Many have called it a huge breakthrough for the future of fighting Alzheimer’s. Earlier this month, the U.S. Food and Drug Administration approved the drug Leqembi via the Accelerated Approval pathway for the treatment of Alzheimer’s disease.
But that might leave you with some questions. Is it safe? Who’s eligible? Who isn’t?
So we asked Mark J. Alberts, MD, co-physician-in-chief for Hartford HealthCare’s Ayer Neuroscience Institute and neurology chief at Hartford Hospital, everything you need to know about the treatment.
“It’s the first disease modifying therapy that has been shown to work. It’s also FDA approved for the treatment of those with early Alzheimer’s disease,” Dr. Alberts says. “This is a very significant and promising advancement – not a cure, but it could change the course of the disease. It’s a positive step in the right direction.”
Dr. Alberts answers six common questions for patients and family members wanting to know more about Leqembi.
1. What makes this drug different?
Plenty of Alzheimer’s drugs have already been approved by the FDA, but Leqembi is unique.
“It gets to the root cause of Alzheimer’s disease in the brain,” explains Dr. Alberts. “You’re really getting to the basic cause of the disease, not just the symptoms.”
And the delivery mechanism is unique, too.
“Leqembi is an IV infusion,” says Dr. Alberts. “The medication drips in gradually for about one hour and would be delivered every two weeks.”
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2. Are there any side effects?
Like most drugs, Leqembi carries the risk of some mild side effects.
“There may be less serious side effects such as nausea, vomiting or an occasional rash,” says Dr. Alberts. “You will be closely monitored by your care team to determine the best course of action.”
But Leqembi’s label does come with a “Black Box” warning.
“This is due to two significant brain complications during the drug trials,” Dr. Alberts adds. “Certain percentages of patients developed swelling or edema in the brain or bleeding in the brain. However, when the medication was stopped or the dose reduced, these complications were resolved in most patients.”
3. Will I need to stay on Leqembi forever?
Dr. Alberts gets this question a lot.
“My answer is, regardless of the treatment, forever is a long time,” Dr. Alberts notes. “Let’s start and see how you respond and what the outcomes are. As medical science advances and we gain more knowledge, treatment plans are often evolving.”
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4. Who is eligible for treatment?
Currently, Leqembi is just for people with mild cognitive impairment or early Alzheimer’s disease.
“Advanced Alzheimer’s patients are not currently approved to receive this medication,” says Dr. Alberts. “If the disease has progressed to the point that they are in a nursing home or need help with their daily living activities, they probably have mid- or late-stage Alzheimer’s.”
5. Does Medicare cover Leqembi?
The price may vary, but there’s hope for patients seeking help from Medicare.
“The Centers for Medicare & Medicaid Services has announced they will cover 80% of the annual cost of the drug, which is estimated to be around $26,000,” says Dr. Alberts. “But this is not taking markups or discounts into consideration.”
6. So how can I start?
The first step is an assessment by your physician or care team.
“Your doctor may need to perform special types of tests or scans,” says Dr. Alberts. “This will help determine someone’s ability to use the drug. For instance, taking blood thinners or having other medical conditions is a consideration.”
But Leqembi just got FDA approval, so there might be a little longer to wait.
“There are a lot of moving parts to this,” Dr. Alberts explains. “Members of our team are getting protocol in place right now to deliver the drug in a safe and efficient manner. We expect to be ready in the next several weeks. We know how to do this – we’ve done it before with other medications.”