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Episode 26: Pharmacogenomics – First Evidence to Action

In episode 26 of GSC’s podcast, we bring back pharmacist and researcher John Papastergiou, as well as Ned Pojskic, GSC’s leader of pharmacy and health provider relations, to talk about their research project that studied the impact of pharmacogenomics testing on patient outcomes.
And now for something completely indifferent

And now for something completely indifferent

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Episode 26 Transcript

[INTRODUCTION]

[00:00:15] SM: Hello and welcome to another episode of GSCs podcast, and now for something completely indifferent where well be discussing the hottest topics and trends in Canadian health benefits. I am the producer and editor, Sarah Murphy.

Before we get started with today's episode, we would like to remind our listeners that the views expressed in this podcast are those of the individuals speaking and not necessarily the views of GSC. We may talk about possibly controversial subjects, and therefore reserve the right to potentially offend some listeners but were apologizing for it up front. You can download this podcast from our website at greenshield.ca\podcast or subscribe to it from wherever you get your podcasts.

We also encourage you to read our publications, The Inside Story, Follow the Script, and g(sc) TALK, which you can also download from our website, and please be sure to follow the conversation on Twitter and LinkedIn.

[INTRO]

[00:01:06] SM: Now, lets get started. Today's episode is hosted by David Willows, GSCs Executive Vice President of Digital Innovation and Brand Experience. Hello, David.

[00:01:16] DW: Hi, Sarah. Its our third teams-generated podcast.

[00:01:22] SM: Third or fourth. I don't know.

[00:01:24] DW: Maybe. Its been – Okay. No, youre right. We probably got –

[00:01:25] SM: I think theres been a few.

[00:01:26] DW: Yeah. No, this COVID thing is going on.

[00:01:29] SM: Its lingering.

[00:01:31] DW: The other thing were struggling here, its like were in early part of July and were in a heat wave. I got to tell you. I'm on this top floor. Ive got the door wide open, so I can get a bit of the air conditioning flowing in, but it's now reached such a level of heat over so many days where I'm sweaty and Ive never done a podcast this sweaty. It's uncomfortable.

[00:01:56] SM: Yeah, I can imagine. I always found the actual podcast recording studio that we built kind of hot. I found it was pretty sweaty in there a lot because thats a small – Well, at least, we know its a super small medical room and it was always pretty hot but also this is more –

[00:02:09] DW: Thats why 34 degrees hot.

[00:02:12] SM: Yeah. Thats unfortunate.

[00:02:13] DW: Heat coming in through the window.

[00:02:15] SM: Im on my main floor. I stayed on the main floor for this one today, so Im full air-conditioning.

[00:02:19] DW: Okay, youre good. Okay.

[00:02:20] SM: Yeah. Get up to the next floor youre very hot.

[00:02:22] DW: Okay. Lets hope our two guests are in a properly air-conditioned room when they do this. Theyre not feeling like me right now. Were bringing back a couple of old friends. They did a podcast with us a couple of years ago now when we launched this randomized controlled trial on pharmacogenomics two years in the making, 200 patients later.

One of our guests, John Papastergiou, our favorite pharmacist, has a few pharmacies in East York, and it was his patients that we ran through the trial. Our colleague, Ned Pojskic, whos our strategy leader for pharmacy benefit management services, he was one of the architects of this randomized controlled trial. I know our old friend, Peter Gove, he would assist all our podcasts, and I want to remind Peter that Ned has a PhD, and that will just drive him a little bit mad on a hot day in Kitchener-Waterloo. But that's why Ned was involved in setting up the trial.

Two years later, we have the results. We have put out a press release. Our Follow the Script newsletter has come out in the last 48 hours or so, so people might've read about it. But we thought we'd ask the two architects of this to come in and walk us through sort of what happened and the very positive and exciting results that came from it.

[INTERVIEW]

[00:03:34] DW: Welcome back, John and Ned. We talked a couple years ago now about starting this big project, and I guess to some degree weve come to an end and were starting to talk about the results of it. We have actually given our readers that subscribe to GSE publications a chance to re-listen to that just in the last couple weeks. But if they haven't, I'm going to ask you, Ned, if you can explain what our company is thinking, GSC's thinking was when we initiated this randomized controlled trial.

