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Health Affairs This Week places listeners at the center of health policy’s proverbial water cooler. Join editors from Health Affairs, the leading journal of health policy research, and special guests as they discuss this week’s most pressing health policy news. All in 15 minutes or less.
Hello, and welcome to Health Affairs This Week. I am your host, Jeff Byers. Before we get in today's episode, I wanted to share with you all that the 2nd annual You're a Health Policy Wonk If contest winner was revealed this week on Health Affairs Forefront. This year's winner is Austin Barcelo with the following entry. You're a health policy wonk if you plan your retirement around CBO's latest Medicare Trust Fund Insolvency date.
Speaker 1:As part of the contest, we are having a flash sale on Insider through July 20th. Use code health wonk life for $30 off of an Insider membership. Also of note, we are still taking submissions for abstracts for upcoming food, nutrition, and health theme issue. Submit your abstracts by end of day, July 29th. And now today on the program, we have HealthFair's own Leslie Erdalak to join the program to talk about the state of Alzheimer's treatment drugs at the FDA.
Speaker 1:Leslie, welcome to the program.
Speaker 2:Hey. Hey, Jeff. Good to be here. Currently sitting here rethinking my entire approach to retirement.
Speaker 1:I know that's right. Leslie, the FDA approved the use of denanumab for early stage treatment of adults with Alzheimer's disease. Before we get into the regulatory and policy arena, And I want to remind listeners that, Leslie, unless I'm wrong, you're not a scientist, right?
Speaker 2:I am not.
Speaker 1:I'm not a scientist either. We hope you, the Health Affairs This Week listener, finds this information interesting, but also note that we are not steeped in denanimab all day long or denanimab clinical trials research. So if you are and, you wanna come on the program, send us an email. So, Leslie, what can you tell us about the rate of Alzheimer's disease in the US today?
Speaker 2:Mhmm. So right now, about 7,000,000 Americans aged 65 and older are living with Alzheimer's. It's a brain disease that we often associate with memory loss and declines in cognitive functioning. And Alzheimer's is the most common form of dementia. It makes up about 60 to 80% of dementia cases.
Speaker 2:And the reason we sometimes have a hard time putting numbers to these conditions, Alzheimer's starts 20 years or more before memory loss and other symptoms start to kick in. So we also have to think about Alzheimer's as sort of a continuum here. So where the disease progresses in stages, you've got the severity of your symptoms increasing from time as the brain changes. So things that might be unnoticeable to the person affected to mild cognitive development to then more pronounced symptoms of dementia. So that's really our best estimate at this point.
Speaker 1:And I know it's on the minds of a lot of people, especially as America ages. I believe we've talked about it with the silver tsunami as well, so it's definitely something that, is it more prevalent these days?
Speaker 2:Yeah, that's a tough one to answer as well. But I think, you know, even though Alzheimer's and other dementias, I mean, the thing that's sad and sort of frustrating about this is that we've been looking at these clinical trials for 3 decades now and we know that Alzheimer's is contributing to more and more cases of poor health and disability, not only in the U. S. But around the world. And despite all of those advancements, there have been a great deal of setbacks.
Speaker 2:And so, sadly, there's there's still no cure, which is really, I think, disheartening, but also motivating for a lot of people.
Speaker 1:I would likely imagine it's motivating for the approval of this new Alzheimer's drug. Just to give a quick setup, I was looking at, The Wall Street Journal before we started recording, and they had an article by Peter Loftus and Joseph Walker with the title approval of newest Alzheimer's drug will accelerate new era of treatment, with the subhead of with the arrival of lilies consola. Alzheimer's care could become more like treatment of cancer and rheumatoid arthritis and their regular infusions.
Speaker 2:I think why, why people are talking talking about this, you know, there's there's not a cure for Alzheimer's, but we do have a very, very small number of these sort of disease modifying therapies and denanumab being one of them. These drugs really work to slow the progression of the disease when you take them in the early stages of Alzheimer's. And one of the hallmarks of Alzheimer's disease, and I can talk a little bit about how this drug actually works, One of the features of Alzheimer's is one reason why scientists think that the disease develops and why it progresses is this buildup of amyloid plaques in the brain. And these are protein fragments that accumulate in the spaces between nerve cells in the brain. And denanumab is thought to help the body remove the excessive buildup of these plaques.
Speaker 2:It's the way it's administered. It's an intravenous infusion. And this drug in particular, it's given once a month. And what sets it apart, and I think the other reason why people are excited about this drug, what sets it apart from other therapies on the market, according to Eli Lilly, the company that manufactures this drug, is that you might be able to stop treatment once those plaques are cleared. So digging into a little bit what they found in the clinical trials, they were able to demonstrate that denanumab reduced amyloid plaques by about 80% at 12 months compared to the start of the study, and that well over half of patients who were receiving the drug were able to discontinue it at 18 months.
Speaker 2:That's something that, to my knowledge, no other study has been able to demonstrate to date. But the big headline, Jeff, is that what this clinical trial showed is that people treated with denanumab had a lower risk of progressing to the next clinical stage of disease than those who were taking the placebo drug. And, yeah, I was looking at I always like to look and see what are people saying about this. And the Alzheimer's Association, you're probably familiar with them. They put out a statement saying that this was real progress.
Speaker 2:It's a major advancement. We now have a couple of FDA approved Alzheimer's treatment options on the market. And as you said, this one's gonna be marketed under the brand name, Kysunla. Doctor.
Speaker 1:Andrew Roark Thanks. Yeah, it does sound pretty promising based on the information that we've reviewed and know. On that, I'm sure there, as with some pharmaceutical drugs, there may be some risks with taking this. Did you find any information about what the clinical trials showed as far as that goes?
