AMCP Podcast Series - Listen Up: The Family Heart Foundation - Hilly Paige

Fred Goldstein 00:01

Hello and welcome to the AMCP Podcast Series - Listen Up as we take a deep dive into the challenges, trends and opportunities in managed care pharmacy. Follow the show's social hashtag #AMCPListenUp, and to learn more about AMCP Visit amcp.org. I'm your host, Fred Goldstein. On this episode, my guest is Hilly Page Chief Innovation Officer of the Family Heart Foundation. Welcome, Hilly.

Hilly Paige 00:27

Well, thank you, Fred. Thanks for having me on. I really appreciate it.

Fred Goldstein 00:30

It's a pleasure to get you on. We're here at the AMCP 20/24 Annual Conference. Obviously, you been here for the whole conference, a little bit of your sense of it.

Hilly Paige 00:37

It's been a great show so far. I think the turnout and the attendance has been really strong. I think they sit close to 4,000, which is great to see. You know, we go to a lot of the medical meetings and it's great to see post COVID the meetings are coming back last week we were at the American College of Cardiology meeting and it felt like pre COVID days, you know, the exhibit hall was full, lots of exhibitors, great sessions, and very much the same here. So it's, it's great to see that medical meetings are back live and in person and we're kind of past the, the COVID lockdown phase, and the sessions have been good. And we've had a lot of great traffic to our booth.

Fred Goldstein 01:12

Well, fantastic. Tell us a little bit about your background and the Family Heart Foundation. 

Hilly Paige 01:17

Sure. So we are the family Heart Foundation, and as you mentioned, I'm the Chief Innovation Officer. I joined the organization about 18 months ago after 30 plus years in the pharmaceutical industry. So I was I started a long time ago in the late 1980s as a sales rep with Parke-Davis and kind of continued my career through sales, sales, training, marketing, for five different companies over the years, starting with Parke-Davis and going through Novartis and ?,  Esperion, Amgen, and so long time there and then just about 18 months ago, decided to leave the industry and join the Family Heart Foundation. And it's really been a wonderful, I've never worked on the non-profit side, it has been really so rewarding for me, because of the work that we do and, and just a word or two about the Family Heart Foundation. So we were founded in 2011, originally, as the FH or Familial Hypercholesterolemia Foundation, and Familial hypercholesterolemia for your audience is a disorder of one of the LDL receptors that clears  LDL out of your blood. And so we have two receptors or two genes that code for the LDL receptor. And if one of them is defective, you have heterozygous FH, which occurs in about one in 250 individuals. And if you have homozygous FH, you have a defect in both of the receptors. And that occurs about one in 300,000 individuals and leads to very premature cardiovascular disease. And so it's a not a rare condition, FH and are the CEO and founder of the organization, Katherine Wilemon, actually had a heart attack when she was 39. A young mother had been told all her life that she had high cholesterol that ran in the family, had never gotten a diagnosis of FH. And she finally after the heart attack, got the diagnosis and designation that she had FH and decided that she looked around and said, there's no support for for folks that have FH there's no education. And so she founded the FH foundation at the time. And then about three years ago, we in so there are about one to 2 million people in the US who have FH. And about three years ago, we expanded the mission to include people with High Lipoprotein(a). So high levels of Lipoprotein(a)  occur, and about one in five individuals are 20% of the population. So there are probably 60 million people in the US that have a high level of Lipoprotein(a) and the diagnosis rate, though, is only about 1%. So incredibly underrecognized. Because it's not part of a standard lipid panel. Most people don't know about it, most people don't get tested. But our founder, Katherine has both FH and High Lipoprotein(a) and oftentimes they run together in a lot of folks. And so that's why we decided to expand the mission of the organization, we became the Family Heart Foundation. And so that's kind of a long winded explanation of how we started as the FH or Familial Hypercholesterolemia Foundation, and are now the Family Heart Foundation. And

Fred Goldstein 04:13

so with these two conditions, you said a number of individuals just don't actually know they have this condition. So how would they go about finding that out?

