German panel finds no added benefit for Alzheimer's drug donanemab

A top German health authority has found no proven added benefit for the Alzheimer's drug donanemab compared to older treatment approaches, according to a decision published on Thursday.

The Joint Federal Committee of doctors, health insurers and hospitals has therefore classified the drug in the same way as it previously did lecanemab – the first Alzheimer's drug approved in Germany that directly targets protein deposits in the brain.

Both drugs are approved for patients in the early stages of Alzheimer's, but are only suitable for a very small number of patients.

"Based on the available data, we were also unable to establish any added benefit for donanemab, the second new drug for early-stage Alzheimer's disease – unfortunately, I say this quite explicitly," committee chair, Josef Hecken, emphasized in a statement, noting that expectations for the drug among patients and medical professionals were high.

No benefit was demonstrated for patients with mild dementia, whilst for patients with mild cognitive impairment there was a lack of data to substantiate any added benefit.

Donanemab – like lecanemab – can continue to be prescribed for the time being despite these decisions, but this is questionable in the long term.

The assessment was based on data submitted by the manufacturer and will weigh heavily on negotiations regarding the price that statutory health insurance funds will pay in future. If no agreement is reached, the manufacturers could withdraw the drugs from the German market.

The committee emphasized that a different assessment could emerge in the future once more data is available.

Lecanemab has been on the market in Germany under the trade name Leqembi since last September, and donanemab under the name Kisunla since November. The drugs aim to delay the progression of the disease in its early stages, but they are not intended to cure it.