Pharma Market Access Insights - from Mtech Access

Market access for digital therapies and digital medicines

• Mtech Access • Season 5 • Episode 2

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In this Global Whispers webinar we explore market access for digital therapeutics. Clare Foy (Global Market Access Director – Mtech Access) speaks to Shefali Shah (Global VP, Market Value and Commercial Effectiveness – MindMaze) about the challenges and opportunities for digital therapies to gain market access and ultimately improve patient outcomes.

In the webinar, Clare asks Shefali about:

  • The opportunities for digital technologies in neurology and how they may impact existing care pathways in the future
  • How the digital technology market differs from the pharmaceutical market
  • Regulatory and reimbursement challenges for digital technologies
  • Her experiences in launching digital technologies in markets such as the US and Germany
  • How digital technologies can be used to enhance and complement existing treatments/pathways of care
  • Lessons other digital health, medical device and pharmaceutical companies can learn from Shefali’s experiences


The episode was first broadcast as a live webinar in June 2023.  Learn more about this webinar at https://mtechaccess.co.uk/market-access-for-digital-therapies/

Learn how Mtech Access can support you with your market access journey at: https://mtechaccess.co.uk/global-market-access-and-pricing/ 

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- Welcome to this Mtech Access Webinar. At Mtech Access we provide health, economics. and outcomes research, and market access services from strategy through to implementation. Get in touch today to discuss your market access goals. First, though, I hope you enjoy the webinar. Welcome everyone. Thank you for joining our Global Whispers webinar. This is the second in our new series, so please look out for more webinars from us coming up in the future. The topic today is market access for digital therapies and digital medicines. I'm Claire Foy. I'm a director here at Mtech Access. I work in the global market access team. We have a great mix of audience today. Thank you everyone for joining. We have a mixture of industry and healthcare systems on the call. I'd like to particularly welcome our global affiliate partners. You all play a key role in the work that we do and we're glad to have you with us. For those of you that don't know us very well, Mtech Access is a global, specialist, health economics, outcomes, and market access consultancy. We have a track record in expert delivery. We provide specially support to pharmaceutical and medtech clients. And we work as a collaborative partner to healthcare systems in the UK and worldwide. Today we're going to be focusing on the market access challenges of bringing digital therapeutics to market. I'm delighted to welcome our guest, Shefali Shah. Shefali is based in New Jersey and she's the Global Vice President at MindMaze. Thank you so much for joining us, and welcome Shefali. Please could you take a moment to introduce yourself and your role at MindMaze?- Sure. Thank you so much for having me today. This is quite a pleasure to talk about a very intense but fun topic. So yes, I am Shefali Shah, global vice president of market access and commercial effectiveness, which means that I am responsible for the overall commercial strategy and making sure that we get reimbursed for the products that we have in our portfolio. MindMaze is a digital therapeutic company, and it's focused on neurology. So before I came to MindMaze I had a long career in life sciences. I've worked at companies like GSK, Novo Nordisk, and I've also consulted with a variety of companies like Biogen and other small rare disease companies. So thanks for having me.- That was great. Thank you for the background. You mentioned there that MindMaze is a company focused on neurology. Could you tell us a little bit more about the company, what the vision is, and what you're currently doing?- Yeah, sure, sure. So MindMaze is focused on solving the disability and the morbidity that is caused by neurological disorders. So that's our vision statement. Why is that important? If you look around, you will notice that neurological diseases are the leading cause of disability globally. In the US, 50% of the health burden of neurological disorders comes from the disability and the morbidity. So it's critical for us to solve that. And we at MindMaze believe that it is solvable. And you know, why do we believe that? Because there's scientific evidence that high dose, high intensity, high quality motor and cognition training that is delivered in a immersive, engaging environment can have significant impact on neuroplasticity and brain recovery, brain health in general. So, of course, you know, we have the evidence. How do we solve for it in a way that is both scalable and accessible to all? And here as you know, technology is a, you know, it's proven time and time again that it's scalable. And it's clearly also very immersive and engaging. I mean, just ask my 13 year old who is sitting in front of video games all the time, right? It's clearly a very engaging and immersive platform. And let's face it, technology is the only way that transcends all cultural, all socioeconomic boundaries, can really reach people in a very massive way. And so if we have a big problem, we need a big solution. And we do believe that using technology is a great way. So what do we do at MindMaze? We have gaming technologies. We have devices, so we have actual physical devices as well. And we also have a data collection platform, both for the patient and the therapist to help with motor and cognition training. And this is done, you know, in coordination with the care team and the therapist for the patient. And also we have products that fit the continuum of care, whether the patient is in an inpatient facility, or in an outpatient facility, or at home. So we do believe in that continuum of care and bringing that technology across the board. One last thing, we don't stop at training. We also have assessments and monitoring for the patient because it's really important to know whether the drug that you're delivering, the treatment that you're delivering is actually creating an impact. And so we have a closed loop process of including assessments and monitoring with our platform. So that's the MindMaze vision and also how we achieve it, really.