Speaker 1: 0:00

In light of CAA and all the new fiduciary responsibilities, how can plans solve the problem of over-medication and mediocre patient experiences and worse patient outcomes, because those cost money? We'll find out on this episode of Shift Shapers.

Speaker 2: 0:19

This is the Shift Shapers podcast connecting benefits advisors with thought leaders and entrepreneurs who are shaping the shifts Shapers podcast Connecting benefits advisors with thought leaders and entrepreneurs who are shaping the shifts in the industry. And now here's your host, david Saltzman.

Speaker 1: 0:33

And to help us answer that question, we've invited Mark Smith. Mark is founder and CEO of Avalon Behavioral Health Solutions. Welcome, mark, thanks for being here. Thanks, david, good morning. Good morning, give us a little bit of background about your journey. How'd you get to be doing what you're doing? I know you've had kind of a long and circuitous path, as have most of us, so just a little background on you.

Speaker 2: 0:52

Sure, I'll make it relevant to your audience. Most of my professional career was in human resources. I had a generalist job with Pfizer. I had a very intense labor job with the Pepsi-Cola company and then I ended up as the head of HR for Blockbuster Entertainment back when we all rented videos and DVDs there. My relevant experiences I assembled and ran a large self-insured plan, so I have experience on the buyer side of working with TPAs, pbms, stop-loss carriers, benefit brokers. Returned back to my hometown, got involved in children's behavioral health, again being as quick as possible. That got me into the world of genetics. Once I entered the world of genetics because of the genotype of a lot of conditions like autism once I got involved in genetics I became exposed to what I do today. I'm exposed to what I do today and that is using pharmacogenomics as a clinical intervention to help any demographic to drive better health and lower pharmaceutical consumption.

Speaker 1: 1:54

And that's a subject that's come up more and more recently. You know we had Lena Chihorsky on a couple of episodes ago and you know we started talking about it maybe three years ago or four years ago and it was very rare and very expensive and whatnot, and so it's nice to see that it's getting a little more mainstreamed and we'll talk about that more. But first I want to assure you of something Given your Blockbuster background, I will rewind this when we get done, I promise.

Speaker 2: 2:20

Remember, Blockbuster was a dinosaur. It doesn't exist anymore.

Speaker 1: 2:23

I think there's like one more Blockbuster isn't there out in the Midwest someplace?

Speaker 2: 2:32

I think there's a franchisee out in Alaska that just I don't know if that's a reflection on their business acumen or a reflection on the culture of Alaska.

Speaker 1: 2:37

Or maybe some of each, who knows, but you know. So let's talk about the problem and start at 10,000 feet for the audience and tell us what the problem is that you're working on and that you're trying to solve.

Speaker 2: 2:49

Sure, there's probably two legs to the problem. One leg is just the over medication of our society. Every demographic, whether it's kids, whether it's adults, whether it's seniors, we're all taking too many pills. Seniors, we're all taking too many pills. And the driver behind that is really the reimbursement incentives, both for pharma and, unfortunately, in the world that we live in and your audience lives in the PBMs, there's an incentive to push more medication as opposed to let's focus on the clinically appropriate medication for an individual, even if that means lowering consumption.

Speaker 1: 3:27

So how big a problem is it, and is it confined to certain medical segments? Is this like strictly a cancer thing, or is it broader than that? Define for us kind of how deep this problem is and how wide it is it transcends every drug class.

Speaker 2: 3:41

So you know, you mentioned the oncology drug classes. We over-medicate in cardiac, we over-medicate in behavioral health. So think about individuals that are on your anti-anxieties, antidepressants, antipsychotics Again, all ages. We over-medicate in pediatrics. We over-medicate in primary care. We over-medicate in geriatrics. So there isn't a niche that I can say needs attention. It's really a systemic problem.

Speaker 1: 4:07

So, given that the scope is pretty pervasive, where do you start? Where did PGX, which is everybody's favorite abbreviation for pharmacogenetics? Where did that start and what's been the history of that?

