October 27, 2023 • 29 mins
More than six million Americans are currently living with Alzheimer's disease and by 2050, that number is expected to skyrocket to 13 million. The FDA approved two new treatments that slow the progression of the disease, but the Centers for Medicare and Medicaid Services, also known as CMS, is setting a dangerous precedent by requiring consent from patients in a way that's never been demanded before. Now many doctors, elected leaders, and families are afraid patients will face health disparities and that the move could be expanded to limit access to other medications. Let's hear more from the Chairman of the Partnership to Fight Chronic Disease and Chairman of Health Policy and Management at Emory University, Dr. Kenneth Thorpe.
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(00:10):
More than six million Americans are currentlyliving with Alzheimer's disease, and by twenty
fifty that number is expected to skyrocketto thirteen million. The FDA approved two
new treatments that slow the progression ofthe disease, but the Centers for Medicare
and Medicaid Services, also known asCMS, is setting a dangerous precedent by
requiring consent from patients in a waythat's never been demanded before. Now,
(00:34):
many doctors, elected leaders, andfamilies are afraid patients will face health disparities
and that the move could be expandedto limit access to other medications. Let's
hear more from the chairman of thePartnership to Fight Chronic Disease and Chairman of
Health Policy and Management at Emory University, doctor Kenneth Thorpe. Welcome to the
show, doctor Thorpe. I'm soglad you could make time for us today
(00:56):
to talk about this important subject.Well, thanks for having me today.
We're talking about Alzheimer's drugs, andparticularly the newest ones that have shown such
great progress, and whether or notMedicare is going to be covering that.
Why don't you start by telling usyour experience with those two things. Well,
(01:19):
sure, so, the efflut inDrug Administration has approved two medications to
slow the progression of early onset Alzheimer's. What they found is that the medications
reduced the plaque build up in thebrain, which is sort of the hallmark
of Alzheimer's. And these are completelynew innovative treatment options for Alzheimer's patients that
(01:49):
hadn't been available up until very recently. That's the good news. The bad
news is that the Medicare program,the Department of Health and Human Services has
decided to not pay for those medicationsthrough Medicare unless your physician enrolls you in
a clinical trial, which could takeyears to conduct and do the evaluations.
(02:15):
And the challenge for a lot ofAlzheimer's patients, I believe, is that
many of them live in rural areas, nowhere near a medical center or a
place that would conduct a clinical trial. So it does raise concerns about health
disparities and health equity, and certainlyit raises concerns for families that are going
(02:38):
to have restricted access to these innovativemedications that slow the progression of Alzheimer's.
Definitely. Now, when you saya clinical trial, I mean, these
are medications that will be FDA approved, correct. Yeah, They've already been
(02:59):
approved by the FDA, and theFDA has found that they have clinical benefits.
They've done three separate randomized trials alreadyof these medications looking at patients that
receive the treatment who have they hada significant reduction in it's called beta plaque.
(03:21):
A lot of the patients who didn'treceive the treatment had no reduction.
So we have sort of the youknow, the surrogate outcomes that we know
that this is reducing plaque build up, which slows the progression. The FDA
has found them both to be safeand effective. It's just that CMS won't
(03:42):
pay for them unless you're enrolled ina clinical truck. Now. I know
they put out a like a factsheet in June of this year and they're
calling what they're doing like a Let'ssee if I can find the exact wording
here. They're saying, you haveto be on a registry. Is that
the same thing? Are we talkingabout the same thing? Basically? Yes?
(04:06):
Yes, Okay, Are there anyother medications that they do the same
way like this where you have tobe on some kind of registry where they
track your everything. Now this isyou know, from cms's standpoint, it's
not just unusual, it's completely unprecedented, and it really should be worrisome to
(04:30):
those even beyond the Alzheimer's community.Uh that you know, CMS may start
applying this to other chronicly ill populations. So these these coverage restrictions and denying
treatments, you know, for PREFTYAapproved drugs, is highly unusual. Okay,
(04:51):
that's what I thought. I mean, are there any barriers to being
diagnosed with Alzheimer's disease it would makeit different? Or you know, is
there expensive testing for early diagnosis thatwould require this change? I mean,
(05:11):
can you find any justification for whythey're doing this? Not really, I
mean if you think about it,you know, so health plans and payers
will pay for, you know,a brain scan, so when you do
a brain scan and you're looking atplaque, you can diagnose whether or not
a patient has progressing Alzheimer's in dementia. That really, I think unfortunate follow
(05:40):
on is that they won't pay forthe treatment so you can diagnose it.
