Garth Sundem   00:00:03:08

Hi, everyone. I’m Garth Sundem, Communications Director at MAPS. And today we’re recording live at the MAPS 2022 Global Annual Meeting with Riad Dirani, Vice President of Global Health Economics and Outcomes Research at Teva Pharmaceuticals, and Omar Dabbous, Vice President of Global Health Economics and Outcomes Research and Real-World Evidence at Novartis Gene Therapies. So, as everyone will have guessed by now, we are talking about HEOR today, And while most of our audience is pretty comfortable with the basics of HEOR, I keep hearing from our MAPS members that we don’t quite understand where HEOR sits in relation to Medical Affairs or market access or what the structures are. So, what do you both think? Should HEOR sit in Medical Affairs or next to in parallel? What do the structures look like and what should they look like?

Omar Dabbous   00:01:05:38

Very good question. And this is something that we’ve been dealing with from the beginning of HEOR. So, it really doesn’t matter where it sits as long as processes that ensure that HEOR team conducts, collaborates with the Medical Affairs, the market access the clinical development, you’re in good shape now reporting structures are dependent and company structure. So, from that perspective, to me, it doesn’t matter where it reports to so as long as the processes in place do allow and ensure that each team has access to medical market access and clinical development.

Garth Sundem   00:02:00:17

Well, it’s interesting, I hear, and I’d love to hear from you, Riad, that I hear of Medical Affairs being described as a connection between commercial and R&D. Is HEOR similarly sort of a connector function.

Riad Dirani   00:02:14:20

So, I would say I would say it’s similar in terms of its approach to Medical Affairs, with with Medical Affairs. We do work very closely, obviously, with the commercial colleagues. We do work very closely with our clinical development colleagues. But I would argue that actually we work the closest with our Medical Affairs colleagues. We share a lot of the same strategic approaches. We share a lot of the strategic plans. And as Omar rightfully said, when you look at the industry as a whole over the years, HEOR and Medical Affairs have been tied together at the hip. We focus together on evidence generation. We focus together on communication of the story, of the value story. We focus quite a bit on ways to demonstrate value. You’ll hear the term value quite a bit. And as he rightfully said again, it doesn’t really matter where HEOR sits. As long as that infrastructure in that integration is happening between the teams very, very closely,

Garth Sundem   00:03:15:43

Well, it’s interesting you bring up the word value in in HEOR. Omar, what what does value mean? Can you define value for us?

Omar Dabbous   00:03:27:58

Well, values in the eyes of the beholder. Right. But let me take you back to the beginning of HEOR. Yeah. And if you go back to the beginning of HEOR this ecosystem which is looking at the clinical, the humanistic and economic aspects of data that we generate. Put them all together. That’s data to support the product value. And most importantly, let’s talk about value messages. And talk about the value proposition. Value proposition, you need value messages. Value messages must be supported with evidence, evidence got generated by clinical development but of a clinical development as we see the progression of where we are and how that data must be aligned with HEOR needs. Why because HEOR needs we do look at endpoints that are important to payers endpoints that important to health technologies assessment agencies, the patient population of interest to payers, length of follow up of clinical trials our patient reported outcomes, which is one aspect of what the HEOR does, but not everything. Contrary to what some people do believe, so you need to take all this into consideration from the HEOR perspective and our medical comes into play because medical team, they know best what the standard of care is. They know how physicians are treated. So that information must also come to inform HEOR and vice versa. Right. So that’s one aspect of what we do with the clinical trials. Now, we all know that clinical trials come with data gaps. So, you have clinical trials sometimes in oncology or gene therapy, others where you go with the phase one, ten patients, 12 patients Right. So, what do you do? You go to HEOR, you I mean the data. So, there’s lots of areas that HEOR covers outside of clinical trials. So, I’m looking at them needs of wellness, clinical differentiation, how to differentiate your product in the absence of having comparative clinical trials.

