Digital Therapeutics for Better Health with Dr. Smit Patel: Part 03 | The Tech Between Us Bonus

Transcript

Raymond Yin:
Welcome to a special episode of Mouser’s podcast series, highlighting questions that didn't make it into our regular episodes. As a subscriber to Mouse's newsletter, you're hearing this content. First, thank you for your continued support and be sure to explore the rest of our empowering Innovation together content series at maer.com/empowering innovation. It's one thing to be able to do one trial with a handful of patients, but to be able to scale at large must be a challenge for something like digital therapeutics.

Smit Patel:
A hundred percent. Think about the world of hardware where we had to give one thing to one individual person. Like in my headset, I have to order it online. It comes down through. Now, thanks to Amazon a lot faster, but not everyone has access to Amazon. Not everyone has access or money for prime. It takes time for individuals to get that headset in their hand or a device in their hand. The digital therapeutics and software based can be downloaded, and over 90% of Americans have smartphones today that can be scaled and deployed in the most efficient way, and we can learn so much from the digital phenotyping on how the users are using these products. That's the most beautiful part of the information that we get back from the users, how they're using it, what are the functions that are working well, what are not, and where individuals are enjoying the user experience of it. We are able to collect in a scalable fashion.

Raymond Yin:
You actually touched on something that is so prevalent right now in any discussion of healthcare, which is the overall rising cost of healthcare in addition to the scarcity of healthcare in certain areas. Sounds like just based on your previous example, that digital therapeutics can truly help lower the cost of treatment for a lot of these diseases and a lot of the chronic diseases.

Smit Patel:
It is very true. I believe that the right digital therapeutics we can, in the whole ecosystem of healthcare, we can reduce down the cost of therapies instead of going through five different drug therapies or injectable therapies. Are there ways where we can assess early on in giving a digital therapeutic product, like take for example, EndeavorRx for ADHD before a kid goes to that medicated or drug route? Are there ways we can deliver digital therapeutics to the kid? Again, for the age group that has been tested, that has the evidence that has been cleared by FDA, that we clearly know it works, can we give the child that digital therapy now instead of they're already playing video games, they're already using tech in multiple different ways on social medias and things like that. What if we use it for medical purpose?

What if we use for improving our own health? I think that's the shift that we need, and bear in mind, we'll have to be cognizant that these are point solutions for chronic patients who have 15 different diseases. It looks differently and we have to evaluate that differently, and we don't want to know 15 different point solutions or 15 different digital therapeutics that a chronic patient has. We have to come from 15 different companies apparently. We have to start small and see where those touch points hotspots are where we can incorporate most effectively and cost efficiently. But we also have a see from a larger scale standpoint in terms of where we can curb those gaps and incorporate them where it'll build a whole care continuum.

Raymond Yin:
How is the adoption of digital therapeutics been within the medical provider community? In other words, are doctors and practitioners prescribing digital therapeutics instead of pharmaceutical regimen, or is it just a, “oh, by the way this exists”?

Smit Patel:
That's a really good question, Raymond, because it is evolving, I would say because a lot of physicians are one overburdened getting out just out of Covid where they had taken short-staffed, taking care of a lot of individuals. Two, they were forced to deliver care through virtual platforms, adopt new telemedicine platforms, adopt new remote patient monitoring R P M devices that they have just started to understand those traditional device platform. That digital therapeutic is on the other spectrum. We have seen physicians from across the board. We have done some studies with the American Cancer Community Centers with American Medical Research, American Medical Association who has done research from 2016 to 2021 and looking at six years of data from 1,400 plus physicians on what their adoption levels are. In 2016, maybe one physician was open to it. During pandemic two physicians were using it, and then very similar to 2022, there were three out of five physicians wanting to use it.

Over 90% of the physicians were wanting. So we have shifted from, oh, I don't want to do it, to yes, this is something we want to use. Again, bear in mind that was more digital tools. Digital therapeutics will take a little bit longer time to reach physician adoption because physicians needs to know about these tools, about the clinical trial. It's not just telehealth platform that they can sit here and deliver care in a digitized way. It's more of they need to learn side effects effectiveness. They have to see the clinical trial information. They have to know how to counsel before they counsel the patient. So there are a few steps that we need to essentially as a field teach physicians to do it right before those physicians will do it. But we have seen a lot of garnered interest, and again, this goes back to similar times of there would be activators who will be the first and forefront who wants to use it, who will use it.

