Garth Sundem 

Welcome to this episode of the Medical Affairs Professional Society Podcast Series, Elevate, gathering the voices of Medical Affairs thought leaders and stakeholders to explore current trends, define best practices, and empower the Medical Affairs function. I’m your host Garth Sundem, Communications Director at MAPS. And today we’re speaking about building Health Economics and Outcomes Research capabilities within Medical Affairs, with Kent Summers HEOR lead at AlphaGroup. And Steve Camper, VP of Medical Affairs at Blue Earth Diagnostics. This podcast is brought to you by Alpha Group, an independent medical communications agency founded on precision, integrity and passion. Kent, let’s start with you. So why does an organization need an HEOR department?

Kent Summers 

Well, thank you guys. I appreciate it, and joy, the opportunity to be with everyone today. First of all, I think the biggest issue with HEOR the biggest value is to be able to leverage the full value of your asset or your product to ensure the appropriate utilization of it in the largest swath of the population possible. In a sense, he or health economics and outcomes research translates clinical features into economic benefits. And we’ve all we’ve all heard of EBM evidence based medicine. If you think about it, health plan administrators, those folks who work in health plans, they’re at the tip of the spear of IBM, they have to use evidence to make informed decisions regarding the utilization of your products once they’re out there on the market. So he or develops the scientific evidence that makes the clinical features that are both tangible and relevant to IBM decisions, EBM policy decisions. So it develops that great breadth and pot and preponderance of evidence to help inform better policy decisions. It’s also used more recently in developing new and innovative clinical designs like large simple trials, pragmatic clinical trials. And it’s used to generate innovative treatment approaches, for example, you can get into the databases and better understand what are the current treatment patterns? Where does your product fit in? Does it fit in early does it fit in late and helps the policy decision maker understand just where is the sweet spot for your product with evidence, it’s also used for site identification. We’ve used this, for example, to vet investigators to make sure that if even though they’re willing and able to do a clinical trial, that they’re seeing enough patients in their in their site, that they can enroll safe, that we feel confident that they can enroll enough patients to participate in your clinical trial. And then also the FDA has recently come out and in fact, they’re doing this. They’re using real world evidence, observational data from administrative databases to evaluate the safety of drug products, which makes a whole lot of sense. You know, historically, we use clinical trials, randomized trials, but when it comes to safety, really large populations of people, and evaluating what happens to them when they’re exposed to the drug makes a whole lot of sense.

Garth Sundem 

Okay, so Steve, you’re over on the MSL side of the world. So you’re, you’re you’re using a Glr, right, you know, with with your MSLs, and taking this agio are driven insights to the HCP side of the world. So what are you seeing with HEOR? From the MSL perspective, man, we’re gonna get enough acronyms in here today. But and our HCPs you know, responding to this using it? Is the landscape changing?

Stephen Camper 

That’s an interesting question. And I’m really kind of, I think, in a in a little bit of a unique position because I’m Yes, I’m involved from from the field medical side, but also from the strategy and development side. So it’s looking at it across the breadth of of use, um, the one thing I will qualify in, in general. Yes, hcps are using economic information, but but that’s typically not our target. It’s more the outcomes side of the HEOR. acronym, like you said, Garth, that is really where the HCP interface tends to be. It’s more payer formulary decision maker, that sort of thing on on the health economic side, so it’s kind of a breath of targets for us. Okay.

Garth Sundem 

So I think that Kant and Steve the the case is made for the need for an HEOR department. And I think the next step is maybe explaining to our listeners, how in the world you would go about building a team with this kind of a capability. Can you want to start with that?

Sure.

Kent Summers 

What I will start with by saying it may be daunting, and it may be unfamiliar territory may be delving into an area that, you know, we don’t know, it’s not clinical trials, you know, we do registration trials, and really this stuff, you know, we don’t know. And so therefore, let’s hope it goes away. It’s not going away, obviously, it’s gonna get bigger. But in the interest of acronyms, I’d like to throw another one into the mix. How about esport? Oh, yeah. Is sports International Society of pharmaco. Economics and outcomes research. There’s a mouthful for you. But it’s developed a framework to help define what is health economics and outcomes research, what are the components of it, and they came out with a framework that has 41 competencies, and 13 domains as to what it what a AQR function looks like. And some of these domains are things like business management, communications, healthcare, delivery, and finance, policy, regulatory issues regarding communications of this information, patient reported outcomes, methods, statistics, large databases, it’s it’s daunting, and it can seem overwhelming. But what I would really focus on that I think makes a lot of sense is really bringing it down to really two domains of what the function of ATR is. And I would propose to you the two functions are primarily evidence generation. So you’re trying to find people who are evidence producers there, you’re going to be looking for folks who have a track record with publications in the field, PhDs, people who who know some of the more technical aspects in order to develop the evidence. And then after that, then you’d be looking for the communicators. These are the people who typically have a clinical degree, so they know about therapeutics, they know about where drugs fit into the regimen. And a bonus, if they have experience with a health plan, they have greater credibility and repertoire with the health plan. audience that you have. So I would start with that look, and hire fit for function, depending on where you are in the continuum of your development of an HEOR function.

