In the second of a two-part episode about suicide, Dr. Seth Feuerstein, the CEO of Oui Therapeutics, discusses the exciting potential of digital therapeutics in preventing suicide. As he says, “So we can use software to tackle problems where we already have lots of prescription options, but -- the thing that really excites me is where can we use software to solve problems that were not previously solvable.
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Seth Feuerstein:
So we can use software to tackle problems where we already have lots of prescription options, but life and death situations where we don't have good answers. The thing that really excites me is where can we use software to solve problems that were not previously solvable?
Daniel Kraft:
Welcome to Healthy Conversations. I'm Dr. Daniel Kraft, and now we're in our second part of a two-part series with Dr. Seth Feuerstein, a psychiatrist, faculty at Yale, and the CEO of Oui Therapeutics. Seth, on our last conversation, we kind of covered the huge challenge of suicide and suicidality. Maybe if you can just give us a 30-second recap about what the problem state is in the US, around the world, and why it's so critical that we find new ways to address suicide.
Seth Feuerstein:
Suicide is the number two cause of death in the US of people in their teens and their twenties. The number four cause of death for people in their thirties, forties, and fifties. It's the only leading cause of death without any prescription products, and it's a cause of death that's been increasing for a couple of decades. There's approximately one and a half million people a year with a suicide attempt and approximately 14 or 15 million a year who think about suicide without really good options that people can prescribe or offer their patients.
Daniel Kraft:
Yeah, it has huge societal costs, and many of us who are health care providers don't often feel well-equipped to deal with those who have suicidal ideations or symptomatic suicidal behaviors. You've recently launched a company called Oui Therapeutics helping clinicians manage and treat these patients. Can you, first off, explain to us what is a digital therapeutic and how might it be used to replace or supplement more traditional therapies, particularly in the setting of mental health and suicide?
Seth Feuerstein:
The phrase "digital therapeutic" is getting tossed around a lot these days. I like to be more specific and say "over-the-counter digital therapeutics" or "FDA approved digital therapeutics." So over-the-counter would be more like vitamins, things that are not regulated by the FDA that are essentially offered in combination with other products that's software and hardware driven to provide an intervention or a therapy in one way or another. Medical devices like pacemakers and hip implants, and drugs like the statins, or the antidepressants, or the antibiotics were the two categories before this.
FDA approved digital therapeutics is a new category in 2017. It was actually created by legislation and then the FDA implemented it, and this new set of rules created something called "software as a medical device" and essentially mandated that the FDA regulate this area and create this third leg of the stool, if you will.
Daniel Kraft:
There's lots of consumer digital apps out there from smoking cessation to forms of mental health to exercise to managing almost any element of care. But to be FDA cleared, you have to bear a few hurdles. Can you help discern what those might be?
Seth Feuerstein:
Generally speaking, it would be the same kind of thing that a drug might go through. I think toxicity is a little bit less of an issue for the most part with software as a medical device. The thing that really excites me is where can we use software to solve problems that were not previously solvable? So we can use software to tackle problems where we already have lots of prescription options, but life and death situations where we don't have good answers. And that's something that's really potentially breakthrough from my perspective and something really exciting to potentially work on.
Daniel Kraft:
So let's dig into that. So your company, Oui Therapeutics, has created a tool for helping manage patients with suicidal ideation and beyond. How does the platform operate?
Seth Feuerstein:
I had a lot of experience by chance early in my career. I founded a first generation digital therapy company back in 2009. Just for context, that was a time when, if things didn't work on your computer, that was because our DVD ROMs were scratched. That's how long ago that is in the software world. We scaled that to tens of millions of covered benefit lives. So from that experience we learned that patients do like interacting with software and, in this case, we made it apps that go on your smartphone. And patients interact with that, and there's a multidimensional interactive experience where you might work with a chatbot function, you might interact with other patients, you might work on practicing exercises to refine the way your brain might react to certain situations. And we combine all of those things into a multi-week experience that typically lasts about 10 to 12 weeks for a patient. They get offered it by a clinician, and they interact with it at their own pace over those two and a half months or so.
Daniel Kraft:
Just maybe take that and dig down into a patient who's recently had a suicide attempt and they're now on the Oui platform. What do they actually do, and how does the clinician interact with that information?
Seth Feuerstein:
In some ways it's like what they do when they're prescribed a drug. In other words, they get prescribed the app, they dose the app according to a schedule that they are told by the clinician, and then can follow through up on their own, which is similar to with a medication. I'd say some of the differences are that clinicians can check in, they can see what's happening, and they can interact with the patient. I would say more interaction is better. One of the nice things about it is that an app can remind them to do more and can learn from some of the information that they've entered to help nudge them along in certain ways. In terms of what's required of the clinician, really it's just to be a responsible and thoughtful steward of the experience.