- Thank you. It's such an interesting area. I think we're all very familiar with the pharmaceutical interventions that are used in neurology and the pipeline of products that are coming in developments at the moment. But the use of technology is something that perhaps some people may not be as familiar with. It'd be interesting to hear a bit about the opportunities for digital technology in this space and perhaps how it differs from pharmaceutical developments.- Yeah, sure. Well, let's take a step back, right? If you had a pharmaceutical drug that had clinical evidence, that was safe, that had real-time visibility to data, and was scalable, and, finally, was also cost effective, what would you say as the opportunity for that pharmaceutical drug? I think you would say it's a slam dunk, right? And so that is what, if you just removed the pharmaceutical drug and replace it with a digital drug, the same opportunities should exist for digital therapeutics. Now, of course, the pathways are not set up, but there is, when you talk about a drug that makes so much sense in that it has the efficacy, the safety, the real-time data, the scalability, there are opportunities. People can touch it, feel it, and know that this is the right thing to. So it's really about, you know, reaching out. Now, of course, this is not to replace pharmaceutical drugs, right? These have a different space than pharmaceutical drugs. And in a lot of times they're complimentary. So let's us take the example of stroke. There are drugs, you need the drugs to help with blood flow into the brain areas that have been affected by stroke. So that is critical. So, you need the blood flow. But after the blood flow, you still need to train your brain, your mind, your body to recover and get back all of the functions that was lost during a stroke. So these are very, very complimentary therapeutics. With the drug and the digital. You know, another example that comes to mind is Parkinson's disease. The drugs work at that cellular level. But that's not the complete disease. The way the brain works is it needs training. It needs to learn. And so, you know, to promote any healthy lifestyle behaviours, to improve gait and balance, to address any of the comorbidities such as anxiety and depression, insomnia, this is where digital therapeutics can have such a wonderful impact in addition to the drug that are disease modifying and doing wonderful things. So there's so much opportunity to create a holistic solution for patients.- That makes perfect sense. I think having that holistic solution where the different interventions are complementing each other, that makes a lot of sense. So perhaps you could tell us a bit about the development process for these digital therapeutics and what the... I know you've worked in pharma as well, so perhaps you could compare and contrast a little bit about the process of coming up with the idea for this and developing it to a state where it's ready to put in front of a regulatory body, and the types of challenges that you might face along that journey.- Yeah, sure. So let's start with the development process. And it's very interesting because I know that a lot of different companies have taken different pathways. You have companies out there that are treating the development process very much like a drug in that the drug is blinded in a very, very carefully controlled way so that you can have very controlled trials. But I think that depends on the burden of proof that you are trying to establish. If you look at where MindMaze is, and we just spoke about it, there is evidence that high dose, high intensity quality training can and will rehabilitate the brain and will rehabilitate function. So our burden of proof is really to demonstrate that our products can deliver the requisite heart rate, the requisite repetitions, the requisite motor and cognition type of training, dual task training, and increase the cognitive load on the brain. So in order to demonstrate those aspects and the fact that it is immersive, it's scalable, there's an economic benefit, in order to demonstrate all of those outcomes, you know, we're looking at more pragmatic trials. We do have clinical trials, but we don't need the heavy blinding that is needed for a drug that is trying to demonstrate efficacy in the first place. So our development process is actually quite dynamic and fun. We do get the opportunity to bring a lot of different stakeholders into this. So we need not only the neuroscientists and neurologists, but we need engineers, therapists, regulatory. And then of course, you know, from a commercial standpoint, we do get the opportunity to give input. We also have to test, you know, you do a rapid development process where you can test out beta versions with customers, with patients. And it's really fantastic to see how dynamic this can be. Yeah.- And I think your technology is available in a number of different countries. It'd be quite interesting to hear about how the process varies in different countries in terms of actually getting the technology to the patients. Any, you know, any challenges you face there, or any learnings, I think that would be quite interesting to the people listening, thank you.