clinics still in flux.

Overview

  • Biogen and Eisai confirmed market availability of the Alzheimer’s antibody in Germany on 1 September, with Austria also among the first EU launch countries.
  • Use is restricted to early-stage cases such as mild cognitive impairment, and only patients with zero or one ApoE4 gene copy are eligible, a subgroup that includes most but not all patients.
  • Treatment requires biomarker confirmation of Alzheimer, ApoE4 genetic testing, baseline and periodic MRI scans, and intravenous infusions every two weeks to watch for brain swelling and microbleeds.
  • Manufacturer pricing points to roughly €24,000 per patient annually for the drug, with an additional estimated €10,000 for diagnostics, administration and monitoring.
  • Health insurers will initially cover costs as the Gemeinsame Bundesausschuss assesses added benefit for price negotiations, though some hospitals may delay starts due to capacity and unresolved clinic reimbursement.