Riad Dirani   00:05:55:41

Yeah, and can I just. Can I also add to that because I think, you know, Omar is clearly laying out how we define value in HEOR. I think the the idea that, you know, we look at as to what extent can we actually infuse that value as he’s defining it into clinical development so early on into development so that not only is the focus on the regulatory side of things and regulatory approvals, but then there’s also an equal focus to large extent on the on the rest of the stakeholders and what they need as well. Right. To be able to bring that back, whether it’s the payer side or even in many instances, patient needs, caregiver needs, provider needs. Right. Those are elements of value that typically go beyond what’s included in in traditional clinical trials with clinical development. And so, we infuse that in there. And then the the piece that we really focus on quite a bit is taking that through the pre-launch, as he mentioned. And then to post launching this launches where a lot of the areas of value come in from a reimbursement from an access standpoint, real world evidence, looking at clinical effectiveness in the real world, that’s where a lot of the HEOR materials come into to support those discussions that happen with formularies and the like.

Garth Sundem   00:07:19:00

Well, so, influencing clinical development you know health economics and outcomes research it seems like in the title it would it’s a little counterintuitive that you would influence the clinical development from an outcomes perspective. Is influencing clinical development new for HEOR or is this been a role all along?

Omar Dabbous   00:07:41:51

It’s not new. Give you a live example and I think was it the case that the head of global HEOR and we work very closely with the clinical development team. About 12 years ago or so we are working on an anti-diabetic product. Okay. And we wanted to show the value of that product pre-phase three and to inform phase three so we can get the evidence that is of interest not only to the physicians to the patients, but to those who are going to review your dossier to approve reimbursement. So, we worked with the clinical development. We were able to influence basically the entire Phase three program where one of the trials was next. We define a composite endpoint based on also payers and HCA’s input and desires to to look at. We changed the types of patient population. We enrich the clinical trial with those patient populations, we added new patient reported outcomes that would help to demonstrate the value to the patients, but also to support the data needed for cost effectiveness models that would go to payers to say your product is cost effective. Cost effective means not only money, your product is effective, then consequence is the economics of it.

Riad Dirani   00:09:23:50

Can I also add to that as well that the notion of as you put it, Garth, outcomes, research and clinical development and clinical trials don’t actually clash from my perspective. Because the the idea and Omar mentioned patient report outcomes as an example, right? You know, those are one of the ways that we sit down with the clinical development teams and we assess what are the gaps that are needed, that are, that are being exhibited or that are being brought up by our stakeholders, by our payers, in particular, right, to reviewers bringing that in and looking at those gaps and some of those gaps could be very clear outcomes that could be part of clinical trials. So, whether it’s patient report outcomes or it could be things along the lines of resource utilization rate to be able to understand the person takes this medicine and exhibits fewer office visits or has fewer hospitalizations and like those are all things that we discuss with a team, with each team in each disease area. Right, because there are nuances from one disease area to a certainly oncology being very, very unique as an example. But we, we talk together and we align on exactly what is needed in, in, in these trials. Now, sometimes we don’t we aren’t able to go there because realistically there are timelines that are involved there, budgets that are involved. And so sometimes there are tradeoffs that we have to go through in order to get something towards the finish line. But those discussions we have and we’ve had those discussions with clinical development for a long, long time in our history in the past 20 years. 25 years.

Omar Dabbous   00:11:01:01

So, here’s something interesting, the question is you don’t have an opportunity to influence the clinical development or you come after clinical development plan as implemented. What do they do? That’s the creative approach that HEOR brings to the table, right, where you have a clinical development that is in place. We have clinical trials data and you have lots of gaps. In terms of the evidence you need not only to talk about the value of basically demonstrating the value, how are you going to demonstrate the value? So, you have only clinical efficacy and safety. Is that enough? No, there’s a lot more than just the other thing is I want to say, as you demonstrate the value, how you’re going to differentiate your product, you have a phase one clinical trial. How are you going to differentiate your product versus a competitor? That’s where the creative work of HEOR comes into play. We’re looking at other methodologies to utilize in this space to do indirect treatment comparison match adjusted in direct comparisons other types of studies going and looking for the natural history of diseases, put in registries, etc. So, it’s not only just influencing the clinical development, you have to be very creative to think about what the end goal is, what the challenges are going to face, go back and create that additional data.

