The Caring Corner®
FDA Approves Lecanemab
FDA Approves Alzheimers Medicine
What’s It Mean for You?
Just a few days ago the FDA gave full approval to Lecanemab, also known as Leqembi. It’s the first drug believed to slow the development of Alzheimer’s. Why is this good news? How does it work? What are the risks? Why do some people feel it was the wrong thing to do? And what does it mean for you?
The Good News
This is good news because Lecanemab is the first FDA-approved medicine proven to reduce harmful beta amyloid plaques in the brains of people with mild Alzheimer’s. The manufacturer claims that it will slow the progression of the disease by 27%. Lecanemab is in a class of drugs called monoclonal antibodies, and there are similar drugs in development that may have even greater benefits for people with Alzheimer’s.
After years of the pharmaceutical industry looking for a solution for Alzheimer’s without success, experts now believe we’re on the verge of a series of drugs that can help manage this disease. This is wonderful news for people with Alzheimer’s and anyone who cares for them. The other part of the good news is that with full FDA approval, Lecanemab will be paid for by Medicare, making it much more accessible to the people who need it.
How Does It Work?
Lecanemab works by targeting the development of harmful beta-amyloid plaques in the brain. It’s administered through an IV every two weeks, lasting up to an hour for each treatment. While going to a clinic for an IV can be burdensome, the manufacturer is experimenting with a different delivery mechanism where patients can give themselves weekly injections at home. So perhaps in the future it will be even more accessible. By reducing the beta-amyloid in a person’s brain, Lecanemab slows the progression of Alzheimer’s. It should be noted, however, that it DOES NOT cure Alzheimer’s. It merely slows it down. It is only recommended for people with early stage Alzheimer’s. However, if your loved one falls into that category, The Alzheimer’s Association reports that Lecanemab will get you 5 months of delay in an 18 month period. That’s precious time to enjoy your life, your family and loved ones and live independently, as well as get your affairs in order for a time when you may not be able to make decisions for yourself.
What Are the Risks?
Lecanemab has potentially life-threatening side effects. Its main risk is that it can produce brain swelling and bleeding. During clinical trials, at least 3 people who were taking Lecanemab died as a result of brain bleeds.
Why Do Some People Think This Was the Wrong Thing to do?
Some experts feel that there is still a lot we need to learn about the long term effects of a drug like Lecanemab. For example, Medicare has said that they will provide coverage but that patients must enroll in a registry which requires their doctors to report on a regular basis on the drug’s safety and effectiveness. Obviously, if there were no concerns about these issues, there would be no need for a registry.
Other people say that patients really won’t notice a difference. They say that Lecanemab’s effects are just “modest” and it’s not clear that it will produce a noticeable change in people’s lives. In the trials, cognitive decline is measured using a subjective, self-reported scale that focuses on people’s performance in areas like memory, judgment and problem solving.
So, the rating method is “very subjective.” On the other hand, that’s how a lot of dementia diagnoses work. Self-reporting is one of the few methods researchers have to quantify the severity of symptoms in patients.
Another limiting factor is that the U.S. healthcare system simply isn’t prepared to diagnose, treat, and monitor a large number of Alzheimer’s patients. In addition to the biweekly IVs, Lecanemab requires an initial test to determine amyloid levels in the brain, and periodic brain scans to detect side effects. Some health experts say that there are not enough specialists who understand how to provide this treatment. ” One was quoted as saying that “We don’t have enough primary care physicians with knowledge and the confidence to provide a referral.”
The final issue is cost. Lecanemab costs $26,500 a year per patient. Of course, the negotiated price for Medicare will be less, but it still represents a huge amount of money. There are an estimated 6.5 million people with Alzheimer’s in the US. If 10% of them take Lecanemab, it would boost drug spending by almost $18 billion, according to an analysis by the Kaiser Family Foundation. That kind of increase in Medicare spending would surely lead to an increase in premiums for all enrollees. When we talk about people’s health and wellbeing, the issue of cost is a harsh question. If you are the one with Alzheimers, or if it’s your loved one, you want well-being at any cost. However, at some point, economic realities set in.
A recent study in Jama Neurology on a similar drug for Alzheimers called donanemab which still is in clinical trials, concluded that at expected prices donanemab would not be cost-effective for early AD in the US.” These decisions are way above my pay grade, but I think the takeaway here is that, after decades of searching for a cure for Alzheimer’s we are indeed on the verge of seeing a light at the end of the tunnel. It still may take years, however, for these drugs to be widely available and affordable and for the needed infrastructure of IV clinics and knowledgeable primary care physicians to be in place. What are your thoughts? Are the benefits worth the risks? Did Medicare do the right thing in approving a drug that still has so many concerns?
