Latest / CareTalk: Healthcare. Unfiltered. / FDA Approves Leqembi: What You Should Know

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FDA Approves Leqembi: What You Should Know · CareTalk: Healthcare. Unfiltered.

• 0:00
  FDA just approved chebe, a drug to slow the cognitive decline of Alzheimer's patients, and Medicare has agreed to pay for it.
• 0:08
  But last year, FDA approved a fairly similar drug, a due helm, and that did not go too well.
• 0:13
  Medicare refused to cover it, and the acting FDA Commissioner Janet Woodcock, was forced to retire.
• 0:19
  So what's changed and what hasn't?
• 0:21
  Is it time for patients, families, and physicians to be excited?
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  Or should we temper our hopes?
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  Welcome to Care Talk America's home for incisive debate about healthcare, business and policy.
• 0:39
  I'm David Williams, president of Health Business Group.
• 0:42
  And I'm John Driscoll, the president of Walgreens Health.
• 0:46
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• 1:01
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• 1:08
  Seasonally appropriate.
• 1:09
  David, tell me what is this chemi drug and, and how should we think about it against this?
• 1:17
  The horrible wasting brain wasting disease of Alzheimer's.
• 1:21
  So it's a new drug and it has.
• 1:22
  Regular approval for early stage Alzheimer's.
• 1:25
  It had received accelerated approval at the start of the year.
• 1:27
  Now it has just a regular approval.
• 1:29
  It's made by eai, which is a Japanese pharma company in partnership with Biogen, who you may remember from, uh, ADU Helm.
• 1:35
  And the way that it works is it, it tries to re reduces the number of amyloid beta plaques that you have in the brain, and it is said to modestly slow the cognitive decline in people with early stage Alzheimer's disease.
• 1:49
  But it's pretty complicated.
• 1:50
  It's not like a typical bill a pill, rather, it's not a stable chemical compound.
• 1:55
  It requires, I think, every other week infusions as well as a fair amount of scans to make sure that there are no side effects to your brain.
• 2:07
  And it's based on the, the theory, um, which I think is, is, is pretty well documented, but not completely agreed on.
• 2:16
  That amyloid plaques, those signs of, of, of brain, of, of the disease in the brain that you have to actually get a, a pretty elaborate scan.
• 2:27
  Uh, it really attacks those amyloid plaques.
• 2:30
  And so you need to have access to a, a really inexpensive scan.
• 2:35
  You need to be a, be required to take these infusions every other week.
• 2:40
  And then you gotta probably be monitored for.
• 2:44
  Brain for any, any side effects to the brain because we're.
• 2:47
  Still at the early stages of understanding this disease as well as the consequences of this drug.
• 2:52
  Is that, is that the right way to think about it?
• 2:54
  Well, John, you went right to pouring cold water, uh, on it, and you're focusing, uh, as we often do here about what's actually happening in the healthcare delivery system.
• 3:02
  And so one reason that this drug is not gonna have the big, such a big impact, even if it were to wake.
• 3:07
  Work great, which it doesn't, is there's a bunch of bottlenecks in the system.
• 3:11
  First of all, just in primary care, getting an appointment and being able to determine if somebody is a good candidate, you do need testing.
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  One is to see if you actually have the amyloid plaques in the first place.
• 3:20
  People have dementia without having that, so you have to have the PET scans.
• 3:23
  Then you have to have the scans as you go, uh, further to make sure you don't have brain swelling or, or brain bleed.
• 3:29
  You also need to have, even before you have the drug, uh, you need to have a genetic test because there is a, a certain mutation that's fairly common.
• 3:37
  Uh, that makes it much more likely to have the, uh, the brain bleeds.
• 3:40
  And then the infusion itself, it's every couple of weeks you have to have an infusion.
• 3:44
  Now the good news, it's this intravenous infusion, uh, which is more like other drugs people might be familiar with, like Remicade, whereas I do, helm actually had a spinal infusion, which is even more complicated.
• 3:55
  And then one more thing, which is, uh, makes it a challenge, but also I think is a good thing, is you need to be en en enrolled in a registry.
• 4:02
  A registry.
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  So the, uh, the government is tracking how well.
• 4:06
  Does this product actually work in the real world, not just in the limited clinical trial that was done.
• 4:12
  Now this is, Alzheimer's is obviously a devastating disease and as people live longer, we're, and we're seeing an enormous increase in the number of, uh, Americans diagnosed with Alzheimer's, which is, you know, sort of an accelerated cognitive decline that is just terribly alienating for any family that suffers from it.