Hilly Paige 04:23

Sure. So for FH, you can certainly get diagnosed it the hallmark is a really high level of cholesterol or LDL cholesterol. And so it's usually picked up in either childhood or in your teenage years. But oftentimes, you don't get the diagnosis of FH. So what you're told is your Oh, you got high cholesterol, watch your diet. And unfortunately, when your cholesterol is 300, or 350, or 400. You can watch your diet all you want and it's not going to really impact it to any great extent. And so that's why we really feel it's so important to actually get a diagnosis of FH because then you know the condition you have it's genetic. And you can actually work with your family and do what we call a cascade screening to actually get out to your parents or your children or your siblings. Because if you have FH, there's a 50% chance that either one of your parents has it, or one of your kids has it so important to do the screening. And right now, the diagnosis rate for FH is about about 30%. For Lipoprotein(a), because it's not part of a standard lipid panel. So if you go to the doctor and you get your lipids done, you get an LDL and total cholesterol and HDL and triglycerides, Lipoprotein(a),   is not part of a standard lipid panel. So it's something you actually have to ask your doctor for. And this is one of the areas where the Europeans have been a little bit ahead of us in terms of the guidelines. So the guidelines for a lot of the European organizations like European Society of Cardiology, and European AStherosclerosis Society, is everybody once in your lifetime, she get tested for LP(a). And the US organizations have been kind of behind on that they've said, Well, if you have a positive family history, or you're high risk, or you've already had an event, then maybe test your test yourself for LP(a), but just recently, maybe two weeks ago, the National Lipid Association came out and said, everybody should get tested at least once. And the nice thing with Lipoprotein(a), because it's genetically determined, it's incredibly stable through most of your life. And so if you test your LP(a), the delay level from the teenage years onward, it's if you're high, you're high, if you're low, your low, it is very stable, and not much affects it. So diet, exercise, nothing really affects it. And so it's it's a, an easy test to get, if you know what the test is, and you know, to ask for it. And it's important, and that's one of the things we really advocate advocate for is to everybody gets should get screened.

Fred Goldstein 06:50

So are you advocating that to both the general population as well as physicians or one group over the other?

Hilly Paige 06:58

Yeah, you know, we are, we're out at all sorts of meetings that we're trying to raise awareness with the payer community, because we find a lot of cases the test is not covered by insurance. As somebody that has to pay out of pocket for the tests. Now, that's if you go through your doctor, you can also go through a company like, like, Let's Get Checked, or LabCorp, or something in order to test directly, but there, it's $80 to $90. And a lot of people are just kind of unwilling to pay $80 to $90. So we really advocate for better coverage. With healthcare practitioners, what we hear oftentimes is, well, there's no available therapy to treat your high level of Lipoprotein(a), so why should I test it? Why should I worry the patient, you know, there's nothing you can really do. And the sad thing is, is that the patient has the right to know if they have a high level of Lipoprotein(a) and there is something you can do in the here. And now because if you address all the other cardiovascular risk factors, you have like high blood pressure and high glucose and smoking and lose weight, all those things will dramatically reduce your risk, even if you have a high level of Lipoprotein(a). So there's something that patients can do now there's something that healthcare practitioners can do now. And so that's why we're really trying to get out there and with all the stakeholders, raise awareness of it's a powerful risk factor. It's under recognized and people need to be screened. 

Fred Goldstein 08:21

So they can do those wraparound health care, things to take care of, or at least minimum lower the risk level of that condition. And for FH, is there some treatment there

Hilly Paige 08:31

There definitely is there are a lot of wonderful therapies for people who have high levels of LDL cholesterol. And so, you know, the standard for years has been statins. Statins have been around since the 1980s. And they're all generic now. And they're and they're wonderfully effective. And in general available for most folks, Ezetimibe is typically the first add on therapy, and that will lower LDL another 15 to 20% on top of a statin. And then beyond that we have a lot of revolutionary therapies like the PCSK9 inhibitors. The first one was approved back in 2015. Actually, the first two were approved back in 2015. And they'll lower the LDL and additional 50% On top of whatever you're currently taking. And so it's really been such a revolution Fred between the 1980s where if somebody had either heterozygous or homozygous FH, I mean, they were doomed to have an early cardiovascular event, a shortened lifespan and it's amazing now because of all of the technology and the drugs that are available, we can get most people's control to a very normal level of LDL with whether you have heterozygous the less severe form, or even now homozygous FH there are some of the Angptl3 inhibitors like evinacumab from Regeneron that lowers 50%, the LDL 50%. And that has allowed people with H O F H, who typically start with cholesterol 800 to 1000 to actually normalize their cholesterol. So it's really wonderful to see in the last 10 to 15 years, there have been an incredible advance in therapies that have made this condition, manageable if you know about it. And if you're aware, and if you actually seek treatment.

Fred Goldstein 10:18

So it really is about making people aware of the situation, providers aware. And obviously, you're at this AMCP conference, what's the purpose here.

