AH068 - The Future of Health Benefits: Integrating the Power of Pharmacogenomics (PGx), with Burns Blaxall, PhD, and Caitlin Munro, PharmD

Transcript

Lightly edited for clarity.

[00:28] Justin Venneri: Hello, and a big thank you for listening to the Astonishing Healthcare podcast. We've got a great episode today to follow up on, something we discussed briefly at the end of our episode with Geneoscopy’s Andrew Barnell on episode 60. And it's also complementary to a blog that we wrote a couple of years back that I've been itching to update. And as content folks out there know, sometimes these things just get pushed down the priority ladder, and you can't get to them. So now we will!  

This one is on Pharmacogenomics, or PGx for short. Our guests are Dr. Burns Blaxall, Senior Vice President of Precision Medicine at Aranscia, and one of our Senior Clinical Program Managers here at Capital Rx, Caitlin Monroe, who oversees our Rx Helix program.  

Thank you both so much for taking the time today.

[01:10] Burns Blaxall, PhD: Thanks for having us. Looking forward to it.

[01:12] Justin Venneri: Burns, as our non-Capital Rx guest, please go first. Tell us a bit about your background at Aranscia and your role there.

[01:20] Burns Blaxall, PhD: Sure. So I've been in the precision medicine pharmacogenomics space basically for my entire scientific career. Spent a lot of time in academia using DNA and RNA profiling to identify new diagnostic and therapeutic targets. And then I transitioned over into the world of kind of implementing precision medicine for patients. And now I am here with Aranscia.  

Aranscia is a parent company and has now, as of last week, four companies. One is AccessDx, which is a pharmacogenomics testing company. For those not aware, Pharmacogenomics is the $10 word for making sure your genes match your medications.  

Then we have YouScript. YouScript just won actually last week for the second time, the PharmTech MedTech Breakthrough Award for the best software available for pharmacy, which looks at both pharmacogenomics as well as drug gene interactions.  

Our third company is one called 2BPrecise, and this is a tool like YouScript that can embed right into the electronic medical record that that can surface results from many different laboratories that do testing for, say, cancer or pharmacogenomics, and then can provide some guidance for patients there.  

And then the fourth is a company called Spesana, founded by Carla Balch, who's been in the health tech space for quite some time. And they have a lot of tools, again, for kind of guiding people down the precision medicine pathway, as well as some other tools that we could talk about if we have time.  

So we're really excited to have all of them and excited to be here.

[02:51] Justin Venneri: That's awesome. And congrats on the MedTech Breakthrough Award. We just got one of those in the InsurTech category for Judi Health™, so we're pumped about that.

[02:59] Burns Blaxall, PhD: So you asked about my role there. My role as Senior Vice President, Precision Medicine is to really help guide implementation of our tools with our partners, whether that be health Systems, individual providers, PBMs, or payers, or employers. And fortunately, the tools that we have in our warehouse under Aranscia are all tools that I had utilized previously in a health system to implement. So I'm really excited to be able to help others do the same.

[03:27] Justin Venneri: Cait, same question to you. Please, to start off, give us a minute on your background and your path to Capital Rx and your role here.

[03:33] Caitlin Munro, PharmD: For sure. Yep. So I received my Doctor of Pharmacy from Ohio Northern University, and that's kind of where I discovered my passion just for how pharmacists can make a real difference, especially through PGx, or pharmacogenomics.  

Prior to Capital Rx, I worked as a pharmacist in a number of care settings. So think community pharmacy, hospital, psychiatry, various areas there. And then when I made my jump over to Capital Rx, I really did so when I learned about how they were leveraging pharmacists like myself along with Judi®, just to help improve how patients are cared for and then also delivering on that mission to improve our healthcare infrastructure. So got really excited about that.  

And as a programs manager here, I work to make care delivery a success. I think this is huge on what we're doing and what Judi's able to do, especially when it comes to improving access to clinical programs like Rx Helix. And I know we'll talk a little bit more about that today. So thanks for having me on.

[04:30] Justin Venneri: Yep. And thanks for being here. So, Burns, back to you. I'm really interested in, you called it the $10 word -- I like that.  

So the $10 word. If someone asks you what pharmacogenomics is and precision medicine, explain to me like I'm five, making sure genes and your medication match. What goes into that?

[04:51] Burns Blaxall, PhD: Yeah, sure. Great question. So specifically, pharmacogenomics is ensuring that the medications you take match well with the genes you have in your body that you've inherited from your parents.  

