0:04 Eugene Borukhovich: Welcome to the Digital Therapeutics Edition of Digital Health Today. I’m your host Eugene Borukhovich. In the last episode in this two-part deep dive inside the Digital Therapeutics Alliance, I spoke to Megan Coder, the Executive Director for the DTA. So if you haven’t heard it yet, just scroll back one episode in your favorite podcast player to hear our discussion. But today, I’m excited to chat with Jessica Shull, European Lead for the DTA. But before we dive in, I remember meeting Jessica in Sitges Spain near Barcelona at a HIMSS EU Health 2.0 event. Jessica struck me as sharp, composed and super knowledgeable, and of course, a great addition to the DTA. With Jessica’s leadership, the DTA expanded its coverage across Europe, LATAM and Australia. And now we jump to my conversation with Jessica Shull.
Jessica, so why don’t you tell us a little bit about yourself, who you are and what brought you to digital therapeutics and more specifically, Digital Therapeutics Alliance?
01:07 Jessica: Well, hello, Eugene, first of all. Yes, it’s kind of a long story, who I am and how I got here, because I’ve been in digital health for 20 years. And so I started out as a medical bio-visualization specialist working on 3D anatomy, using the visible human building in Washington, DC, virtual surgery simulators. And this was high tech, super-funded NIH, DARPA, BOD grant kind of stuff. And I learned a lot in that company, though. It was a startup, and we built simulators, which were then sold. It was sold to Layered all eventually, that company.
But just how to work between the tech developers, the haptics engineers, the surgeons, and the funders and the patients and everyone involved, it’s a different language and set of requirements for each area, let’s say. And so…
02:04 Eugene: And a specialty, right? I mean, everybody sort of was an expert in a particular area, right?
02:09 Jessica: Exactly. And they didn’t really know the other areas of expertise, and so I was oftentimes just liaison between all of them. But that taught me a lot about what could be accomplished in digital health. And so from there, I wanted to go a bit more broad, like what can be actually accessed by a more global population. And so I moved to Europe in 2005, and started working for the WHO, and what was then called E-Health program in countries like Rwanda. And it was the other side of the coin, let’s say, just getting a complete low resource and what could be done in digital health there.
And after 6, 7 years on and off with WHO, I worked with the World Bank, and through different projects, and so forth, E-Health became M-Health, which became Digital Health, and I ended up in Barcelona to do a PhD and here began working with requirements for the way countries could actually adopt and integrate and M-Health tools and started with the UK actually at night, and then began working at a hospital.
So I’ve been at a hospital here in Barcelona for about two years working on all kinds of projects, including clinical trials, which has given me insight as to what in physicians and research and clinical trials actually entail. So all of that brought me to the Digital Therapeutics Alliance. And when they needed someone to take over or to even start embark on what was happening in Europe for digital therapeutics.
03:34 Eugene: And when was that? What year was that?
03:36 Jessica: That was 2018, as a Strategic Advisor, that’s the way I started and then came on more full time after that once we realized there was a lot of work to be done in Europe. It’s a lot happening here.
03:49 Eugene: So I know, first of all, I think you forgot the word connected health. I mean, you had m-Health digital health. Yeah, I mean, there’s all kinds, right? So from one perspective, 2018 was just around the corner, right, feels like yesterday on the other side. It’s been two years. I know, in the last six months-ish, there’s just been a slew of announcements. And I think with a pandemic kind of speeding us up, as far as approvals for digital therapeutics, what have you seen in these last two, two and a half years change within the DTA, its focus, but also, I guess, in broadly in the space? So maybe you start a little bit broader, and then we kind of go into the DTA, if any changes?
04:34 Jessica: Yes, things have changed a lot for the industry and digital therapeutics, when the Alliance first started weren’t even known as a name as a category. So the Alliance was instrumental in getting the definition published, recognized. And it’s still something I have to say that we spend a lot of time emphasizing, because it can be misused the term digital therapeutics. There is consensus being created, but it’s still not globally recognized. And so that’s been a huge piece of the work, because definition matters.