• 4:31
  Um, and some of those cases are showing up.
• 4:34
  Early in, in, uh, in people's lives as, as early as in the fifties, as well as the, the, the folks who are really old.
• 4:41
  I mean, one of the challenges for Alzheimer's is while it's growing like crazy, it actually requires a fairly specific set of tests, um, carried out by a specialist, determine even whether you've got.
• 4:53
  True early indications of Alzheimer's or whether it's your, your cognitive decline is, is, is consistent with sort of your, your, your genetic makeup and your age.
• 5:04
  I mean, it's not that, uh, uncommon for folks to have modest cognitive decline as the brain shrink with, with age.
• 5:11
  Um, the challenge is we've got this devastating disease Alzheimer's that's growing like crazy within the population that is.
• 5:21
  Devastatingly burdensome for the healthcare system and for the families.
• 5:26
  And so I do think that the FDA is leaning in, trying to.
• 5:30
  Build support.
• 5:32
  The positive case that aside the manufacturer and Biogen are making that even a modest slowdown in cognitive decline that is shown in the tests, uh, in, in the clinical trials rather, I is a rationale to at least get this drug out into the population, to lighten the burden for those families affected.
• 5:54
  But it's not cheap.
• 5:55
  It's, uh, I think it's north of $26,000 a year.
• 5:59
  Um, per drug, and that's before you even get into all the tests and scans in, in addition, it's gotta be probably administered and managed by specialists.
• 6:08
  But, um, I, I, I, I'm, I'm en, I modestly encourage Dave that the, this drug actually is showing some results because this is an area where most drugs have failed and failed pretty miserably in showing success at slowing or stopping this disease.
• 6:26
  John, there's a lot of big picture questions from a policy standpoint, clinical standpoint, and so on.
• 6:32
  One thing that people are asking who you know, who are affected by this in their family, they ask me, you know, does Medicare cover LA mbi?
• 6:38
  And the answer here, I.
• 6:39
  Is Yes, that there is broad coverage by Medicare now that the drug has regular approval.
• 6:44
  And that's a big difference from a due helm, which just had conditional approval.
• 6:48
  Uh, yeah, you have to meet the criteria.
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  You have to be part of a registry.
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  You're also likely to have some out-of-pocket costs that are up to about $6,000 per year.
• 6:56
  This is something where unlike the previous drug, ADU Helm, it actually does demonstrate some impact on cognition.
• 7:03
  ADU Helm just showed that, you know, the plaques were reduced, but didn't show any, necessarily any, any improvement here.
• 7:09
  So Medicare covers it.
• 7:11
  Um, and I think the other thing is that there, there are some differences, uh, with ADU helm in terms of, um, the safety profile.
• 7:18
  We mentioned this concern that you have to get scans.
• 7:21
  That's right.
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  That's because for a helm, 40% of the patients had some evidence of brain swelling or brain bleeds, and that's compared to 21% in the CHEBE trial and about 9% of those on placebo.
• 7:32
  Now, no, not all of those are symptomatic, and one of the reasons for the registry is to try to understand, uh, what's going on in terms of the price.
• 7:40
  John, you're right, it's 26 and a half thousand dollars, what they put it on the market for now, helm is on.
• 7:45
  At 28,000.
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  Originally it was 56,000.
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  Uh, so they actually cut the price there, but it's still, it's still above, you know, Biogen's, um, involved with both.
• 7:54
  So I think those are some of the questions that people are actually needing to make the decision for their family members or themselves are confronting.
• 8:01
  I think that the, there, there's elements here as we think about the devastation and the, and, and the importance of kind of a, a real social investment here.
• 8:10
  That there are.
• 8:12
  Other conditions that are tightly associated with, uh, advanced risk for Alzheimer's.
• 8:18
  Uh, one is diabetes, the other is high blood pressure.
• 8:21
  And, you know, some of the, I think, public health questions are, why aren't we spending that money that we might otherwise would use for expensive drugs in really testing out better public health responses to how to manage high blood pressure?
• 8:38
  Um, and how to manage or, and change behavior in diabetes.
• 8:43
  You know, these are, these are really cluster diagnoses in, in the sense that they start with one disease and they spider on into all kinds of other disease conditions.
• 8:52
  That if we can get our, our, our, our arms around as a society, diabetes and, and, and, and slowing that down, um, see a coronary, uh, chronic heart failure, uh, chronic heart disease.