Speaker 2: 4:18

I became aware of it in about 2010, when I was working on genetics in the autism area and I deal with a number of very large national labs, and at that point I would probably describe PGX as somewhat of a boutique science. At that point, none of the large labs had gotten involved yet, and in 2010, the efficacy of the test had some questions to it. The price points you mentioned earlier, david, they were crazy. And the application theory was that there's kind of this test, everyone idea, and that's like give everybody a med. I mean, you don't apply a clinical hammer to everybody, you only apply it to those that need it. And at that point everybody didn't care, because I was in the middle of my autism genetic journey.

Speaker 2: 5:06

But in 2018, the labs that I deal with in autism began to develop and launch their own PGX tests. So, just by example, mayo Clinic spun out a lab called One Ohm. Cleveland Clinic developed their own PGX test. Mount Sinai spun out a lab called Semaphore. So that caused me to start to talk to my lab directors that I knew from my autism work about hey guys, what's going on here? And I was convinced that number one the efficacy was going to be airtight, because these are institutions that will only put out solid science, that there had to be a business model there, because these labs are going to create and launch a test to generate revenue, and so I was convinced by my lab directors that one day, pgx would be standard of care. So I formed Avalon in 2018 to be part of that journey, to be one of the classic earliest adopters to help drive PGX to standard of care.

Speaker 1: 6:07

So for those listeners who maybe aren't familiar with PGX, can you talk about kind of what it is and how it works?

Speaker 2: 6:15

Yeah, the easiest way to. I'm a lay person, I'm obviously not a clinician, I've got a business background. The easiest way to describe it is it's a test that looks at your metabolism of various meds. So, metabolically, how do you metabolize the med? Do you metabolize it at all? Are you a slow metabolizer? Are you a rapid metabolizer? And all those interactions with the meds are obviously going to have an effect on the clinical result. And then it also looks at the way drugs interact with each other and the way genes interact with drugs. So in PGX we talk about drug-drug interactions, gene-gene interactions and gene-drug interactions. So it's a genetic test that lays out that personalized roadmap for every individual.

Speaker 1: 6:57

Can you give us a practical example?

Speaker 2: 7:00

The best for the layperson because this is easy to share with others as you're making decisions is the blood thinner, the cardiac med. The brand name is Plavix. The generic name is Clopidogrel. If you have a clotting problem, plavix slash.

Speaker 2: 7:16

Clopidogrel is the number one prescribed med in the country. At the PGX level. At the genetic level, 30% of the individuals in the population either do not metabolize Plavix at all or inefficiently metabolize Plavix. So you end up with a situation where you're taking a med to prevent a stroke, but 30% of the population are very likely to still have that stroke. So when you talk about better health and number two, an ROI Plavix is the greatest example because if I can prevent a stroke by running a test that is $150 to $200, I've not only saved potentially $100,000, but have also saved on the long-term care post-stroke and also the human toll of having a stroke. In our world that employee after a stroke is not who they were before. So Plavix slash Clopidogrel is a perfect example of spending relatively small money on a PGX test to prevent a huge expense and a tragic expense.

Speaker 1: 8:21

And if you don't metabolize the Plavix at all or if you're a slow metabolizer, the doctors switch you to a different therapy.

Speaker 2: 8:28

That's what PGX will target for the doctor. So the doctor, should they run a PGX report on their patient, the doctor would get the results that says your patient is either a non-metabolizer or a rapid metabolizer, which isn't good, or a rapid metabolizer, which isn't good, or a slow metabolizer, which isn't good. Then the doctor would have to switch to a medication that is more effective and more clinically sound, because the goal is to prevent the stroke. And in that case what we offer up is a telemedicine platform with PharmDs, doctors of pharmacy training PGX that can help your doctor go through what I call, as a layman, the. Now what question? My patient's not metabolizing Plavix. Now what?

Speaker 1: 9:10

Are there certain conditions where it actually makes sense to run the test before the initial prescription is done?

