Meet Drs. Patrick Gleason, PharmD, and Nick Friedlander, PharmD

Gregg Masters

This is the AMCP Podcast Series powered by PopHealth Week. Welcome everyone. I'm Gregg Masters Managing Director of Health Innovation Media the producer co-host of the show. Joining me in the virtual studio is my partner, colleague and co-host Fred Goldstein, president of Accountable Health LLC. On today's show, our guests are Patrick Gleason PharmD, Assistant Vice President for Health Outcomes. And Nick Friedlander, PharmD Clinical Programs Pharmacist also in the health outcomes division. Prime Therapeutics is an innovative pharmacy benefits manager or PBM, that launched in 1998. Formed by two Blue Cross and Blue Shield plans. And with that brief top line, Fred, over to you.

Fred Goldstein

Thanks so much, Gregg and Pat and Nick. Welcome to PopHealth Week.

Pat Gleason

Hello, Fred.

Nick Friedlander

Thanks for having us.

Fred Goldstein

Yeah, it's really a pleasure to get you both on and why don't we start, Pat, give us a little bit of your background and then we'll go to Nick

Pat Gleason

great pharmacist by training, health services researcher as well. Current title at Prime Therapeutics, my employer as assistant vice president of health outcomes been at Prime for just under 20 years. I'm also an adjunct professor in the University of Minnesota College of Pharmacy, a pleasure to be here and talking about digital therapeutics with you Fred.

Fred Goldstein

Fantastic and over to you Nick

Nick Friedlander

Thanks, Fred. I am a current clinical programs pharmacist on Pat Gleason's health outcomes team here at Prime relatively new employee. I completed the pharmacy residency program at Prime Therapeutics and started on with Pat's team, immediately thereafter, proud graduate of the University of Wisconsin School of Pharmacy and happy to be here to discuss digital therapeutics today.

Fred Goldstein

Yeah, that's fantastic. We've had the I believe he's the current president of the University of Wisconsin governor Tommy Thompson on before so it's great to get another representative from the University of Wisconsin. So why don't we start first, Pat, give us a little background into Prime Therapeutics.

Pat Gleason

Yes, thanks Fred Prime Therapeutics, is a pharmacy benefit manager (that's a PBM in the lingo), so Prime started in 1995 by Blue Cross Blue Shield plans a few of them. Currently we're partnering and owned by 19 nonprofit, Blue Cross Blue Shield plans across the US as our owner clients. I will say that this unique ownership structure makes it possible for us to remain absolutely committed to the health of our members that we serve Prime Therapeutics as a PBM serves over 33 million Americans, and then with our relationship with our health plans, and we're servicing employer groups and their employees and family members, government programs, including Medicaid and Medicare. We believe in health benefits landscape founded on fairness and focused on outcomes. And with our 19 BlueCross BlueShield plan owners are providing total drug management by integrating drug services across both the medical and pharmacy benefits and more recently, in looking into in helping to assess the value of in determination of the clinical offerings that are provided by digital therapeutics in the marketplace.

Fred Goldstein

That's fantastic, Pat. So why don't we get into this a little bit, this whole issue of digital therapeutics, perhaps let's start with what the heck are digital therapeutics?

Pat Gleason

So digital therapeutics are generally software applications that you can download say on your phone. They're, they're out there to help with the patient, the individual, we call those insured members, when we're a pharmacy benefit manager providing services and coverage for things like digital therapeutics for in the case of insurance, they may sometimes be paid for by insurance. So these applications are generally helping the patient and provider, the physician, nurse practitioner, with the management of the given disease. Examples of digital therapeutics out there to help with diabetes management, including monitoring what foods you take intake in the caloric intake of given foods, your exercise program, your blood sugar's any other any symptoms of low or high blood sugar, providing support with given weight management, exercise, food, caloric intake and glucose monitoring that through blood sugar, that would be an example of a digital therapeutic that would help with those the service offerings and maybe even providing coaching as well. So digital therapeutics around the gamut of many conditions help with many, many conditions, they may also help with the drug therapy that is associated drug therapy management associated with those conditions. Digital therapeutics also have a varying degree of their ability to interact with and provide to a given healthcare professional information about the given the condition being managed to some of them are really for the individual patient, only others are connected to the provider and ultimately can information can flow into the electronic health record or electronic medical record that is being maintained by your physician and provider. So there's a there are many there are literally 1000s of digital therapeutics. I will say that there are very few though only six that are FDA approved as prescription digital therapeutics meaning that they are intended to be written for as a prescription from the prescriber, the provider healthcare professional that has prescriptive authority to be given to the patient to then be submitted for insurance coverage in and then that given coverage paid for by your insurer provides access to open up that digital therapeutic application. And so there is a difference between that prescription digital therapeutic and other digital therapies in the market that we may want to explore. I'll toss it over to Nick for further. I'm sure I missed some things here. Nick, do you have further thoughts?