These are in Europe, medical devices with CE marks. They have evidence. They have a series of regulatory requirements. And so we’re not talking about monitoring or tracking apps. And so that was a big part of the beginnings and the industry since then has changed drastically in the sense that there are now multiple products already integrated into healthcare systems around the world, Europe in particular. And of course, last year, Germany wrote and passed this Digital Care Act, which now nationally allows for the reimbursement of digital therapeutics and other DiGA. So there’s been leaps and bounds changes across the board.
05:43 Eugene: Yeah, and we’ll obviously get into a little bit, I’m curious about Europe, I think everybody uses Germany as the example. But I know, [inaudible 05:52] is doing all the work. But let’s just pause on that. Because one of the things interestingly you said, the actual description, and the definition of digital therapeutics, as it’s been defining, my question always, and I kind of look at some companies and say, well, is it prescription digital therapeutic with all the science and rigor behind it? And/or is there a novel health service, which are also starting to call themselves digital therapeutic, right?
So I’m kind of curious where you look at from a definition perspective, and whether you can give examples of one or the other? Because I know members of the DTA are both prescription. Digital therapeutics like Pierre, for example, and others. So let’s dive a little bit deeper into the definition and the difference between DTx as a PDT prescription, and a health service.
06:40 Jessica: So there are members that do all kinds of things in the way that the products are sold, I can’t really speak to that. But the term “prescription” in a sense in Europe doesn’t really matter, because anything in Germany will be prescribed, whether it’s a DTx or not, I mean, under this DiGA law. And so the same holds true in the UK. The same holds true in France. And so we don’t really need to say prescription. And if it is offered by an insurance company, or offered by a private hospital, it may not be prescribed, but it is still digital therapeutics. So that’s a bit fuzzy. But of course, the evidence is still there, regardless of how it’s delivered.
So I think as frameworks become more robust, and numerous in Europe, prescription will be the norm. And so that’s almost unnecessary in Europe, to say that. However, and to distinguish, if it helps emphasize the fact that these products are clinically evaluated and rigorously tested and have clinical trials behind them published in peer reviewed journals, great. The main thing we want to communicate, though, is that these products are software interventions that move a clinical endpoint for a specific disease in a patient. And so if an endpoint is not reached and improved, that’s not a digital therapeutic.
07:56 Eugene: That sounds pretty crystal clear, right? Of course, there’s nuances as well as you dig deeper. And that’s, I think, part of the challenge. But yeah, let’s switch gears because you mainly cover Europe, right, and I think Australia we talked about, and some Latin American countries. So at a broader level, and I know for our American listeners, Europe is not Europe. There’s many, many, many, many, many countries, and everybody has their own rules, regulations, etc. So maybe contrast at a higher level kind of Europe, Australia, and some of the countries that you cover in Latin America, and then we’ll dive deeper into Europe?
08:31 Jessica: Yeah. So Europe is, of course, the EU plus the UK plus Switzerland, and a lot of differences among those countries. However, most countries in Europe are single payer. The one interesting country, I think that people maybe don’t realize is that Netherlands used to be single payer, is now nearly 100% private, however, it’s still required to have health insurance. And so they’re quite open to looking at innovation. So anyway, there’s a broad range of ways to approach incorporating DTx across those kinds of countries.
In terms of Australia, so I haven’t been able to go there actually since this whole COVID thing, but…
09:10 Eugene: Understood.
09:12 Jessica: But I would love to, because there’s a lot happening there actually. And the TGA, which is the Therapeutic Goods Administration, they’re FDA, let’s say, are looking at digital tools and coming up with a new kind of framework to be published in I believe, February. So what we’re doing is working with groups in Australia to ensure that we can be aware of all those changes in development.
And the same goes in South Korea. In South America, there’s a lot less published and done for digital therapeutics. But all countries because of COVID, of course, are highly aware that telemedicine is needed and needs to be paid for, it needs to be supported, and thus the sort of a portal into a wider world, the digital medicine and digital therapeutics. And so I’m engaging with and coming up with ways to communicate to a broader range of physicians in South America and Central America through just having our documents distributed and holding webinars now and then.
10:10 Eugene: And of course, I’m sure translating it to so many languages just all around the world for DTA, right, as well?