I do think that in the future there'll be more ways to have more interaction with the clinicians. We want to make sure we're bringing them along on the journey so they can provide more useful tools. I will say an important part of this are the payers. We've had really good relationships and conversations with some payers including, for full transparency, the sponsor of this podcast. Payers do seem interested in allowing the right digital tools with the right data to be reimbursed and used with their health plan members. One way to think about it is the early days of the patient portal. It was not a good experience for patients, and so clinicians would send a message, patients had a hard time logging in. We're trying really hard to avoid that, and so we only want to require what's absolutely necessary for all the parties.
Daniel Kraft:
For the patients, it's all about user interface that might be tuned to age, culture, language. What might a session look like on Oui Therapeutics' platform?
Seth Feuerstein:
We're very mindful of that. There's no questions, some patients respond differently to different experiences, language, so we include different types of peer and group therapy type content that aligns with a diverse set of individuals. I might log in and I might be speaking with a chatbot, and that chatbot explains that they're going to guide me through a certain exercise. And in that exercise I might get to watch four or five other patients and pick one or two or all five of them and see what their experience was like doing that exercise, and then apply what they did to my own experience doing that exercise.
And what's interesting is some patients like to choose people who have had different experiences or look different to them, which helps them realize that, in fact, the experience that they're having is a more universal experience and not just limited to people like them. That's akin to what might happen in a good group therapy session.
Daniel Kraft:
Got it. And as a digital therapeutic that you're trying to get through this FDA process, it's often still about comparing it to standard of care. So as I understand it, you have a design right now studying your intervention, comparing that to in-person therapy that had good results in reducing suicide attempts in military folks. Can you tell me about that study and how you find the methodology evolving?
Seth Feuerstein:
We founded our company a lot like a biotechnology firm. We worked together to create a single software intervention that took the best assets from the very best interventions and put them in one place. The study you're referring to was published in 2015 and was actually launched a few years before that. So the researchers, what they showed was that just 12 doses of this digital therapy delivered over just a couple of months was far more impactful than all the treatment that these patients were receiving. So everyone in the control arm got everything. They got medications, they got therapy, they got inpatient, they got everything the system could throw at them.
But just 12 doses of this intervention, in that particular study, reduced suicide attempts by more than 60%. They estimated that they reduced, by more than six out of 10, the number of suicide attempts that were occurring in those populations over just a period of several months. They did follow up for almost two years, which is a very long time for follow up and found that the intervention seemed to have a bigger effect the longer you looked after only 12 doses.
Daniel Kraft:
And are you digitizing that in-person type of intervention?
Seth Feuerstein:
Yeah, so it's following up and layering in additional tools and resources, but that is a core part of what we do. The first data around the intervention was actually published in the Journal of the American Medical Association in 2005 by our team. And I think the thing that was shocking to me was that we could have an intervention that showed it was cutting potentially deadly events by more than half, and I couldn't find a single psychiatrist or psychologist, scanning across hundreds and believe it or not actually hundreds of thousands because I was at a national health insurer at that point after selling my first company. I couldn't find anyone doing this intervention.
That was a top five killer of groups of people in this country in different age cohorts, and there's something that can reduce their risk of a potentially deadly event by more than half and nobody's getting the intervention. That is a tragic situation, and it's fundamental to why we do what we do and what we built.
Daniel Kraft:
And as you're building this, you've been able to develop separate tools for children, adolescents, and adults. How do you see the data and the interface shift?
Seth Feuerstein:
There's no question, kids are different. The brain is still developing into your twenties, and what you expect when you're 15 is different than when you're 20. No question. They're still developing their ability to understand when their brain isn't functioning well and when stressors are really pushing them to the limit. They also need to go to adults very often to access interventions in care, but I think most of us can remember when we were teenagers communicating with the adults in our lives and especially our parents wasn't always that easy. We didn't necessarily have the words. We were scared because we were afraid how they might react.
So we're actually using software to create an adult support network around at-risk youth. The preliminary studies around which that software is based showed an 80% reduction in death among at-risk teenagers over 10 years from suicide as well as from accidental drug overdose and all violent deaths. And we believe that's because the software helped those adults understand how and when to communicate with those youth and vice versa when the youth can and should be communicating with the adults. They now had a more fluid way to access an intervention. And that intervention doesn't necessarily need to be a doctor and it doesn't necessarily need to be a treatment. It needs to be communication and rescue, essentially.
Daniel Kraft:
That's super impactful. Of course you can't just prescribe the pill or the device. It's interacting with the socio and your family, friends, and community that often play a big role in outcomes. Have you seen any reluctance from providers or payers to think about this new digitally enabled mental health approach, and how might you address those misconceptions?
