Private Power, Public Health: The Role of Private Institutions in Health

Name: Private Power, Public Health: The Role of Private Institutions in Health
Uploaded: 2026-01-30T13:35:09.0566667Z
Duration: 58 min 25 s
Description: Ravi Gupta, MD, MSHP, Johns Hopkins University School of Medicine December 4, 2025 Yale GIM “Research in Progress” Meeting, Presented by: Yale School of Medicine’s Department of Internal Medicine, Section of General Internal Medicine

January 30, 2026

Ravi Gupta, MD, MSHP, Johns Hopkins University School of Medicine

December 4, 2025

Yale GIM “Research in Progress” Meeting, Presented by: Yale School of Medicine’s Department of Internal Medicine, Section of General Internal Medicine

About the speakers

Patrick G. O'Connor, MD, MPH, MACP
Dan Adams and Amanda Adams Professor of General Medicine; Chief, Section of General Internal Medicine; Head of Advisory House, Yan House, Office of Student Affairs

Information

ID: 13793
To Cite: DCA Citation Guide

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00:03Will begin. Welcome to new
00:05conference on an auspicious day.
00:08Doctor Justice just told me
00:09today would have been Alvin
00:11Feinstein's,
00:12one hundredth birthday,
00:14which is pretty,
00:16pretty poignant,
00:21event to remember. And I
00:22think it's well served today
00:24as we have a outstanding
00:25young investigator who I think
00:26would make Alvin proud and
00:28excited to be speaking on
00:29this day. So, before we
00:31get started with that, CME
00:33code for today's
00:35conference.
00:38Upcoming,
00:39oh, big news. Next week
00:41is our research and scholarship
00:43retreat. So,
00:45if you have an RSVP,
00:47please do so. If you
00:48have something like an abstract
00:50that you want feedback about
00:51or to,
00:53any other research ideas you
00:55want to discuss with the
00:56group, reach out and let
00:58us know.
00:59That's next week.
01:00February will be the professional
01:02development retreat also at the
01:04West Campus
01:05and in the spring, the
01:06education retreat.
01:10The Yale,
01:11general medicine
01:13section has been superb at
01:15getting all of our FDAC,
01:17family family. But we are
01:19a family. Faculty
01:20mentorship,
01:22program,
01:25surveys completed in a timely
01:27manner. So please pay attention
01:28to your FDACs.
01:30They are open. They are
01:32ready for you to jump
01:33right in and and complete
01:34and have them sent to
01:35your,
01:36to your mentor for further
01:38discussion.
01:42Upcoming other sessions,
01:44next week, Mary Jane Lincoln
01:46will be presenting at, general
01:48medicine grand rounds, menopause from
01:50forbidden topic to
01:53favorite
01:54topic. And then, noon will
01:55be the, section,
01:58faculty and staff meeting.
02:01Here are the disclosures.
02:05More disclosures.
02:06Okay.
02:08So I'm really pleased to
02:09present,
02:11returning back to New Haven,
02:12doctor Ravi Gupta.
02:14Ravi started his educational
02:16career at Ohio State where
02:18he majored in both political
02:20science and molecular genetics.
02:23I think that overlap of
02:24politics and science actually
02:27led you
02:28eventually to become a clinician
02:30scholar after attending medical school
02:32here.
02:34You were a clinician scholar
02:35at the Penn NCSP site.
02:38And then went back to
02:39Hopkins,
02:41where he had done his
02:42internal medicine residency training, and,
02:45you are now an assistant
02:46professor of medicine.
02:48And Ravi has been amazingly
02:50productive in his short career,
02:51has,
02:53published multiple high impact papers
02:56looking at privatization,
02:58of health care, looking at
02:59regulatory policy,
03:00looking at how we care
03:02for patients with
03:03oh, yeah. How we care
03:04for patients with, dementia.
03:06And I think we're going
03:07to be touching, on several
03:08of those issues during today's
03:10talk. So we're really pleased
03:12to have, Doctor. Gupta joining
03:14us here, from Hopkins,
03:16but more importantly, from Yale,
03:18to discuss,
03:19private power, public health, and
03:21the role of private institutions
03:23in health. So thank you
03:24for joining us.
03:31Well, I'm very pleased,
03:33to be back and to
03:35be able to give this
03:35talk.
03:36And I really wanna thank
03:37Joe Ross, Carrie,
03:40Patrick, Reshma for being such
03:41gracious hosts. I feel like
03:43this is a I'm playing
03:44a home game.
03:45I I also took classes
03:46in this room, so it
03:47feels,
03:49it it's nice to be
03:50up here too, which
03:52is on the other side.
03:53So,
03:55as Carrie mentioned, I'm talking
03:57today about a topic that
04:00connects
04:00a lot of the work
04:01that I've been doing probably
04:02for the last decade at
04:03this point since I was
04:04a medical student here. And,
04:06so I'll be talking about
04:07the role of private institutions
04:09of health, and that's a
04:10very broad topic. I could
04:11it could be a whole
04:12course for a semester.
04:14So I'm going to talk
04:15about very specific aspects of
04:16that.
04:18I am a member or
04:19yeah. So I'm a member
04:20of Doctors for America FDA
04:21task force, board member, for
04:23health care, for action and
04:25was a prior board member
04:26for the United University's Allied
04:27for Essential Medicines. All of
04:28that was noncompensated,
04:30and then I do receive
04:31some funding from Arnold Ventures
04:32for my work on prior
04:33authorization.
04:35So, just to give you
04:36a little bit of an
04:36overview and to talk about
04:37some of the objectives of
04:38my talk today, I will,
04:40give a little bit of
04:41background and just a bit
04:42of an exploration of how
04:43private institutions shape US health
04:45and health care, and I
04:46make a distinction between the
04:48two. Health care,
04:50it is a distinction that
04:52I think I realized a
04:53bit later in life,
04:54and the importance of both.
04:56So we'll talk about both
04:56of those. And then to
04:58narrow the focus of what
04:59I'm talking about, I will
05:00use three case studies. I'll
05:02use pharmaceuticals, which is a
05:03big area of work that
05:04I've spent a lot of
05:05time thinking about, coverage policy
05:07and insurance and its role
05:09in health care. And then
05:10I wanna move a little
05:11bit to the public health
05:12piece, and so I'll talk
05:13about this idea of commercial
05:14determinants of health, which is
05:15a bit newer,
05:17and something
05:18great interest to me. And
05:20so, I'll use those three
05:20case studies
05:21to bring to draw out
05:22some themes about how private
05:24power shapes public health.
05:28Okay. And so Carrie kind
05:29of already mentioned my path,
05:30and I only bring this
05:31up in case their students
05:33are, trainees who would like
05:34to talk about the, the
05:36various aspects of becoming a
05:39doctor and then doing other
05:40things alongside seeing patients. But
05:42the one thing I did
05:42wanna point out is that,
05:44Sally's is my favorite pizza
05:45anywhere, and I'm happy to
05:47take questions on that.
05:50Okay. So
05:52the
05:53motivation for my work has
05:55been driven by a very
05:57central question of how private
05:59institutions
06:00impact health and health
06:02care. And that this is
06:03something that has been on
06:04my mind for the last
06:05decade. And when I first
06:07started thinking about how to
06:09address this question,
06:11I was a medical student
06:12here, started working with Joe
06:13Ross, and we started to
06:15work,
06:16on thinking about how the
06:17pharmaceutical industry operates,
06:19how farm how,
06:21what are the factors involved
06:22in patient's ability to access
06:24medicines and to make sure
06:25that those medicines are affordable.
06:28That then translated
06:29into what I think is
06:31a very related topic of
06:32how we
06:33cover these medicines from a
06:35regulatory perspective.