10:17 Jessica: Yeah. It’s interesting, because digital therapeutics in English, so then in French, it’s thérapeutique, you know, so there are different terms. And in Germany too, you know, DiGA includes digital therapeutics. And so we’re having to sort of understand how to align these categories that overlap, but maybe not 100%.
10:36 Eugene: So maybe, and I know, there’s been quite a lot of podcasts and talks done on DiGA, that’s been kind of the little bit of the shiny light in the EU. So maybe spend a little bit of time describing what DiGA does actually, for the entrepreneurs or digital therapeutics in general. But then I want to contrast because I do believe that UK with NICE, is not that far behind, I know Belgium and a few others. But you’ve been virtually at least these days traveling around Europe. So let’s start with DiGA.
11:09 Jessica: Yeah. So DiGA is interesting. The whole DiGA framework, the fast track is interesting, because like you say, NICE has been doing a lot of evaluation work, and they have this evaluation framework, which is very solid, however, it does not lead to reimbursement. It’s a necessary step, but does not mean you will be reimbursed. Whereas the B. Pharm framework, if you are accepted, you’re automatically in line to be reimbursed as long as doctors prescribe your product. And so they’ve gone one step further even the NICE.
And UK is an interesting country because fantastic health care, the NHS is loved, they’re looking always at how to integrate and improve and become innovative. NHS is doing a great job now of trying to incorporate AI into all kinds of things. However, still to have a product distributed across the country from a central NHS is impossible. So companies go CCG to CCG, which is Clinical Commissioning Group to Clinical Commissioning Group to have their product recognized and adopted on the little pockets around the country, which is a way to do it, but a little more slow going then the German method right now.
12:11 Eugene: And Belgium, France, just contrast a little bit there, where are those some additional countries are?
12:17 Jessica: Sure. So Belgium is to me, they don’t get enough recognition. Because not only have they now developed this three step pyramid for integrating and reimbursing for digital therapeutics, which they’re calling the M-Health pyramid, because it may be a tablet, whatever, but they’re still calling it M-Health, and it may also be for things that are diagnostic, which digital therapeutics are not. So they developed this pyramid, which is first level being to E-Mars, like a level being interoperable with the whole Belgian system.
And the interesting thing is that it’s interoperable with the entire nation, because they also in the last couple of years have made their whole system interoperable nationally in three languages across mental health and hospital care. So really impressive work. It’s not all completely, you know, things have not quite worked out yet. There hasn’t been one product now approved for national reimbursement, it’s sort of a test case. But already there’re site anyone can log in and see how many products are going through the pyramid process. There are, I think, 15 or so at level one, I think six or seven at level two, and one at level three, which is reimbursed. But the products can be used in Belgium even if they’re not at level three, but just you have to find your own hospital and way to have it integrated.
13:33 Eugene: Which is interesting, right? Because one of the questions I had kind of interesting when they set for DiGA, as long as it’s prescribed and kind of similar. If you think about hop over to UK, you’re cutting deals with CCGs at the very local level, and what sounded like in Belgium, so if you’re not level one at the national level, you’re kind of selling or trying to sell across, again, probably hospital systems or regions.
What is your at least perception on the prescribe ability? So how many doctors are actually aware of it? How do they become aware of it, right? I mean, if you follow the normal molecular pharma model, there’s a lot of education going on, a lot of spend on marketing, etc, and engaging the physicians. Can you contrast a little bit to the digital therapeutics world?
14:19 Jessica: So I think in the UK, it depends because, for instance, there’re products that have been offered in large CCGs, like the Greater London area offered to everyone. And so those are paid for and then people can just subscribe. So it depends a bit on the model.
So I think in Germany, the differences that physicians and similar to the UK, if physicians aren’t aware, if they don’t understand the value, they’re not going to say yes, okay, I’ll prescribe. And so this is something actually that we’ve been working on with stakeholders in Germany to come up with either webinars or articles in German, published in German medical journals with the German Medical Societies to say, and this exists, whether you know what these products are yet or not, and this is happening, this is what some benefits have been, these are products that are already in the German system.
So we’re trying to convey some kind of friendly sort of peer to peer information, so that and it’s going to be slow, I think over the next year, there will be more diffusion, more awareness. I think that’s a big part of it. And like you said, the pharma companies have these masses of market access people, commercial teams that go out. And I think maybe we could harness that, too, especially if pharma companies are involved, it makes sense to invest in getting the word out.