So it turns out that in many global studies, it's been found that greater than 99% of people have at least one variant in their DNA that would impact the way they process or respond to a medication. So learning about that before you take that medication could be incredibly valuable to reduce this trial-and-error prescribing that is so commonplace in our medical practice.  

Precision medicine is a little bit more broad than that, but it again, is utilizing all of the clinical data, in addition to genetic and spontaneous mutation, or what's called somatic testing, to guide therapy decisions for patients. Largely, precision medicine has been advanced most in cancer, but it certainly applies in many other fields as well.  

So precision medicine is really making sure that we use all the data that is available to us, including genetics, to ensure that the patient is getting the best possible treatment currently available.

[06:03] Justin Venneri: Got it. And about how many drugs out there have pharmacogenomics in their labeling now? How has that grown? I remember when I wrote the blog a couple years ago, I was looking at it and it was striking to see how many more, year over year, had it and which categories were dominating that or benefiting most from it.

[06:20] Burns Blaxall, PhD: Yeah, it's an interesting question.  

So essentially every disease category almost has at least one drug therapy for which there's pharmacogenomic labeling. The FDA has a list, depending on how you look at it, it's anywhere from 140 to over 200 different medications. But there is at least recommendations or suggestions on the label to say there may be a pharmacogenomic interaction with this, and it's something to consider.  

Different areas of the world have different views on what you should test for and what you shouldn't. But in general, we try to follow FDA guidelines. Then there's an international body called the Clinical Pharmacogenomics Implementation Consortium, or CPIC, and those tend to be very high level of evidence. They review a lot of data, we review a lot of data to then come up with the guidelines that we provide.

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[07:13] Justin Venneri: Okay, and can you give us a couple of examples or some detail on specific categories where maybe there's a greater concentration of drugs that have a potential pharmacogenomic label or benefit?

[07:25] Burns Blaxall, PhD: Yeah. So there are - back to our lab, our AccessDx lab, we have a pretty comprehensive panel; it's the broadest available on the market today - 37 different genes with over 120 variants across those genes that impact a variety of different medications, over 120 with CPIC and FDA guidance.  

So big categories in this, probably the largest right now is behavioral health.

[07:50] Justin Venneri: Interesting. Okay.

[07:51] Burns Blaxall, PhD: So very sadly, about 40% of patients fail their first antidepressant. And often that can largely be attributable to a genetic variant that renders them unable to benefit appropriately from the medication at standard dosing. So behavioral health is a big one. There's a lot in cardiology and oncology, in gastrointestinal reflux medications, or nausea, pain, et cetera. It really is across all categories.

[08:21] Justin Venneri: Okay. Cait, I think people in general are aware of the potential for precision medicine and pharmacogenomics within that to help improve the patient experience and outcomes. Why hasn't this taken off? It seems like it's such an intuitive solution, something we've been talking about for years.

[08:38] Caitlin Munro, PharmD: Yeah, I definitely want Burns to weigh in here as well. But from a pharmacist’s perspective, I think it's really a mixed bag of reasons.  

Big thing that comes to my mind is access to PGx testing. It could be tricky. It's oftentimes expensive. It's confusing for some to just navigate all of the testing companies and options that are out there, not knowing what questions to ask about the panel that they're wanting to obtain. And that's just to get a test right. That's not any of the additional support that might be needed once those results come back.  

So, there's been progress over the years, for sure. I do think it's crucial, though, to just continue bridging the educational and the operational gaps, to not just get prescribers and patients to understand their PGx test results, but to understand the value and also to have access to these results when it matters most. I think those are two reasons that really come to my mind.  

Burns? I don't know, do you have anything?

[09:32] Burns Blaxall, PhD: Yeah, there's. I think a lot of things stand in the way. There was a great editorial published in The Lancet about four or five years ago now, and it basically said we have all these great tools like pharmacogenomics and cancer-specific testing. And yet when they surveyed, they found that 15% of the patients who should get a cancer specific test, genetic test, to guide their therapy were actually getting it. So it really comes down to implementation awareness.  

Let's be honest, the vast majority of physicians who trained more than 10 to 15 years ago probably haven't really heard much of this. So it's something new for them. There's the barriers that Cait spoke of. There's coverage barriers. A lot of commercial payers are not necessarily covering this, and if we have time in the podcast, we can talk about the work that we and others are doing to try and advocate for this.  

And then there's guidelines. So in general, people don't adopt things until there's either lawsuits or guidelines. And so far, there are very minimal, you know, major medical bodies that have advocated for guidelines for broad pharmacogenomic testing. Recently, the National Comprehensive Cancer Network listed one medication for which the physician should discuss pharmacogenomics with their patients. So, I think we have a long way to go on the implementation side as well.  