• 9:05
  We actually might slow down Alzheimer's using the tools we've already got.
• 9:10
  John, this is a real conundrum for people working in public health and especially with minority communities.
• 9:15
  So on the one hand, as you say, hypertension, diabetes are real contributors, uh, causal contributors to, uh, dementia to Alzheimer's and, and all sorts of other challenges.
• 9:27
  And if you look at what happened in this clinical trial, Even though black people are more likely to have Alzheimer's than, than other parts of the population in the us fewer were enrolled in the clinical trial.
• 9:38
  There's a couple reasons for that.
• 9:40
  Crazy one.
• 9:40
  Well, there's a couple of reasons, John.
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  One is that there's tends to be because of uh, less access to, uh, healthcare people tend to be diagnosed later.
• 9:49
  They're not gonna be eligible.
• 9:50
  Cause this drug only works at early stages.
• 9:52
  And then as I mentioned before, there's a genetic test that you have to take to make sure you're not gonna be affected by the brain bleed.
• 9:57
  And, uh, black people, at least for the trials, are something like twice as likely to have that mutation.
• 10:02
  So now if you're in the, in the, in the community, you're saying, I wanna do something here.
• 10:06
  Say, well, on the one hand I've got a drug.
• 10:08
  That's approved and Medicare will pay for it.
• 10:10
  So I'm not really deciding, hey, do I spend this $28,000 or $26,000 on prevention versus treatment?
• 10:17
  No.
• 10:17
  That you're not being offered that.
• 10:19
  So it's a real conundrum, but I, I think it highlights from an overall policy standpoint where the focus should be.
• 10:25
  And by the way, uh, if you have, you know, if you don't have diabetes and you, and you don't have hypertension, You don't have the chance of a negative side effect maybe from the drug, but it's generally you're gonna feel better.
• 10:35
  You're gonna be better.
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  Whereas you take this drug, there may be a modest effect that you might not even notice.
• 10:40
  The family might not notice, but you've got a real risk of a serious side effect.
• 10:45
  Well, I think, I think the, the, the public health warning we can, we can give without any clinical background is based on what the clinical trials showed.
• 10:54
  Anyone who's on this drug should, has gotta be finding their way to a specialist and making sure they're scanning for any of the risks.
• 11:02
  But I think that what I'm encouraged by David is that they're, You know, in a, in a way that the process didn't see positive results, but had hope.
• 11:10
  With ADU Helm hope more than performance with Lubi there, you're actually seeing some performance and I think that more drugs can build on that.
• 11:19
  Um, so I'm, I'm modestly uh, um, optimistic.
• 11:22
  And the other thing I'd say is that the CARES Act that Biden pushed through actually requires much more of a.
• 11:29
  Uh, um, of a, of a, of a, of a more representative sample in clinical trials.
• 11:34
  And so we're actually making progress on that.
• 11:36
  Again, I think that, I think Alzheimer's deserves more time and probably with someone who's a clinical expert, but, uh, at least from the cheap seats, I think this is, this is modestly positive.
• 11:46
  John, I, I agree with that.
• 11:47
  You know what I mentioned before, uh, Janet Woodcock basically lost her job, had to go into retirement, uh, cuz she helped to press do, uh, do helm.
• 11:56
  Uh, if you keep in mind the broader context where there's a lot of money being invested in drug research in different places.
• 12:02
  We wanna encourage it to go into Alzheimer's, which is a gigantic unmet need.
• 12:07
  And so the idea that, hey, okay, we, if we believe this plaque hypothesis, which some do, uh, here's something that reduced plaques in the case of Idu Helm, so it was approved.
• 12:15
  Now here we've got something that shows some evidence.
• 12:17
  On the cognitive decline as well.
• 12:19
  So you wanna actually encourage companies to continue doing, uh, development.
• 12:24
  Otherwise they may say, well, there's no drugs for Alzheimer's 10 years from now, because we found out that you can't actually get approved and make money, uh, from doing it.
• 12:30
  So we have to keep all of those things, uh, in mind as well.
• 12:35
  Well, John, that's it for yet another episode of Care Talk.
• 12:38
  We've been talking about Alzheimer's today and a drug that looks at least a little bit more, uh, exciting and worthwhile than what we've seen in the past.
• 12:46
  I'm David Williams, president of Health Business Group, and I'm John Driscoll, the president of Walgreens Health.
• 12:51
  If you liked or what you heard or you didn't, please subscribe on your favorite service to care talk.