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2mo ago

Germany Rules No Added Benefit for New Alzheimer Antibodies After Major Review Finds Little Effect

The rulings could limit reimbursement for the drugs in Germany.

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Bei der Alzheimer-Demenz bilden sich Verklumpungen von Beta-Amyloid-Proteinen, durch die Hirnzellen zugrundegehen (rechts). © selvanegra/ iStock
Die nachteilige Bewertung von zwei neuen Alzheimer-Wirkstoffen ist bei Fachorganisationen in Deutschland auf Unverständnis gestoßen. Die Deutsche Alzheimer-Gesellschaft warnte davor, dass die Hersteller die Medikamente vom Markt nehmen könnten.
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Overview

  • Germany’s drug assessment body, the G‑BA, which ruled Thursday, found no proven added benefit for Donanemab after reaching the same view earlier for Lecanemab.
  • A Cochrane overview published Thursday pooled 17 trials with about 20,000 people and found little to no meaningful slowing of cognitive decline over roughly 18 months.
  • The antibodies cleared amyloid plaques yet raised brain-scan abnormalities called ARIA, with about 119 cases per 1,000 on treatment versus 12 per 1,000 on placebo.
  • Both drugs remain prescribable in Germany, and EU use is limited to patients with zero or one APOE4 gene copy because those with two copies face higher ARIA risk.
  • Patient and research groups warned the stance could discourage trials and said manufacturers might pull the drugs if price talks with insurers fail.