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G-BA Finds No Added Benefit for Alzheimer’s Drug Leqembi in Germany

The ruling triggers price negotiations shaping access for publicly insured patients.

Overview

  • The decision follows an IQWiG assessment that found no advantage for Lecanemab over established symptomatic therapies on symptoms or quality of life.
  • Prescriptions remain possible for now, and the GKV-Spitzenverband and manufacturer Eisai have six months to agree on a reimbursed price.
  • If no deal is reached, the company could pull the drug from the German market, a prospect clinical societies say could create a care gap.
  • A stark cost gap underpins the talks, with Lecanemab therapy estimated at about €25,000 per year versus roughly €250 annually for acetylcholinesterase inhibitors.
  • Use has been limited to only a few hundred patients given strict eligibility and MRI monitoring requirements, while a separate G-BA ruling on Donanemab is expected by mid-April.