But they're not going to pay fortreatments that have been found to be safe
and effective and slow the build upof plaque. Wow. The immediate knee
jerk reaction is is that this isa severe government overreach. Which would you
(06:00):
agree with that or what are yourthoughts? Oh? Yeah, I think
completely. I mean, it's oneof those things where it's you know,
penny wise and pound foolish. Youknow, there's an initial upfront annual costs
of the medications. Obviously, youknow, they cost something on the order
of twenty five twenty six thousand dollarsa year. On the other hand,
(06:26):
the alternative for these patients is thatthey go into memory loss centers, long
term care facilities, and you know, the cost of those those alternative treatment
venues is more than twenty five ortwenty six thousand dollars, you know,
over two month period. So ifyou're slowing the progression of this by several
(06:50):
months, obviously you're you're saving familiesmoney, and on the long term care
side, you're saving Medicare some moneytoo. So I don't know that the
full financial and clinical picture was wellthought out. Yeah, and I think,
I mean, I think you willagree with me. We already know
(07:13):
as a general public and as ageneral rule, that insurance, while it
can be helpful for paying for things. It can be very problematic when you're
the person who is sick and tryingto get treatment or a diagnosis, because
they have people who aren't even doctorsgoing through basically a checklist of did you
(07:34):
run this test? Oh you did, okay, well let me follow the
flow chart. Now you have torun this test before we'll pay for this
or do this, when the doctorsreally don't always need all of those steps
correct, right. You know,for a lot of medications, you know
this is a good one, butyou know, take type two diabetes or
(07:57):
high blood pressure or elevated cholesterol.Making sure that patients build and refill their
medications is going to prevent stroke,it's going to prevent hospitalizations, emergency room
visits, ambulance rise. And youknow, for those types of medications where
we know they work and they affectchronically old patients, there shouldn't be any
(08:18):
cost sharing. I mean, there'sreally no point of charging patients money because
they're going to be less likely totake medications that we know clinically work and
save money. So I think,you know, a similar analogy could be
taken for this medication too, thatyou know we have the clinical data that
(08:39):
shows that it has an impact onplaque build up, and there's really not
a real strong reason to limit patientsaccess to this innovative new set of medications
that would provide a clinical benefit forthem and their families. Yeah, I
agree, Like you said, itcan help save costs in the long run
(09:03):
too. Now, there's more thanjust one drug that is in this list
of recently FDA approved and proven tobe successful drugs for Alzheimer's. Correct,
right there, there's two of them. Okay, will you give us the
name of those just so we're familiar. Yeah, one is, and they're
(09:26):
hard to pronounce, so you haveto just to forgive me. The first
one is the la quimbi. It'sl equ e mbi, and the second
one is ad you have a du h E l M. So those
are the two medications that the FDAhas approved. Okay, and you said
(09:48):
they're both like in the twenty thousanddollars range for a year's supply something like
that, something like twenty five twentysix thousand dollars. But again, you
know, for a family, theother option is that if they don't have
access to this, it slows theprogression and you have to put a loved
one into a memory care center,which Medicare doesn't pay for. You're going
(10:11):
to spend more in two months onthat memory care center than you know,
years worth of treatment on these medications, right. Well, I was just
thinking from you know, the policycenter from Medicare there, from their perspective,
maybe they don't want to spend thatmuch. But to be honest with
you, we all know that mostlikely those drugs didn't even cost that much
(10:35):
to make, and it's probably overinflatedas it is. Well, it's one
of those things. I mean,bringing a drug to market is incredibly expensive.
You know, for most of thesecompanies that you know have a drug
disapproved by the FDA, there's probablyanother twenty or thirty that never make it,
(10:58):
but they all cost this saying todo the clinical trials in the development,
So across the board, you're lookingat a time when though to recoup
the investment costs of doing the clinicaltrials across your whole portfolio of innovations you're
trying to bring the market. Andagain, I think if you put this
(11:18):
into context, twenty six thousand dollarsa year, if you look at the
treatment costs of an Alzheimer's patient.We're spending three hundred and fifty five billion
dollars to treat Alzheimer's a year.So the institutional cost, the long term
care costs, the cost to caregiversin terms of time loss perhaps from a
(11:41):
job are substantial, and just youknow, that needs to be weighed against
the cost of the innovation. Yeah, definitely. Now, I know in
that fact sheet I mentioned earlier,the centers for Medicare and Medicaid services,
they kind of listed out some ofthe things there will be tracking. It
(12:01):
says they will take the clinician orsubmitters demographic information, which would include their
provider identifier and their address, whichI don't understand why they would need that,
but okay, the Medicare beneficiary IDobviously because if Medicare is going to
pay for it, they're going toneed that. Then it talks about the
patient's clinical information, individuals clinical diagnosis, whether the individual is taking an anticoagulation
(12:28):
or anti platelet drug, results ofthe individual's amyloid positron emission tomography scan,
a PET scan, a CSF test, other amyloid tests, evidence of adverse
effects, and results of overall functionused to diagnose and treat. Why would
(12:52):
they need all of that? Isn'tthat something? Those things are things that
were tracked before the FDA gave approval, Is that right? Right? Yes?
So it was approved during their acceleratedapproval pathway. Excuse me, So
you know, these drugs have beenlooked at in three separate studies, representing
(13:13):
its total of just under four thousandpatients. They consisted of double blind,
randomized controlled studies for patients that haveAlzheimer's and what they found is that patients
that received the medications had a significantreduction in the amyloid beta plaque, while
(13:33):
patients in the control arm that didnot receive the medications had no reduction.