06:37How does health insurance cover
06:38and to develop policies
06:41to,
06:42enable access to these medicines
06:44or to limit access to
06:45these medicines. And so,
06:47and other services, obviously, but
06:48I am particularly interested in
06:49medicines. And so I've been
06:51doing some more work on
06:52health insurance and
06:54various techniques that, insurance companies
06:56use like prior authorization. So
06:58I'll be talking about that
06:58as well. And then,
07:02the the idea that private
07:04institutions are central
07:06to public health as well,
07:07so this idea of commercial
07:09determinants of health
07:11and that I'll I mean,
07:12I'll talk about in a
07:13little bit more detail, but
07:14it's the
07:15the way in which commercial
07:16actors shape public health. And
07:18an example of that is
07:20the pharmaceutical industry and the
07:21opioid industry and how they
07:23were how they contributed to
07:25the opioid epidemic. And so
07:26that's what I'll be talking
07:27about.
07:28So just for a little
07:29bit of background, I think
07:30this audience will be quite
07:31familiar with this background, so
07:32I won't spend too much
07:33time on it, but it
07:33kind of sets the stage.
07:35And I think it's important
07:36to think about we spend
07:37a lot of time thinking
07:38about the US, but there
07:39are,
07:39there's a lot of lessons
07:40to be drawn from what
07:42other countries are
07:43what what is happening in
07:44other countries with respect to
07:45health. And I think it's
07:46important to start by understanding
07:48that the US is an
07:49outlier in terms of health
07:50spending. As a share of
07:52GDP, we spend way more
07:53than comparable countries,
07:57on health care, and that
07:58has a lot of downstream
07:59consequences, of course. And it's
08:01also important to understand how
08:02we spend that,
08:04how we spend
08:05those dollars. And there's a
08:07few notable differences between the
08:08US and comparable countries. We
08:10spend,
08:11we spend a lot more
08:12on inpatient and outpatient care,
08:14so the actual delivery of
08:15health care. But we also
08:17spend twice as much on
08:19administration.
08:20And that, I think, is
08:21a really important point because
08:23a lot of that spending
08:24on administration comes from
08:26private,
08:27because of private companies, because
08:28of health insurance. And we
08:29spend,
08:30far more, for example, compared
08:31to Canada,
08:33on the administration of health
08:34care. We spend much less
08:36on long term care. We
08:37spend much less on preventive
08:39care. So a lot of
08:39the upstream of the preventive
08:41care at least is upstream
08:41and could potentially help reduce
08:43overall spending if we dedicated
08:44more effort to preventive care.
08:46And despite that spending, life
08:48expectancy as we know in
08:49the US is is lower
08:50compared to other OECD countries.
08:52And so we're not really
08:54getting,
08:55the returns from the money
08:57that we're spending in the
08:58way that we may want.
09:00There's a number of reasons
09:01for why there is high
09:03spending here.
09:04Administration and the administrative cost
09:06is one piece of it.
09:07We also have really high
09:08prices for services and medications,
09:10which the flip side of
09:11it is the that there's
09:14it also potentially incentivizes innovation.
09:16So and so the US
09:17is,
09:18is innovating,
09:21as well. So that's the
09:22flip side. I think under
09:23insurance, we focus a lot
09:25on health insurance, and so
09:26I think under insurance is
09:27an important piece of this
09:29as well.
09:31And yet what I have
09:32come to realize, both in
09:34clinical practice and as I've
09:36studied this,
09:37is that
09:39health care is only one
09:41piece of someone's health.
09:43And so,
09:44I think it's really important
09:46to think about the fact
09:47that social determinants of health
09:48this is all I think
09:49everybody here will know this,
09:50but social determinants of health,
09:52public health, the effects of
09:54corporate behavior, which is a
09:55piece of this that I'll
09:56get into,
09:57chronic illness and obesity rate
09:59and societal atomization and loneliness
10:02also all contribute to poor
10:03health in the US,
10:05especially relative, I think, to
10:06other countries.
10:10And so
10:11market based factors shape US
10:13health. They also drive innovation,
10:15but then it leads to
10:16questions of access and equity.
10:19Market based logic drives the
10:22payment and delivery of health
10:23care, and then there's this
10:24corporate influence on public health.
10:28I think it's important for
10:29me to just delineate what
10:30it is exactly that I
10:31am talking about and what
10:32I'm not talking about because,
10:33as I said, this could
10:34be an entire course. And
10:35I drew this from a
10:37really nice paper that was
10:38published last year, in the
10:39New England Journal of Medicine
10:41in which they differentiate between
10:42the different types of privatization
10:45or,
10:47I would say the different
10:48types or different ways in
10:49which private power exerts,
10:52influence. And so one aspect
10:54of this is corporatization. So
10:55if you think about, for
10:56example, vertical and horizontal integration.
10:58So,
10:59consolidation
11:00of hospitals and health systems
11:02potentially as a bargaining chip
11:03against,
11:04with negotiations with corporations,
11:07That's, you know, that's the
11:08horizontal integration. Vertical integration would
11:10be where insurance companies are
11:13buying out provider groups. So,
11:15United is, at this point,
11:17the largest United, the insurance
11:18company, is the largest,
11:20employer of doctors. It it
11:23employs ten percent of the
11:24US's doctors. And so that
11:26allows for,
11:27that has a lot of
11:28downstream effects as well. I'm
11:30not really talking about that
11:30today.
11:31There's also financialization,
11:34and a big part of
11:34that in recent years has
11:36been the growth of private
11:36equity. I'm not talking about
11:38that. But what I am
11:38talking about is the fact
11:39that in health care, there's
11:41been an increasing amounts of
11:43buybacks of share. So instead
11:45of spending pharmaceutical companies, for
11:46example, are the biggest,
11:47the biggest entities that do
11:49this, instead of spending more
11:50money on research and development,
11:51They're spending more money on,
11:53stockholder,
11:55share buybacks to help their
11:56shareholders.
11:57So that piece I will
11:58talk about briefly. I'm also
12:00talking about privatization. So the
12:01fact that pharmaceutical companies are
12:03private entities, I'll be talking
12:04about Medicare Advantage,
12:07and there's also direct primary
12:08care concierge practice. There's been
12:10a massive growth of that
12:11in the recent years, and
12:12I'm not talking about that.
12:13And then finally, this commercialization
12:14piece is something that I
12:15added. They didn't talk about
12:16this in the,
12:18in the Nedjem article, but,
12:20the commercialization piece. So this
12:21is the role of commercial
12:22actors in shaping health. A
12:23big part of that is
12:24marketing. I think marketing is
12:25a through line in a
12:26lot of this, and I'll
12:27talk about that, and then,
12:29the role of commercial actors
12:30in public health.
12:31Okay. So the first case
12:33study that I I'd like
12:34to talk about is the
12:35pharmaceutical industry, and so I'll
12:36talk about various aspects of
12:37it. And this too, there
12:38could be a lot of
12:39things to talk about, but,
12:40I'll focus in on a
12:41few things. So it's important
12:42to note that the US
12:43is, again, an outlier in
12:45many respects.
12:46When it comes to brand
12:47name drugs, from two thousand
12:49eight to twenty twenty one,
12:51new drug launch prices have
12:52increased by twenty percent per
12:54year. And so this is
12:55outpacing inflation,
12:57and
12:58it's unclear why that why
12:59that's necessarily the case. It
13:01doesn't have to be, but
13:02launch prices are increasing over
13:03time.
13:05Launch prices of cancer drugs
13:06are nearly they nearly tripled
13:09in the US over the
13:10past decade,
13:11whereas they have not increased
13:13as much in other countries.
13:15And it's also the case
13:17that once the once the
13:18brand name drug is launched,
13:20the drug prices continue to
13:22increase. And so,
13:24relative to Germany and,
13:26Switzerland, which was shown in
13:27this paper,
13:28in the US, prices continue
13:30to increase for drugs even
13:31after they've been launched, whereas
13:32in other countries, they continue
13:34to they they go down.