[00:04:06] NP: Yes. Dating back to I want to say as early as 2017, the topic of pharmacogenomics has sort of dominated I think our industry's various conferences and discussions and whatnot. There was a lot of irrational exuberance around the pharmacogenomics and huge amounts of excitement, and so we obviously wanted to make sure that were on top of that. We did a lot of investigation, understanding of wheres the research. How much support is there for pharmacogenomics?

Then at that time, I think we questioned the level of evidence that exists to support pharmacogenomics as a viable benefits plan cost management or just health improvement strategy. We felt that it was really necessary for us to sort of step in and contribute to that over literature and to look at it from the perspective of a private payer. Its a very unique lens, right? You can take many different lenses to any particular type of technology, including this.

We felt that we kind of needed to contribute to that through our lens. So we, in collaboration with John, did a study looking at the value of pharmacogenomics, right? It was an in-depth look utilizing highly effective randomized controlled trial design, again, with the perspective being that we wanted to answer some fundamental questions around the value of pharmacogenomics from a health improvement perspective. That was really the backdrop for this whole project.

[00:05:27] DW: This study and this research project actually happened in a few of your stores, and we worked with I guess over 200 of your patients. Can you tell us a bit about what's the profile of these patients were that came in? I don't want to broad brush, but can you give listeners an understanding of what we were looking for?

[00:05:46] JP: Yeah. I mean, we have very specific criteria for the study itself so that patients had to be either new or existing patients with depression or anxiety. The vast majority of patients in this demographic are kind of middle-aged. Theyre not always exactly sure of their diagnosis, but we tried to verify it as best as we could as a diagnosis of depression. But we know for a fact there were anxiety patients that fit in there as well. These are patients that were complex. Most of them tried multiple medications in the past. They had failed their medications. They had other challenges with their depression and anxiety over a course of many years, and were looking for something that would help, and I think that's what drove them into the study.

It's interesting. Even up to today, the study has been completed because we reported the study with clinicaltrials.gov, and its ended. I still get calls. These are patients that I think are really – Theyve been struggling with their condition and theyve had challenges being managed and theyre looking for something else. I think we were able to offer that. At the beginning of the trial, we weren't sure what the impact would be. We have published a previous paper that showed, Hey, yeah.” Pharmacists could use the information to intervene and intervene appropriately, but didnt have any outcome data. Thats what we wanted to show here. Complex patients, psychiatric conditions, all of them depressed or anxious that were looking for something else.

[00:07:10] DW: Right. Just to remind our listeners, what did you do with them? What was the course of treatment for these folks?

[00:07:17] JP: I think it was a very unique study design and something that you don't see done in community pharmacies in the real world pretty much ever. It's very hard to blind patients with the blind pharmacies in the front-line community setting. But what we did is we had patients come in. If they express they had some issue with their medication, so other side effects, medication wasnt working, they were bouncing around between drugs or whatnot, we would let them know about the study. Theyd fill out kind of a modified questionnaire that we created to assess if they were good candidates for the study.

Once they filled that out, if we felt they qualified and they consented, we would randomize them either to standard of care or kind of standard of care plus a pharmacogenomics test. The difference between the two obviously in the standard of care group, wed have the patients swabbed and have access to their genetic data. The placebo or standard of care group was also swabbed.

At that time, they didn't really know who was in what group. We swabbed everyone. Patients would leave. Somewhere down the line, usually anywhere between three to seven days, wed get the results back in the standard of care. Or the pharmacists would intervene as they would without any additional information, so they would do what they would do in a typical clinical setting. A pharmacogenomic pharmacist would have access to the genetic test results and then make a decision based on the results. Obviously, we have to loop the physicians in in both scenarios if were changing medications.

We could change doses in Ontario without a physician's intervention. Most of the interventions involve switching the drug, and that would involve collaboration with the physician as well.

[00:08:54] DW: A couple years ago, Im sure I asked you questions around sort of the interaction between different arms of the healthcare system and pharmacists working with physicians. Two years on when you were coming to these physicians and saying, Hey, we think we need to change in meds,” how did that go if you can generalize it?

[00:09:08] JP: Yeah. Thats a great question. Early on and my practice sites are pretty advanced practice. If the physicians in this local area, theyre used to us doing different things, genetic testing got them off guard early on. Im talking about the first study where we started doing it. They were like, What are you doing? Where are you getting this technology? Is it accurate? How does it work?” We had to do a lot of education. If Im fortunate enough, I get invited to the journal clubs of the physicians in the local area, so I try to use that time to tell them about what we're doing and kind of educate them.

