Standardizing the Field of Digital Medicine: Insights from an Industry Expert

Join us in exploring the challenges and opportunities in the development, approval, and integration of digital therapeutic solutions with ZS Associates Consultant Yash Prajapati.

Read the full transcript: 

Welcome back to Pophealth Perspectives, a conversation with the Population Health Learning Network where we combine expert commentary and exclusive insight into key issues in population health management and more. 

To start out if you could share your name, your title, and a brief overview of your professional history. 

My name is Yash. I'm a consultant at ZS Associates. I represent practice, which is part of a bigger umbrella within our firm. I'm in digital health. We are about 200 experts who live and breathe the current products that are coming out in the industry. 

My background is I'm a pharmacist by education who started early on when Obamacare and health care technology started influencing the sector. I grew up in the digital health startup world learning the tips and tricks with different experiences in specialty pharmacy, Medicare Advantage plan, most recently working as a payer trying to adopt digital health throughout the pandemic. And in my current role I work with manufacturers, MedTech technologies, and health tech manufacturers who are looking to commercialize their solutions, which are usually digital health applications but at times combination products as well. So, excited to be here to have this chat. 

We’re excited to have you, too. How has the expanded accessibility and utilization of digital therapeutics influenced disease management and patient care access across the health care spectrum?

First of all, I would like to question the premise. Accessibility, if it has expanded or not, and adoption of digital health technology has already been challenged by multiple different groups. We see different nuances in there. We see that diabetes or mental health have been therapeutic areas where it has been heavily accepted by the provider groups and more often than not, patients are seeking similar solutions because of the ease of use and data it provides. Namely, you see fitness trackers like Fitbit, Apple Health, or even WHOOP, kind of variables which are driving adoption for the users. And we also see groups like Omada or Dario, which are disease management programs, which are taking digital medium to the provider groups. 

So we have started seeing signs of success, however, it has not been converted throughout the spectrum of different disease groups. Not to mention that providers have started adopting not just EHRs but disease management programs and they are keen to start adopting these tools. It's about time we start seeing the shift in the mindset where standard of care is not just a traditional standard of care, which is dictated by the advocacy groups, but it is complimented by these desired solutions that often patient advocate for or the innovators try and bring it up to the practices.

What are some of the key challenges faced in the development, approval, and integration of digital therapeutic solutions in health care practices?

I'll start with the development first. Most of the digital health solutions, if we've seen in the last decade, were developed because of the clear need or wide space in the business market, which was to support patient engagement and adoption and namely adherence. So, these solutions were to support lifestyle diseases and data collection. A lot of development nowadays or specifically in oncology is co-led by the medical groups and providers are actively taking part. We have also started seeing the shift where manufacturers are being more and more interested in developing their own suite of products which are focused on digital health. So, there has been a change in how we see digital health products. 

To summarize this, the challenges that we see right now is for these kind of developments, FDA's framework or their understanding came in 2016, so market is still fresh. There aren't 20 or 30-year-old veterans who have been doing this for a long time. So, need for experts and understanding of how exactly to develop something that is useful is the most important thing. 

So, expertise takes a first place. The second is for all the different disease state workflows are different, different practice settings, site of care, they all have different requirements. So the one-size-fits-all all model doesn't work here. We saw that with Babylon Health being one of the unicorns that failed in the NHS practice in UK, which was doubted as the AI-driven one size fits all model. Whenever someone has attempted to go that route, even IBM Watson for example, they've failed. So how do we balance out the utility of the function and make sure that you can grow that solution with the practice or with the standard of care? That has been the challenge. 

The third is having the commercial pathway or adoption pathways where market is ready to absorb the solution. Traditionally evidence-based medicine, which has been practiced in modern science is always looking for the clinical effectiveness more so than just economic effectiveness. Digital health solutions are designed to make sure that they're adopted, but to gain clinical great evidence for them becomes challenging by the sheer nature of what they are, the drugs can find therapeutic windows so that their efficacy can be measured. However, if you open an app, do you use it for 1 minute, 5 minute, 10 minute? And how do you engage with it differs from person to person. So, coming up with these new ways of measuring the evidence and communicating the same to the medical society is going to be very important and we have seen that digital biomarkers are being developed by different advocacy groups. 

So, from the challenge of how do we convince the medical society and professionals that this is useful and how do we shape the value story that they start adopting, it has been one of the major challenges. Now I know I've started shifting towards the adoption of this technology. There are other forces as well which are at play. For example, the regulations. We know that DiMe society has been advocating for access to DTX as one of the new laws because CMS does not currently reimburse for all the PDTs which are coming to market. The evidence is still being built up. We saw in this month of January 2024, a HeartFlow AI got its first CPT I category code. That's a huge milestone for a digital application to start receiving consistent revenue, which in this industry for last 5 years, developers haven't seen. 
So, there is clear lack of reimbursement pathways for technologies to go and tap into. We have seen innovative approaches by Free Spirit Health where they got Medicaid partnership. We have seen the applied VR technology which got the veterans to approve them. So, there are pockets of reimbursements, but there is no consistent pathway or end goal for digital health technologies right now. That I would say is one of the major challenges. 