13:36And I think drug prices
13:38is one of the rare
13:40bipartisan issues,
13:43in the US right now,
13:44and that
13:45so eighty two percent of
13:46Democrats believe that it's an
13:47an issue. Sixty eight percent
13:48of Republicans believe it's an
13:49issue. There's, really, there's not
13:51that many issues that there's,
13:52this amount of consensus across
13:54political across the political spectrum.
13:56And many one in five
13:57adults, we see this in
13:58the clinic all the time,
13:59but many patients are not
14:00able to afford medicines and
14:01they think that, the drug
14:03prices are or they say,
14:05and experience
14:06the high drug prices as
14:07a reason for why they're
14:08not able to attain those
14:10medicines.
14:11And yet,
14:13studies have shown over and
14:15over again that it's actually
14:16US taxpayer dollars that contributed
14:18to the development of these
14:19drugs.
14:22And so this was a
14:22nice paper that looked at
14:24how
14:27all newly approved drugs can
14:29be traced to publicly supported
14:31research. And so if you
14:32this paper looked at the
14:33different patents that had been
14:34filed. And at some point
14:35in the journey of that
14:36drug drugs development,
14:38a,
14:40public support was,
14:42was a part of it.
14:45And one argument that the
14:46pharmaceutical industry often makes is
14:47that,
14:49you know, that
14:51drugs are
14:53expensive or they're priced at
14:55the the way that they
14:56are because they're spending a
14:57lot of money on research
14:58and development. But as it
14:59turns out, there is no
15:00correlation between how much they
15:02spend on research and development
15:03and the list price. And
15:04so, really, it's a question
15:05of what they believe that
15:06the market will be able
15:07to sustain or what the
15:08market will bear in terms
15:10of the the cost of
15:11the drug as opposed to
15:12what the inputs are in
15:13terms of how much they're
15:14spending on developing the drugs
15:15themselves.
15:16And, really, what they're doing
15:17is not exclusively. I don't
15:19wanna overstate the case, but
15:20they are spending,
15:22increasing amounts of money on,
15:24total shareholder payouts,
15:27engaging in, share
15:29buybacks. And so this this
15:30is a nice figure from
15:32a paper that a scholar
15:33who is here, Victor Roy,
15:35published last year or this
15:36year.
15:37Oh, and Carrie was on
15:38it.
15:39Yeah. So, payouts I mean,
15:41total share shareholder payouts,
15:45one aspect of that is
15:47the shareholder
15:48buyouts.
15:50Sorry. Not the shareholder buyouts,
15:51but
15:53companies purchasing their own stocks
15:55to inflate the stock price.
15:57And so instead of investing
15:59money in the research and
16:00development, they're they end up
16:01spending more money on, increasing
16:03the amount of money that
16:04they're able to, yeah, pay
16:06to the shareholders.
16:08What are the other ones
16:09here? Yeah. The share buybacks.
16:13Yeah. The dividends piece, I'm
16:14not I I can't comment
16:16on, but, those are the
16:18for the other terms.
16:21The figure that I didn't
16:21show here is so they
16:22I mean, Carrie, you this
16:24is your pay.
16:26But so please. Yeah.
16:49No. The the payout is
16:50the sum of those two.
16:52So there's a two different
16:53ways we get
16:55I would direct
17:01it.
17:05So this is just to
17:06say that,
17:07it's not just research and
17:08development that companies are spending
17:10their money on. There's also,
17:11and this is, you know,
17:12a form of financialization.
17:15Does this work, actually?
17:16Oh, this is just a
17:19oh, okay. I'll use this.
17:23And I think another
17:25aspect of this is that
17:26companies pharmaceutical companies are also
17:27spending a lot of money
17:28on marketing, and they're spending
17:29a lot of money on
17:31marketing to clinicians specifically. And
17:33we we we know this.
17:34We've learned this in,
17:36in our classes, and maybe
17:37we've experienced this in the
17:38clinic as well. A lot
17:39of detailing of physicians to
17:41prescribe certain drugs. And so
17:43this was a paper that,
17:44well, this is from, there
17:45are two papers that we
17:46published on
17:49a lawsuit that was filed
17:51and successful against Biogen for
17:54inducing and rewarding clinicians
17:57much beyond what,
17:58is reasonable to try to
18:00increase the prescriptions of their
18:02multiple sclerosis drugs. And,
18:04what we found was that
18:06there's two ways in which
18:07this works. So companies will
18:10induce clinicians to
18:12prescribe more of the drugs
18:14that they're selling by,
18:16by detailing them, by, you
18:17know, providing them with food
18:19or
18:20other types
18:21of benefits.
18:22But the what they will
18:23always also do is reward
18:24clinicians who are already high
18:25prescribers of those drugs as
18:27a way to continue
18:28to to incentivize them to
18:29continue to prescribe the medicine.
18:32And so that's that's what
18:34we found for this specific
18:35case is when Biogen was
18:36selling these different multiple sclerosis
18:38drugs and trying to induce
18:39and reward clinicians. And so
18:40there's also this element of
18:41how the pharmaceutical
18:43industry is able to increase
18:45the or promote the sale
18:46of their drugs,
18:48and something else that they're
18:49spending a lot of money
18:50on.
18:54One and and so one
18:55piece of this that I've
18:56been very interested in since
18:57I was a medical student
18:58here is that
19:00the most effective way
19:02to increase access to prescription
19:04drugs is by decreasing their
19:06cost. And the most effective
19:07way of decreasing the cost
19:08is by allowing the drug
19:09to go generic so that
19:11there's there's more manufacturers.
19:13And what we know, this
19:14is from an FDA analysis
19:15and it's been shown over
19:16and over again, is that
19:17it doesn't it's not as
19:18if you just have one
19:19generic and all of a
19:19sudden the price drops for
19:20a drug. You need three
19:21to four generics to be
19:22able to compete in a
19:23market for the price for
19:25that drug to drop. And
19:27so,
19:28this was
19:31this idea is what,
19:33led me to to
19:35was, like, my entry into
19:37this type of research.
19:39And, so I'll talk about
19:40that,
19:41in a second. But,
19:43there's
19:44even though there are we
19:46know that we need generic
19:47drugs for them to be
19:48more accessible, there's a number
19:50of barriers to adequate generic
19:51competition. And so there's regulation
19:53and market dynamics in which,
19:57you know, there's prioritizing FDA
19:58approval and allowing for the
20:00availability of generic drugs. Then
20:02there's also the role of
20:03consolidation
20:04among generic manufacturers and acquisitions.
20:06And what that ultimately does
20:08is reduces
20:09competition in the marketplace, and
20:11so prices can go, prices
20:12can increase, and so, you
20:14know, drugs become less accessible.
20:16And then
20:17there's a whole host of
20:19other gamesmanship that's happening in
20:21which, which which is anti
20:22competitive behavior where a lot
20:24of man brand name manufacturers
20:25will make it more difficult
20:26for generic companies to enter
20:28the market and to compete
20:29and bring prices down. And
20:30so they engage in a
20:31number of different,
20:33strategies including what's called reform
20:35reformulating drugs, but what's called
20:36product topping or evergreening. And
20:38so I'll talk about that
20:38and give some examples. And
20:39then they also develop these
20:41things called patent thickets. So
20:42they'll just throw as many
20:43patents as possible to protect
20:44the drug so that it's
20:46harder for generic drug companies
20:47to fight those patents and
20:48bring their version onto the
20:49market. So I'll talk about
20:51all of these in a
20:52little bit of detail, but,
20:54this is what
20:55was my entry into this
20:56type of research,
20:58now ten years ago almost,
21:00that I published with Joe.
21:02And so we were interested
21:03in understanding what is the
21:05landscape of the prescription drug
21:07market, How many drugs that
21:09exist on the market that
21:10have been approved in the
21:12last three decades, four decades
21:14have enough generic competitors? How
21:16many did how many of
21:17these drugs have four let's
21:19we picked four as a
21:20threshold. And it turns out
21:21that only two thirds of,
21:24of the drugs on the
21:24market that have been approved
21:25in the last several decades
21:26have four or more generic
21:28manufacturers.