Hilly Paige 10:25

So the purpose here really is twofold. So we want to raise awareness around Lipoprotein(a), and that part of our mission, the broader part of our mission, really, I think, is focused around better control overall of LDL cholesterol. So cardiovascular disease, as you know, is the number one killer of Americans leading cause of death. And unfortunately, for a long time, we were making great progress against cardiovascular disease. So in the 70s, the 80s, the 90s, we had all these new treatments, these new available therapies, these new procedures, and there was steady year over year decrease. And then in around 2010, we plateaued in terms of the rate of cardiovascular deaths, and the total number of cardiovascular deaths. And now, every year since 2010, that rate of cardiovascular death is actually increasing in this country. So we're losing ground in terms of something that is, in general, 80%, modifiable and preventable, cardiovascular disease. And so one of the major modifiable risk factors is LDL cholesterol. And while our population is only one in 250, and only one to 2 million, we really have the sense that a rising tide will lift all boats. So if LDL control in general gets better, it's going to get better for people with FH. And so we're very focused at these sorts of meetings on trying to improve LDL control for high risk Americans, which includes people with cardiovascular disease, people with FH, and that was the session that we had, on Tuesday afternoon was very much focused on how are we doing in terms of LDL control? How can we do better? And we had a little taste in there of lipid protein, little a and just a sense sensitize people to that as a risk factor?

Fred Goldstein 12:08

And is there any research going on around lipoprotein(a) and what maybe can be done for that?

Hilly Paige 12:14

There is let me say just one more word on on LDL, because one of the great assets of the Family Heart Foundation has is the Family Heart Database. And so we have, it's a database of medical claims and laboratory data on over 300 million Americans. So we have procedural claims, diagnosis claims, medication claims, lab values on over 130 million. So in total, we have an incredible dataset that goes from 2012 through 2021. So it's nine years worth of data, we're just importing now the 2022 and 2023 data and we looked at in the dataset to say among high risk individuals, how are we doing in terms of LDL control. So we pulled out the data from 38 million people who either have cardiovascular disease, or they have FH, or their high risk primary prevention. And it was really striking Fred, because less than a third of those individuals are actually achieving their LDL targets, according to the guidelines. And so despite all of the different therapies, we have statins and ezetimibe and they're cheap, and they're generic, we're doing a terrible job in terms of controlling LDL cholesterol. Because we have data dating back to 2012. The average follow up in this study was 60 years. And so we were able to say even if somebody gets to goal, how long do they stay at goal? What was fascinating, you would think that normally, if you achieved your goal, it's kind of like Nirvana, you would want to stay there forever. And yet, we found the average time that somebody stays a goal was less than six months, and people kind of cycle on and off therapy, they cycle above and below goal. And what was also interesting is that 80% of clinicians, never prescribed combination therapy for people who are high risk, they tend to just stick with statin monotherapy people get to the level they get to. And and so you know, it's a huge issue that we have in terms of controlling LDL, in this country. And so we're really trying to put a big educational initiative with all the stakeholders to try to move the needle on that.

Fred Goldstein 14:18

Well, that's what I was about to say. And I think you touched on a little bit, but maybe you can go a little bit deeper. How much of that was associated with practitioner behavior and with physicians are doing an ordering and how much of that might be associated with adherence from the individual side? 

Hilly Paige 14:33

Yeah, I think we're facing a tremendous amount of apathy in the space. So of course LDL cholesterol or hypercholesterolemia, like hypertension is asymptomatic. You don't know, you have it, in some ways people draw a corollary between high blood pressure and an adverse outcome like stroke in a much, much more much finer way, I think than they do in high cholesterol. So high cholesterol is kind of one that can gum up your arteries and maybe you'll increase your risk of a heart attack. But people don't necessarily draw that direct link between my cholesterol is high or my LDL is high. I'm really at risk, I need to do something about it. So there's clearly some apathy. I think the biggest challenge we face though, is if the quality measures and how we how we judge how payers and health care practitioners are doing, in terms of control is not controlled at all. So the quality measures have changed in 2016. To right now, for CMS and for NCQA. For somebody who has atherosclerotic cardiovascular disease, the quality measure is are they prescribed a statin? And are they adherence to the statin? And so it really is not LDL based? It's not? Are people actually achieving a certain 

Fred Goldstein 15:45

it's a process measure? 

Hilly Paige 15:46

It's a process measure

Fred Goldstein 15:47

Instead  of an outcome measure? 

