Lecanemab & Donanemab FAQ

On July 6, 2023 the U.S. Food and Drug Administration granted Leqembi (lecanemab) full approval for patients with mild symptoms caused by Alzheimer’s Disease based on evidence of approximately 25% slowing of progression (corresponding to less progression by 0.45 points on an 18 point scale). The action means that Leqembi should be widely covered by Medicare. So, more people who are in the early stages of the disease will have access to the drug – and be able to afford it. More than 30 years after the introduction of cholinergic drugs (donepezil, galantamine, rivastigmine) this is the second historic moment in the treatment of Alzheimer’s Disease. The results are statistically robust but practically modest at best; no symptomatic improvement is claimed or expected; progression is not prevented; and side effects, while uncommon, can be serious. None of these caveats however diminish the historic significance of this development. In the near future, we expect that a similar drug, donanemab, will also receive approval so the clinician and patient will have an even broader range of choices.

This is an ongoing process, and we will update this page as we get more information about when this medication may be available to our patients.

- Marsel Mesulam, MD, Chief of Behavioral Neurology

Read our statement on Lecanemab and Donanemab

At Northwestern Medicine, our patients are our top concern. Know that we closely study each medication before we recommend it for you. We look at its benefits and risks.

What are Anti-Amyloid Monoclonal Antibody Treatments for Alzheimer’s disease?

Amyloid is a substance that accumulates in the form of plaques in the brain of persons with Alzheimer’s disease. Lecanemab and Donanemab are medications designed to remove amyloid plaques from the brain. They are in the same class of medications as the previously approved aducanumab (Aduhelm).

What are lecanemab and donanemab?

Lecanemab is marketed by Eisai and Biogen as Leqembi. Donanemab is marketed by Eli Lilly as Kisunla. Each of these medications aims to delay cognitive decline due to Alzheimer’s disease. Each of these medications was studied in 18-month clinical trials, and the results of both of these studies suggest that these treatments may slow the rate of cognitive decline, though they are not expected to improve cognition or memory. The amount of slowing over an 18-month period is quite small and may not be noticeable by patient, family or physicians. These medications do not reverse existing disease or stop the progression.

What do I need to know about the FDA’s approval of lecanemab and donanemab?

On July 2, 2024 the U.S. Food and Drug Administration granted Kisunla (donanemab) full approval for patients with mild symptoms caused by Alzheimer’s disease based on the evidence of approximately 29% slowing of progression (corresponding to less progression by 0.67 points on an 18 point scale).

How is it given?

Patients will receive lecanemab and donanemab via infusion into the vein at an infusion center at Northwestern. The frequency of infusion is every 2 weeks for lecanemab and every 4 weeks for donanemab. For lecanemab, the infusion lasts about 1 hour, the entire visit to the infusion center will last about 2 hours. For donanemab, the infusion lasts about 30 minutes, with an additional 30 minutes of observation.

What is the cost?

CMS (Centers for Medicare & Medicaid Services) have announced that broader Medicare coverage is now available. Some private insurance companies have also started covering these medications for appropriate patients. The price for Leqembi set by Eisai/Biogen is about $26,000 per year, without insurance coverage. The price for donanemab set by Eli Lilly is $32,000 per year, without insurance coverage. It is important to note that this amount is only for the medication and does not include costs associated with the infusion visits themselves or the MRIs of the brain which will be needed for monitoring of potential side-effects.

View the CMS Statement on Broader Medicare Coverage of Anti-amyloid monoclonal antibody therapies.

What are the side effects?

Side effects can include brain swelling and brain bleeds that are usually small. Some patients have also reported headaches, falls, dizziness, vision changes, nausea, diarrhea, seizures, and confusion. Other side effects may include: fever, flu-like symptoms, changes to your heart rate or palpitations, difficulty breathing. There seems to be a higher risk of these side effects in those who have two copies of the E4 variant of the ApoE gene (a risk gene for Alzheimer’s disease), and we will not be recommending this medication to these patients. The risk of a symptomatic brain bleed also is higher in those on blood thinners, and we will not be recommending this medication for any patient who is on such medications.

Can I receive lecanemab or donanemab?

Lecanemab and donanemab are medications in the same class indicated for patients with mild and early stage of cognitive impairment due to Alzheimer’s disease who have evidence of brain plaques by lumbar puncture or amyloid PET scan. Clinicians will prescribe the medication in alignment with strict guidelines. Only specialized clinics will carry this medication.

Are There other FDA-Approved Medications?

There are very safe FDA-approved medications that have been in use for several decades and have been shown to offer symptomatic improvement and may also slow the disease. But these effects, while statistically significant, are very small. Nonetheless, at the Neurobehavior Clinic we routinely use these medications, known as cholinesterase inhibitors. They are donepezil, rivastigmine, and galantamine. These medications can be given in addition to lecanemab.

To learn more, visit the Northwestern Medicine Neurobehavior and Memory Clinic’s website. Talk with your physicians about lecanemab. They will let you know if you are eligible for the medication. They can also explore other treatment options with you.

FAQs Last updated: October 3, 2024