In January, the Food and Drug Administration fully approved the Alzheimer’s drug Leqembi, marking the first time that a drug meant to slow the progression of the disease has been granted full regulatory approval. The approval of this new medication opens doors for treatment of the disease that more than six million people live with each day, granting many of them a higher quality of life.
Dr. Margaret Frey, a board-certified neurologist with the Institute for Neuroscience and the Medical Chairperson of Neurology at Memorial Healthcare in Owosso, Michigan, answers some common questions people may have if they’re considering Leqembi as an intervention for Alzheimer’s disease.
As a general neurologist with a neuromuscular subspecialty, Dr. Frey sees patients who have Alzheimer’s disease in her everyday practice. She is passionate about offering more people different treatment options and providing them with the knowledge they need to make thoughtful decisions about healthcare for themselves and their loved ones.
Q: How does Leqembi work to treat Alzheimer’s disease? Can it stop or cure it?
A: “Up until Leqembi gained full FDA approval and reached the market, we couldn’t modify the disease course of Alzheimer’s disease at all. There was nothing to change the underlying pathology of it; all we could do was treat the symptoms. There are a number of medications that have been around for a long time that treat the symptoms of memory loss, but they don’t slow down or affect the progression of the underlying disease. With Leqembi reaching the market now, it allows us not to stop — not cure, but slow down to some extent — the progression of the underlying Alzheimer’s disease so that we can try to give people a little bit more time.”
“Essentially, Alzheimer’s disease is a progressive disorder, which means that tomorrow will be a little bit worse than today, and the day after that will be a little bit worse. There’s no guaranteed response to the medication for any specific patient, but the effect of the medication is to allow you to hold on to today’s skills a little bit longer.”
“When a patient is diagnosed with Alzheimer’s disease, the disease has an overall course of, generally speaking, somewhere between five to 10 years in total. When you look at these drugs, they’re effective, statistically, in slowing down that progression by approximately 27%. If you get 27% of 10 years, that’s a significant amount of time that you can help people kind of hold on to what they can do, who they are, longer over that whole course of the disease.”
Q: If someone starts taking Leqembi, do they have to take it forever? Are there signs that it’s time to discontinue the medication?
A: “The drug is very new, and I think what we do in this situation down the road is answer these questions on a case-by-case basis. It doesn’t stop the progression, so, eventually, the patient will still reach a point where you may, as an individual or as a family member, ask the question, ‘What are we holding onto?’ Similarly, with drugs that don’t slow down the disease but just treat the symptom of memory loss, that memory loss eventually reaches a point where, although those medicines may improve things slightly, it is like spitting in the wind — it is such a small effect in the face of a substantial deficit that it just doesn’t make enough difference. So in those cases, you would stop the memory medications that are just not making a substantial clinical difference.”
“With Leqembi and other drugs that slow down the progression of Alzheimer’s, we’re crossing into a new frontier that we have not dealt with before. Doctors might have that conversation with the patient or their family, saying, ‘Your loved one has reached such a point in their disease state; do you want to continue this medication that keeps this slowing?’ The drug is so new that I think that those kinds of clinical questions will have to be felt out and answered on a case-to-case, individual basis, of course with the guidance of the provider prescribing those medications and managing the disease.”
Q: What questions should people ask doctors when considering Leqembi as a treatment for Alzheimer’s disease? What are some of the risk factors and complications people should know about?
A: “The first important question is, ‘Do I have Alzheimer’s disease, or is it some other type of dementia?’ A very frequent question that we get in the office is, ‘What is the difference between dementia and Alzheimer’s disease?’ An analogy I often use with my patients is that dementia is a broad category of diseases. Underneath that category, there are types of dementia, of which Alzheimer’s disease is just one — kind of like mozzarella is a type of cheese.”
“The medication Leqembi, and the ones that are coming to the market, are specifically only going to be helpful in Alzheimer’s disease. So, if you have dementia but Lewey Body Dementia or something else, this would not be an appropriate treatment. So the first question is, ‘Do I have Alzheimer’s disease? And is this treatment appropriate for me?’”
“There are other factors that will weigh into whether or not we can use Leqembi in a patient based on some of their other history. For instance, we have to be able to monitor for side effects, which is another question that you should go over with your doctor. To monitor for side effects, we have to be able to get MRI imaging, so if you have a pacemaker and that pacemaker is not MRI-compatible, for example, you may not be a candidate for Leqembi.”
“There are various risk factors, and you have to have a neurologist who is knowledgeable in dementia and Leqembi so that they can adequately assess if the diagnosis is correct. People should be asking, ‘Do I have any specific risk factors or medical issues that would make me not a candidate for it to begin with?
“And then, of course, you want to know the potential complications that you are watching for. The biggest ones are the potential for bleeding and swelling in the brain, which is one of the things we need the MRI to monitor. That has to be assessed at baseline, monitored carefully, and made very clear to the patient as something we have to keep an eye out for. That’s not to say that these are all the potential complications of Leqembi, but it’s definitely one of the bigger things that we need to watch for.”
“And then, as a patient, you want to know, ‘What will this drug do for me?’ And the answer to that is doctors cannot predict the future, and we can’t tell you what it will specifically do for any individual person. All we can tell you is that, statistically, across a broad population, Leqembi slows the disease and gives you a little bit more time.”
“So those are probably the biggest questions: what will it do? Is my diagnosis correct? What are the potential complications?”
Q: Are there any words you’d share with some people who may have reservations about trying Leqembi or are trying to decide if it could benefit them or a loved one?
A: “I feel as a provider that my role is to provide clear and accurate information to the patient and their families so they can make the decision they feel most comfortable with. Some of the fears that people may have with a brand new medication are legitimate, and it’s up to them to decide — given this legitimate fear and legitimate concern — if the benefit they’re potentially going to get from this medication is worth it to them. We, as doctors, can provide all of the information regarding the benefits and the risks, but it comes down to a very individual choice of whether or not the benefit is worth that risk to you and your family. I can’t answer that for people, and I wouldn’t try to sway them in one direction, but I can ensure they have all the information they need to make that decision themselves.”
Q: Are medications like Leqembi covered by insurance? How accessible are they for those who could benefit from them and have decided to explore them as an intervention?
A: “Regarding the medicines that just sort of help memory a little bit in the moment, the symptom-relieving medications, those have pretty good coverage across the board with insurance. Regarding Leqembi, part of the advantage of receiving full approval from the FDA is that it came with a green light from Medicare regarding coverage. Now, that doesn’t mean that Medicare will cover a hundred percent of the cost for everybody. And people have so many differences in insurance coverage that it’s case-by-case; you have to evaluate each person’s coverage and their specific benefits. But the appearance is positive because of that FDA approval and Medicare making a statement that they will cover it
Q: As a medical provider, how does it feel to see these medications becoming more accessible and more prevalent as an intervention for Alzheimer’s disease that can change people’s lives?
A: “In neurology, in medicine in general, our goal is always to help the patient, and whenever you have a patient in the office, and you have to tell them, ‘I’m sorry, but I don’t have anything that can change the course of this disease.’ It’s always difficult as a provider because we don’t want to see patients suffer, and sometimes, there’s nothing that we can do to change that. So, as a provider, having drugs available that can give the patient any hope and quality of life is incredibly rewarding. It makes you feel like, ‘Well, now I can help. Now I can do something, and now I can do the main purpose of the whole reason I became a doctor, which is helping people.”
“So, yes, we are definitely excited for every medical advancement that we see come through the door that can make a real difference in the lives of our patients. It makes a definite difference in the quality of how we feel. We’re able to do our job.”