21:29And what that does is
21:31if if there isn't a
21:32sufficient amount of competition, potentially,
21:34the prices have not dropped.
21:36But, also, it could be
21:37that because there are not
21:39enough generic competitors, the prices
21:41are then increased. And so
21:42around that time,
21:44Martin Shkreli was in the
21:45news because he had bought
21:46the rights to,
21:48Daraprim, and overnight, it went
21:50from fifty cents a tablet
21:51to seven hundred fifty
21:52dollars a tablet because there
21:53were no other competitors in
21:54the market. And so that's
21:55what drew a lot of
21:56attention to this,
21:57as well. And what we
21:59did in a subsequent paper
22:01was try to identify how
22:03often are drugs that have
22:05limited amount of competition, how
22:06often are they acquired.
22:09And it turns out that
22:10it happens
22:11half the time,
22:13that these drugs are acquired,
22:14which then makes them susceptible
22:16to dramatic price increases or
22:18it makes them susceptible to
22:19shortages because if you have
22:20a hurricane in Puerto Rico
22:22and that's where your manufacturer
22:23is, then there is no
22:24other manufacturer that can make
22:25the drug. And so there's
22:26a lot of downstream consequences
22:28to this,
22:29and really points to
22:31in this, scenario,
22:36trying to promote more either
22:37more competition or having some
22:39sort
22:40of a manufacturer, like a
22:41public manufacturer that can with,
22:43withstand
22:44those types of,
22:47events.
22:49Okay. So, the second piece
22:51of this is
22:52anti competitive behavior that pharmaceutical
22:54companies engage in. And,
22:58the idea here is that
23:00companies
23:01will reformulate a drug,
23:03which could be beneficial for
23:04patients. We do we see
23:05this in clinic all the
23:05time. Right? I would like
23:06to give the example of
23:07metformin.
23:08I usually will I I
23:09don't even use immediate release
23:11metformin anymore because of side
23:12effects, and I'll instead use
23:14extended release because it it
23:16happens to have less side
23:17effects, but it also makes
23:18it so that patients don't
23:19have to take the medicine
23:19twice a day. They can
23:20take it once a day.
23:21So there are true benefits
23:22to reformulations,
23:24but the problem is that
23:25oftentimes companies will seek and
23:28obtain approval for reformulations
23:30as a way to extend
23:31their control over the market
23:32for that drug. And so
23:34that was
23:36the motivation for,
23:38a study in which we
23:39tried to characterize the timing
23:41of reformulations
23:43for an original drug, so
23:44the first version of metformin.
23:48The timing of the re
23:49the approval of the reformulation,
23:51so when the extended release
23:52comes out
23:54relative to when the generic
23:55would have come out for
23:56the original drug. So if
23:58the company is able to
23:59introduce the reformulation right before
24:00the generic is going to
24:01be approved, they could potentially
24:03try to draw patients onto
24:04the reformulation,
24:07and away from the generic
24:08and the reformulation is more
24:09expensive than the generic. There
24:11could be benefits, right, as
24:12I mentioned,
24:13but the timing is still
24:14suspect. And so what we
24:16found was when we tried
24:17to create this timeline,
24:20is that there's reformulations throughout
24:21the life cycle of a
24:22drug, but it tends also
24:24to increase
24:25right before the generic drug
24:26is about to be approved.
24:28And then after the generic
24:29drug is approved, companies lose
24:30interest in that. They seem
24:32to lose interest in,
24:34that portfolio, and so then
24:35they stop seeking
24:36reformulations. And so,
24:38they're they're just
24:40at least, and, again, I
24:41don't wanna overstate the case,
24:42but this does,
24:44I think, lend some credence
24:45to the argument that there
24:46is some gamesmanship going on
24:48here.
24:49And what we also did
24:50was we tried to characterize
24:51the types of drugs that
24:52companies were reformulating
24:54and were more likely to
24:55reformulate around the time of
24:57when the generic version was
24:58going to be approved. And
25:00we found that if a
25:01drug was more profitable, so
25:03something called a blockbuster drug.
25:04Right? They're making more than
25:05a billion dollars on this
25:06drug every year. They were
25:08much more likely to reformulate
25:09that drug and try to
25:10hold on to the market
25:11share, but they were not
25:12as likely to do it
25:14if the drug was considered
25:16clinically
25:17useful. And so,
25:19here, we used a couple
25:20of different measures
25:21of what clinically useful or
25:23therapeutically valuable would be, and
25:25there wasn't really any statistically
25:26significant signal here. So it's
25:28not as if companies are
25:28trying to reformulate drugs that
25:28themselves are considered a companies
25:29are trying to reformulate drugs
25:31that themselves are considered to
25:33be clinically valuable to try
25:34to find additional incremental improvements
25:36to try to,
25:37to try to help patients
25:39take the drug.
25:41And really, what's more important
25:43than the fact that they're
25:44not reformulating those drugs is
25:45the contrast between the
25:49the the contrast between the
25:50fact that they are reformulating
25:51the most profitable ones.
25:57And then the last piece
25:58that I'll talk about in
26:00with respect to pharmaceuticals,
26:01is patent thickets.
26:03And,
26:04so there's a number of
26:05different factors that go into
26:08whether a generic manufacturer
26:11decides to enter a market.
26:12Right? So one is market
26:14potential. If the drug is
26:15making a lot of money,
26:15a generic manufacturer will be
26:17more likely or may be
26:18more likely to enter a
26:19market because there's more money
26:20to be made there. But
26:22a great barrier, as I've
26:23said, is patents.
26:25And another factor that they
26:26might consider is just the
26:27difficulty of manufacturing the drug.
26:29Right? If
26:30injectables are,
26:32notably more difficult to manufacture
26:33than oral drugs and then
26:35also the market size, how
26:37many patients are potentially eligible
26:38for treatment. So these are
26:39just factors that a generic
26:41manufacturer there are there are
26:42probably others, but these are
26:43some of the four main
26:44ones that I've identified that,
26:47that may inform a generic
26:49manufacturer's decision to enter a
26:50market.
26:54He would have cost of
26:55the the wage.
26:57This would be a big
26:58budget. I'm just curious, but
26:59it seems like somebody could
27:01do with that.
27:02How much is it? Yeah.
27:06I think that's a great
27:07idea. I I I'm and
27:08there have been some papers,
27:09but they've been limited to,
27:10like, a drug. I think
27:12there was a big paper
27:12a couple years ago on
27:13atorvastatin,
27:15but no one's done it
27:16systematically
27:17across all the drugs, but
27:19definitely would be a good
27:20idea.
27:21There might be others that
27:22I'm not thinking of right
27:23away. But,
27:26so we,
27:27we
27:29we wanted to investigate the
27:32relative
27:33importance
27:33of
27:34the revenue of a brand
27:37name drug versus
27:39the number of patents
27:41that protect that drug and
27:43how that might impact the
27:44availability of a generic drug.
27:47And so we mapped
27:49we mapped,
27:51the revenue against the number
27:54of patents that protect a
27:55drug. And so here, the
27:55numbers are a little bit
27:56small, and I apologize for
27:57that. But the number the
27:59numbers here are,
28:01the number of years since
28:03the approval of the original
28:04drug.
28:06And what this graph shows
28:07is that
28:09every I mean, if it
28:10just it's kind of just
28:11like a diagonal line here
28:12with the numbers as well.
28:13So one, two, three, four.
28:14So it's the number of
28:15years after the original drug's
28:16approval.
28:18The revenue for that drug
28:20appears to increase until year
28:21nine.
28:23But what's really interesting here
28:24is that the number of
28:25patents that that the manufacturer
28:28of the brand name drug
28:28is able to obtain
28:30also increases over time.