There would be some that are still in this state of maybe I need to learn more, and then there would be laggards who are like, oh, I don't think this is even real in the first place. So this old curve that we will have to go through in the physician's community. But I'm very optimistic that once they see the evidence underneath that, once they see how much patients enjoy using it, patients who want to use it is no one wants to wait for an hour, drive up, miss their work, go to the doctor, wait 30 minutes in a doctor's office and then see doctor for 10 minutes. Patients don't want to do that.

Raymond Yin:
We are conditioned to the point where it's all about instantaneous gratification. We want to be able to download something and begin using it, and you want to see results

Smit Patel:
And why wait? That's my notion is why do we have to wait for care to come to us when we have technological options right at our fingertips? Let's use it again. Yes, there are questions around reimbursement and infrastructure that we need to fix and we need to make sure we do it right in the most ethical, equitable way. But if we have these digital therapeutic solutions out that are working for the patient that are evidence-based, that have been cleared by FDA, making sure it's a check mark on safety and effectiveness levels, all we have to do is make sure we are activating our patient community and physician community so that they are doing it not out of being forced to, but rather empowering them to use digital therapeutics to improve care across the board.

Raymond Yin:
I’m sure there are different methods that doctors learn about new pharmaceuticals, new medicines, but there's always that pharmaceutical salesperson that is in the doctor's office giving them samples, providing little chotkis. I think we've all seen it in the doctor's office. Is there such an organization for digital therapeutics or do they come to the DIME website and learn about new therapies there?

Smit Patel:
They may. So digital therapeutic companies may have account managers who educate the physicians on what it is because it's a new one. Similar to drug. It's not as easy as drug like, Hey, this is something, a drug that a patient will pop in and it'll have these magical effects. No, it has to be taught. It has to make sure physicians know what and where it is being downloaded from. What are the onboarding process? Maybe it's a physician, maybe it's a physician assistant, someone nonclinical colleague who's teaching that to a patient. So that needs to be taught. I think organizations like Dime Digital Medicine Society creating these few resources are sister organization, digital Therapeutic Alliance. DTA is another one that has product library that you can actually see on their website all different kinds of products and summaries of the products, whether they're regulated or not, if they're regulated by what risk levels, the clinical studies.

So, organizations, like DIME, are producing those for the larger community to educate. DIME has just started our education. We call it Diamond Academy, which has corporate learnings for larger corporate if someone wants to actually teach the full team on what digital health is, digital medicine, digital therapeutics. We also have directed learning consumer course on ethics and equity in terms of how are we building ethics in digital health. So our organizations have started to do that. It'll take lion's share of work from every different stakeholder to make sure that we are educating in the right way, like regulators, payers, health systems, clinicians and patients are all on the same board. So that's our ultimate goal that we are educating them together on the benefits and the risks for these digital therapies.

Raymond Yin:
That's terrific. So there is a group of passionate people like yourself who are in the doctor's offices working with physicians to help them understand the advantages of digital therapeutics and digital medicine. That's awesome!

Smit Patel:
A hundred percent. And I'm a clinician myself, and we have clinicians in both organizations looking at this from a perspective of we're not just creating toolkits and resources that are for anybody. We are creating ones that physicians can pick up and also teach their patients. It'll take time. It'll take a lot of work from medical associations, the continuing medical education communities to our pharma colleagues who are building some digital therapeutics to share with their networks. A whole ecosystem has to do, but if we are not able to teach our patients and providers, we will not have the adoption that we want.

Raymond Yin:
I know we've been talking a lot about FDA, which is US-centric. How is the adoption of digital therapeutics been on a global basis? I know every individual country has their own department similar to FDA. Are you seeing a global adoption or is it primarily in, for example, the US or Europe or Asia or other areas?

Smit Patel:
You tapped into the mind - I was thinking about there's a lot of progress happening. Yes, US is on the forefront of a lot of these innovative solutions, but we have also seen a lot on the global front. I had co-led a partnership with German Minister of Health's, a health innovation hub that came out in 2019 with one of the most ambitious and most agile regulatory and reimbursement fast track pathway. It was called DVG pathway that allowed innovators to bring their product to market within a span of one year, get the regulatory clearance and get the reimbursement for those German population of 70 million patients. Essentially, that shifted the entire world mindset of how we can bring these various innovative digital solutions to the market. So DVG have, I think, cleared and authorized over 40 different digital applications and solutions. Every country has a health technology and a digital medical device, and digital therapeutics is different lexicon to it.

