FDA approves new Alzheimer's treatment, donanemab from Eli Lilly
What conditions must be met for Medicare coverage of donanemab?
For Medicare coverage of donanemab, prescribing physicians must agree to enter patient information into a federal registry2. This requirement is set by the Centers for Medicare and Medicaid (CMS) to encourage the collection of additional real-world data to better understand how the drug works in clinical practice2.
What is donanemab's mechanism of action?
Donanemab is a humanized monoclonal antibody that targets the N-terminal of a specific type of amyloid beta (Aβ) - pyroglutamate Aβ - which is found only in the brain amyloid plaques associated with Alzheimer's Disease24. It works by inducing microglial-mediated clearance of existing Aβ plaques with the intent of slowing the progressive decline in cognitive function associated with AD.
How often are donanemab infusions administered?
Donanemab infusions are administered every four weeks. Patients receive intravenous donanemab infusions for around half an hour during each session. The treatment duration varies depending on brain scans measuring amyloid levels, with some patients able to stop taking the drug after as early as six months.