- Yeah, sure. Okay, so let's start with the regulatory process and then we will go into more of the reimbursement, if that makes sense? Okay, so starting with the regulatory process. Now, let's face it, you are going through the regulatory process so that you can market your product and you can get reimbursement, right? So I will summarise the whole thing in one crude statement, and it's really coming from the perspective of the digital therapeutic manufacturers in general, in that the US is leading the EU when it comes to the regulatory process. But when it comes to reimbursement, the EU is far ahead of the US. And that's not to say that one is good or bad. I know there is very thorough rationale for why the EU regulatory processes the way it is. It's just from our perspective, when it comes to navigating through all of these different challenges, the US is a little bit easier from a regulatory standpoint. And the reason for that is that if you think about a pharmaceutical drug, you have to establish all of the clinical trial and the evidence before you're given the authorisation to launch. Whereas in the US the digital therapeutics, they're treated more like medical devices, in that if there is a predicate product that generally has low risk, then you have the ability to seek FDA clearance and not a full approval. So you get a clearance, and then you are free to market the product, unless you want to make very specific claims that were not in the predicate product to begin with. So in that case, you do need to demonstrate that the proof of burden is there on you first, right? Now, again, also, if you have a product that is de novo, that there is no predicate product in the market, then you do have a longer process in the US. But, you know, there are ways, so at least there are options, right, in the US. In the EU, you know, and I'm not an expert on their EU regulatory process, but I do know that there are more stringent requirements for data privacy. And additionally, with the MDR process, all digital therapeutics are going to be classified in at least at a minimum of class 2A, which means that a notified body needs to be able to review your application. So it's a little bit longer. Fortunately for MindMaze we already have our CE mark and you know, we have the ability to market in the EU market as well. But if we want to make any more changes, we have to freeze the product and go for that process. So I think that in that way the implications for clinical trials, it's really how much is required before you go to market. So I'll pause there because there was a lot that was said there. (laughs) And come back to the statement I had said earlier, right, about the US versus EU in terms of the regulatory process. If you want, we can just go directly into the reimbursement process from here. Does that make sense?- Yeah, I mean, you read my mind. That was going to be the next question.'Cause we know that, obviously, regulatory approval is not the end of the journey. There is the challenge of getting reimbursement. And we know from the work that we do for our clients that the pathways to achieving reimbursement's often very fragmented, more so for digital technologies and medtech than it is for pharmaceuticals. Although, obviously, there's similar challenges there, too. So yeah, it would be really interesting to hear a bit about the challenges you've faced, perhaps contrasting the areas, again, like you did with the US and the EU, just to add a bit of colour to that example. That'd be great.- Yes. Yes, yes, yes. So where do I start, right? Let's start again with the US. And let's take the example of prescription drugs. The traditional prescription therapies, drug interventions. In the US any FDA-approved drug that is deemed to be medically necessary must be covered by insurance. Now we can say there are a lot of nuances, right? We don't know at what price the insurer will cover. That has to be negotiated. If there are multiple products in the same class, that is, you know, your drug may or may not get the full coverage. It may be higher on the tier. So there is a lot of different hurdles, granted, to access. But the point is that insurance companies will engage with pharmaceutical companies because they are required to do so, right? Not so the case with digital therapeutics because they're still deemed experimental in a lot of ways. So what that means is that digital therapeutics have to establish clinical, economic, and operational superiority at a very high bar. And that bar is not really codified. Now that means there is no set standard. Now I have to acknowledge the work done by the DTA, the Digital Therapeutics Alliance. And also the DiMe Society. It's a nonprofit that is establishing clinical pathways for digital therapeutics. And they have both made tremendous progress. However, there's no mandate for their standards to be adopted by insurance companies in the US. So, are there opportunities in the US? Absolutely, yes. And I would break them down into short-term and long-term opportunities. In the short term, it's critical that we work with our providers to generate demand. MindMaze also has a category 3 CPT billing code, which means that providers are free to bill on the medical benefits side, and there could be coverage by some insurance companies. But there could also be denials. And denials are not a bad thing. It allows for dialogue and engagement to appeal the denial, right? So we need to establish that pathway. And ultimately what payers want, the payers want evidence, but they also want to see that there is a demand from their providers and their patients. So unless there is demand, they don't feel the need to cover something that is already not mandated. But if there is demand and there is economic benefit, there will be coverage. So it's critical to establish that provider relationship and start billing. And, you know, for us, of course, having that category 3 code has been a great advantage. That's the US.- Yeah.(both laugh) Do you want to talk about the EU as well, in contrast?- Yeah. Yeah, and before I go to the EU, one last thing about the US. I talked about the short-term opportunities. The long-term opportunities, there is tremendous hope and optimism. There's a bipartisan bill in congress for access to prescription digital therapeutics. And that is not only, as I said, not only does it have bipartisan support, which is very rare in the US, but also has the backing of very strong specialty organisations such as AMCP, which is the Academy of Managed Care organisations. So insurance companies, through their specialty societies, recognise the need to cover these digital therapeutics. So, and I just want to make that comment saying that there is great optimism for the future. The EU, on the other hand, the governments are recognising the challenges in front of them. For example, in Germany, there is a recognition that the population is ageing, they're going to need therapy, and there's just not enough therapists in the country. And so the state has decided to invest in digitising their care and therapy, which really opens the door for companies like MindMaze. In the UK we have some exciting news coming in. In 2023, there were new guidelines established for stroke. And those guidelines recognised the need for high dose, high intensity training and for monitoring training that is self-directed by the patient. So this is a tremendous opportunity for companies like MindMaze. Yep.