So we have this information already bythe FDA approval, they've deemed it to
be safe and effective in terms ofinteractions and the impact on adverse events.
(13:54):
So they've already gone through the initialaccelerated approval process and they don't have to
go through the full FDA approval processsoon. But yeah, this information is
already available. But that's that's whythe drug was approved, right. I
mean, do you think that maybethere's hesitation about that accelerated approval and you
(14:22):
know, there are people out therewho are very skeptical the COVID vaccine and
it was rushed through. Do youthink maybe this is some kind of cover
your tush thing that they're trying todo, because that was also accelerated just
in case it doesn't work quite asgreat as they originally thought. Well,
ultimately, anything that goes through theaccelerated approval process has to go through the
(14:46):
full FDA approval process. And thething to remember, you have to remember
where this accelerated approval process started.I mean, it goes all the way
back to the explore of HIV AIDS, where there were no treatment options really
on the market at all. Andby developing this process, we're able to
(15:11):
bring the market medications that actually worksthat otherwise would have taken years and years
and years to get onto the market. So it's been a highly successful program
in the scheme of things in termsof drug spending, really inexpensive. I
(15:31):
mean it accounts for less than oneto two percent of state medicaid spending,
for example, unaccelerated approval drugs.So it's a really inexpensive program that's proven
over the years to be highly effectivein bringing treatments to market dramatically fasted or
(15:56):
then otherwise would have happened. Yeah, that makes sense. Do you,
by chance have in front of youhow many people are affected by Alzheimer's disease?
Yeah? Right now it's about sixmillion, and you have about two
thousand people each day that are progressingfrom mild to moderate Alzheimer's. And the
projections are that you know, byI'll say twenty fifty, this number is
(16:21):
going to more than double. Ohwow, perhaps as many as thirteen millions.
So it's a growing problem, andit's expensive. I'm already mentioned three
in a fifty five billion dollars ayear in terms of the cost of treating
and managing Alzheimer's patients. So,you know, the frustrating thing is we
have two treatments on the market thatcan slow this progression. That just they're
(16:45):
going to have real limit patients interms of having patients available to access them,
right, right, So is thereany reason in particular why they're expecting
that number to grow? Is thatjust based on population growth or is there
something else that I'm not aware of. I think it's a combination of population
(17:08):
growth in that Secondly, we've gottenbetter at diagnosing it in recognizing the symptoms
early on. So the technology throughas you mentioned, the pet scans,
is innovative in terms of really identifyingthe plaque and plaque build up. So
I think it's more awareness in identifyingthe symptoms and you increasing the rates of
(17:36):
diagnosing it. Okay, Now,I assume that with like most medications,
doctors will be given samples of thisthat they can give to some of their
more indigent patients who maybe can't affordthings out the gate. But that's very
limited. I mean, you don'tget that many samples, and that leaves
a lot of people out cold.Well, I mean, you know,
(18:00):
historically, what a lot of thepharmaceutical companies have done is that they provide
patients with coupons to pay for theiryou know, take care of their copays.
Unfortunately, there is just a courtdecision that came out that says that
those coupons can be basically credited towardsdeductibles and copays in your health insurance plan.
(18:23):
So I think there's been a realconcerted effort to make effective medications available
to as medications as many patients aspossible through the use of these coupons that
reduce or eliminate out of pocket costs. Okay, So if I am one
(18:45):
of the Alzheimer's patients and I'm seeinga doctor and I need one of these
medications, is my doctor going totell me that they're going to put me
on this registry or in this trialthat is being required, or am I
not going to know it and they'rejust going to do it anyway? Now
they'd have to ask you. Youhave to do consent, informed consent on
(19:08):
enrolling in the trial, So thatwould be up to the patient. The
patient doesn't have to enroll in thetrial. The benefit would be though,
if you do enroll in the trial, then you know Medicare is going to
go ahead and pay for the medication. Right. Is there anything that the
patient can do, or even thepublic can do to express our displeasure with
(19:33):
this new rule and possibly get itoverturned? Well? Yeah, so certainly
informing your member of Congress, you'retwo US senators of the highly unusual and
like I mentioned, completely unprecedented decisionthat the Center for Medicare and Medicaid Services
(20:00):
has made, and just to makethem aware of it, I'm pretty certain
that a lot of members of Congressare not even aware of this unprecedented decision
that CMS has made. So thatwould be a good start is to at
least let your members of Congress knowthat Medicare has made this coverage determination that
(20:21):
is going to restrict access to theseinnovative, innovative, big drugs. Okay,
so contact lawmakers for sure. AndI know we're speculating here, so
want that on the record. Whatwould you think would be the next drug
or whatever that might be treated thesame way as this with these forced trials,
(20:47):
Well, we hope not any.I mean, this is really the
first one that has gone through theFDA processed and been approved and shown to
be safe and effective and say clinicalbenefits. I think there's concern among the
chronic disease community in general that,you know, the next round of any
(21:10):
new innovative drug that comes through theFDA process that CMS so as they've gone
down this road, could subject thatmedications to the same type of rule.