Early on, there was pushback. Theyre like, Ah, whats the evidence like?”

[00:09:47] DW: Dr. Ned.

[00:09:48] JP: Yeah. Then I assured them, Listen, well take on the brunt of the work. Its not going to bother you,” because they were worried patients would be coming with these detailed reports, and they wouldnt know how to interpret them and they wouldnt have the time. I committed that we do all that work and we just send off the intervention request. Two years later, we have physicians sending patients to us. Now, they have some clinical experience with it.

We had the initial trial that had probably 200 patients. We had our trial here. Then in between, weve been doing a lot of testing as well, so weve probably seen about a thousand patients now in this area that have been tested. The local docs have had some experience with it, and I think they bought in. Its not for everyone obviously. But in those more complex patients that have had some challenges I think, they see the value in it now and I think our results show the value as well.

[00:10:36] DW: Let me ask this question. Can doctors refuse to take your suggestion here and do they?

[00:10:41] JP: Yeah, sure. They can refuse when you're making an intervention in Ontario. We actually have the pharmaceutical opinion program, and that program was created where a pharmacist could make a recommendation to a physician and get reimbursed for it. They get reimbursed $15, if the physician accepts it or rejects it. That funding was there for that. So I think physicians are used to us making interventions.

What we did see in our first study is when armed with pharmacogenetic data or a report, physicians are more likely to accept the recommendation, and we saw that same trend in a randomized trial as well. It seems when the pharmacist has something to support their intervention, theyre more likely to get it accepted. What does that mean? The acceptance rate of the trial was very high. It was over kind of 80%. I think that's because we chase them down a lot too.

Its not like the physicians are saying, Hey, no. Im not going to accept your recommendation.” Usually, what happens is you don't get a response, and the average pharmacist is not going to take the time to kind of hunt them down and get a response. But in the study, we really took time to do that. Hey, we sent you this. Are you going to respond when we sent you this? Worst-case scenario, [inaudible 00:11:45] the patient after them as well to see if we could get that intervention accepted.

Does that happen exactly like that in the real world? It depends on the pharmacy I guess. But we do know now in two studies that, hey, if youre armed with this type of information, the physicians are more likely to accept the recommendation.

[00:12:01] DW: Okay. Its great to hear that in your neighborhood that physicians are now sort of tuned into this. Is it right to say that East York is the epicenter of pharmacogenomics in Canada probably?

[00:12:12] JP: I would say in the world. [inaudible 00:12:14]. I think I've had the opportunity to present this data prior to the pandemic in Europe and in Dubai, and I think were being viewed now as kind of one of those hotspots for pharmacogenomic testing on the real world. I think hospitals were doing it to some extent. What differs in this situation, were able to offer it across a broad range of therapeutic areas. We focused on depression and anxiety because we had the skills in the randomized trial.

But really, were offering it to patients with GI issues, cardiovascular issues. Its a really broad group of patients that could potentially benefit. Yeah, we become in a way experts in this field, which is cool because there is a movement towards pharmacogenomics globally and in Europe. It's kind of I think even a little bit further along than we are here, so this data is going to be I think received very positively. When I did show it the first time ever globally was in Dubai. It was the keynote, and we had probably a thousand people in the audience, and it was a packed house just kind of to see our results. It was exciting to see that.

[00:13:11] DW: Ned, why dont we talk a bit about those results and if you can summarize them for us. I know we put out a press release. We put out a publication. But in sort of lay peoples terms, what did we find at the end of the day?

[00:13:23] NP: In many ways it was – John mentioned the skepticism with probably sort of heading into this, and thats a healthy skepticism to have any time you're evaluating something brand new. I think we were really pleasantly surprised at the level of impact.

John talked a little bit about sort of how we measured the impact, which was around using these standardized scales to measure various levels of the mental health aspects or the depression level of anxiety, level of functional impairment in everyday life, right? Thats really important in terms of how youre going about your daily activities that you love to do. No matter how we slice and dice the data and no matter how much sort of stress testing we put on it, the findings were incredibly favorable for the intervention group, meaning that when patientsdrug therapy was optimized on the basis of the pharmacogenomic test results, they ended up having far more positive results than those who were purely on the clinicians judgment alone, right?