15:44 Eugene: Yeah. I think, the relationships, I kind of call it the DTx is the cuddle with pharma versus making their own market access paths, right, so I think that that will depend. You know, insterestingly, you kind of say, well, Belgium did some great stuff, Germany led the way with DiGA, NICE has been doing stuff for quite a while, I’ll say pre-Brexit, of course. But does that all bubble up to the EU, other organizations? If I rewind back, probably around two years ago, there was another organization, I’ll say, running around Brussels, something with digital or digital therapeutics. So how does that all, does it all get synchronized or is it sort of each country, even within the EU is doing their thing, and other organizations working with you guys?
16:29 Jessica: No, it’s interesting, because healthcare is one of the few areas which is completely independent of EU. And so even it could be that a drug that is prescribed in Spain, you can’t get in the UK, or vice versa. And so right now, there is no central European way to have all these products recognized and the way they’re assessed and so forth. We’re working on that just because it is so new, and the European Union itself, and the Commission is really heavily invested now in creating a European health data space. So that would mean interoperable health data across the European Union, which means sharing standards, which means suddenly, we have to work together on health data.
So I think the confluence of COVID plus that plus the fact that these products are out there and being used, whether they like it or not, yeah, I think they like it. But it can’t be ignored any longer. The way it is too big. And so I think the confluence of those three things is going to mean that yes, there is some European recognition at some level, and we are actually working on having a coalition letter recognized the EU level, first, just what digital therapeutics are. And we’re circulating that in Brussels. And it takes a bit of who you know, and getting in front of the right people. But there’s been some good support so far.
17:51 Eugene: And of course, just timing right. I don’t think you’re going to get much done in December.
17:56 Jessica: No. No. And in fact, you know, the European Council seat is changing, but we’re always in touch with the countries that are involved and upcoming, and it’s interesting. It’s actually really fascinating work. I think there’s the willingness to work together. I think there had been some resistance on some fronts at some point. But now I think everyone recognizes that this is the way to do it, not just for digital therapeutics, but for vaccines, for distribution, for telemedicine norms, all kinds of things. Like right now, because of Brexit, if you are using telemedicine, and you’re a physician in the UK, you cannot be working with a telemedicine company that’s in Europe. So all kinds of oddball norms that have to be worked out, and we want to ensure, of course, best healthcare for citizens here.
18:37 Eugene: You mentioned earlier also in Belgium that there’s a very transparent process as you are going through this pyramid. What about, I’ll call it, real world data on usage? I know, a lot of the European countries were very open in like open health data, which I know I personally was tracking back, back, back in the day. Is there anything that’s been actually published on usage of digital therapeutics across at least the countries that you’re aware of or not yet?
19:02 Jessica: I think each company has their own data. I don’t think it’s been compiled in a way to present the whole industry in Europe, but there’s been an impressive uptake. I can send you to some companies, and they can tell you for themselves and kind of what that’s been. Yeah, so we don’t have like a running chart of how many patients are engaged.
19:25 Eugene: Yeah, I mean, it was less about DTA tracking this. I think it was more around again, the transparency like the guy, the pricing is very transparent. So to me, the question would be the follow on, you know, what’s the usage and the outcome? So are they transparent, are there talks about it, other plans about it, etc. But…
19:43 Jessica: Well, yeah. I think, there are if you look, for instance, at the medic innovation briefings from NICE, there are some usage data. B-Pharm has published all of the data that are accepted on their portal, and right now the pricing is all there, but usage has not been fully implemented yet, so that data is upcoming, I suppose. And I suppose it will be public eventually, but they’re looking at after one year. So at various levels, I think you can find that kind of data, but there’s no one source that I know of.
20:13 Eugene: Any organizations, companies, again, let’s focus on the EU that kind of stand out, so something that we should watch in 2021 closely or I’m going to kind of very broadly for you, any countries that you think are next to adopt some frameworks?