And last but not the least, one of the reasons why we don't have reimbursement challenges is because we don't have a standard way of evaluating these technologies. The traditional HTA frameworks which were established to monitor any health technologies were developed in context of those technologies being used in very limited use cases. Now with the technology use cases are evolving beyond just like I mentioned the patient-reported outcomes measurement but there is an ongoing engagement. Aspire RX for example in diabetes care, which can have a time-based engagement course and patients can make sure that behavior can evolve with it. So these kind of new technologies are not being assessed and communicated in a way where regulators, providers and payers can start putting it into their current frameworks. So long story short, industry is still trying to adapt to all these new advances that technology has already made but we within the workflow and individuals haven't really adopted. 

To be honest, anyone who has been in the industry knows that health care tends to run 10 years behind every other industry. So, I'm not surprised and I'm sure many of the innovators themselves aren't surprised. It's just about making sure that we chip away from these barriers. And it's great to see that there are so many experts and minds both from academic as well as industry coming together and solving for those. For example, the group ICER or PHTI institute, they have built frameworks which not only value the clinical effectiveness but also the economic evidence for these solutions. 

Another forefront where I know my firm is engaged in building the integrated evidence plan. So rather than trying to build evidence at once, we create a roadmap for solutions so that you can start at the solution conceptualization on what you would need to go through initial regulation, but also to start planting the seed because you will need the real world evidence so that you can prove to the payers how is your solution complementing the current standard of care or how is it aiding into their cost savings. So how do you speak the language that the payer is looking for and how do you fit into the bigger picture? Because more often than not, you are part of only one of their problems. So how do you make sure that you understand your position in the market and within the patient's total cost of care? That is something that industry is getting much smarter into, and they are trying to make sure that their evidence speaks to it.

So considering the challenges outlined, there is a growing need for standardized evaluation criteria in digital health care solutions. The Peterson Health Technology Institute (PHTI) has announced its intention to create an assessment framework for these solutions to encourage participation. From your perspective, how can we effectively tackle these challenges to offer guidance and information to stakeholders for evaluating such solutions? 

I'm glad to hear that PHTI, Peterson Health Institute, has already started this initiative. One of the best ways to make sure that innovators and all these clients are supported in their pursuit will be to, like I mentioned, coming up with an integrated evidence plan. Now what do I mean by integrated evidence plan? We have seen in the manufacturing industry that evidence planning starts with phase one trial. You absolutely know what the market needs. You are not just looking for the clinical effectiveness of a solution, but you're balancing it with the business need. More often than not, the clinical effectiveness has to translate into the economic need of the client. In this case, more often than not technology is being used by the patient, the provider, or the payer.

A better understanding for solution owners to make sure that they the understand market access needs the end user and their current workflow. How do you currently position your product within their current workflow? And to make sure that as you are trying to get into the market with your first client or make sure that you're at a stage where now you're a medium-sized company or a solution with about 5,000 or 10,000 patients, you are constantly making sure that you're evaluating against an initial plan on how does your technology help both you, the patient, and the entire ecosystem. An example of that would be a recent study that Dario and Sanofi published where economic evidence was measured for everyone using Dario’s program in comparison with their total health care utilization rather than just in the silo of the diabetes related care so that you can measure the impact of your solution for the direct diagnosis and in addition, all that health care utilization that is being currently considered. 

I'm a huge proponent of making sure that because digital health is never going to be just within the clinic, it's going to be in the home of the patient, you have to understand the real world scenarios, real world data and real world evidence. So how do you make sure that you get to the point where you can communicate the story not from just a clinical effectiveness, clinical trial point of view, but an actual study where you partner with payers or providers to understand how is your technology impacting their lifestyle? How is it reducing their burden? So that will be a very important factor to consider for solution owners. 

Digital health technology is not meant to be just in the hands of provider and traditional medicine has always had this point A to point B journey where you go for your initial visit for a diagnosis and then over the period of time you go for after 2 months or 3 months the second visit. An example of that would be I recently worked with one of our clients, we published a study for Great Lakes Technology and their focus is remote patient monitoring for Parkinsons. An average patient does not get seen by the neurologist for 3 to 4 months. Now within those 3 to 4 months disease progression is going to happen. Disease doesn't wait for the clinic visit. How do you make sure, if you have the technology, to make sure that you gather more data that can provide more insight to the provider or the patient, how do you utilize that? 