Garth Sundem 

Okay, and Steve, you’ve done this. So what lessons Do you have from this? Well, I

Stephen Camper 

I think all of what Kent said, is spot on. But I really think you know, as we’re implementing this, I think you really have to, or a company really has to start with the end in mind. You trying to get out of your department, what are you trying to generate? What are you trying to accomplish? The worst thing that can happen is to have delivery not meet expectation. And so I think there really needs to know that the company’s senior management needs to get together and they need to say, you know, what are what are we trying to accomplish here? And, you know, we talked about something a couple minutes ago about perhaps having a field force that can do this and can do that. You know, again, the thing you don’t want to do is have this mismatch between expectation and delivery, if you’ve got a bunch of, for example, field medical folks. Just because they have an expertise in perhaps discussing, describing, speaking about the clinical data does not necessarily mean they’re going to have that same competency for more economic related data, or, or even real world evidence, as Kent was talking about, oh, you really need to first start with a plan, what what are we going to what do we need to do and what do we need to accomplish? And then you kind of work backwards and fill from there. Because otherwise, it’s I’ve just seen too many cases where a company is thinking that one thing is going to happen, and they haven’t put the pieces in place for that to actually happen. And so I think start with a plan.

Garth Sundem 

So with the plan, and it seems like I mean, so the products that we’re working with in pharma are different than biotech are different than diagnostics are different than devices. Are you saying to look at you know, maybe your product and and say, where do we want this to go and then work backwards towards your AGR team from there.

Stephen Camper 

Yeah, yeah, exactly. Right. Exactly. Right. I will say though, in my experience, and this is an excellent one. Um, I don’t know that it’s so different than If you’re in pharma versus biotech versus devices versus versus diagnostics, what you need to do, your product may be may be different and your approach may be different. And even your audience may be a little bit different, but the skill set that comes from an experienced a to our team if you hire the right people, I think it’s fairly easily transferable once people understand Okay, well, if I’m in now in the device world, what? Who am I talking to here? what’s important to them? A good HEOR person can can adapt to that if they don’t know a Glr, though, very difficult to be responsible for something.

Garth Sundem 

What do you think, can

Kent Summers 

it well, Garth, I would like to suggest that a way to get there, whether you, you’ve got a mature product and existing product, a product well down the pipeline, for any product, I would strongly advocate that every product should have a core value dossier. Basically laying out it’s a compilation of all your clinical data, your patient related or piraro data, and then your economic data all in one, you know, it’s a Dynamic Document. And that and that can help inform the value proposition that you’re going forward to. So that can help you understand what evidence is available to inform a value proposition for a payer, for a physician or for whomever. But primarily, here, we’re talking about the health plan. So to Steve’s point, begin with the end in mind, what evidence do we currently have is currently out there that we can just do a literature review and a slide presentation? versus what do we need to produce and hire an HEOR group or hire someone, you know, third party to produce it for us?

Garth Sundem 

Okay, so, you know, I hear I hear you saying that, that he or the skills in HEOR are flexible enough maybe to be pointed in, in the different directions of pharma, biotech, diagnostics, devices. And so you would probably want to, you know, design from the back, forward. And so, you know, designing from the forward back would be a pitfall, what other pitfalls Do you see potential mistakes that people make when they’re trying to build an outcomes team?

Stephen Camper 

And you wanna start with this one, or you want me to?

Kent Summers 

Go right ahead. Go right ahead. No.

Stephen Camper 

Well, my first goes back to what we’ve already talked about. And and that is, they haven’t put the team in place for the end product that they’re hoping is delivered. That to me is, I think that’s the number one pitfall. So for example, you have folks in place, and you can even go to one small segment of what we’re talking about here, for example, a biostatistics expert to help you because a person has training in in clinical study biostatistics. And when that does not necessarily mean that person is going to be have an expertise in doing something on the real world evidence side of the world. And in fact, it’s really unfair to put that person in that no win situation. So certain skills are not necessarily transferable. Okay, have to have the expertise in place to do what you what you want to have another example. Because you have a field medical team that can do a great job of describing what your clinical data are. That does not mean they have the expertise, the mindset, or what have you to understand what a payer may really find important and interesting and and pertinent to their decision making process. And it’s fair, it’s unfair to put them in that situation. So it’s really finding an expertise to meet what your what your end product needs to be.

Garth Sundem 

Okay. Kent, what do you think what have you seen?

Kent Summers 

Well, I would echo that, but I have also seen situations I’ve hired folks like Steve has suggested, I’ve hired folks from the clinical side into this virgin AQR site that just at the end of the day, they didn’t enjoy it. Because there are so many pieces. There’s so many things evolving around, it’s not a clinical trial. It’s very complex. The customers are a different bird. They’re not they’re clinical. Usually they’re clinically trained, but they’ve got so many different pushes and pulls on them, that it can be very, I’ve had people come in and then leave because they really didn’t like the HEOR space. Further have also seen companies Who have wanted to jump into the ETR space, they’ve wanted to have some kind of a liaison and relationship with the pet with the health plans. And so they put together a field based team without having the evidence for the field based team to share. So, you know, if you’re going and talking to a customer, you got to have the data. And the clinical data is nice, it’s necessary, but it’s not sufficient to inform the decisions that these folks have to make. They need the economic and the HEOR data to make their policy decisions.