However, various countries emulating on what Germany has done, France this year replicated it into a PECAN Pathway that does similar fast track approval. If there are specific clinical outcomes that digital health and digital therapeutics shows, if there are specific technological characteristics based on privacy and security infrastructure in place, any innovator can bring digital therapeutics to market with the right reimbursement structure in place, we have seen not only in the Europe, from UK, Belgium is looking into similar models, we've also seen a lot of progress in APAC region, which is very impressive because China and Japan, South Korea being one of the fastest growing market in the digital therapeutics. Japan had one smoking cessation app that was the first digital application approved through the Japanese FDA to South Korean government released first insomnia digital therapeutic application by Welt, which shows that not only the magnitude and technological advancement, the stretcher of a country like us can have, but rather various other countries are progressing. This regulatory and reimbursement approaches, and I think my last point is hotspots that is happening, but there are also countries that are still lagging Africans, sub-continent, south Americans of continent. We have not seen the progress in those countries yet that we would have liked to see. So as we think of global and harmonization approaches, we will have to look at it from a large, broader perspective.

Raymond Yin:
Sounds like it is definitely going global. It's some hotspots in areas of concentration, primarily in more technologically advanced areas that are really starting to adopt some of the principles of digital therapeutics.

Smit Patel:
A hundred percent.

Raymond Yin:
The insurance companies, depending on your personal experience can be good or bad, but how has insurance been able to keep up with some of these new digital therapeutics? Are they actually recommending them or reimbursing for them at the patient level? Does that help with the adoption, do you think?

Smit Patel:
Yes. Reimbursement helps patients and helps the entire ecosystem because no matter how great a product is built, no matter if it's FDA regulated or not, if there is no reimbursement for that, we wouldn't see any market access for patients that providers would not be able to prescribe or providers would not be able to authorize that product to the patient. Reimbursement is one critical step, and I think in 2023 it has become one of the largest one for digital therapeutics. As we see large payer organizations, including insurance, PBMs or pharmacy benefit managers who make formulary decisions to health plans to public and private and employer, different kinds of payers, which we have in the tapestry of the US payer organization, we are seeing that yes, they have started to pay for it. Where we are seeing some opportunities where we can improve on is around say I'm an innovator, I'm building a digital therapeutic product, and I go to a payer organization like, Hey, I built this product.

My a hundred patients will benefit if you can get reimbursed for it. On the counterpart, payers have to think about from a population level, they don't cover just one or two or 10 patients or 50 patients. They cover sometimes 30 million lives that if payers are making decisions, they want to make informed decisions when they're reimbursing the digital therapeutics, because if they put something on a formulary, it means that anyone who has these clinical symptoms can have access to this digital therapies. So right now where we are seeing developments because we work very closely with our payer colleagues, is essentially understanding assessment of evidence underneath that because one of the other things we have seen in the industry is evidence has not kept up from a lot of digital health companies that it should have to make right reimbursement or market access decisions. When I say evidence, digital health is a new field.

We are evaluating the evidence. We can't compare any digital therapeutic with a drug therapy. Yes, we have done it, but what is the standard baseline? Where do we look at what are the standard criteria that should be assessed when it comes to clinical value, clinical effectiveness, safety, measurements, risk? Those are questions. As an industry, we need a lot more research before we can say that one NT is reimbursing why and the other is not. I think there's some research that we still have to do, but overall I can say that those are the things that has been looked at actively at insurance companies. I know there's a prescription digital therapeutic act that is in place by a few congressmen bipartisan act that is in Congress right now that is awaiting approval or denial in there. So there's a lot of movement happening from policy levels, from payment levels that will give access on public payers, but also on the private payer side. The question is time. I think with time and with the right evidence and with the right infrastructure, we will have more reimbursement.

Raymond Yin:
I know that is a gating factor for a lot of people and a lot of different therapies out there. Smit, thanks so much for your insight. We really appreciate your time and thanks for joining the Tech Between Us.