And that can only happen if you understand, does a patient have the phone, does a patient have Wi-Fi? Does a patient have an understanding of how to utilize your solution? If that does not get taken into consideration while you're building your evidence, you'll always face challenges or scrutiny from the providers or payers because ultimately payers' interest is to make sure that they provide a fair value for your technology and you are not communicating fair value if your value is just based on the previous work of someone else's and trying to extrapolate the value to your solution. Your solution is unique. It's unique for the patient population that it's addressing now and for the payer who is going to go and review it. So, to make sure that you meet them in the middle while making sure that you have taken all the considerations into account and partner with them so that you can run that initial study and meet the benchmark that the payer needs to meet so that you can build this partnership in a sustainable way to grow your solution would be a very important way to grow.

There are many digital therapeutic offerings already on the market across disease states, especially regarding diabetes care. What is the state of prescription digital therapeutics for diabetes care, and what are the anticipated developments in this area of health over the next few years?

Interesting that you bring up diabetes as an area of focus. Right now, the entire world is focused on overall diabetes management programs rather than just the digital aspect of it. One of the reasons being the recent infusion of GLP-1s in the market, payers are really concerned in making sure that they can control the cost and pretty much the behavior of the patient. And one of the technologies that I've seen from Better Therapeutics come out, which is the PDT here, is AspireRX. I foresee, and again my views are my own, not my firms here, I foresee that more and more technologies and programs will start focusing on improving patient behavior, retaining their current state or HbA1c on an ongoing basis. We have all in the industry accepted that HbA1c is the gold standard for monitoring a diabetic patient. A few food for thought there is we will start seeing more biomarkers come out, specifically the digital biomarkers, who will start speaking the language of if a patient A engages with PDT B on certain cadence, they are going to improve their behavior that sticks to the GLP-1 program for example. 

Partnership between the digital health product owner, the provider practice, and manufacturer in this case is going to go a long way considering that in this equation no one can control the entire patient behavior. So coming up with more and more partnership models, which again has always been proven that it's never a provider that treats a patient, it's a provider team. So how do we build a team where digital health has a seat at the table to make sure that, like I mentioned, from point A to point B between diabetic patient's journey, you're not only monitoring them based on the CGM or the variables, but you are also taking into consideration how does the patient behavior change, how do you motivate them? How do you make sure that some of the other chronic conditions that the patient has are also managed? Where I believe digital health will be a huge role. 

In August 2023, the American Diabetes Association disclosed findings regarding the influence of digital diabetes solutions on all-cause health care resource utilization costs among patients with type 2 diabetes. The results demonstrated that digital diabetes solutions led to notably lower all-cause health care costs than non-users. Considering this data, will standardized guidance and transparent information substantially impact stakeholders evaluating digital therapeutics for various disease states, particularly when they observe results indicating reduced health care costs?

There are a couple of ways of looking at it, ADA coming out and making sure that there is thorough research done in comparing the cause for a diabetic patient with the digital health intervention and without that, that's again from scientific point of view. I did review the study, they do have substantial sample size, they have randomized the trial and it's very positive for the entire industry to follow. 

A few caveats there, just to keep in mind is not all patients are diabetic and because this has to do, like I mentioned a lot with behavior, we have to take that into consideration. How does it change from one therapy to the other similar studies and more and more work in understanding patient behavior based on their different lifestyles personas. And one of the aspects that I felt was missing in that study was the social determinants of health, which again, digital health tends to focus more on. 
So more evidence behind these kind of studies that not only speak to the economic evidence on why it's helpful for the payers, but also shedding light on how does it bring more health equity, how does it improve if the social determinants are met would be very important. I think that's a step into the right direction. I'm hoping for more and more studies to come out that start influencing the standard of care where standard of care is not just dictated because that's the safest way of treating patient, but it's also the best way of improving their behavior. If I could that there is a plea to all medical societies where in last 2 decades they've always been conservative in adopting new things and rightly so. 

Biological drugs are not easy to adopt and as a pharmacist I can vouch that therapeutic window can influence patient the wrong way. But the best thing with digital therapeutics is side effects are usually going to be error in application or patient having to call the provider and the benefits are substantially more compared to what you would see in the traditional medicine. So standard of care, having the preferred digital standard of care attached to it, would be a great way for societies to come out and help all the providers start adopting these technologies. 