So it could be I mean,who knows, it could be a new
cancer medication, it could be wholerange of different things that you know,
(21:32):
ironically, the administration is trying todramatically reduce cancer rates, and you know
a lot of that it's going tobe through innovations in new medications. So
I just hope that you know thatthis process doesn't get extended beyond Alzheimer's.
Yeah, definitely, I agree withthat for sure. Do you think there
(21:56):
will be any court cases that comeout of the US. Oh, I'm
sure that there's going to be challenges. I mean, CMS, does you
know they they technically have the theymay deny coverage of FEA Groove treatments to
what it's called a national coverage determinationand coverage you know, with evidence of
(22:18):
development. But you know that doesn'tmean that there's not going to be legal
challenges to that particular rule. Okay, and I assume that you already see
some patients with Alzheimer's and offer thesetreatments. Yeah. I mean, again,
this is shown to be in thoseclinical studies, you know, really
(22:41):
has delayed the onsets of you know, early onsets dimension Alzheimer's, So it
hasn't does have a clinical benefit thatwe've seen in all of these clinical studies
that the FDA evaluated, right.I was just wondering if you've had any
patients personally who have opted out ofthese new innovative treatments, simply for the
(23:06):
fact that they know they're going tobe tracked and monitored by the government.
Oh no, no, so I'mnot a position. So okay, so
I don't I don't have any patients. I'm just wondering if there's I mean,
I doubt we have numbers on thatyet, but I'm wondering how many
patients are going to say thanks,but no thanks because I don't want to
(23:27):
be, you know, tracked likea lab rat. Well, yeah,
I mean it's it's not easy toget patients to enroll in clinical trials.
So it is difficult, and it'sexpensive, and as I mentioned before,
secondly that unless you really live neara medical center or a university that conducts
(23:48):
these clinical trials, you know yourability to participate is going to be really
limited. So if I live ina rural part of a state, my
ability to actually participate in this trial, even if I wanted to, is
going to be very difficult. Yeah, that's very true. Like you said,
(24:10):
the rural areas are going to behit the hardest, which is unfortunate
because they don't deserve treatment any lessthan people in urban areas. Let me
ask you this, I'm just reallycurious about all this, and you're kind
of the expert. Is there anythingthat the audience needs to know that I
just don't know to ask you aboutnow, other than I mean just knowing
(24:37):
that there are really innovative solutions thatare coming under the market and they could
make a significant difference for families andpatients that have early onset Alzheimer's. You
know, keeping a patient out ofa memory loss center for months, maybe
a year or so, or along term care facility, it has a
(25:00):
lot of real importance to a family, to that patient, and it's just
unfortunate that by CMS restricting access tothose medications, the alternative for many of
these patients really is that memory losscenter or long term care facility. Yeah,
(25:22):
it's an unfortunate choice. But thereare solutions on the market, and
the FDA has approve them and foundthem to be effective, and we just
like to find a way to makesure that there is widely available as possible.
Yeah, definitely. Now, isthere any place online where people can
(25:44):
go to learn more about this problem? Yeah, So if you go to
our website, which is at wwwdot fight chronuct disease one word Fight Productdisease
dot org, we have a wholebunch of information of not only Alzheimer's,
but other key chronic healthcare conditions,and we have them available in terms of
(26:11):
national statistics and also state by state, so you can look up your state
and look up the specifics to thestate that you live in. Oh,
that's very helpful. Okay, that'sgood, And that's fight chronicdisease dot com,
dot org, dot org dot orgo RG. Okay. And then
(26:34):
also, like you said, reachingout to your lawmakers, your senators,
your representatives, probably through a malecampaign. You think email doesn't matter,
Probably doesn't matter, right, No, I mean foe call you know,
just to get you know. Certainly, staff keep records of those phone calls
(26:57):
on issues and the positions that peoplepay. So I think the more calls
and more correspondence you have with yourmember to make them aware of this really
unprecedented decision will start to get someattention. Yeah. I think so too.
(27:18):
Well. I feel like we've coveredit pretty well. What do you
think? Yeah? No, Ithink we I think we nick got it
nail. Okay, great, well, thank you so much for your time
today, and thank you for informingus about this, because I think majority
of us would never have known thiswhat's going on now, that's right.
(27:38):
And the sad thing is that bythis coverage determination for Medicare, that makes
you know, a lot of patientsjust completely unaware that there are these new
innovative treatments that are available. Right, and just to clarify, this is
not something that we'll be had happeningfor people with regular insurance. Correct that
(28:03):
they don't have to sign up forthis trial. No, but you know
again, you know, every healthplan is going to make your own decision
on the coverage side too, SoI think in this case they'll probably sit
back and follow Medicare's lead. Butit's unclear, but that's certainly up to
each individual payer. Okay, wellthat's good to know too, so we
(28:26):
need to keep an eye on thatas well. All right, well,
again, thank you so much foryour time. I really appreciate you coming
on the show and informing us.And hopefully we can all get fired up
and let our lawmakers know how wefeel about it. That would be great,
That would be a terrific start.I appreciate you having me up.