Nick Friedlander

Yeah, Pat that was excellent, really robust background on digital therapeutics as a whole. I guess what I would add here is that there is a very important distinction between kind of digital health products and digital therapeutics, specifically, because digital health products really run the gamut in anything from wearables, like a Fitbits, or Apple Watches, to telehealth applications and medication adherence applications. Digital therapeutics, really more specifically, are intended to have direct impact on clinical outcomes that can be measured. And this is kind of the idea behind needing research and trials to support the value of these products. And why some of them can be approved, says it's because they have a demonstrable effect on clinical outcomes. And that's something that I think insurers are interested in seeing. And something that sets apart some of these FDA reviewed products, that necessarily make specific health claims. So I would just add that really, there are 10s of 1000s of digital health products. And then within that there are 1000s, of digital therapeutics, and then a much smaller subsection that have and have evidence to support them and have undergone FDA review.

Fred Goldstein

Yeah, I think it's a really good point that you brought that out, because we've talked about it before on the show, Greg and I and others, this whole issue, everybody out there has got an app, they're all building these apps, but but as you point out, very few of them have data to back up what they do or claim to do. And even fewer have enough of the data to I guess, meet that FDA approval. And so those are areas that you as a PBM are beginning to say, Maybe we should begin to integrate some of these into our therapeutic offerings for patients within our drug plans.

Pat Gleason

Yeah, I respond positively to a yes to that for Fred. And we do that through what historically has been used the term formulary review and with the Prescription and Therapeutics Committee Assessment, that's a body of external health care professionals, physicians, pharmacists, generally, and it's a pretty standardized process. It goes back many years to assess generally pharmaceuticals. And that what they call P&T that pharmacy and therapeutics committee is presented, usually, with information summarized by in this case Prime Therapeutics, team of healthcare professional pharmacists. Experts in data, in medical data review, and economic assessment of the value that a given product may bring to the marketplace assessing the impacts on outcomes, hospitalizations, other events avoided, hopefully by that given product, as well as assessment of safety, and then the uniqueness and the delivery. convenience factor that a given product, pharmaceutical may have. So in those three areas, the P&T is presented with information and then makes and provides guidance as to whether or not the insurer should cover that product and pay for it through the insurance. So using that pathway of review, we're looking to bring that assessment process and rigor to the digital therapeutic space in particular to the prescription digital therapeutics that are FDA approved. And right now there are six of those in the in the areas of Attention Deficit Hyperactivity Disorder or ADHD. There's one it's actually a game that helps manage ADHD a handheld video game. Irritable Bowel Disease. So thats a really painful and upset stomach and it's just chronic and ongoing. So Irritable Bowel Syndrome. Insomnia, chronic insomnia or sleep, difficulty sleeping. So Cognitive Behavioral Therapy is really what the application is. It's it's coaching and training and helping to control symptoms and, and train you to avoid triggers and address issues with trying to sleep. A fourth a prescription to do therapeutic is for cognitive behavioral therapy and substance abuse disorder. A fifth is specific to opioid abuse disorder and lastly Post Traumatic Syndrome or PTSD, driven traumatic nightmare, digital therapeutics. So those six are unique in the marketplace, in that they have prescription FDA approval for the given products.

Fred Goldstein

So before we get into the products you're using, can you talk about I'm thinking about having sat on a P&T committee going through that process for a pharmaceutical? Are there differences when you go through that process for a digital therapeutic? I'm thinking things like adverse events or stuff like that? Are they similar the same? Or do you look at it slightly differently?

Nick Friedlander

Yeah, Fred, I think that's a really great question. I think really, at its core, the process is fundamentally similar, we still want to see safety and efficacy. Admittedly, with something like a digital therapeutic, the risk for adverse effects that are serious is obviously much lower than with a drug, it's difficult to really anticipate serious adverse effects associated with interaction with a screen or video. At this point, there really isn't evidence to support that. And I think the FDA takes that into consideration when they're evaluating the evidence around these. And the obvious difference that we see is much smaller, less robust clinical trials, supporting their approval. With that said, I think we still want to see a demonstration of efficacy. We also ideally want to see real world evidence supporting benefit of the product in populations outside of the clinical trial and users of the actual application in practice. And I think the one really unique consideration around the digital therapeutics, when it comes to evaluating them is around the security of data. And this is not an assurance that's given by an FDA by the FDA when they approve an application. They're simply looking at efficacy and safety data at this point. So really, I think it's important to have assurances around so the data handling abilities of the manufacturer in question, and have those conversations with the manufacturer to ensure that they're protecting member data and member privacy, particularly in some of those sensitive health conditions that Pat mentioned that there are digital therapeutics currently approved for

Fred Goldstein

I think, Nick, that you raise a fascinating point I hadn't thought of which, which is, the FDA is going to approve that. Because it showed that in patients with these conditions, we saw these better outcomes, etc. But they don't do anything in regards to security. So do you specifically have to develop sort of the questionnaire or approaches to ensure that what they're doing meets those security requirements?