Speaker 2:Yeah. So, these, the drugs in this class, they're anti amyloid drugs. They target the underlying biology of Alzheimer's. Of course they have side effects, they have safety risks, and one of the risks associated with these drugs includes swelling and bleeding in the brain, and these types of abnormalities again can range in severity from asymptomatic to fatal. So in this trial, about a quarter of patients treated with the drug had some level of brain swelling or bleeding.
Speaker 2:It's typically a manageable side effect of the treatment, and it can be detected by ordering MRIs. And it's part of the reason why these medications carry a black box warning, which is the highest level of a warning that FDA can recommend. Kasemma's safety profile has also been perceived as slightly less favorable with respect to some of these reported side effects. But, again, in the eyes of the FDA and sort of the independent panel of experts who kind of weighed in on this decision, these risks are generally consistent with this class of drugs.
Speaker 1:One thing we like to do here on this program is try to identify some of the trends in the health care business and policy world. With this approval from the FDA of denanimab, it comes on the back of the FDA approval of, and my apologies for not saying it right already, lequimbi, which was another Alzheimer's treatment drug that was approved by the FDA. And there was another story for a similar drug, Aduhelm, that was actually taken off the market that was for Alzheimer's treatment. So when you look at these stories in concerts, just so listeners are aware, what was Aduhelm's story?
Speaker 2:So FDA approved Aduhelm in June of 2021 under this accelerated approval pathway, even though so that the controversy was that outside panel of experts that they called in said that there wasn't enough evidence to show that the drug worked. It was approved for a broad label indication of people with Alzheimer's disease that was really not supported in the eyes of, you know, a lot of people looking at the the clinical trials. It was not supported by that clinical data for people with different stages of the disease. You saw major health systems like Cleveland Clinic, the Department of Veterans Affairs. They took it upon themselves not to offer Adahelm.
Speaker 2:The list price was exorbitantly high. It was $56,000 a year. And then to kind of top it all off, you had this 18 month congressional investigation that documented irregularities with FDA's process. And so the way the drug came on the market, I think, was just extremely polarizing. And earlier this year, the drug maker, Biogen, announced that it would discontinue the sale of the drug, and that also meant stopping the post market confirmatory study that they were supposed to do when they got FDA approval.
Speaker 2:So they stopped all that. They decided to redirect the company's resources to its other Alzheimer's drug, which is Lekembi, which you mentioned was approved earlier this year. So Lekembi saw a much smoother road to full approval, and so and that drug was really the only amyloid targeting therapy available until just recently, with Kasimla now coming on the market.
Speaker 1:And you mentioned the cost of Aduhelm, which is a different drug than, lekimbi and denanumab. But going back to denanumab, Eli Lilly, I noticed in their press release for this FDA approval, shared that the potential cost for denanimab for at 12 months would be about $32,000 and in 18 months, $48,000 give or take. As you noted, the goal is to hopefully stop taking these drugs after some time. But when we look at it from a policy perspective, what can we expect these drugs to be covered by insurers or Medicare?
Speaker 2:Yeah. So I will, I'll talk about private, sort of, commercial insurance first. And, yeah, so the the total cost of the therapy is going to vary based on when patients complete their treatment. And the out of pocket cost, of course, is going to depend on the length of treatment and the type of insurance coverage the patient has. Some private insurers are still and I looked to see what insurers were thinking when Lekembe was approved.
Speaker 2:And some insurers still see the drug as experimental, so they're not covering it. So I think the full picture on commercial insurance coverage is still emerging. Many insurers say they have they have yet to make a decision on it. But CMS almost immediately following the approval, CMS made Medicare coverage available for kasumla, and Medicare covers drugs that have traditional FDA approval in this class under a couple of conditions. Right?
Speaker 2:So the prescribing clinician has to say, this treatment is appropriate for you, but they also have to enroll patients in a real world sort of data collection effort through a registry in order to get Medicare payment for the treatment. And so CMS has gone back and forth on its coverage policies for Alzheimer's drugs. On one hand, you know, the requirements for coverage might be seen as too restrictive, but on the other, I think it's important to have a mechanism to be able to generate evidence about the ongoing effectiveness and safety of these drugs, which I think is kind of the point of the registry.
Speaker 1:And as we wrap up, is there anything else we should note about the progress of Alzheimer's treatment to watch out for? I know we've published a lot in health affairs on Alzheimer's. Anything you care to bring up?
Speaker 2:Yeah. So, I mean, there are, you know, of course, limited treatment options right now for Alzheimer's, and we don't yet have treatments that completely stop the decline or restore function. So that's obviously an important goal. I did see Eli Lilly said it's planning trials to test these drugs in patients who are genetically predisposed to developing Alzheimer's, which would be, I think, a pretty significant development. There are some large scale studies happening looking at lifestyle interventions on cognition in older adults.
Speaker 2:CMS is launching a pilot model in dementia care management. So I think the hope is that some of these results, some of what we learn from these initiatives will give us a better understanding of how these amyloid targeting drugs and other sort of novel therapeutic strategies can either be used alone or in combination with each other to really reduce the burden of Alzheimer's, as well as just the costs and long term care costs of people living with dementia.
Speaker 1:Well, Leslie Erdalak, thank you for joining us today on Health Affairs This Week.
Speaker 2:Anytime.
Speaker 1:If, listener, if you enjoyed this episode, please share it with, a friend or colleague, and, make sure to subscribe to wherever you listen. Have a great day.
Speaker 2:Thanks, Jeff.