(28:49):
I hope you've enjoyed today's show.Thanks for tuning into the show on your
favorite local radio station. You cannow listen to this show or past shows
through the iHeart app or on iHeartdot com. Just search for Virginia Focus
under podcasts. I'm Rebecca Hughes withthe Virginia News Network, and I'll be
here next week on Virginia Focus
More than six million Americans are currentlyliving with Alzheimer's disease, and by twenty
fifty that number is expected to skyrocketto thirteen million. The FDA approved two
new treatments that slow the progression ofthe disease, but the Centers for Medicare
and Medicaid Services, also known asCMS, is setting a dangerous precedent by
requiring consent from patients in a waythat's never been demanded before. Now,
(00:34):
many doctors, elected leaders, andfamilies are afraid patients will face health disparities
and that the move could be expandedto limit access to other medications. Let's
hear more from the chairman of thePartnership to Fight Chronic Disease and Chairman of
Health Policy and Management at Emory University, doctor Kenneth Thorpe. Welcome to the
show, doctor Thorpe. I'm soglad you could make time for us today
(00:56):
to talk about this important subject.Well, thanks for having me today.
We're talking about Alzheimer's drugs, andparticularly the newest ones that have shown such
great progress, and whether or notMedicare is going to be covering that.
Why don't you start by telling usyour experience with those two things. Well,
(01:19):
sure, so, the efflut inDrug Administration has approved two medications to
slow the progression of early onset Alzheimer's. What they found is that the medications
reduced the plaque build up in thebrain, which is sort of the hallmark
of Alzheimer's. And these are completelynew innovative treatment options for Alzheimer's patients that
(01:49):
hadn't been available up until very recently. That's the good news. The bad
news is that the Medicare program,the Department of Health and Human Services has
decided to not pay for those medicationsthrough Medicare unless your physician enrolls you in
a clinical trial, which could takeyears to conduct and do the evaluations.
(02:15):
And the challenge for a lot ofAlzheimer's patients, I believe, is that
many of them live in rural areas, nowhere near a medical center or a
place that would conduct a clinical trial. So it does raise concerns about health
disparities and health equity, and certainlyit raises concerns for families that are going
(02:38):
to have restricted access to these innovativemedications that slow the progression of Alzheimer's.
Definitely. Now, when you saya clinical trial, I mean, these
are medications that will be FDA approved, correct. Yeah, They've already been
(02:59):
approved by the FDA, and theFDA has found that they have clinical benefits.
They've done three separate randomized trials alreadyof these medications looking at patients that
receive the treatment who have they hada significant reduction in it's called beta plaque.
(03:21):
A lot of the patients who didn'treceive the treatment had no reduction.
So we have sort of the youknow, the surrogate outcomes that we know
that this is reducing plaque build up, which slows the progression. The FDA
has found them both to be safeand effective. It's just that CMS won't
(03:42):
pay for them unless you're enrolled ina clinical truck. Now. I know
they put out a like a factsheet in June of this year and they're
calling what they're doing like a Let'ssee if I can find the exact wording
here. They're saying, you haveto be on a registry. Is that
the same thing? Are we talkingabout the same thing? Basically? Yes?
(04:06):
Yes, Okay, Are there anyother medications that they do the same
way like this where you have tobe on some kind of registry where they
track your everything. Now this isyou know, from cms's standpoint, it's
not just unusual, it's completely unprecedented, and it really should be worrisome to
(04:30):
those even beyond the Alzheimer's community.Uh that you know, CMS may start
applying this to other chronicly ill populations. So these these coverage restrictions and denying
treatments, you know, for PREFTYAapproved drugs, is highly unusual. Okay,
(04:51):
that's what I thought. I mean, are there any barriers to being
diagnosed with Alzheimer's disease it would makeit different? Or you know, is
there expensive testing for early diagnosis thatwould require this change? I mean,
(05:11):
can you find any justification for whythey're doing this? Not really, I
mean if you think about it,you know, so health plans and payers
will pay for, you know,a brain scan, so when you do
a brain scan and you're looking atplaque, you can diagnose whether or not
a patient has progressing Alzheimer's in dementia. That really, I think unfortunate follow
(05:40):
on is that they won't pay forthe treatment so you can diagnose it.