Nick Friedlander

I think that is a really essential element of the conversations that we have with manufacturers, when we're considering the addition of these products. I think we also have to look at the history of the company as far as how long their products have been around, if they've had issues raised with data security in the past. I think that this is a very new and novel space. So it is difficult to have those assurances from kind of any regulatory body at this point. But there are bodies that do offer accreditations in this area that can be looked at. But I will say that I think that it is really key to have those conversations when determining whether these are suitable for addition. And it's not really something that we can externally evaluate without an a buy in from the manufacturer and the ability to get information around their data security and data privacy handling concerns.

Fred Goldstein

So you know, I'm thinking about past P&T committees and I never recall having an IT expert on the committee. Have you had to bring in that kind of expertise, or how are you looking at that?

Pat Gleason

Yeah Fred, that that will be a component that will be necessary. So the answer is yes.

Fred Goldstein

Wow. Fascinating. I mean, that's a unique thing to consider, obviously, as we move into this space, and there's others consider digital Therapeutics is bringing in that kind of expertise to a committee that's typically been very clinically and data driven. So fascinating.

Nick Friedlander

Yeah, Fred, one thing I guess I would add in In addition to kind of that data security element is the usability concerns around these as well. familiarity of the population is that you have membership in whether they're, you know, used to using phone applications, if they have kind of that same familiarity with them that the clinical trial population had. So I think usability, accessibility, the need for high speed internet, typically a wireless, high speed internet connection, and Wi Fi in the home is really preferable to any other option, the need for a smartphone. In the case of the application for PTSD, it also actually requires additional hardware that the member would be expected to have on their own. So these are some additional factors with them that maybe aren't, don't reach the same level of evaluation needed, that security does, but certainly something that we've thought through around these applications and kind of some barriers to access for them that are unique.

Fred Goldstein

Right now, obviously, you mentioned earlier, we'll kind of diverge here a little bit this, you know, your plans, take Medicare, Medicaid, commercial, you know, the and other groups. Are you concerned, I know, there's a lot of concern now with a digital divide, that perhaps we further that by bringing these types of apps in that then require, you know, an internet connection which certain populations may not have access to. And if it's something you're considering looking at how you might rectify that in the future.

Nick Friedlander

I think that's a really very realistic concern. I will point out that one thing that's sort of interesting is recent census data really suggests that the internet accessibility issue is becoming less and less severe as we move forward. As far as rural access and low income access. There are still obvious limitations in both of those populations, but the majority of individuals making less than $30,000, and the majority of people in rural communities, for most recent census data actually do have high speed internet access and Wi Fi. So I think that, you know, that's certainly a consideration. And hopefully, in the future, this will continue to be less and less of an issue. But I do find it interesting that, you know, smartphone access, internet access, and things are becoming more and more ubiquitous, regardless of income and where somebody lives in terms of rural or urban communities.

Fred Goldstein

Right. And obviously, it's part of the infrastructure bill. So we'll see if that gets through to put I think $100 billion to communities, which would be great to give them access. And interestingly, I noted when I was looking through the press release, and let's get to your the products that you've actually brought on board, Pat perhaps you'd like to discuss what those are, and and why you chose to use them.

Pat Gleason

Sure, Fred, I do want to touch on if I could. The health disparity issue just mentioned, I'm happy to talk about products in a moment. But I would like to add that there is concern that these some of these products are meant to be cognitive behavioral training, and they're in English, and we have many native, non-native English speakers. So when we do asking the manufacturers, minimum, they include Spanish as a language in as many other languages as possible, so that we don't create these health disparities that we know exist as well.

Fred Goldstein

Yeah, I think that's a that's a great point. I'm glad to hear you're doing that. I know that in some of the programs, the states would require, depending on their populations, you had to produce your materials in up to five, you know languages, in one of the programs we worked on, we end up with people who spoke 65 different primary languages, obviously, getting to that point, it's really difficult, but at least focusing on those major ones is great. And it's, I'm glad to hear you're pushing the manufacturers to do that.