- Yeah, I understand. So you can sometimes leverage those visions of the future and the things that care systems want to achieve. Could you perhaps tell us a bit about the strategies you've used to get reimbursement. For example, perhaps starting small, giving some patients access. You were talking earlier about if there's demand, then it tends to snowball from there. And I think that is a strategy we sometimes recommend to our clients, particularly in this area where the pathway is quite fragmented. So sometimes having local access, you know, in a small number of patients, perhaps, show that the technology works well and then it can grow from there. Is that something that you've seen as well?- Yes. A local market strategy is key. You know, once you have a provider, a champion, build the market around that health system, that provider, because once the provider starts billing, you will know what insurance companies are accepting or denying, and create that dialogue. So it's all about that local market dynamic, and building from... You know, the US is a very big country. You have to break it down into pieces. I mean, and in Germany we are able to, through the state, you know... Again, we're going to start a small pilot, but we will have access to almost 40% of the patients there, if we are able to get through the pilot quickly, right? So it's a very different approach. In the US you have to be laser focused on each of those local markets where you have an implementation and you make all of the stakeholders within that local market really work together. So you start with the provider, you have inpatient, outpatient, you make sure the hospitals are referring to the outpatient facility, to the inpatient facility. And as the patients are getting discharged, you have make sure there is continuity of care with the home health agencies. So there are a lot of stakeholders surrounding in that local market. So really focus on, hone in on, that local market and make that market shine. That's really the key. And collecting the data in that local market is really important. Yeah. So thank you. Yeah, good advice to your customers.- I'm curious to know now. You talked earlier about the kind of the nature of this technology and it's essentially a game in a lot of cases, isn't it? So how have patients perceived that, you know, when a doctor has told them that they've got to play this game and it will help them recover from stroke, for example, what's the reaction been from patients?- Yes, that's an interesting question. So again, digital therapeutics come in many different flavours. So, you have prescription drugs or you can have over the counter, right? You have the ability to get access to that app or digital medicine without really a prescription. We have chosen to go down the prescription route and we believe that it's important that it's a therapy that is prescribed by the doctor and delivered under the care of the therapist. And inherently the patients really do trust their therapist because you have a relationship, you're going in for an hour at a time. And so generally patients have taken... I mean, once the patients are educated, they have taken in the product quite well. I mean, again, like any drug, you will have your patients that are compliant and adherent, and then you'll have your patients who will not, right? So it's important to stratify your patients and see what the challenges are and help them. But in general, we have found tremendous positive feedback from patients because they are independent, right? So we, again, as I had said earlier, we have solutions that are in facility, but then the solutions that go home with the patient, that gives them tremendous freedom. They have the ability to own their own treatment. You know, it's like, taking a class, trying to learn the violin. You go to the teacher and you practise with a violin, but you come home and all you have is a sheet of paper that tells you to do three exercises. It's like having an air guitar at home. You can't really practise. So by giving them a tool that is telling them, look, this is the amount of repetitions you need to do. And if you are compensating, what is the quality of your movement, not just the quantity. And you get to see your progress on your app. That's tremendously empowering to patients. They haven't seen anything like this before. So they are generally very excited to be participating in these programmes. And they see results, right? They see results. So.- Has it been a similar reception from healthcare professionals? Have they been quite open-minded to accept this kind of new technology?- Yeah, I mean, again, you have a variety of people, providers, you have your leaders, your early adopters, you have your fast followers. And it's important to stratify your customers. And you know, you are going to need KOL adoption, the early adopters to lead first. Because any new process, any new drug, it is going to create some disruption in their workflow. And it makes to question and change the way things are being done. So that it comes with the territory. But our early adopters have been wonderful partners at Mount Sinai, at Zybra, they have not only helped us with, you know, demonstrating the outcomes, but also operationally making it more and more seamless. So I think that once we have, you know, it's really about taking these stories and then moving them into different organisations. So yep, that's been our approach.