But they're not going to pay fortreatments that have been found to be safe
and effective and slow the build upof plaque. Wow. The immediate knee
jerk reaction is is that this isa severe government overreach. Which would you
(06:00):
agree with that or what are yourthoughts? Oh? Yeah, I think
completely. I mean, it's oneof those things where it's you know,
penny wise and pound foolish. Youknow, there's an initial upfront annual costs
of the medications. Obviously, youknow, they cost something on the order
of twenty five twenty six thousand dollarsa year. On the other hand,
(06:26):
the alternative for these patients is thatthey go into memory loss centers, long
term care facilities, and you know, the cost of those those alternative treatment
venues is more than twenty five ortwenty six thousand dollars, you know,
over two month period. So ifyou're slowing the progression of this by several
(06:50):
months, obviously you're you're saving familiesmoney, and on the long term care
side, you're saving Medicare some moneytoo. So I don't know that the
full financial and clinical picture was wellthought out. Yeah, and I think,
I mean, I think you willagree with me. We already know
(07:13):
as a general public and as ageneral rule, that insurance, while it
can be helpful for paying for things. It can be very problematic when you're
the person who is sick and tryingto get treatment or a diagnosis, because
they have people who aren't even doctorsgoing through basically a checklist of did you
(07:34):
run this test? Oh you did, okay, well let me follow the
flow chart. Now you have torun this test before we'll pay for this
or do this, when the doctorsreally don't always need all of those steps
correct, right. You know,for a lot of medications, you know
this is a good one, butyou know, take type two diabetes or
(07:57):
high blood pressure or elevated cholesterol.Making sure that patients build and refill their
medications is going to prevent stroke,it's going to prevent hospitalizations, emergency room
visits, ambulance rise. And youknow, for those types of medications where
we know they work and they affectchronically old patients, there shouldn't be any
(08:18):
cost sharing. I mean, there'sreally no point of charging patients money because
they're going to be less likely totake medications that we know clinically work and
save money. So I think,you know, a similar analogy could be
taken for this medication too, thatyou know we have the clinical data that
(08:39):
shows that it has an impact onplaque build up, and there's really not
a real strong reason to limit patientsaccess to this innovative new set of medications
that would provide a clinical benefit forthem and their families. Yeah, I
agree, Like you said, itcan help save costs in the long run
(09:03):
too. Now, there's more thanjust one drug that is in this list
of recently FDA approved and proven tobe successful drugs for Alzheimer's. Correct,
right there, there's two of them. Okay, will you give us the
name of those just so we're familiar. Yeah, one is, and they're
(09:26):
hard to pronounce, so you haveto just to forgive me. The first
one is the la quimbi. It'sl equ e mbi, and the second
one is ad you have a du h E l M. So those
are the two medications that the FDAhas approved. Okay, and you said
(09:48):
they're both like in the twenty thousanddollars range for a year's supply something like
that, something like twenty five twentysix thousand dollars. But again, you
know, for a family, theother option is that if they don't have
access to this, it slows theprogression and you have to put a loved
one into a memory care center,which Medicare doesn't pay for. You're going
(10:11):
to spend more in two months onthat memory care center than you know,
years worth of treatment on these medications, right. Well, I was just
thinking from you know, the policycenter from Medicare there, from their perspective,
maybe they don't want to spend thatmuch. But to be honest with
you, we all know that mostlikely those drugs didn't even cost that much
(10:35):
to make, and it's probably overinflatedas it is. Well, it's one
of those things. I mean,bringing a drug to market is incredibly expensive.
You know, for most of thesecompanies that you know have a drug
disapproved by the FDA, there's probablyanother twenty or thirty that never make it,
(10:58):
but they all cost this saying todo the clinical trials in the development,
So across the board, you're lookingat a time when though to recoup
the investment costs of doing the clinicaltrials across your whole portfolio of innovations you're
trying to bring the market. Andagain, I think if you put this
(11:18):
into context, twenty six thousand dollarsa year, if you look at the
treatment costs of an Alzheimer's patient.We're spending three hundred and fifty five billion
dollars to treat Alzheimer's a year.So the institutional cost, the long term
care costs, the cost to caregiversin terms of time loss perhaps from a
(11:41):
job are substantial, and just youknow, that needs to be weighed against
the cost of the innovation. Yeah, definitely. Now, I know in
that fact sheet I mentioned earlier,the centers for Medicare and Medicaid services,
they kind of listed out some ofthe things there will be tracking. It
(12:01):
says they will take the clinician orsubmitters demographic information, which would include their
provider identifier and their address, whichI don't understand why they would need that,
but okay, the Medicare beneficiary IDobviously because if Medicare is going to
pay for it, they're going toneed that. Then it talks about the
patient's clinical information, individuals clinical diagnosis, whether the individual is taking an anticoagulation
(12:28):
or anti platelet drug, results ofthe individual's amyloid positron emission tomography scan,
a PET scan, a CSF test, other amyloid tests, evidence of adverse
effects, and results of overall functionused to diagnose and treat. Why would
(12:52):
they need all of that? Isn'tthat something? Those things are things that
were tracked before the FDA gave approval, Is that right? Right? Yes?
So it was approved during their acceleratedapproval pathway. Excuse me, So
you know, these drugs have beenlooked at in three separate studies, representing
(13:13):
its total of just under four thousandpatients. They consisted of double blind,
randomized controlled studies for patients that haveAlzheimer's and what they found is that patients
that received the medications had a significantreduction in the amyloid beta plaque, while
(13:33):
patients in the control arm that didnot receive the medications had no reduction.
So we have this information already bythe FDA approval, they've deemed it to
be safe and effective in terms ofinteractions and the impact on adverse events.