28:32So it's not as if
28:33they've obtained all of their
28:34patents before the drugs come
28:35to market. It's that they
28:36continue to seek additional patents
28:38to protect
28:39their drug over time. And
28:41it seems to,
28:42peak in year nine, which
28:44makes sense because the average
28:45time for a generic drug
28:47to come onto the market
28:48is about ten years,
28:49eleven years after
28:51the original brand name drug
28:52was approved.
28:54But what is also interesting
28:56is that we separated this
28:57out into Blockbuster again and
28:59non Blockbuster drugs. And Blockbuster
29:01drugs,
29:04they have higher revenue as
29:05which is, obvious. That's that's
29:07what defines a Blockbuster drug.
29:09But then there's the number
29:10of patents also
29:12seem to increase not for
29:13till nine years, but till
29:14thirteen years after. So what
29:15this shows us is that
29:17companies are,
29:19are really motivated to try
29:21to increase the try to
29:22obtain additional patents, particularly for
29:23their most profitable drugs and
29:32great. Yeah. Yeah. I'm happy
29:32to take any
29:33and all questions while I
29:35speak.
29:44Alright. I'll I'll I'll alright,
29:46please.
29:47Well, how can we prevent
29:48or combat a Martin Shkreli,
29:50situation
29:51in the futures? Given the
29:52new drugs were
29:55developed as a result of
29:56the public funding, can we
29:58insist that new drugs are
29:59not priced out of reach?
30:01Can patents,
30:02padding or tickets be prevented?
30:07Yeah. I mean, there
30:09the the answer
30:10to all of those questions
30:12is yes.
30:13There are various ways in
30:15which we can do that.
30:15I think there's potentially a
30:17lack of political will, but,
30:18also, it just depends on
30:19who's,
30:20who's motivated to to do
30:22this. So whether it's the
30:22US Patent Trade Office,
30:26addressing these patent tickets, which
30:28was being done, to a
30:30certain extent during the Biden
30:31administration.
30:32When it comes
30:33to avoiding what happened with
30:35Martin Shkreli, there's a number
30:36of different solutions.
30:37One I mentioned is public
30:38manufacturing,
30:40and there's examples of that.
30:44You know, with the and
30:46and so in that scenario,
30:47we're talking specifically about generic
30:49drugs.
30:51And so to increase to
30:53eat to to have a
30:54public manufacturer of old drugs,
30:55which are more susceptible
30:57to,
30:58for that kind of behavior,
31:00I think public manufacturing is
31:01one potential solution. And there
31:03are others too that we
31:04could talk about.
31:06Are there other questions too?
31:08We'll add one more. There's
31:09a couple here, but I'll
31:10do one now, and then
31:11we'll, I don't want to
31:11interrupt you too much.
31:13Jorge Moreno, do you wanna
31:16Yeah. No. Hi. Thanks so
31:17much for the conversation. I
31:19just wanted to talk about
31:20the competition of compounded versions
31:23of medications, like GLP ones,
31:25and if you could comment
31:26on
31:27that competition for pendant medications.
31:32Yeah. I mean,
31:34the compounding issue with GLP
31:36ones is a really big
31:37issue.
31:39I think that the I
31:40think when I talk about
31:41it clinically, I'm a little
31:42bit wary of the compounded
31:44versions of drugs just given
31:45the lack of,
31:47lack of evidence and making
31:48sure that they're safe.
31:50With the GLP ones specifically,
31:53there's so many new companies,
31:54Hems and Hers and Roe
31:55and oh, there's they were
31:57send they were selling and
31:58I think they may still
31:59be even they're not supposed
32:00to be selling compounded versions
32:01of GLP ones. And the
32:02reason that they were able
32:03to do that is because
32:04there was a shortage
32:05that was declared by the
32:06FDA.
32:08Once that shortage ended, they
32:09weren't supposed to be able
32:10to,
32:12to market and sell compounded
32:14versions.
32:15And I I actually don't
32:15know where the conversation is
32:16on that right now. But,
32:18I think,
32:21clinically, I have also I
32:23mean, patients have said, well,
32:24we'll go with the compounded
32:25version because it's cheaper, and
32:26it's hard for me to
32:28know whether it's safe or
32:29not. And so I think
32:30that's one issue with compounded
32:31medicines, but
32:34I don't know a whole
32:35lot more about compound compounded
32:37medicines. Thank you.
32:39It's a good question.
32:42So I will
32:45I think,
32:46you know, what we found
32:47in this paper was just
32:48that
32:49what's intuitive. Right? If there's
32:50more if the brand name
32:52drug is making more money,
32:53then there's it's more likely
32:54for the generic for there
32:55to be a generic drug
32:56version.
32:57If there's more patents, there's
32:59a slightly lower
33:01likelihood that there will be
33:02a generic version on the
33:03market in the in the
33:04first year. We looked only
33:05in the first year.
33:07And so the implications of
33:08this is, you know, we
33:09need policies to remove improperly
33:11patented
33:12improperly granted patents. We need
33:14to potentially reduce portfolio sizes
33:16and expedite generic approvals.
33:20And, I think it's worth
33:21saying that the so I'll
33:22just finish this part of
33:24the talk, but the pharmaceutical
33:25industry is a double edged
33:26sword.
33:27It's I I think it's
33:28unequivocally
33:31a piece in driving innovation,
33:32but the goals are often
33:34misaligned with what's best for
33:36the population's health,
33:37especially when we think about
33:38the fact that investments in
33:39r and d do not
33:40explain the high US drug
33:41prices, and companies
33:43are spending a lot of
33:44money on marketing and,
33:46as we're increasingly discovering
33:48on, shareholder
33:49buyouts.
33:51And we need stronger levers.
33:52We need stronger regulation,
33:54to ensure public return on
33:55public investment and market competitiveness.
33:57And as I've mentioned already,
33:58public manufacturing is one piece
33:59of this.
34:02Section nine.
34:05So your argument is that
34:07that the companies are sort
34:08of running amok and behaving
34:10like companies behave without regulation.
34:15In the earlier part of
34:16your talk, you pointed out
34:18that other countries have similar
34:19economic
34:20resources spend a lot less
34:22on health care. So my
34:23question to you is what
34:24proportion
34:25the excess US spending can
34:27be explained by the phenomenon
34:28you're describing?
34:30We,
34:31so ten percent of US
34:33health spending is
34:35on prescription drugs.
34:38The graph that I showed
34:39earlier shows that there's a
34:40similar percentage of overall dollars
34:42or overall, you know, yeah,
34:44overall spending on health care
34:45that,
34:46is spent on
34:48on prescription drugs and medical
34:49goods together.
34:51I don't know
34:53I I don't know. Other
34:54others may know how much
34:55what the relative percentage is
34:57specifically for prescription drugs in
34:58other countries. But I think
35:00one piece of this that's
35:01worth pointing out that I
35:02didn't talk about is that
35:03other countries,
35:04not all, but many have
35:08their agencies in which they
35:09evaluate the cost effectiveness of
35:10a drug.
35:11And
35:13they also may say that
35:14we're not going to cover
35:15this drug. And so,
35:18one of for example, the
35:19newer dementia medicines,
35:21which I'll talk about in
35:22a moment,
35:25in the UK and in
35:26other countries, they've said we're
35:27just not covering this drug.
35:28It's too expensive, and the
35:29benefit isn't aligned with how
35:30much it costs. We don't
35:31really have that mechanism in
35:32the US, and so we
35:33end up spending a lot
35:34of money on drugs that
35:35may not have the benefit
35:37that
35:38is commensurate with how much
35:39they cost.
35:42So that's, I mean, that's
35:43one piece of this, but
35:44I don't, yeah, I'm not
35:46sure how much
35:47what percentage specifically
35:49were
35:49is, for prescription drugs here
35:52versus other countries.
35:53Little complicated just because we
35:55have different
35:57shareholder payouts compared to other
35:59countries in terms of CEO
36:01compensation,
36:02stock buybacks, dividends being significantly
36:05higher compared to other countries.