Speaker 2: 9:14

I would say, as we go forward, we hit standard of care, probably any medication. I talk with a lot of labs, obviously, and my one lab director said how do you know you metabolize aspirin appropriately? Well, you don't. But really, in today's world it's going to be the specialty meds, the very, very high-end, expensive meds, particularly if the world starts to move more to value-based care for pharma. So hey, before I put this quarter of a million dollar oncology infusion med into this patient's arm, I probably want to know that it's going to be effective.

Speaker 1: 9:50

Do you foresee a time when all of us will have as part of our electronic medical records some kind of a baseline score for each of us? Like some people go in business, they use the Colby test to determine how people work, or Myers Briggs for personality or whatever. Is it possible that as we go down the road we'll just have that as part of our record so the doctor can refer to it? Or is it drug specific?

Speaker 2: 10:13

That's the ideal I often say. I'm a father of five, so I've been through five deliveries and part of the delivery process of the Apgar test, where the nurse checks the baby for vitality. The Pollyanna side of me says why aren't we taking some cheek cells from that baby at birth to run their pharmacogenomics test? And in the ideal world of seamless, interoperable health information records that just follows the baby from birth till death, we're not there, obviously. So really it's going to be kind of the one at a time or the one employer at a time.

Speaker 2: 10:45

I ran a pharmacogenomics test on my 17-year-old son. Because he's a travel soccer player and has had several orthopedic events, I wanted to make sure he was on the right pain medication. Well, he now has in his cell phone his PGX profile for the rest of his life so as he ages and goes through different clinical conditions, he can share with his doctor. In the moment, at the point of prescribing, hey, this med will or will not work for me, so we can get there. The infrastructure is there to get there. It's really an adoption challenge.

Speaker 1: 11:19

All right, so let's talk about adoption for a moment. A lot of the folks listening to the podcast deal with self-funded plans. If I'm an employer and I'm looking at my claims spend and I've already gone through my entire box of tissues, how do I go about implementing this? Is it something that I just talk to my broker about and say, hey, go find me a company that does this and we'll scrape the top 10% of claims? Or the people with chronic or multiple chronic conditions? How does that work practically in the field?

Speaker 2: 11:47

Really like the CAA. The employer probably has very little or no knowledge at this point. So it's going to take the broker community to really spread the word, or even what we call the transparent PBM community, and we can debate the word transparent. But the way to get the employers is not directly to them by individuals like myself. The ideal way to get to them is through a trusted relationship that they already have, either with a PBM or with a broker. The way my process starts as I enter a new account is we look at data and the data could be electronic health record data and hospital systems. So we're looking at the patients of a given hospital and there we're interrogating a SIR and EPIC and all scripts. For a large self-insured employer. It's the PBM data, it's the drug consumption data. So if we can get two years of claims data, we can interrogate that with a risk stratification engine and we're going to find those employees that are taking medications that have a history of contraindication. One combined have a history of toxicity, one combined have a low metabolic rate, like my Plavix example. You're an employer of a thousand employees. Well, we'll say a,000 total, being an employee's independence, we harvest or interrogate your claims database and we find 10 Plavix users. Well, that risk algorithm is going to trigger right away. Plavix is a single trigger for algorithm versus some of the combinations and contraindications.

Speaker 2: 13:19

So we're going to say to that I'm going to use titles, david, I apologize. We're going to say to that CFO, you need to test these 10 people. Well, why do I? Well, three of them are at risk for a stroke. Yeah, but why would I test all 10 of them? Well, if I can get you a test for $150, you're going to spend $1,500 to test the 10. You're going to tell seven of them good news, you're on the right med, you're on the right clinical path. You're going to tell three you're not the employer. The data never goes to the employer, so let me be careful with my language. We're going to tell the employee's doctor for three of them they're on the wrong med. You need to call the PharmDs and adjust their meds. So, at the end of the day, you prevented three $100,000 strokes by spending $1,500.

Speaker 1: 14:05

So two questions come to mind. The first is okay, I'm a savvy consumer. I say you know what the hell with my plan? I don't want to wait for them to do that. I want to go out and get a test that I can put in my medical records, as you did for your son. Is that something that the average human being can just do?