(13:54):
So they've already gone through the initialaccelerated approval process and they don't have to
go through the full FDA approval processsoon. But yeah, this information is
already available. But that's that's whythe drug was approved, right. I
mean, do you think that maybethere's hesitation about that accelerated approval and you
(14:22):
know, there are people out therewho are very skeptical the COVID vaccine and
it was rushed through. Do youthink maybe this is some kind of cover
your tush thing that they're trying todo, because that was also accelerated just
in case it doesn't work quite asgreat as they originally thought. Well,
ultimately, anything that goes through theaccelerated approval process has to go through the
(14:46):
full FDA approval process. And thething to remember, you have to remember
where this accelerated approval process started.I mean, it goes all the way
back to the explore of HIV AIDS, where there were no treatment options really
on the market at all. Andby developing this process, we're able to
(15:11):
bring the market medications that actually worksthat otherwise would have taken years and years
and years to get onto the market. So it's been a highly successful program
in the scheme of things in termsof drug spending, really inexpensive. I
(15:31):
mean it accounts for less than oneto two percent of state medicaid spending,
for example, unaccelerated approval drugs.So it's a really inexpensive program that's proven
over the years to be highly effectivein bringing treatments to market dramatically fasted or
(15:56):
then otherwise would have happened. Yeah, that makes sense. Do you,
by chance have in front of youhow many people are affected by Alzheimer's disease?
Yeah? Right now it's about sixmillion, and you have about two
thousand people each day that are progressingfrom mild to moderate Alzheimer's. And the
projections are that you know, byI'll say twenty fifty, this number is
(16:21):
going to more than double. Ohwow, perhaps as many as thirteen millions.
So it's a growing problem, andit's expensive. I'm already mentioned three
in a fifty five billion dollars ayear in terms of the cost of treating
and managing Alzheimer's patients. So,you know, the frustrating thing is we
have two treatments on the market thatcan slow this progression. That just they're
(16:45):
going to have real limit patients interms of having patients available to access them,
right, right, So is thereany reason in particular why they're expecting
that number to grow? Is thatjust based on population growth or is there
something else that I'm not aware of. I think it's a combination of population
(17:08):
growth in that Secondly, we've gottenbetter at diagnosing it in recognizing the symptoms
early on. So the technology throughas you mentioned, the pet scans,
is innovative in terms of really identifyingthe plaque and plaque build up. So
I think it's more awareness in identifyingthe symptoms and you increasing the rates of
(17:36):
diagnosing it. Okay, Now,I assume that with like most medications,
doctors will be given samples of thisthat they can give to some of their
more indigent patients who maybe can't affordthings out the gate. But that's very
limited. I mean, you don'tget that many samples, and that leaves
a lot of people out cold.Well, I mean, you know,
(18:00):
historically, what a lot of thepharmaceutical companies have done is that they provide
patients with coupons to pay for theiryou know, take care of their copays.
Unfortunately, there is just a courtdecision that came out that says that
those coupons can be basically credited towardsdeductibles and copays in your health insurance plan.
(18:23):
So I think there's been a realconcerted effort to make effective medications available
to as medications as many patients aspossible through the use of these coupons that
reduce or eliminate out of pocket costs. Okay, So if I am one
(18:45):
of the Alzheimer's patients and I'm seeinga doctor and I need one of these
medications, is my doctor going totell me that they're going to put me
on this registry or in this trialthat is being required, or am I
not going to know it and they'rejust going to do it anyway? Now
they'd have to ask you. Youhave to do consent, informed consent on
(19:08):
enrolling in the trial, So thatwould be up to the patient. The
patient doesn't have to enroll in thetrial. The benefit would be though,
if you do enroll in the trial, then you know Medicare is going to
go ahead and pay for the medication. Right. Is there anything that the
patient can do, or even thepublic can do to express our displeasure with
(19:33):
this new rule and possibly get itoverturned? Well? Yeah, so certainly
informing your member of Congress, you'retwo US senators of the highly unusual and
like I mentioned, completely unprecedented decisionthat the Center for Medicare and Medicaid Services
(20:00):
has made, and just to makethem aware of it, I'm pretty certain
that a lot of members of Congressare not even aware of this unprecedented decision
that CMS has made. So thatwould be a good start is to at
least let your members of Congress knowthat Medicare has made this coverage determination that
(20:21):
is going to restrict access to theseinnovative, innovative, big drugs. Okay,
so contact lawmakers for sure. AndI know we're speculating here, so
want that on the record. Whatwould you think would be the next drug
or whatever that might be treated thesame way as this with these forced trials,
(20:47):
Well, we hope not any.I mean, this is really the
first one that has gone through theFDA processed and been approved and shown to
be safe and effective and say clinicalbenefits. I think there's concern among the
chronic disease community in general that,you know, the next round of any
(21:10):
new innovative drug that comes through theFDA process that CMS so as they've gone
down this road, could subject thatmedications to the same type of rule.
So it could be I mean,who knows, it could be a new
cancer medication, it could be wholerange of different things that you know,
(21:32):
ironically, the administration is trying todramatically reduce cancer rates, and you know
a lot of that it's going tobe through innovations in new medications. So
I just hope that you know thatthis process doesn't get extended beyond Alzheimer's.