- Thank you. So thinking about the future now, what do you see as the future for digital technologies? Not necessarily just for MindMaze, but for other creators. You said before about the ageing population, I think there, you know, this kind of crisis is upon us of ageing patients with, perhaps, neurological conditions that will require different therapies to the ones that we currently have available. Is this an area of opportunity in your mind?- Oh, absolutely. Absolutely. I mean, every day we get evidence that motor and cognition training, meditative, you know, opportunities, these are what's going to retain vitality and connection to the community. So I feel very, very optimistic that, you know, we have so much opportunity. And look at all of us. I'm ageing, right? My family is ageing, and we are all tech savvy, right? At this point we're not where we don't know how to use the mouse, right? So we have grown up with technology, we're going to age with technology. So this is the pathway for the future. You know, we have integrated it. And, especially after COVID, have had no choice but to integrate it into our lives. So and you know, the scientific evidence on what is needed is building as well, right? So I think that there, with the two coming together, there's tremendous opportunity for a number of different situations, neurological, ageing, all of that.- It's exciting to see what will happen. I think, you know, so much has changed in our lifetimes. It'll be incredible. Continue to change. And I think what you've said has been quite inspiring. You've talked about some challenges faced and how you've overcome them. What kind of lessons do you think some of our audience might be able to learn from this, other medtech companies, pharma companies. You know, what are the challenges that you think you've learned from that you think other people can kind of benefit from, if you like?- So I think grit is really important. (laughs) You know, there is no playbook right now. And let's face it, I've launched many pharmaceutical drugs, right? And there is a general playbook. Yes, there are decisions and challenges along the way. But there is a general playbook. There is no such playbook here. And so having a commitment to your vision, you know. You'll see at MindMaze so many of us have a commitment to the vision. I personally have, you know, grown so much in my leadership, through my yoga practise that I was taught by a neurophysical therapist. She helped me learn that motor and cognitive training done in a variety of different repetitious moves will have an impact on neuroplasticity. I have grown as a leader, I have grown as a professional, as a mother, in so many ways by having that disciplined regimen for myself. And so I think that, you know, having that commitment to the vision, that you know that you are doing the right thing, that is so critical because this is a very long journey, right? So first and foremost, have that vision. Believe in your vision. Second of all, be very focused. And, you know, have a few irons in the fire because not all of them are going to take hold. So you do need options, but you cannot spread yourself thin, either. So make sure you have a few irons in the fire that are very analytically determined. You know, dive into the data and figure out what those irons are for you. And then the third thing is process. Make sure you have a really strong process for scalability. And then fourth and final is do it with empathy. You know, bring people along. This is not something that is just going to happen. We have to bring the masses along, and that can only be done with empathy and dialogue. So I thank you for this opportunity because this just helps, you know, further that dialogue and that empathy to tell the story to everybody. So thank you for doing such important work.- Thank you. It's been very interesting. I think I'd like to just finish with one final question. You talked about how some countries are, you know, looking at the future and coming up with policies that reflect the greater adoption of digital technologies in healthcare. What would you like to see changed based on the barriers and challenges that you've faced? I mean, we've talked a bit about how fragmented access can be. Maybe the different regulatory requirements. What would you like to see happen over the kind of short, medium, and long term?- (laughs) That's an interesting question. I think we have to be in the present moment and accept where we are,'cause only then, you know... I don't know that I want, you know... I wish this was the true is not a recipe for... You know, it is what it is. And you have to live in the present moment and make things happen. What I would like to see is, you know, that we have established enough value, and not just MindMaze, but other digital therapeutic companies as well. And I know a lot of people who are working in peer companies in different areas, and we know we're committed bunch because, you know, we are in a lot of conferences together and we know we are a committed bunch. We're a small but committed bunch. And we're mighty. And we believe in this cause and we are going to chip away at this one at a time. So it's not just about MindMaze, but the whole industry to succeed in a very meaningful way. So yes, I would like to see that.- Thank you. Shefali, that was very interesting. I think, you know, this area is fascinating. It's innovative, it's changing all the time. It's been, very, very interesting to hear about it, and thank you for your time. Yeah, and thank you to the audience for listening. We tried to cover some of the questions that you sent, but if you have any other follow-up questions that we didn't cover today, we'd be happy to come back to you. So please do get in touch. And yeah, thank you everyone for taking part. That was really great. And we look forward to presenting more webinars in the future.- Thank you so much, Clare. This was really fun.- [Clare] Thank you for watching. If you'd like to find out more about our work or how we could support your market access goals, please email info@mtechaccess.co.uk or visit our website at mtechaccess.co.uk.