Lecanemab for early-stage Alzheimer's disease: IQWiG benefit assessment concludes no added benefit

Based on previously unpublished data, IQWiG concludes that lecanemab offers no proven benefit over the current standard of care in Germany.

Lecanemab has been available in Germany for the treatment of early-stage Alzheimer’s disease since September 2025. The drug is intended to slow the progression of the disease and must only be used in adults who

- have mild cognitive impairment or suffer from mild dementia,

- exhibit typical protein deposits (amyloid-beta plaques) in the brain and

- carry at most one copy of the ApoE ε4 gene variant in their DNA.

The German Institute for Quality and Efficiency in Health Care (IQWiG) has now examined in a benefit assessment whether lecanemab offers benefits over the present standard of care for these patients. For patients with mild cognitive impairment (MCI), the Federal Joint Committee (G-BA) specified ‘watchful waiting’ as the appropriate comparator therapy, also because there are currently no approved drugs available for this group. Treatment with acetylcholinesterase inhibitors is the current standard of care for people with mild Alzheimer’s dementia.

For both patient populations, IQWiG concludes that there is no proof of added benefit lecanemab compared with the current standard of care in Germany.

“Our assessment is based on previously unpublished data which the manufacturer was required to provide in its dossier. Thanks to the high level of transparency in the German AMNOG procedure, these are now also available to the public,” explains Daniela Preukschat, Head of the Chronic Diseases Division in IQWiG’s Drug Assessment Department. “However, the data still leave some questions unanswered, as further relevant information was missing in the dossier.”

The comparison with the standard of care in Germany is decisive

Selected results from the pivotal lecanemab approval study CLARITY AD were published in 2023. Since then, experts and the general public have been discussing, above all, these originally published data on the study’s total population. The study demonstrated that lecanemab slows cognitive deterioration compared with the control group. However, due to serious side effects, the European regulatory authority has significantly restricted the therapeutic indication of lecanemab, meaning that these original findings – which are still the subject of debate today – are no longer decisive. Moreover, a comparison with the German standard of care is also crucial for use in Germany. On the one hand, the assessment therefore focused on the on-label use of lecanemab and, on the other hand on a comparison with the standard of care in Germany.