One of the biggest challenge right now for any practice to go and start prescribing PDTs, there is no society telling you how to prescribe PDTs. There is no society training you as a provider to make sure that your team understands how to troubleshoot if a patient has to bring a challenge to you. So providers on the other hand do feel helpless if they don't have enough guidance. And we have heard this from, again, confidential research or speaking with provider groups where they do see the potential. They just don't have agreement within themselves on how to interpret data. So making sure that these advocacy role is there to not only shout out that this is important for you, but also to make sure that they are able to set standards on how to manage a patient within the parameters of ideal PDT experience for a patient would go a long way. [24:17]

Considering PHTI's endeavors and studies illustrating the triumph of integrating digital therapeutics, what transformations do you foresee in the treatment landscape for disease states with accessible digital solutions that payers and providers should focus on?

Now this might be a controversial point of view, however, I think this is still early for payers and providers to jump into this right of way. They have been consciously looking at how do we adopt it. The framework that PHTI institute has created is a great start. Like I mentioned about now there is a requirement for industry-wide acceptance of which factors matter the most for uptake. We have gone through the phase where FDA to come and dictate how do we classify the medical device grade for all the prescription digital therapeutic. We have gone through initial understanding or initial approval by CMS on does this belong in a CPT III code? Does this belong in a DME? We have also gone through this access to digital therapeutics phase. 

So industry has gone through the phase of is it important, how do we understand it? Is it clinically effective? If it's clinically effective, how does this impact my economics? We need an evolved version of what PHTI institute has already created as a framework to start measuring the uptake and impact on ongoing basis. The factors for that could be looking at the health system wide, the quality improvements, patient behavior improvements, making sure that you understand the cost at patient level, but also how does it factor into your overall health care dollar. Where does it fit? Is it a 2% of your overall cost? How is it saving or shifting the current cost for the entire health care system? The other aspect of this is also improving the health care professional side of the house where you need more digital literacy, you need more standard of care for each of those PDTs. You need the amendment into the current workflows so that providers know how to fit these new technologies into their workflows. 

Something interesting that came out a couple weeks ago from the DTX Alliance, which is laying out how do we get these things into market? One of the biggest challenges for the PDTs right now is while we built it, how do we get on the formularies? How do we get prescribers to prescribe it? So even if we have a patient who desires it, providers who's looking for it, the mechanism that this industry has created on coming up with a drug formulary, a dispensing mechanism, how do we evolve those things on a wider scale so that the behemoths like the CVS, the Walgreens, also start adopting it rather than only the players who have limited distribution? 

So how do we make sure that we evolve these frameworks to the point where it's easily acceptable? Not from that just clinical effectiveness, but also from a feasibility point of view where IT systems are ready, the legal and compliance folks from all these different stakeholders understand how it works. The management of patient data is clear, the ownership of that data is cleared out. And last but not the least impact is measured not at a study level, but also on an ongoing basis an actual analysis where a PDT is part of an actual report coming and going to a payer's committee. How do we make sure that influence of this PDT goes from this one adoption study or case study to it? Being part of all these different mechanisms is going to be very important. And I think PHTI has done really good work in creating that framework. We need to just make sure that now that framework evolves so that every stakeholder has their own little piece of, here's my checklist. 

PDT is not always on a formulary. Different commercial pathways can exist. Your patient population, if they're heavily for Medicaid, knowing which payer you need to go and approach will change how you communicate that. If the technology is suited for veterans, you go to VA. If your technology is suited for the elderly, you go to Medicaid, depending on again, which Medicaid you go, the requirements are different. If you believe that your technology is suited for more commercial players, then you go to commercial health plans, you go to employers if that's a better route. And we have seen that Akili going direct to consumer. if there are technologies which can prove that patients will be willing to pay for it because they see more value than the providers, absolutely you need to go to a direct-to-consumer route. 

Even within that route, there are nuances of do you sell it on an app store, do you sell it separately? Do you go and go to Costco to get more distribution? Or you can work within the IRS's HSA approval so that your technology is now reimbursed by HSA. So again, to wrap it up, there are so many different ways you can get paid, but every path will require to make sure that you plan accordingly and you prove to the last, or end, stakeholder that you mean business. You are here. Not just because it's a new flashy technology, but there is substance behind it. And that substance is being required by everyone in the industry right now.

Is there any one key takeaway from this interview that you would like the audience to walk away with?

For sure. And I hope we can do toward 3 different takes because there are just so many ways to skin this cat. Yes, we are in an industry where the industry is young and everyone's expectations have already been high because we are dealing with the health of the person. As digital health professionals, we need to keep in mind that it's the mountain of evidence that we will have to generate while making sure that we collaborate in partner. This is not going to be a one-man show. Seek partnerships, seek collaborators. Make sure that you're able to grow sustainably rather than having to shoot for the sky on your day one. Consistent and sustainable growth is desired. And yes, there are challenges, but you can still succeed. So my one takeaway will be: be patient, be meticulous, and find partners.

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