Stephen Camper 

dovetail on that if I can think I’d actually a perfect segue segue can another pitfall, if you will, and this might be getting into something that we’re gonna talk about down the road a little bit, but that is calling the HEOR function into play too late. In the process, unfortunately, I think can slip this, I know I’ve lived this, where you know that now you’re you perhaps you’re beyond phase two, and you’re actually approved. And, and now they’re their test drill about, okay, we’ve got agenda because we’re behind the eight ball, we’ve got to generate data. If I could say one thing about the input of an HEOR department, I would say get involved early, and structure, your clinical development program such that it also starts to answer those questions that you’re going to have, in terms of, for lack of a better word payer acceptance. Too often that’s, that’s just put off to the side, I find that being one of the biggest mistakes that companies make.

Kent Summers 

If I could dovetail on that, I’ve been involved with a large company, I was a team leader, and in HEOR, in phase two, way, early way early, but the reason for it is that’s where we develop this whole notion of a value dossier, we did the compilation of what evidence is available. But even more importantly, is the prs, the patient reported outcomes. So often we’ll see people they get into phase three and say, Oh, my gosh, you know, the physicians want to know about quality of life, what can you give me? And the answer is nothing. You’ve got to have these instruments developed. That’s a phase three trial is a hypothesis test, you don’t develop during a phase three trial. So those those instruments have to be all developed and qualified by the FDA, to put into your phase three trials during the development of them in order for you to use that quality of life or any other sort of patient reported outcome. So that’s an extreme example of how ATR is historically brought into light.

Garth Sundem 

Right. So in phase two, are you are you just preparing to generate the data in phase three? You know, if we’re talking about outcomes, and we’re talking about real, real or world evidence, you know, we’re talking about actually implementing after phase two, right?

Kent Summers 

Yeah, well, it’s, it’s really helpful, because you can set the investment timeline, you can set the the scientific evidence development timeline, you can set the investments that are going to be needed. And you can also use it typically, in phase two, it’s more of a platform look. So you’re looking at a therapeutic area. And that gives you the opportunity to see for example, prs, or their existing p arrows that could be applied in our clinical trials or not, there may be, but that helped. That gives you a lot better investment, a lot more efficient investment in your ultimate and a more effective investment in your AQR activities.

Garth Sundem 

Okay, cool. Well, we’ve have only about two minutes left, but I wanted to ask about what you see as the future directions for Ah, yo are, you know, I think that teams, now they know that this is something that they should be implementing, but it’s still relatively new capability. What do you see as the future for HEOR use within organizations? Maybe Steve, do you want to start?

Stephen Camper 

Yeah, I’m happy to a couple things. I think one and Kent touched on this earlier. But, you know, we, the FDA is has come out with with beginnings of recommendations and acceptance of real world evidence in the application process. So to me, that’s one of the huge things that that is it’s still it’s still in the works and it’s still you know, it’s evolving through but the ability to Submit and the willingness of the FDA to accept for submission, world evidence to support a product’s application to my mind. Is is huge. I think so that’s one. Yeah. In a nutshell, I really do think that no matter what your therapeutic area and things like oncology, and all that sort of thing used to have, they used to get a pass on this. But being able to produce and, and disseminate here related data and information is not going to be a nice to have, it’s going to be a need to have. And and I think companies need to just understand that you don’t do it on the cheap, you do it the right way to get what you need to get, and you move from there. But it is it’s not going to be acceptable to simply have your clinical study registration data, for example, that’s an extreme case, that’s just not going to be acceptable, even in the oncology space to have payer acceptance. So those are the things that I see.

Garth Sundem 

Okay, approvals, peer acceptance, can’t What do you think?

Kent Summers 

Well, I think what we see in investments in large and even smaller pharma these days is to have a whole separate section that deals exclusively with real world data. And it’s a single entity within an organization. That is the compilation or the library of all the available data sets to help leverage that data to make better decisions. So it’s utilization treatment patterns. pharmacovigilance safety is a big area that makes a whole lot of sense. And also study design. I think that’s really where the future is going is in addition to the evidence, we’re going to always need the evidence to make informed policy decisions.

Garth Sundem 

All right, well, it sounds good to me, I’d sounds like I should work on saying the word words real world evidence without stumbling over them every time I come across them. So thank you both for joining us today. And to learn more about how your organization can partner with alpha group to drive value in medical communications, visit alpha group med comm.com. Maps members, continue the conversation at our community portal and don’t forget to subscribe. And we hope you’ve enjoyed this episode of the Medical Affairs professional society podcast series. Elevate