20:29 Jessica: Interesting. I think Finland is a place to look. I mean, it’s a very small population, but they are so well poised. And a lot of great companies, their infrastructure is supreme. So I think the Nordics in general could do whatever they wanted in digital therapeutics with a drop of the hat. It’s now getting the frameworks in place, though. Other countries, I think, are not far away, but it just takes a long time to step into legislation. So Italy, there are rumblings, it would take some time to get it through Parliament there too. Spain is a regional system. And so each region, I think Catalonia and Lucea, are actually quite forward thinking in this. So there are several countries I can name.
21:10 Eugene: So what’s next for DTA or I guess, maybe specifically your work within the DTA? I mean, it sounds like you have a lot of head in the coming year zip. But kind of what are the main goals for next year or 2021?
21:28 Jessica: Yeah. So 2021 looks interesting. It’s super exciting, and I think, yeah, there’s not enough time in the day. So one thing is, of course, to ensure that all countries are cognizant of the definition and value of digital therapeutics, then it’s having more physician engagement. So at national and regional level, even at specialty level, like the Societies of Endocrinologist, like we need to be in touch with them as well for getting in touch with actual physicians and not having this be something that comes out of left field.
And then there’s having actual publication of some kind of recognition of the basic requirements for a DTS product in Europe. That’s something we’re working on, and we see similarities in many of the frameworks. It’s just a matter of pulling together the countries to have them actually discuss and agree and decide that there’s a way forward with us.
22:25 Eugene: Well, that sound means it’s time for a question from my journalistic partner on this podcast, Brian Dolan, who is the founder Exits & Outcomes, and as I like to call him, the “Digital Health Detective”. Let’s see what question Brian has for our guests today.
22:40 Brian: Okay, here’s my question. What advice do you have for us based prescription digital therapeutics companies thinking about commercially launching in Europe? So assuming they have already commercialized in the US with prescription only DTx, what are a few other considerations that maybe aren’t relevant to their prior us launch that these companies should be ready for a head of a commercial launch in Europe?
23:06 Jessica: Okay, well, thank you for the question, Brian. It’s a very good question, actually. So I think a good thing for companies in the US to understand is the way that healthcare works in Europe for one thing, and about the pricing, is not the same pricing. So the system in general, though, there is no central FDA. Each DTx, especially after May in 2021, will have to be CE marked under MBR. And so that requires a very specific set of evidence of post market follow up of all kinds of things, which all companies need to be aware of and find a notified body and work to get that straightened out.
And it could be that in Europe, and we’re seeing this more and more agreed upon is that probably it will be class two or higher, and so that’s not the case in the US. That said, it does lend a good deal of credibility to DTx products just because that level of rigor is substantial. And so before embarking on that, look at the countries that you’re interested in distributing in what markets because the requirements are right now different. And so if you can, it’s not a one shot takes care of everything. But if you can match the CE marking requirements and evidence generation with what the countries require, I think you’d save yourself a lot of time and go for the high bar, because doing the minimum is not going to cut it.
24:31 Eugene: Perfect. This was wonderful, Jessica and I guess, as our listeners, a key component of this is actually getting to know the person on the other side of it. So we want to ask you a question. What gets you up in the morning? What is your why?
24:47 Jessica: I guess, to me, it’s really fascinating how this is evolving, how fast it’s moving and just seeing sometimes people who you wouldn’t even suspect are open to changes in healthcare which in 20 years ago, it was just really like pushing on a brick wall. And so it’s so encouraging. And I think we really have a chance to revolutionize in a sense the way healthcare is delivered. And COVID, be what it is, that being silver lining, there’s a chance to really make healthcare efficient.
25:20 Eugene: Thank you very much for your time.
25:22 Jessica: Of course. It’s a pleasure.
25:20 Eugene: Thanks so much for tuning into Digital Therapeutics Edition of Digital Health Today, production of mission based media. Be sure to hit that subscribe button to this podcast on your favorite podcast player, so you then automatically notified when we post our upcoming episodes where I speak with dozens of leaders and trailblazers who are forging the path for digital therapeutics.
If you’d like to learn more about your Coach Health, or Brian Dolan’s Exit & Outcomes, you can always find the links to this and more in the show notes for this episode. You can connect with me personally on twitter at Health Eugene, or follow my journey of writing my first book “Hard Pill to Swallow” at hardpilltoswallow.substack.com.
I’m Eugene Borukhovich and catch you next time.