Another thing that I think is important for many patients is the use of their genetic information to guide their care. And there's been a lot of worry about that in the past. Turns out, actually a good friend of mine, Louise Slaughter, wrote what is called the Genetic Information Nondiscrimination Act, which was passed, and it protects any patient from their medical information and their genetics to be used to discriminate against their healthcare. And so there is protection for any sort of testing that is done. There's no impact on your future care, and it provides a lot of opportunity for benefit.  

And if I could, I'll just give a patient example that we use. We've been advocating for quite some time for what's called the Right Drug Dose Now Act. We introduced that first in 2022 with Representatives Swalwell and Emmer, a bipartisan bill. And actually our testimony for that was a fun patient example. It was actually the Chief Nursing Officer at the hospital where I was working at the time who had randomized to a trial we had. And sometimes we think of really big things like avoiding death with pharmacogenomics or this kind of precision medicine. But her story was on its face, you would call it simple. She had 12 years of really bad gastroesophageal reflux. She had seen three specialists, gotten scoped four times, had tried six different medications at standard doses, had no relief of symptoms, had this sleep sitting up bed, completely changed her diet, still no alleviation of symptoms, had them for 12 years almost daily. And after one pharmacogenomic test consultation with a pharmacist, we optimized her medications. Two days later, no symptoms. And she hasn't had any since then.

And so this was the testimony in Congress of why can't we please have coverage for this incredibly beneficial test? So in her case, if you imagine just the clinical impact, the lifestyle impact on her, and the fiscal impact, because 12 years of trying all these different medications, seeing all these physicians that could be prevented with a very low cost, one-time pharmacogenomic test could be really beneficial.  

So I really hope that our advocacy will work, and we can talk more about that later in the podcast.

[13:11] Justin Venneri: Yeah, it makes a ton of sense. That example is a great one. The behavioral health aspect of it. Trial and failure for depression. Obviously the costs associated with the time it takes to find the right medication seems like a no brainer. Yet there's still this friction in wider adoption, working it into the guidelines. Can you explain, Burns, a little bit about the quality and rigor at YouScript? You mentioned the panel. How does this work in practice?

[13:37] Burns Blaxall, PhD: Sure, absolutely. So YouScript, as we mentioned, has won a number of awards for its innovative approach to optimizing medication management. So what we can do is ingest the results from any pharmacogenomic testing lab; our partner lab is AccessDx. Anyone who tests with them, their results pour right into YouScript. And it's a really great tool both on the before and the after testing side.  

So on the before testing side, we have something called our pharmacogenomic interaction probability score. Bunch of big words, but basically it is math that we have published and validated in over 36,000 patients that demonstrates that if we know a patient's medications through these FDA and CPIC guidelines, we know the genes that impact those medications, and then we also in population studies know the prevalence of variants in those genes, we can develop a probability score, the likelihood that we would change a medication that a patient is currently taking if we were to do pharmacogenomics. And we have validated that probability score retrospectively in 100,000 patients, where we showed that that score could predict an ER visit or a hospitalization better than hypertension, diabetes, kidney failure, heart failure, et cetera. So it's a really robust tool for either individual patient or population level identification of who should be tested based on their current medications.  

Reference Links

• Validation of Pharmacogenomic Interaction Probability (PIP) Scores in Predicting Drug–Gene, Drug–Drug–Gene, and Drug–Gene–Gene Interaction Risks in a Large Patient Population‍
• ‍Crenshaw and Swalwell Introduce Bipartisan Legislation to Prevent Adverse Drug Events

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So this is a really great kind of a priori tool. And then after testing it brings in all the data - and even before testing it looks at drug-drug interactions. So there are other tools available that many pharmacists use. They look at binary drug-drug interactions. YouScript incorporates all the current medications and looks at multiplex interactions among drugs and can then provide recommendations. And furthermore, after the testing, it will also incorporate the pharmacogenomics and identify the medications that aren't currently working either with the genetics or the other drugs in the milieu.  

And then it provides opportunities for suggestions of medications that the provider, the pharmacist could choose that would better work with their current medications. And this is all validated with over 19,000 peer reviewed publications. That number grows every month. So it's an incredibly powerful tool to help optimize medications in a very easy way. And so that's how we're trying to play with you all in optimizing medications for your patients and your members.

[16:14] Justin Venneri: Yeah, we see all the time the real-time nature of pharmacy claims. It's a very good indicator that there's something going on with a patient and it's a very good predictor of what could happen in the future, right?