Pat Gleason

Right. Yeah. So and then to address the question you pointed to me. So right now, our focus is on the prescription drug therapy sub marketplace to review and do a deep dive into and provide guidance and recommendation to our Blues plans. So I think the Blues plans, ultimately, are going to make the insurance decision decision coverage. So when our review is provided to them, we started with the pair of therapeutics product reSet O, for cognitive behavioral therapy and opioid dependence, providing a recommendation to cover that product, as well as we have a value based purchasing agreement with that manufacturer as a part of the press release. And that ensures that this this given program has a list price of $1,665 for an 84 day service. With the application is that it's that there is value to the product and when individuals may discontinue, not continue to use that application after a period of time prior to that 84 days from which the clinical trial data showed there was benefit in patients staying actively engaged with their providers on their substance abuse, and opioid abuse treatment program. That was the value that the product delivered and we we felt we needed to ensure that we receive some remuneration if an individual were to discontinue early use of the application. We also have contracted terms around that there is a total cost of care reduction, that there's an event avoidance that the provider is actually the prescriber and the caregiver here in terms of any healthcare professional is is accessing that data too. Because what is unique about these prescription digital Therapeutics is that there is a communication of the patient's activities and use of the application to the to the healthcare professional, that that is a differentiator from other digital therapeutics in the marketplace. Those that are prescription data, therapeutics have that data transfer availability portal information for the healthcare professional to ensure that they're having a conversation with their their patient about use of the digital therapeutic.

Nick Friedlander

I would also add, Pat, that one really unique things around the digital therapeutic is kind of with the exception of some of these ingestible sensor technologies that we're also seeing in the digital health space, we'd never really know whether or not a member is actively using their therapy, in a lot of cases. And a lot of that can be attributed to automatic pharmacy refill programs, 90 day supplies, it's really difficult to track whether members are actively engaging in using their therapy, particularly those are dispensed from a pharmacy, and the digital therapeutics are really unique in the ability to really actively track engagement with the application and see how much members are utilizing it. And really track if there is a drop off after a period of time, if members aren't using it, we're able to have some visibility into that that wouldn't be possible in areas outside of the kind of digital space.

Fred Goldstein

And Nick, the, you know, these are for substance use disorders and opioid abuse disorders that the two apps you're using, what do you believe they bring in addition to what you would have in normal therapy? How do you expect this to work?

Nick Friedlander

Sure, I guess from the clinical trial perspective, what they really demonstrated was a statistically significant increase in retention and outpatient treatment relative to a control group that did not use this application, in addition to kind of their baseline outpatient care for substance use disorder. So really, the expectation is that that is a surrogate outcome measure for long term success in rehabilitation. And what we would expect to see, I guess is, like Pat mentioned, reductions in the cost of care and reductions in hospitalizations, and ER visits, basically improvements in overall health, that would be akin to improvements in rehabilitation long term. So the way that I envision this working is really, as it's indicated, as a supplement to everything else that's given as part of comprehensive outpatient treatment for substance use disorder. So in addition to in person therapy members are able to access these cognitive behavioral therapy modules that can reinforce some of those things that are learned through those in person sessions, maybe touch on specific issues that are not addressed in those sessions that are relevant to the member. They have a large number of optional modules that members could be able to select independently that might be beneficial to them uniquely. So that flexibility to have focused cognitive behavioral therapy in areas that are relevant to them. It also is really essential that it has that provider integration. And so it's able to share information around cravings, triggers, and other things that might be of relevance to the provider and kind of determining if maybe there needs to be an adjustment to therapy to increase their likelihood of long term success. Or maybe it changes to their in person therapy. So it really providing that enhanced visibility to the provider around what's going on with the member who's in recovery. So I really envision is sort of this additional digital support system for individuals who are struggling with substance use disorder and who are amenable to using this digital app as a means of receiving cognitive behavioral therapy and providing information to their physicians as well.

Fred Goldstein

That's, that's a great answer there, Nick, really appreciate you getting into it. And that depth, I think we're gonna have to get you both back on and maybe hear about how this worked in the future, as well as to discuss other areas in digital digital therapeutics that you might be looking into or excited about. So with that, Pat, Nick, I'd like to thank you both for joining us on PopHealth Week.

Pat Gleason

It's been a pleasure. Thank you.

Nick Friedlander

Thanks so much for your time. Appreciate it.

Fred Goldstein

And back to you, Gregg.

Gregg Masters

And thank you, Fred. That is the last word for today's broadcast. I want to thank doctors Patrick Gleason, Assistant Vice President for Health Outcomes and Nick Freelander clinical programs pharmacist in the health outcomes division at Prime Therapeutics for their time today. For more information on Prime Therapeutics go to www.primetherapeutics.com and do follow them on Twitter via @PrimeTherapeutics. For the AMCP Podcast Series Powered by PopHealth Week my co-host Fred Goldstein and Dr. Gleason and Friedlander, This is Gregg Masters encouraging you to follow and subscribe to this series at www.amcp.org/podcast.