Lecanemab (Leqembi), Germany’s first disease-modifying Alzheimer’s drug, is currently assessed by the G-BA as offering no proven additional benefit over existing therapies, despite its potential to slow progression in early-stage patients.

The drug has been available in Germany since September 2025, with initial pricing covered by manufacturers for the first six months; after that, price negotiations between Eisai and the GKV Spitzenverband determine funding and access.

There remains hope that new data could demonstrate an added benefit and preserve access, while Donanemab (Kisunla) is also under pending G-BA assessment with similar questions about added value.

IQWiG’s assessment that there is no added benefit influenced the G-BA's ruling and will shape reimbursement levels and potential market withdrawal if negotiations fail.

Even with the ruling, Lecanemab can stay prescribed temporarily during six-month price negotiations; a failure to agree could lead Eisai to withdraw the drug from the German market.

Actual patient access remains limited: only a few hundred Germans currently receive infusions due to strict eligibility criteria and the logistical burden of biweekly infusions and extensive monitoring.

The price negotiations are central; a large gap between the manufacturer’s price and what the statutory insurers will pay could trigger withdrawal from the market.

The decision frames the drug’s value as limited relative to other treatments, affecting reimbursement discussions and potential market exits if negotiations falter.

From a patient perspective, ongoing access may depend on research arrangements or private funding, with studies or private insurers potentially filling gaps.

The report is sourced from DIE ZEIT via dpa, with date and attribution noted.

A second drug, Donanemab, is under similar assessment, with a mid-April expected decision on added benefit.

The real-world pool of eligible patients is estimated at 10,000–20,000, but current treated numbers are in the hundreds due to eligibility criteria and treatment burdens.