Again, this is really ultimately what we were looking into, right? The idea is that if you add this additional layer, can you really improve outcomes over and above what a normal really high functioning clinician would do? In fact, we were able to see that, right? From a statistical perspective, every one of our findings was significant, and really the difference between the two groups at the end of the trial were not trivial. They were not only sort of different from a perspective of statistical significance because there's always questions around, well, you can make the numbers work however you wish. But the reality is that they were also clinically significant, right? The differences were meaningful from a patient perspective. They translated into substantially different outcomes for these patients with these mental health conditions. It was a really puzzling surprise and fascinating to see.

[00:15:03] JP: Then, Ned, to add to that, what that means is we have patients at the beginning of the study that were moderate to severely depressed based on their page PHQ-9 scores, and we were able to get them down to kind of a moderate level based on the score. What was really the cutoff on whether these patients would actually even need medications. I think when you show that data, its really impressive because it's hard to see that type of improvement over a relatively short period of time as well. I think we really showed that these patients werent on the most optimal therapy and we were able to get them on a more optimal therapy with the testing. 

Another point I think, Ned, thats important is they did improve in the standard of care arm as well. I think we expected that because the pharmacists were still intervening but didn't have access to the pharmacogenomic test results, so they did use trial and error intervention, which is done clinically in practice. The other aspect here that was important is pharmacists were assessing patients at kind of our intervals using these scales, and that's not done commonly in practice. I think we show theres value in that as well. Just having that discussion with the patient and asking them to fill out an assessment scale and then reacting to that I think alone is important as well. I think hopefully we start to see that in pharmacy practice also.

[00:16:22] NP: Thats a great point, John. I mean, I think that there's an old global movement happening right now around standardizing treatments to mental health and using scales because it's been widely reported that even from a perspective of psychotherapists and others is that there's an overestimation around how much impact they are having. So scales are another huge finding. Utilizing standardized scales to measure impact and treatment trajectory is huge.

[00:16:46] DW: John, just to give your stores a little more credit and your team a little more credit. Even the group that testing wasn't used, they improved too, in health.

[00:16:59] JP: It was a substantial improvement when you looked at it from the beginning of the study to the end. It shows really that pharmacists own that relationship with the patient. They have a great rapport with them. The patients trust them. If the physicians are accepting the recommendations either way, we can see improvement in these patients. Its just having access to that care, and I think were slowly seeing that change or revolution in pharmacy practice, but it's different depending where you are in the city, in the province, nationally, globally. It would be great to see more and more pharmacies embrace this type of change.

The pandemic has set everything back. I think it's worth mentioning because what happened is we fell into the pandemic, social distancing becomes an issue, and almost everyone reverted back to kind of dispensing and managing these high-volume trips that were seeing through. As we get back to basics or back to normal, Id love to see all these clinical programs get off the ground again, and it goes beyond just pharmacogenomics testing but all the other great things that are happening in pharmacies across the country, because in the end the pharmacists were there during this entire thing. We didnt shut down. We were providing care. We were there for patients and we were there under very difficult circumstances. I think that's worth being said.

[00:18:12] DW: Yup, absolutely. On this team's call right here and were reporting a podcast or a giddy little pharmacogenomics bubble right here, right? One, it seems to exist now in East York, Toronto, Ontario, Canada. John, in the end, when we take sort of COVID out of it, which is impossible but post-COVID world, how will this technology spread? What is your most optimistic view of how beyond East York this will gain traction?

[00:18:39] JP: I believe that's a great question, and it's what we struggle not only with pharmacogenomic testing but with all these enhanced practice stuff is how do we get pharmacists to overcome the two barriers. Theres always two barriers, time and workflow. Thats always what they report as being a challenge, right? Too busy, cant do it, cant do it.

One way around it is reimbursement, so hopefully reimbursement comes in this area for the pharmacists, so they have their – Its sustainable and it makes economic sense for them to offer the program. The other thing is the time aspect, and what were seeing in pharmacies are shift to centralization services. A lot of shared services for things like compliance facts. I even offer – My vial refills don't happen in the store anymore. Many of them now go to a central fill facility which has freed up a ton of time for my pharmacists to do this type of stuff. I think that change is needed as well, so pharmacists will have a little bit more time to offer these services.