[16:25] Burns Blaxall, PhD: Absolutely.

[16:26] Justin Venneri: Cait: Rx Helix and Judi. How are we trying to help with Dr. Blaxall and his team? What are we trying to pull together, and what do you think the future state could look like?

[16:37] Caitlin Munro, PharmD: So through Rx Helix we're really trying to solve for a few things, and I've touched on them a little bit, but we're really giving plan sponsors the option to help increase access to this PGx testing and the related services we're providing.  

So patients that Judi identifies as needing testing based on the medications that they've been filling or they're refilling, it's giving those individuals the option to take advantage of this level of support. Also, too, because our dedicated team of PGx trained pharmacists here at Capital Rx, because they're on stand standby through this high-touch program, they are helping patients and these prescribers better understand results and really how to take action on them. And I think this is really key to helping see those improved outcomes and the reduction in total cost of care that we want to see, right? So I think those are two things that we are solving for right now.  

I think looking ahead, the more we can integrate PGx within Judi, I think that will help close some of the gaps that we're still seeing out there today. So, meaning if Judi can notify a pharmacy about a drug gene interaction before that medication gets dispensed, then imagine the potential avoidance, right? That could be costly. It could be an adverse drug event, it could be a chronic condition that's just not being treated the way it should be.  

So we're definitely looking forward to what the future holds there.

[17:54] Justin Venneri: And do our platforms, because they're -- I'm assuming, Burns, yours is an open platform data exchange, pretty efficient as well. And Judi's obviously an open platform. So is that kind of how it's intended to work, is in seamless, real-time integration between and everybody can see what's going On.

[18:09] Burns Blaxall, PhD: Yeah. And that's the way it's designed with what are called API calls that in between us to make sure everyone's got the information.

[18:15] Justin Venneri: That's great. Okay. Dollars and cents question, how much does PGx generally cost? Burns, you want to take that first?

[18:22] Burns Blaxall, PhD: So right now there are what are called local coverage determinations that if the testing is done within one of these LCDs for Medicare or Medicaid, it will be covered as a benefit as long as you have either two suspected drugs or genes, which is in general true for most patients. So if done in the appropriate manner for Medicare and Medicaid, it's covered as a Medicare/Medicaid benefit.  

There are some commercial payers that will cover distinct types of genes or panels. But the American Cancer Society Cancer Action Network, ACS CAN, is really strongly advocating for what's called biomarker coverage. And they now have legislation that they have helped drive forward in 21 states where there is mandated coverage for biomarkers. This guarantees again from Medicaid, but then also is intended to force payers, commercial payers, to cover this. Not always easy to get that coverage because you go through these denials that you then try to negotiate or navigate. But for a patient who wants to do kind of a direct-to-consumer test, there are in general opportunities to do that for between $250 and $350. Or if they're really fortunate, they're part of a member benefit program like Rx Helix.

[19:42] Justin Venneri: Right.

[19:42] Burns Blaxall, PhD: That's covered for them.

[19:44] Justin Venneri: Cait, how does that work through the pharmacy benefit?  

[19:47] Caitlin Munro, PharmD: Rx Helix is offered at a fraction of the cost that health plans would otherwise incur if that test was billed as part of the medical benefit. So, I think that's a huge deal in terms of promoting access to this testing. And we're also including those wraparound clinical services, right? So it's not just the test, it's not just the panel that we care about. It's also what are we going to do about those results and see the change we want?  

So it's just one of the value adds of having it through that pharmacy benefit instead.

[20:14] Justin Venneri: Okay, I just had two more questions for you two. Thank you for spending time with us today. Burns, first one. You guys are sitting on top of four companies and used to do a bunch of work in my old life on genetic testing companies. And I vividly recall consolidation, M&A, Grail and the big guys, Garden. What's the landscape like right now in terms of M&A and what's going on in the space?

[20:38] Burns Blaxall, PhD: Yeah. So I'm going to go back a few years to around 2018, 2019, where there were a lot of labs popping up offering pharmacogenomics and they weren't necessarily validated and providing clinical guidance without validation. And so the FDA really cracked down and tried to limit them.  

It's starting to open up a little bit again now. But I think we're in a phase right now of market consolidation. So there are some acquisitions either in discussions or happening between these different labs. I think that we'll get down to a small number of larger companies than what is the current landscape. We're very proud to be the best of the best in the testing and the clinical decision support space. So I think we'll see a little bit more consolidation before things really settle out.  