Speaker 2: 14:24

They're not prevalent yet, but there are ways to get what we would call a direct-to-consumer a DTC pharmacogenomics test. The hesitance that I have there, Dave, is it's not like 23andMe You're not getting a test that says you're 22% finished. You're getting a test that really focuses on your health. So let's keep going back to Plavix. I apologize for that, but it's easy. So I'm a Plavix consumer. I have a clotting condition, I run a DTC and it says I'm a non-metabolizer. Well, do I then just make the decision to stop taking it or do I consult with my doctor? My concern is, if there's not a clinician involved a doctor, a PharmD that patients will react to their PGX tests in ways that are not in the interest of their health PGX tests in ways that are not in the interest of their health.

Speaker 1: 15:15

That's fair. So that leads to my second question, which is are doctors aware of this and is this becoming part of their normal practice protocol?

Speaker 2: 15:23

If you would have asked me that in 18, I would have said no. I would say the adoption curve in the medical community is creeping upwards. It's obviously not even close to where. If I was to call 10 MDs just randomly today, I would probably have and I mean this literally, I probably have one who's aware of it and may has written a script. But no, the knowledge within the medical community is very, very thin right now and that's why this is it's not direct to consumer in the literal sense, but it's direct to consumer in the and if you can get individuals talking to their doctors about it, their neighbors or family members or anyone that they touch during the day, this is going to be a ground, a bottom-up adoption mission.

Speaker 1: 16:10

How do you see that curve going time-wise? It's funny.

Speaker 2: 16:13

I look back because I've been in genetics for a while. I look back on the development of, or the adoption of, brca1 and BRCA2, which is the hereditary breast cancer test that Myriad launched in 2001. It wasn't until, I'll safely say, about 2015 that we had full adoption. By full adoption, I mean patients were aware of it. So everybody knew that there was a genetic test out there. Payers were aware of it, providers were aware of it In the world of CMS, medicare, medicaid, the bureaucrats, the politicians were aware of it. That's where we need to go with PGX. But again, I think it's going to be bottom up. We have to get individuals talking about it, whether it be employees, whether it be residents of a long-term care facility.

Speaker 1: 17:00

Will Medicare pay for this test?

Speaker 2: 17:02

Medicare pays for PGX for two classes of meds for individuals that are on cardiac meds and for individuals that are on behavioral health meds meds. Now, the good news is the reimbursement rate is such that my labs can run a full panel, and by a full panel I mean today they can report out on about 350 meds. So it's going to go beyond cardiac and behavioral health. It's going to get into pain, it's going to get into oncology, it's going to get into gynecology, dermatology, all your allergies.

Speaker 1: 17:34

So we've got about a minute left. Where do you see the future? What does it look like near term and then a little bit longer out?

Speaker 2: 17:41

I think the near term it's going to be continued adoption by the visionary early adopters, people that are interested in two. There's two classic outcomes with PGX and I always put them in this order intentionally. There's better health If you're consuming the right number of minimal medications, you're going to be healthier and there's a savings Because at the population level, fewer meds will be consumed. So it's going to take those organizations that believe in the science, have that primary concern of taking care of their employees. You know, I think about if I could wave a magic wand. You think about Walmart and all those centers of excellence work that they're doing. They'd be a perfect early adopter for PGX because it's going to provide better employee health, better retention, better productivity. So I see the growth in the early adopters to continue to ramp up. But it's really the payer community that's got to jump into it.

Speaker 1: 18:37

And that's a great place to leave our conversation for today, but we do hope you'll come back as this gets more pervasive and becomes more a part of the day-to-day nomenclature. Mark Smith, founder and CEO of Avalon Behavioral Health Solutions. Mark, thanks so much for a fascinating interview. Thank you.

Speaker 2: 18:51

David, I look forward to coming back. The Shift Shapers podcast is a production of Shift Shapers Strategies and may not be reproduced or quoted in whole or in part without our express written permission. Copyright 2020. All rights reserved.