The third part comes I think falls on the owners, and they really have to say, Okay, pharmacies are professionals changing.” Historically, what everyone kind of tries to do is shave some labor, cut some hours, be a little bit more productive. Its a negative kind of spark because you can't really offer any program sustainably for doing that. It takes a little courage as an owner to say, You know what? I want to invest a few pharmacist hours here, so I could offer a genomics program or I could offer a point-of-care screening program or whatever.” It is a shift in the mindset of those operators to say this is the direction of the profession and this is what I want to offer my patients. The patients are starting to learn which pharmacies offer these programs and which don't. I think that's important to say because every time I do a talk like this or Im on the radio or whatever, all of a sudden I see people coming to me because theyre like, Were looking through this type of service.”

I think competitively it offers you an advantage as a pharmacy owner also, and the final part of this is Ned and I have to hit the streets to promote these results, because the manuscript will be published shortly in a good journal. Then as conference season kind of gets back into swing, we were already slated to headline a bunch of conferences that unfortunately got canceled because of COVID, and I think well be back on that dock and be able to show the results, because there is going to be a lot of interest in this. Its really the first time we've been able to show in a real-world setting that pharmacogenomic testing does improve patient outcomes. Theres been isolated little trials and things like that in very controlled settings.

This is the front line in a frontline pharmacy which, okay, maybe used to offering these type of programs and doing some research, but these patients were patients that you see in the real world. I think that's where we have a big advantage as well.

[00:21:08] DW: Okay, terrific. Ned, final word to you. As strategy guy for a pharmacy benefits manager, how are you thinking about this now and interacting into our world on this topic?

[00:21:20] NP: The big consideration I think for us was to be thoughtful around what does it mean to pay for pharmacogenomics within a benefits plan, because theres a slightly different set of consideration from a clinical perspective versus from a payer perspective. From a payer perspective, I think you really have to think about sort of the cost-effectiveness and the value and how do you ensure that youre hitting those right populations and sort of keeping the cost overall sustainable.

I think we learned a lot and the trial itself was hugely instructive in figuring out how were going to actually pick these people, because I think that, Ill be honest, our industry to date has been very unsophisticated about this. It was sort of like, As of this date, were paying for these tests. Send in your receipts,” which is absolutely the wrong way to do this.

Into trial, we were driven by clinical scenarios. We needed people with specific parameters or there's no point testing a patient who was doing absolutely fine or theyre antidepressant. Why would we even alter therapy? We have to think about it from a perspective of what is that situation that warrants from getting testing. Thats exactly what were doing right now. Working towards our product, were very much thinking about that kind of scenario.

Were also thinking about from a perspective of we certainly don't want ultimately the patient, as John mentioned, have a PDF file walking to their doctors office. Thats not the right thing. We need to think about an ecosystem and we need to think about it from a perspective of involving physicians and pharmacists equal fashion when ordering these tests and then being able to utilize those test results in optimizing drug therapies. Were trying to think about this very thoughtfully, and the product should hit all those keynotes as we look to launch this later in this year.

[00:22:50] DW: I want to thank you both for coming back and closing the loop on this story. I want to congratulate you both for this sort of groundbreaking work and I want to send my regrets that COVID has probably stolen the chance. We have Banting and Best Canadian duo. We would've had Ned and John, but COVID may have stolen this from you.

[00:23:08] JP: I know. Too bad. 

[00:23:08] DW: You may not ever get your due.

[00:23:10] JP: Its not too late.

[00:23:11] DW: No plaques at UoT. Lets hope this has a long life though and we can keep the dialogue going. But thanks again, guys.

[00:23:17] JP: Oh, boy. Thanks for this.

[00:23:18] DW: Okay.

[00:23:18] NP: Thank you.

[00:23:19] JP: Bye-bye.

[END OF INTERVIEW]

[00:23:24] SM: Thank you to our listeners for tuning into another episode of And Now For Something Completely Indifferent, a Canadian health benefits industry podcast. To be sure to get future episodes, please subscribe to this podcast wherever you get your podcast or visit our website at greenshield.ca/podcast to download. As a reminder, we talk about these issues consistently in our publications, which are available on our website as well as on social media. So be sure to follow the conversation. For this specific episode, you can check out our September issue of the Inside Story.

Thanks for listening and well talk again soon.

[END]