You know, the real question with limited adoption is the value proposition. And so I think that's why some people are struggling along the way. And again, with what we offer in our business model, I think we're excited to be partnered again with you and with many others to drive this forward to really democratize the adoption of precision medicine for all.

[21:43] Justin Venneri: And last question. So, Burns, I'll stick with you first. What is the most astonishing, surprising, or interesting thing you've seen related to PGx? I'm sure you've seen a lot over your career, but something definitely safe, compliant, to share is what I'm looking for.

[21:58] Burns Blaxall, PhD: So I'm actually going to advocate for one thing. Pharmacists get a lot of training on medication management. And I love the idea of having a pharmacist embedded in the care team because they can communicate with providers across the care team to ensure that we're trying to optimize medication management across all the specialists who may or may not be communicating.  

We had a personal example where we embedded a pharmacist in testing prior to elective total hip or knee replacement surgery. And that reduced unanticipated revisits and hospitalizations by anywhere from 40% to 70%. And just by having the pharmacist helping guide the prescribing after the surgery helped reduce opioid prescribing by over 40%. So I think that was exciting.  

Probably one thing that's helpful for the listeners to know is that there are a growing number of lawsuits in this space that are going to help people pay attention. I'll talk about two very briefly.  

One was a medication called Clopidogrel, which is given quite often after a patient's had a heart attack. And it turns out that a much higher percentage, Asian and Pacific Islanders, have a variant in the gene that activates that medication once it's taken in the body. It needs to be activated by an enzyme. And it was the state of Hawaii just finalized a successful lawsuit for *$700 million against the makers of Plavix because the Asians and Pacific Islanders in the population were coming back with twice as many heart attacks while taking this drug as their Caucasian counterparts because they had this variant in the gene that they should have been recommended for pharmacogenomic testing.  

And then another brief example is a lawsuit that came against the Oregon Health Sciences University where a patient was given a very common gastrointestinal drug, 5 Fluorouracil, or Capecitabine, which is commonly given for prevention of recurrence in gastrointestinal cancers. And there are a small percentage of Caucasians and a broader percentage of other ethnicities that have a variant in the gene that breaks this down. So when you take a dose of that, it accumulates and ultimately patients have very bad symptoms or even die, and this patient passed away. And so a lawsuit that has ultimately led to the legislation we talked about, where NCCN is pushing for this, but right now has in their guidelines a recommendation for testing.

[24:22] Justin Venneri: It just occurred to me that having this information at the doctor's fingertips at the point of prescribing, so at the point of care in their office, would be -- and I feel like people have been working on this for over a decade, right? How to filter this in? I mean, is that the ultimate holy grail here? Where I'm about to write this med, the data's all in the system for the patient, it's a value-based world,  boom -- I know not to prescribe you drug XYZ because it's not going to metabolize. Your body's not going to handle it. But if I write you ABC, that's the one you're most likely to respond to.

[24:54] Burns Blaxall, PhD: I really do think having it at their fingertips with a decision support tool like YouScript is incredibly valuable. But again, there needs to be guidelines and lawsuits and legislation that drive adoption.  

Because let's just imagine being a primary care physician. You have 12 minutes to ask about a thousand questions about all the preventative care and do all of this work. So having something as a decision support tool at your fingertips will be very helpful. But then also having guidelines can really ensure that that's how we drive things like mammograms and colonoscopies. And hopefully that'll happen for pharmacogenomics as well.

[25:33] Justin Venneri: Agreed. Okay. And Cait, how about you? Tell us a good story to send us off here. What's the most astonishing or surprising thing you've seen related to our discussion today that's safe to share?

[25:41] Caitlin Munro, PharmD: Well, it's, it's funny that Burns touched on Plavix because I actually got an opportunity to, to see a real-life patient scenario involving that medication. And so, what was going on is the patient was actually adherent to the drug, right? But having a repeat history of cardiovascular issues. And so the doctor was even doubling up the dose of this medication to help keep that patient safe. And so, you know, luckily we had access to the results, the PGx test results. And so I just kind of thought to myself, wow, imagine taking a sugar pill to prevent another stroke or a heart attack. I mean, there's no amount of dose increase that's really going to make this drug work for this patient.  

So we were able to make the changes we needed to, but it just got me excited about the potential here, tying everything together and just seeing how much of a positive impact that we really can make. So thanks for having us on, Justin.

[26:30] Justin Venneri: Yeah, that's a good one. Thank you both for joining us today. Hope you have a great rest of your day.

[26:34] Burns Blaxall, PhD: It's been a pleasure. Thank you.

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