36:06So if you take that
36:06into account, that also
36:08adds into kind of the
36:10financialization picture that we have
36:11here in the US. But
36:12some similarities is that a
36:13lot of actually prescription drug
36:15coverage in other countries, including
36:16in Canada, is actually privatized,
36:17which is why they're also
36:18having difficulty
36:20and are using coverage policies
36:21to be able to control
36:22costs. But if you look
36:24at, like, similar formularies of
36:26drugs, prices actually don't vary
36:28so much between us and
36:30Canada between us and Europe
36:31because they have the health
36:32technology assessment groups, and they
36:34do do cost effectiveness. Although,
36:35that's changing now with this
36:37administration
36:37in making deals with countries.
36:39Yeah. It's also becoming increasingly
36:41privatized too.
36:43Yeah. But I and I
36:44I also think that this
36:44is a growing problem, as
36:45Rishma was saying, across other
36:47countries as well. It's just
36:48the fact that a lot
36:49of these new medicines are
36:50just breaking the bank,
36:52like selling gene therapies and
36:54fairly expensive oncologic treatments. And
36:57so,
36:58and that has a lot
36:59of consequences.
37:01Yeah. I think they the
37:02company pharmaceutical companies may also
37:04point out that physician salaries
37:06in the US are two,
37:08three, four times as high
37:09as they
37:10are in the income terms.
37:12That's another driver. But I
37:14wanted to ask you about
37:15that comment made about patents.
37:17So you're saying that it
37:19is accepted that there are
37:20improper patents, and if there
37:22are, what's how does that
37:24actually work?
37:28I think I mean, there
37:30I could give you an
37:30example, like, with
37:33adalimumab.
37:35I think they had a
37:36hundred thirty patents. I I
37:37might be getting the number
37:38wrong, but they're just
37:42there's a lot of reasons
37:43for that. I think companies
37:45will just try to obtain
37:46as many patents as they
37:47can, see what sticks.
37:50We don't have enough resources
37:52in terms of reviewing the
37:53patents.
37:54And,
37:56so
37:57there isn't as much
38:00there isn't as much
38:02there aren't enough resources to
38:04carefully assess whether these patents
38:05actually present
38:07something or actually are valid
38:09and confirming something that is
38:11a nontrivial
38:12advance or something that is
38:13eligible to be patented.
38:16So I think there's just
38:16a lot of I think
38:17there's a lot of gamesmanship
38:18here to try to and
38:20then they'll protect they'll patent
38:21various aspects of the same
38:22medicine,
38:24like with extended release. They
38:25might try to patent the
38:26mechanism of delivery as opposed
38:28to the active ingredient. And,
38:29you know, you get into
38:30auto injectors or you get
38:31into inhalers. And then when
38:32they continue to iterate on
38:33the same drug, they can
38:34continue
38:36to obtain patents on whatever
38:37that small iteration is.
38:41One other question.
38:42Peter Ellis?
38:48Peter. Thank you very much.
38:50No. Fascinating to talk really
38:52regularly
38:53supported.
38:54It's it the message is
38:55very clear.
38:56It brings me towards policy
38:58issues.
38:59So, for example, if there
39:01there's consensus in both political
39:03parties
39:04that the drugs are too
39:05expensive by pharma, what are
39:07the next steps? You mentioned
39:09manufacturing.
39:11The current administration is buying
39:13up minority shares
39:15in critical industries like rare
39:17earth.
39:19Why couldn't they do the
39:20same with pharmaceuticals that make
39:22critical drugs like GLP ones?
39:26They could,
39:27but, we haven't seen that
39:29as much.
39:30There are some examples of
39:31public manufacturing. That's not the
39:32only way to do this,
39:33but I think it would
39:34be very helpful to have
39:35an agency that in the
39:36US
39:37that is like the health
39:39technology assessment agencies in other
39:40countries that assess the cost
39:41effectiveness of a drug, but
39:42also to have some teeth
39:44behind it and to be
39:45able to enforce it. The
39:46Inflation Reduction Act,
39:49which was passed last year
39:51or year before,
39:53was a a small step
39:54forward. And it allowed Medicare
39:56to start to negotiate some
39:57of these drugs, which Medicare
39:59was not able to do
39:59or not allowed to do
40:00until, recently, but that too
40:02is only targeted towards ten
40:04drugs, now twenty drugs. And
40:06so,
40:08I think expanding the ability
40:09for a public payer to
40:11negotiate down the the price
40:12of drugs is also an
40:13important,
40:15is one important solution.
40:17There's a lot of other
40:18solutions that states
40:20are taking, like, penalizing pharmaceutical
40:22companies for increasing the price
40:24of drugs beyond inflation.
40:25It's just been hard to,
40:28that it's just been fought
40:29vigorously, and so it's been
40:31hard to actually implement over
40:32time. But,
40:34there are
40:35I mean, what you mentioned
40:36was, you know, aside from
40:38public manufacturing, it's almost like
40:39nationalizing the pharmaceutical industry. I
40:40think that is,
40:42you know, that's,
40:43not going to happen, nor
40:45it may also have a
40:46lot of other unintended consequences,
40:47but I think there's a
40:48lot of other things that
40:49we could do before then.
40:50Thank you.
40:54Okay. So I will spend
40:55a little bit of time
40:55talking about coverage policy. And,
40:59what I mean by coverage
41:00policy oh, this got a
41:02little bit messed up on
41:02here. But,
41:03in the US, there's two
41:04stages of enabling access. One
41:07is the FDA approval stage,
41:08which I just talked about.
41:09But even after a drug
41:10is approved, it has to
41:12be covered by,
41:14it has to be covered
41:14by insurance, and CMS has
41:17to,
41:19be involved in
41:20in,
41:23in coverage policy of that
41:25of that drug.
41:26And there's a couple of
41:27different ways in which this
41:28happens.
41:30One is that CMS may
41:32have a what's called a
41:33national coverage determination for whatever
41:35new drug or device has
41:36been approved.
41:38And,
41:40when they set the national
41:41coverage determination, all insurers have
41:43to follow that that,
41:45that coverage determination.
41:46One piece of this that's
41:48really,
41:49no noticeable and,
41:51or notable and,
41:53you know, folks here at
41:54Yale,
41:55have been writing about this
41:56for a while is this,
41:59version of this called coverage
42:00with evidence development. So if
42:01there's a new drug,
42:03or device that's been approved
42:04that,
42:06may have some,
42:09may have been approved by
42:10the FDA,
42:11but there's still some uncertainty
42:12about the safety and efficacy
42:13of the drug. Or if
42:15there's a a drug or
42:16a device that has,
42:18that's particularly promising or affects
42:20a large,
42:22number of people,
42:23then, oh, I'm sorry. That
42:25that's what national coverage determinations
42:27are are targeted for. But
42:28coverage with evidence development is
42:29when we don't have
42:31as clear evidence about the
42:32safety and efficacy of a
42:34drug. And so what CMS
42:35may say is that, yes,
42:36this drug can be made
42:37available. We will cover it,
42:38but it will have to
42:40they they may, for example,
42:41have to be a registry.
42:41So all patients who are
42:42prescribed this drug will have
42:44to be enrolled in some
42:45sort or, you know, they
42:46they have to their name
42:47and some information will have
42:48to go into a registry
42:49so we can continue to
42:49study this in a longitudinal
42:51fashion.
42:52Or they may say,
42:53that there's such limited evidence.
42:55The FDA did approve this,
42:56but there's such limited evidence
42:57that we think that to
42:59cover this drug, patients who
43:01are prescribed this drug have
43:02to be enrolled in a
43:03randomized control trial. And that
43:04happened, for example, in the
43:06recent years with,
43:08the first in the three
43:09new treatments for Alzheimer's disease.
43:13This
43:15if some of you may
43:15know, many of you may
43:16know that aducinumab,
43:18Aduhelm,
43:18was approved a couple of
43:20years ago,
43:21but then CMS said that
43:23as part of the coverage
43:24with, evidence development, all patients
43:26who were prescribed this medicine
43:27would have to go would
43:28have to be enrolled into
43:29a randomized controlled trial.
