A New Alzheimer’s Drug Gets FDA Approval

A New Alzheimer’s Drug Gets FDA Approval

Americans love our independence. From the ability to go where we want to go to the simplicity of moving around freely in our homes, being independent and doing things for yourself can bring great satisfaction.

Most of us want to age in place, and there are many aging in place solutions that allow us to do just that. We readily modify our homes to make life easier, use a medical alarm pendant or wristband to provide us with peace of mind and security, and take the medications prescribed to us, exactly as directed. These are just a few of the things we do to stay healthy and safe.


But what if something outside of your control takes away your independence? That’s what Alzheimer’s does.


This devastating disease takes an enormous toll. Those who are diagnosed with it in the early stages usually have enough cognitive ability to fully grasp what is happening to them, and they can do little more than try to live their lives as fully as possible while the progression of the disease marches on.


It robs them of many things we often take for granted: hobbies, the ability to drive, astute judgment, laser focus, and eventually, even the ability to recognize those they love the most.


Unfortunately, we have yet to find a cure for Alzheimer’s, but scientists have found medications that promise to slow the course of the disease for some. These medications go through the long and rigorous process of clinical trials to prove their effectiveness before getting approval for prescription distribution from the U.S. Food and Drug Administration.1


Finding a treatment for Alzheimer’s has been very slow going, but a drug has finally made the cut. It’s called Leqembi.


All About Leqembi


Leqembi, with the pharmaceutical name lecanemab-irmb, was created by the pharmaceutical companies Biogen and Eisai. Studies have shown it clears amyloid plaque build-up in the brains of those who have mild Alzheimer’s disease. These plaques grow as the disease progresses; by clearing the plaques in the early stages, the drug delays the more serious symptoms of the disease. In fact, an 18-month clinical trial showed that taking the drug slowed the cognitive decline of Alzheimer’s disease by 27%.


The drug has been approved for use in those who have early symptoms of Alzheimer’s, including mild cognitive impairment or mild dementia. They must have scans that confirm the presence of amyloid plaques in the brain. Of all those who have Alzheimer’s, an estimated one million patients will qualify for the prescription for Leqembi.


The medication is given as an IV infusion every two weeks. This can be done at a doctor’s office, hospital, or specialized infusion center. Those who are on the medication will need regular brain scans to show that the drug is working in order to continue taking it.


As with many promising drugs, there are a few dangers associated with taking it. About 13% of those in the trial suffered brain swelling or bleeding. This was especially true for those who have underlying medical conditions or were taking blood thinners at the time of the testing. Because this is a serious potential side effect, the drug has a “black box label” that states the risk, so that those who choose to prescribe it or take it are well aware that they could face complications.


Other potential side effects include headache, confusion, changes in vision, dizziness, nausea, difficulty walking, and seizures.2 Though these side effects are rare, they can be a serious problem if they do occur.


This is a very good reason to wear an emergency button alert at all times, but also serves as a reminder to use medical alert technology as a safety net no matter what sort of drug you are taking. Side effects that can affect your balance and ability to walk can happen with a wide variety of medications, thus increasing your fall risk.


Scientists aren’t sure what the drug does for those with advanced forms of the disease. That’s being studied now, but because clinical trials are not complete, there is no approval for those who have moderate to severe Alzheimer’s. That’s the next step researchers are working on.


Expanded Coverage for Leqembi


When the drug was first approved under an accelerated program in January 2023, many patients with early-stage Alzheimer’s were overjoyed at the prospect of slowing the progression of the disease. There was only one problem, but it was a big one: a $26,500 price tag.


Because the drug didn’t yet have full FDA approval, coverage was very limited. Medicare, Medicaid, and private insurance didn’t cover the drug and so if someone wanted to use it, they had to pay the full price (as well as the cost of brain scans, most of which were not covered for the purpose of getting the drug).


But now, the Centers for Medicare and Medicaid Services (CMS) will expand coverage for the drug, which makes it available to millions of people at a more affordable price.3 The expansion of coverage comes because the drug now has the traditional, full approval of the FDA. That means that those who have mild impairment and are fighting to keep their independence can be rest assured that there is an option out there to help them.


As part of the coverage approval, there are some requirements for patients and doctors to meet. Those who are on the drug, as well as those who prescribe it, must be willing to participate in collecting as much information as possible on how the drug works in the real world, with real patients. They will enter this information into a registry that can be accessed by researchers who are tracking the efficacy of the drug.


Problems with Coverage


However, there are still hurdles to getting the medication.


The brain imaging required to qualify for Leqembi and to stay on the drug are not always covered by Medicare, Medicaid, or private insurance. And while those imaging tests aren’t usually as expensive as the high price tag of Leqembi before coverage kicks in, they are still expensive enough to put the tests – and thus, the drug – out of reach for some who could benefit from it. However, drugmaker Eisai says that they expect a CMS coverage decision soon.


There is also the question of just how high the out-of-pocket costs will be. Those in traditional Medicare pay 20% coinsurance for their Medicare-approved drug after they meet their deductible. Depending upon what Medicare chooses to approve as the coverage amount, that could leave those who need the drug with hundreds or even thousands of dollars in co-insurance before they can get the infusion.


Those who are on Medicare Advantage plans, many of which close the coverage gap for prescriptions, will have to pay based on the terms of their policy. That’s still being hashed out as well.


Given the high price of the drug, expanded coverage by CMS could affect those who aren’t on the drug at all. That’s because the cost of paying for Leqembi could drive up the overall program costs for CMS.


To put it in perspective, consider this: according to the Kaiser Family Foundation, if only 10% of those diagnosed with early-stage Alzheimer’s take the drug, Medicare pays $26,500 per infusion for an annual spend of $17.8 billion. That number is greater than the total Medicare spending on the top 10 most common drugs for the elderly combined.4


If CMS chooses to provide the coverage for the necessary brain scans to get the drug – which experts believe it probably will cover – that drives up overall Medicare spending even more.


As a result of this much higher spending on the part of Medicare, those who have Medicare Part B can expect their premiums to go up. How much they will go up is anyone’s guess at this point, but with the increased spread across all enrollees in the program, hopefully that increase won’t be much. And it will certainly be a significant help to those who are fighting Alzheimer’s progression. 


Staying Safe, No Matter What


Though anyone who has been diagnosed with cognitive impairment should consider using an in-home or on-the-go (mobile) alert for elderly adults to keep them as safe as possible, those who have been diagnosed with any sort of medical condition, or who live alone, can benefit from using a medical alert device. A medical alert pendant, wristband, or watch can give you the peace of mind that if you do suffer a medical event or emergency or accident of any kind, help is literally one button press away.