Hilly Paige 15:49

It would be like for hypertension, I mean, the hypertension metric is less than 140 over 90 is the quality measure. If we replace that with are they on a diuretic or not. And not whether or not is the blood pressure control? That's the same kind of nonsense we've gotten to with LDL. And so that's one of the you know, we advocate for a lot of things. It's one of the things that we and we've joined a number of the professional societies to advocate with CMS and NCQA that we need to get back to where we were in the early 2000s, which was we actually had an LDL cholesterol control metric. And that will be a very helpful thing. 

Fred Goldstein 16:25

And that's something we've been pushing from the population health side for a long time. It's we got to get beyond measuring process, measure true outcomes. We have these indicators out there, grab a hold of them. Let's use, those is the measures. 

Hilly Paige 16:36

Yeah, totally agree. Totally agree.

Fred Goldstein 16:39

So where's the organization going from here? 

Hilly Paige 16:41

Well, as you mentioned, we're getting into increasingly to lipoprotein(a). So the population of FH people in the US is one to 2 million. The number of people who have a high level of lipoprotein(a) is 60 million. So it's a much larger population. Our mission expanded dramatically, in 2021. But we took that on and right now there's nothing that you can do. But there are four exciting therapies that are in development right now for high levels of lipoprotein(a). And so we're working to raise awareness. And I think our community in general, is really appreciative of all of the investment that is going into the development of these products, because the each one has to have a large cardiovascular outcome trial to test this hypothesis of Yes, high LP(a)  is a marker, if it's high, it's bad, you're at increased risk for cardiovascular disease, does lowering it reduce your risk of events, because we've been burned before with the whole HDL cholesterol story

Fred Goldstein 17:43

sure

Hilly Paige 17:43

HDL looked like it was great. It's a epidemiologically very strong predictor. But when you raise it with things like niacin and CETP inhibitors, it has no impact on events. And so the all of the four companies that have drugs in development, are investing in these large 8, 10, 12 15,000 patient outcomes studies. The first will we should have data sometime late next year, from the lead compound, which is pelecarson from Novartis. And so we're excited about that. And then there are a couple that are right behind that. And so will soon I think by late next year have an answer as to whether or not lowering LP(a)  lowers risk. We certainly hope so for our community that where people have a high level of lipoprotein(a), they feel like it's a weight hanging over them. 

Fred Goldstein 18:30

Right

Hilly Paige 18:30

Because it's not much you can do about it, you can manage the other risk factors, but it's like, I feel like this sense of dread because my LP(a). And so we're excited about trying to raise awareness, encourage people to manage the other risk factors and just continue to push forward on it.

Fred Goldstein 18:51

Well, fantastic. Thanks so much for joining us really great discussion on this issue and glad we were able to raise it.

Hilly Paige 18:56

And maybe one other thing I'll say quickly is one other thing that we launched about three years ago as a care navigation center. So if there are people that are struggling either with you, we know that time in primary care is precious. Now oftentimes there's not a lot of time to explain LDL, why it's bad for you, why is  lipoprotein(a) bad for you? So there is we've launched this care navigation center right now we're up to three care navigators. One is a genetic counselor, one's a nurse practitioner and one's an expert in public health. And they're there to provide that education that support if somebody has been denied access to a therapy through prior authorization that can help navigate that they can do a referral to a specialist, you know, if you're uncomfortable or unhappy with the clinician you're currently seeing, we have a whole specialist map that they can steer you towards. And so this care navigation center has been incredibly successful. And we have, as I say, three folks who have been who've dedicated themselves to really engaging with the community and making sure that people's journey is just a better and more productive journey?

Fred Goldstein 20:01

Well, actually, I want to thank you for bringing that up. I think care navigation is near and dear to my heart, and that the Family Heart Foundation is doing that as fantastic. That's one of the key things we could be providing to patients to help them better get through our system and work through this rather complicated healthcare system we have. So thanks again, Hilly. 

Hilly Paige 20:19

Thank you, Fred. Have a great day.

Fred Goldstein 20:22

And thank you for joining us today. If you liked this show, you can find all our episodes at amcp.org/podcast on our show page at HealthcareNOWRadio.com or on your favorite listening platform by searching Healthcare NOW Radio. You can follow our show's social hashtag at #AMCPListenUp. And don't forget to share, like and follow AMCPorg on LinkedIn, Twitter, Instagram and Facebook. I'm Fred Goldstein for AMCP. Until next time,