43:31And,
43:32ultimately, that drug has failed.
43:34No one has prescribed it.
43:35No one's covering it. But
43:36then subsequent versions, leucanumab and
43:38denanimab, which I'll talk about
43:39in a second, have also
43:41been covered through coverage with
43:42evidence development.
43:43Now if CMS says that
43:45if CMS does not have
43:46a national coverage determination for
43:47a particular new drug or
43:48device, then it's left to
43:51local coverage
43:52determinations, and that's done just
43:53locally in various
43:55demographic areas.
43:56And those coverage determinations
43:58are made by what's called
44:00Medicare administrative contractors, which are
44:02actually private entities.
44:03And,
44:04so they
44:06will, you know, review the
44:07evidence and ultimately make a
44:09decision about what the coverage
44:10will be, but it will
44:11only apply in that local
44:12jurisdiction.
44:14And then it may be
44:14the case that there just
44:15isn't any formal coverage determination
44:17for a drug or device.
44:18There's a lot of new
44:19drugs and devices, and the
44:20CMS does not necessarily,
44:22make a coverage determination for
44:24all of them. And what
44:25that does is when CMS
44:26has not made a statement
44:27about any about a particular
44:29drug or device,
44:30then there's,
44:31then insurers,
44:33commercial insurers, Medicare Advantage, they
44:35are able to,
44:38they there's no
44:40they can continue to limit
44:41the drug in whatever way
44:42that they deem,
44:44makes sense to them. And
44:45so what that ultimately leads
44:47to is what I have
44:48on the bottom right here,
44:49which is
44:51private insurers will often engage
44:52in utilization management.
44:56Or what one form of
44:58that is prior authorization, which
44:59we see in the clinic
44:59all the time. So I've
45:00been doing some work on
45:01prior authorization, which I will
45:02talk about in a second.
45:05But I did just wanna
45:06briefly talk about the,
45:08because this, I think, is
45:09really nice example of of
45:11CMS coverage policy is the
45:12new drugs for Alzheimer's disease.
45:14And, this is dementia, as
45:16Carrie said, is also a
45:17growing interest of mine. So
45:18I wanted to,
45:19mention this briefly.
45:20But the new monoclonal antibodies
45:22for Alzheimer's disease were, as
45:24I said, covered through coverage
45:25with evidence development because,
45:28its benefit was unclear
45:30in terms of it being
45:31able to successfully slow cognitive
45:33decline and what that means
45:34clinically for a patient. But
45:35then there's also very serious
45:37side effects associated with these
45:38new medicines in terms of
45:39brain bleeds and brain swelling,
45:43which,
45:43they're called amyloid related imaging
45:46abnormalities or ARIA.
45:48And,
45:49it is it's a serious
45:50side effect potentially. And so
45:51we are interested, and this
45:53is some work that's ongoing,
45:54in understanding how many people
45:56have actually been prescribed leucanumab,
45:59which is one of these
45:59new monoclonal antibodies,
46:01and how long are people
46:02taking them, what are some
46:03of the factors associated with
46:04them discontinuing the drug.
46:06And so we use this
46:07national electronic health record database,
46:09which covers thirty health systems
46:11to try to understand this.
46:12And one notable finding is
46:14that in the last two
46:15years since the drug's been
46:16available,
46:17across these thirty health systems,
46:19only about five hundred patients
46:20have been prescribed this medicine,
46:22which was a bit surprising
46:23to me. There's a lot
46:25of barriers to obtaining the
46:26medicine.
46:29The, you know, patients have
46:30to be they have to
46:30go into the registry, which
46:31is not a huge barrier,
46:32but it's a twice monthly
46:35in,
46:35infusion. And,
46:37people may be wary of
46:38the side effects. And what
46:39we found ultimately,
46:40this work is ongoing, but
46:42a third of patients will
46:43discontinue the drug within a
46:44year. And so now we're
46:45trying to figure out what
46:46are some of the factors
46:46associated with it. Is it
46:47truly the side effects,
46:49or is it, out of
46:51pocket cost, or is it
46:52something else that is leading
46:53some people to or is
46:54leading people to discontinue this
46:56drug?
46:58And
46:59so, I I mean, I
47:00think that
47:03I think the re the
47:04the way this links in
47:05with,
47:06you know, the the idea
47:07of coverage with evidence development
47:08is that
47:10it may be reasonable to
47:11have some sort of
47:14additional layer for drugs that
47:16have a limited
47:20that that
47:21that have an unclear,
47:23safety and efficacy profile.
47:25And I think this work
47:27is,
47:29is linked linked to that
47:31in terms of just the
47:32fact that even within the
47:33first two years, people have
47:34been discontinuing this drug. And
47:35so,
47:37so we're we're trying to
47:38figure out why they're discontinuing.
47:40Yeah. It's just really striking
47:42how few people are getting
47:44these drugs.
47:46When they first came onto
47:47the market, people were saying
47:48this
47:50average, twenty percent of the
47:51entire Medicare budget. Right. Do
47:53you have any idea in
47:55very
47:56broad strokes?
47:57How many people are in
47:58these health systems that might
48:00have been eligible for the
48:01track? Like, to to do?
48:03There's about yeah. I think
48:05there's about four million people
48:06with dementia.
48:08In these health systems? Yeah.
48:11And only or do you
48:12Or maybe that's patient encounters,
48:13but there there's a it's
48:14a there's a notable number.
48:16Yeah. So it's a But
48:17they're eligible for. Yeah. Many
48:19of them might be too
48:20advanced. Yeah.
48:23Anticoagulation
48:24or yeah. Right. So it's
48:26relatively low utilization.
48:28Yes. Yeah. Yeah. Yeah. Yeah.
48:30Regarding the discontinuation.
48:31I mean, people discontinuation
48:34discontinue meds all the time.
48:35So how does this compare
48:37to an average rate of
48:38discontinuation?
48:39Yeah. That's a good point.
48:40I don't I mean,
48:42I don't know what that
48:43number is.
48:46I mean, GOP wants people
48:47to discontinue after a few
48:48months on average.
48:51Yeah. That's a good point.
48:52They're incredibly effective.
48:54Yeah. Right.
48:57Yeah. That's a good point.
49:02I think that
49:04I will skip over this.
49:06I yeah. I think I'll
49:07skip over it. It's just
49:08talking about how,
49:10CMS is trying to think
49:12about covering AI and machine
49:14learning based
49:15devices and
49:17the lack of transparency in
49:19the data that's review that
49:20is made available by manufacturers.
49:24I will just spend a
49:25couple of minutes on prior
49:26authorization.
49:28And,
49:29I mean, everybody's, I think,
49:31especially clinically familiar with prior
49:33authorization.
49:37Medicare Advantage. So this is
49:39just trying to explain Medicare
49:41Advantage versus traditional Medicare.
49:43I don't I mean, I'm
49:44sure people are quite familiar
49:46with Medicare Advantage, but there's
49:47some interesting differences
49:48between traditional Medicare and Medicare
49:50Advantage. The reason I bring
49:51this up is because
49:52Medicare Advantage is
49:54represents
49:55what was either an explicit
49:57or
49:58implicit decision to privatize a
49:59public program,
50:01because Medicare Advantage represents,
50:03you know, you have capitated
50:04prospective
50:05risk adjustment payments that is
50:07made from the government to
50:08private insurers to then cover
50:10that patient for the for
50:12the year,
50:13and,
50:14it's grown dramatically
50:16over the last decade. It's
50:17more than half of Medicare
50:18beneficiaries,
50:20who are enrolled in Medicare
50:22Advantage.