Riad Dirani   00:12:44:02

And I can tell you, I can tell you, based on what I’m saying and based on my experience, we’ve we’ve seen we have numerous examples where we we got to the point later in the game for a multitude of reasons. And we don’t have data at the time of launch so we don’t have it at the the critical data that we would need to take the payers, for example, and the like. And that’s where the creativity, as he mentioned, comes in, that’s where the importance of HEOR becomes quite critical. So you really see the teams then gravitating to look at HEOR to to talk about how do we demonstrate value, how can we in this very limited data environment, if you will, how can we utilize approaches whether it’s real world, it’s systematic literature of use, network med analysis, a whole bunch of things doing prospective work that we would need to do, etc., to be able to again derive value for the products that are being launched.

Garth Sundem   00:13:46:31

And you’re saying, though, that ideally HEOR would be involved earlier and you wouldn’t end up with those gaps in in the first place? Correct. But that if you come late, then you find these gaps and that’s when the creativity is required. Omar, you said something earlier that I just wanted to make sure that I had understood. Well, you said there are three pieces of value. It was it was a clinical, humanistic and economic? Okay. And is that how is that how HEOR? I mean, are these factors that go into the soup that you stir around and you come up with for value? Is that sort of accepted that it’s clinical, humanistic and economic?

Omar Dabbous   00:14:24:00

Pretty well accepted.

Riad Dirani   00:14:26:10

Yeah. It’s been like that for again, for pretty much the entire time that we’ve been in the industry. You know, each one of them as I was speaking to Omar, each one of them has different elements of that value story range, whether it’s modeling work that you do, whether it’s, you know, focus on the patients, how they feel and their caregivers and a focus, of course, on the therapy and its effectiveness. Right. I mean, those are those are three key pillars that really, again, generate that notion of value.

Garth Sundem   00:14:56:45

Well, and I wonder if those three key pillars, ebb and and flow in the importance that we give them, you know, is the clinical the biggest piece of value at times or is the humanistic the biggest piece of value at times? Or is the economic you know, is that always fixed or does that depend on different diseases? Like is it different in oncology? Or is it different in 2022 than it was in 2015?

Omar Dabbous   00:15:23:41

But they’re not equally distributed in terms of weight. And that depends on payer system. So, some payers see the clinical value as more important than the economics and I’m a physician. So if you come to me with the product, you say this is cost effective and I’ll ask you about the efficacy and safety. And you don’t have a story though. I don’t care about your cost model. Yes. But so there is the sequence of events also, right? So it helps to have a product that works, makes your life easier. But if you have a product that works but not by a big magnitude of difference versus the competitor, yeah, that’s when also creativity comes into play to articulate the, the value based on robust and relevant data that you can defend. And then you translate this into economics, but those three pillars are very important. From a patient perspective, I care about the efficacy, I care about the safety, I care about my quality of life. Then I think about the money. But if you’re a payer, you think about the money. In the US do payers get a lot about quality of life? Not really. This is something that payers are struggling with in the US. In Europe they’re more advanced than US and the use of patient quality of life and impact on the patient’s life, care giver, parents, society, we’re far away from accepting society, societal impact in the US. I can say more.

Garth Sundem   00:17:09:45

I’m sure we could. But let’s leave it there for today. So cheers. Thank you, Omar and Riad, for joining us today. We’ll release you back to MAPS. 2022 Global and we hope to see all of you at future MAPS events as well.

Riad Dirani   00:17:24:25

Thank you.

MAPS.  00:17:25:24

For more information on how you can participate in the upcoming MAPS 2022 Masterclasses in London June 13-14 and Zurich September 26-27, visit medicalaffairs.org/events/ and Join The Movement.