Yeah, definitely, I agree withthat for sure. Do you think there
(21:56):
will be any court cases that comeout of the US. Oh, I'm
sure that there's going to be challenges. I mean, CMS, does you
know they they technically have the theymay deny coverage of FEA Groove treatments to
what it's called a national coverage determinationand coverage you know, with evidence of
(22:18):
development. But you know that doesn'tmean that there's not going to be legal
challenges to that particular rule. Okay, and I assume that you already see
some patients with Alzheimer's and offer thesetreatments. Yeah. I mean, again,
this is shown to be in thoseclinical studies, you know, really
(22:41):
has delayed the onsets of you know, early onsets dimension Alzheimer's, So it
hasn't does have a clinical benefit thatwe've seen in all of these clinical studies
that the FDA evaluated, right.I was just wondering if you've had any
patients personally who have opted out ofthese new innovative treatments, simply for the
(23:06):
fact that they know they're going tobe tracked and monitored by the government.
Oh no, no, so I'mnot a position. So okay, so
I don't I don't have any patients. I'm just wondering if there's I mean,
I doubt we have numbers on thatyet, but I'm wondering how many
patients are going to say thanks,but no thanks because I don't want to
(23:27):
be, you know, tracked likea lab rat. Well, yeah,
I mean it's it's not easy toget patients to enroll in clinical trials.
So it is difficult, and it'sexpensive, and as I mentioned before,
secondly that unless you really live neara medical center or a university that conducts
(23:48):
these clinical trials, you know yourability to participate is going to be really
limited. So if I live ina rural part of a state, my
ability to actually participate in this trial, even if I wanted to, is
going to be very difficult. Yeah, that's very true. Like you said,
(24:10):
the rural areas are going to behit the hardest, which is unfortunate
because they don't deserve treatment any lessthan people in urban areas. Let me
ask you this, I'm just reallycurious about all this, and you're kind
of the expert. Is there anythingthat the audience needs to know that I
just don't know to ask you aboutnow, other than I mean just knowing
(24:37):
that there are really innovative solutions thatare coming under the market and they could
make a significant difference for families andpatients that have early onset Alzheimer's. You
know, keeping a patient out ofa memory loss center for months, maybe
a year or so, or along term care facility, it has a
(25:00):
lot of real importance to a family, to that patient, and it's just
unfortunate that by CMS restricting access tothose medications, the alternative for many of
these patients really is that memory losscenter or long term care facility. Yeah,
(25:22):
it's an unfortunate choice. But thereare solutions on the market, and
the FDA has approve them and foundthem to be effective, and we just
like to find a way to makesure that there is widely available as possible.
Yeah, definitely. Now, isthere any place online where people can
(25:44):
go to learn more about this problem? Yeah, So if you go to
our website, which is at wwwdot fight chronuct disease one word Fight Productdisease
dot org, we have a wholebunch of information of not only Alzheimer's,
but other key chronic healthcare conditions,and we have them available in terms of
(26:11):
national statistics and also state by state, so you can look up your state
and look up the specifics to thestate that you live in. Oh,
that's very helpful. Okay, that'sgood, And that's fight chronicdisease dot com,
dot org, dot org dot orgo RG. Okay. And then
(26:34):
also, like you said, reachingout to your lawmakers, your senators,
your representatives, probably through a malecampaign. You think email doesn't matter,
Probably doesn't matter, right, No, I mean foe call you know,
just to get you know. Certainly, staff keep records of those phone calls
(26:57):
on issues and the positions that peoplepay. So I think the more calls
and more correspondence you have with yourmember to make them aware of this really
unprecedented decision will start to get someattention. Yeah. I think so too.
(27:18):
Well. I feel like we've coveredit pretty well. What do you
think? Yeah? No, Ithink we I think we nick got it
nail. Okay, great, well, thank you so much for your time
today, and thank you for informingus about this, because I think majority
of us would never have known thiswhat's going on now, that's right.
(27:38):
And the sad thing is that bythis coverage determination for Medicare, that makes
you know, a lot of patientsjust completely unaware that there are these new
innovative treatments that are available. Right, and just to clarify, this is
not something that we'll be had happeningfor people with regular insurance. Correct that
(28:03):
they don't have to sign up forthis trial. No, but you know
again, you know, every healthplan is going to make your own decision
on the coverage side too, SoI think in this case they'll probably sit
back and follow Medicare's lead. Butit's unclear, but that's certainly up to
each individual payer. Okay, wellthat's good to know too, so we
(28:26):
need to keep an eye on thatas well. All right, well,
again, thank you so much foryour time. I really appreciate you coming
on the show and informing us.And hopefully we can all get fired up
and let our lawmakers know how wefeel about it. That would be great,
That would be a terrific start.I appreciate you having me up.
(28:49):
I hope you've enjoyed today's show.Thanks for tuning into the show on your
favorite local radio station. You cannow listen to this show or past shows
through the iHeart app or on iHeartdot com. Just search for Virginia Focus
under podcasts. I'm Rebecca Hughes withthe Virginia News Network, and I'll be
here next week on Virginia Focus
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