Seth Feuerstein:
Innovation is a process, and so what we've seen is that, around suicide and around what we are doing, payers have been pretty receptive. They recognize that there aren't good options for their health plan members. They also recognize, if what we're doing works, it saves them a lot of money. There's no question that health insurers want to see good results. From Aetna and CVS, incredible support around the mission and the outcomes. The first large Blue Cross Blue Shield plan just announced full coverage of FDA approved digital therapeutics. We expect that trend will continue. In some ways what we are doing is specific, kind of like a new cancer treatment or for an orphan disease. It's something where there really aren't good options, and people do want to figure out how to cover that.
Daniel Kraft:
And of course CMS drives a lot of this in terms of reimbursement codes and they have a new billing code, as I understand it, earlier this year. How does that change the game?
Seth Feuerstein:
I think there are two ways that CMS will help drive success in this area. One is, as you mentioned, coding to pay for the digital interventions. The other is to provide reimbursement for clinicians to spend time with their patients around those digital interventions. And I think we'll see a trend from CMS and elsewhere where they're encouraging follow up and connectivity with their patients around treatments, around social determinants which will also help drive adoption.
Daniel Kraft:
And are you seeing this ability to create digital health formularies not just for cardiovascular disease and diabetes, but now across mental health?
Seth Feuerstein:
Absolutely. The first formularies that came up that received widespread attention were from CVS Caremark and Cigna Express Scripts. Those were largely over-the-counter digital tools. I think we're going to see them evolve where this is finally a place where value can really come into the prescription environment. I think there's been a lot of tension for a long time between the pharmaceutical industry and the payers around the value that each prescription brings in the drug world. One of the great things about software is we can collect a lot of data on outcomes and utilization, and I think payers want to pay for that. They just want to know what they're paying for. And digital provides a platform for them to do that through those formularies.
And I don't want to leave out employers. Suicide, when you think about the statistics I laid out at the beginning of our discussion today, if you look at any large employer, and large employers are usually at risk for the costs of their employees healthcare benefits, that means that suicide is a leading killer of their working population. Suicide is taking between five and 15% of all of their employee deaths. Think about that. Approximately one out of every 10 employee deaths is from suicide. Suicides are extremely costly to those employers, both from a loss of good personnel, spiritual wellbeing of the team, disruption in the workplace. They want to pay for that.
Daniel Kraft:
Yeah, I think number one, of course there's always the reimbursement and regulatory challenges, but then there's also the challenges to get those solutions into the hands of clinicians and their patients and into the workflow without having to log into 12 different apps. Where are we on that paradigm?
Seth Feuerstein:
It's tricky. I think in some large health systems, they've already selected certain platforms for certain problems that I would say generally lean towards low intensity, less sick patients. There are some platforms that have a half dozen or a dozen different interventions around mood, and sleep, and anxiety. I don't think it's clear yet what the right place of distribution and commercialization will be for these products. My guess is it'll come from a variety of places initially.
What I can say from my own experience is that patients are not the issue. Patients like the tools, they use the tools, they interact with the tools much more than they do with traditional office visits. The patients are not going to be the roadblock here.
Daniel Kraft:
And so just to finish up with what you're doing with Oui Therapeutics, where are you now in this development process?
Seth Feuerstein:
We have multiple products going through the FDA. We're optimistic that within a year or two, the first ones will be available to patients. We are actually working on some things that will not require FDA approval that should be helpful around suicide. More to come on those fronts.
Daniel Kraft:
Fantastic. And just to close with putting our futurist hats on, if we were to jump forward 10 years, do you think, with these new emerging digital layers therapeutics, new forms of data, analytics, we can start to inoculate against the issue in the first place?
Seth Feuerstein:
I don't know if we'll get to inoculation in 10 years, but I do think we may get closer to what we see for cancer, where we've got certain subtypes. Cancer is a whole group of diseases. I think the types of suicide risk are going to be one of those areas. And I think there are going to be some patients where we really can understand who they are in advance and almost completely eliminate their risk. I think there are going to be some cases where we can significantly reduce their risk, and then there are going to be some where we're still struggling. And that's where I think we'll be probably in eight to 10 years.
Daniel Kraft:
And in my world of oncology, we now have the ability to sequence, sometimes multiple times, or look at the cancer stem cell protium. Hopefully this era, precision mental health will continue to unlock pieces in the neuroscience of the brain and hopefully being more proactive and preventative rather than waiting for the therapeutic component.
Seth Feuerstein:
I completely agree. I'm extremely excited for the next decade.
Daniel Kraft:
Well, number one, thank you, Dr. Seth Feuerstein, for your amazing work in the space in the past and now and into the future. And thank you so much about sharing with us on Healthy Conversations. For those of you who are listening and you missed our initial episode, Dr. Feuerstein and I had a fascinating discussion diving into the etiology, the current state, and the challenges and opportunities to understand suicidal ideation, suicide in general, and to hopefully move the needle in that regard more broadly. So thanks for joining us on Healthy Conversations. We'll see you next time.