50:23And there's some there's some
50:24benefits to enrolling in Medicare
50:26Advantage,
50:26including that there's no out
50:28that there is an out
50:29of pocket maximum, whereas in
50:30traditional Medicare for part b,
50:32which covers your infusions and,
50:36other physician services,
50:39there isn't an out of
50:39pocket maximum. You continue to
50:41pay twenty percent.
50:44And,
50:45one notable difference
50:47is that in Medicare Advantage,
50:48there's extensive prior authorization
50:50or extensive use of utilization
50:52management. And that's one way
50:53in which Medicare Advantage is
50:54able to,
50:55limit their spending
50:57because they're given a lump
50:58sum at the beginning of
50:59the year by from the
50:59government. And so then if
51:00they can limit the spending,
51:02you know, then they're able
51:04to
51:05obtain a better a higher
51:07profit.
51:08But what we we and
51:10so
51:11I became prior interested in
51:13prior authorization because it's very
51:14much related to,
51:15you know, coverage policy and
51:17what happens to
51:19it's another way in which
51:20access to patients can be
51:22limited.
51:23And
51:24what we know is that
51:24there's been an increase in
51:25prior authorization as managed care
51:28has grown.
51:30There is a great deal
51:31of administrative burden for clinicians
51:33and for patients, also for
51:35insurers who have to, you
51:36know, adjudicate claims and figure
51:38out what's happening with,
51:40with particular,
51:42prescriptions.
51:45It also discourages the evidence
51:46has shown this across a
51:47wide number of, examples, but,
51:50excuse me, it discourages and
51:51delays appropriate care. And so
51:53there's also been,
51:56there's been a tremendous amount
51:57of attention on prior authorization.
51:59Right? United CEO was killed
52:01and
52:05as I guess, as a
52:07response to, health insurance companies'
52:13strategies and,
52:14the use of prior authorization
52:16and denials. And so this
52:17is an ongoing area of
52:19reform. And so we were
52:21but what we don't know
52:23necessarily is just basic facts
52:25about prior authorization. What is
52:27the scope of prior authorization?
52:28Is there much consensus between
52:30insurers and prior authorization requirements?
52:32Because,
52:34you know, one argument is
52:35that prior authorization can help
52:36reduce waste by reducing
52:38low value care, and it's
52:39a targeted technique or targeted
52:42tool.
52:43But then on the flip
52:43side, it it's just potential
52:45it's also a tool to
52:46reduce the use of very
52:47expensive services. And so we
52:49don't know basic facts about
52:50prior authorization. And,
52:52what we found
52:53is that in Medicare Advantage,
52:57we we pulled prior authorization
52:59rules from five major Medicare
53:01Advantage insurers
53:02and tried to figure out
53:03how much of US spending
53:05would that be
53:07how much of US total
53:09US spending would be,
53:12would there have been a
53:13prior authorization requirement
53:15for those services? Right? So
53:16which services the services that
53:18are accruing for that spending.
53:19And what we found was
53:21that
53:22two main findings, actually. The
53:23first is that forty percent
53:25of overall
53:27US spending in Medicare part
53:28b
53:29would have required prior authorization
53:33by at least one insurer.
53:34And I'm I'm skipping over
53:35a couple of details, but
53:36I'm happy to answer any
53:37questions. But
53:40the the main takeaway here
53:41is that a substantial portion
53:42of overall spending,
53:44is,
53:47you know, is
53:50it may have prior authorization
53:52requirements.
53:53So we're spending a there
53:54are a lot of dollars
53:55here at stake. But then
53:56I think the second main
53:58finding here is that there
53:59isn't much consensus between insurers
54:00on which services to require
54:02prior authorization for. And so
54:04this,
54:05I think is,
54:07I think this is one
54:08of the most important findings.
54:10And when there was consensus
54:12between insurers,
54:13it was on the most
54:14expensive drugs, which are often
54:17hematology and oncology drugs. And
54:18so I think this lends
54:19credence to the argument
54:21that
54:22it is two things. One,
54:23it's really hard to target
54:25low value services,
54:27and it's really hard to
54:28figure out what constitutes waste.
54:31But what companies are able
54:33to do is just limit
54:35or to require prior authorization
54:37for the most expensive services.
54:38And that so that's,
54:41that's and then that's where
54:42we have the greatest that
54:43that's where we saw the
54:44greatest amount of consensus.
54:46And so,
54:49this is one I think
54:50prior authorization is one piece
54:51of this bucket of coverage
54:53policy, and it's a tool
54:54that's being used by private
54:56insurers increasingly. And now there's
54:58newer models that CMS is
54:59releasing that allow,
55:01not allow, but that,
55:05that are testing the use
55:07of prior authorization in traditional
55:08Medicare, which traditionally has not
55:10ever it hasn't, for the
55:11most part, had prior authorization.
55:14So, and there's some critiques
55:16of that as well.
55:18But I think it's an
55:19example
55:20of privatizing public programs.
55:23So I just to summarize
55:24here, and then I don't
55:26think I'll get to my
55:26third part. But,
55:28so while coverage policy, while
55:30national national coverage determinations are
55:32formally a federal process. Right?
55:33CMS is making these coverage
55:34determinations.
55:35Private institutions influence which evidence
55:37CMS sees. Right? Even the
55:39evidence that that is generated
55:40from the trials in which
55:41they evaluate the drug,
55:43and then also the, you
55:44know, the policy context around
55:46what's medical messes medical considered
55:47medical necessity.
55:49And then it it's really
55:51worth noting that outside of
55:52a handful of national coverage
55:53determinations,
55:54most coverage rules are set
55:56by private max, the medic
55:58the Medicare administrative contractors that
55:59are setting the local cover
56:01coverage determinations
56:02and by MA plans and
56:04their ability to use utilization
56:05management and prior authorization, which
56:07is really shaping,
56:09the services that are and
56:10medicines that are available to
56:11patients.
56:12Utilization management is ultimately a
56:14form of private governance,
56:16And,
56:17I think it's worth noting,
56:18as I said, that MA
56:19is it reflects an implicit
56:20and explicit choice to privatize
56:22a public program. And so
56:23I think,
56:24coverage policy
56:26generally also is,
56:28an important aspect of how
56:29private institutions are shaping public
56:31health.
56:33So I don't think I
56:34have time for getting into
56:35this, which is unfortunate, but
56:36I need to just time
56:37things better, I guess.
56:43Yeah. I think then I
56:44will just end here and
56:47say,
56:50that,
56:50you know, US health and
56:52health care,
56:53is based on a series
56:54of iterative changes that have
56:55reflected varying priorities and group
56:57influences and rent seeking.
57:00We I've talked about the
57:01pharmaceutical industry, but then there's
57:02also,
57:04you know, private institutions are
57:05shaping the payment and delivery
57:07of,
57:09of health care. They're also
57:10shaping public health, which I
57:12didn't talk about.
57:13And market based logic in
57:15the US has been central.
57:16There are certainly some virtues,
57:18but is it appropriate in
57:19all settings? Is it appropriate
57:21is an open question, and
57:22then there's constant tensions between
57:24innovation,
57:25efficiency, and what's,
57:27what's best for the public.
57:29And,
57:30I think there's some regulatory
57:31gaps and information asymmetry,
57:33which is sometimes
57:35deliberate,
57:36that hinders accountability.
57:39And so,
57:41I think private institutions play
57:43an enormous role in shaping
57:44US health for
57:45better or worse. I mean,
57:46I think there is obviously
57:48a lot of positive. There's
57:49also a lot of negative
57:50that needs to be
57:53tackled.
57:54And the task is not
57:55to necessarily eliminate private power,
57:56but to realign it with
57:57public values.
57:59Thank you.
58:05And I you know, there's
58:06a lot of people that
58:06think that I couldn't fit
58:07on one slide, but so
58:08I thank all my mentors.
58:13K. Well, thanks, man.
58:14We're just about we are
58:15out of time.
58:16Maybe I haven't heard people
58:18do,
58:19approach you after with specific
58:20questions, but thanks again for
58:22Yeah. Thank you so much.
58:23Thank you.