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Business Of Biotech
The Business Case For Health Economics And Outcomes Research With ISPOR's Rob Abbott
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On this week's episode of the Business of Biotech, Rob Abbott, CEO of ISPOR, explains how startup and early-stage clinical drug development companies benefit from conducting health economics and outcomes research (HEOR), and not just with patients and commercial payers. HEOR, viewed as a strategic lever as opposed to a compliance exercise, can help answer investor questions about market differentiation, pricing pathways, and real world product validation. Abbott talks about the value of cost-of-illness studies, burden-of-disease analyses, and payer landscape assessments, and how AI, real world evidence, and patient-centered research can improve drug and trial design and accelerate market access.
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Welcome back to the Business of Biotech. I'm your host, Ben Comer, chief Editor at Life Science Leader, and today I'm delighted to speak with Rob Abbott, CEO at ISPOR, that's the International Society of Pharmacoeconomics and Outcomes Research, which is a global professional society for health, economics and outcomes research, or HEOR. ISPOR was established in 1995 and has been growing ever since. There are now 20,000 members active in more than 100 countries. I wanted to have Rob on the show today to talk about HEOR and its value proposition in life sciences, particularly for listeners at startups and earlier stage companies who may not be as familiar as large pharma is with HEOR and ISPOR, but and I suspect Rob will make this case during our conversation they absolutely should be. We'll learn how to set up an HEOR program, how it can help companies attract investors, current trends in HEOR and how it's changing in light of emerging technology like AI and what's on ISPOR's agenda in the near future. Thank you so much for being here, Rob.
Rob Abbott:Ben, you've just done an extraordinary job of introducing myself and the topic. It's a great pleasure to be here on behalf of ISPOR and I really look forward to sharing some of the insights that we have from a health economics and outcomes research perspective with your listeners, particularly, as you suggest, those listeners that are actively engaged with a small to midsize or indeed early stage biotech. I think there's a lot that ISPOR and HEOR have to offer those kinds of companies, as they clarify their value proposition and really seek to explain themselves to audiences, including investor audiences, that may not otherwise be as familiar with health economics, no-comes research and the value that can help to provide.
Ben Comer:That's excellent and I want to jump right to that. But first, before we do, I want to get to know you a little bit better. Rob, you have a diverse set of background experiences and I'll just I'll ask you maybe you know what are some of the through lines that connect those various experiences. You've worked in nonprofits, you've worked at a private company, you've worked in government. Tell us a little bit about you know, your approach to your career and what circumstances led you to the CEO role at ISPOR.
Rob Abbott:No, I really appreciate this opportunity because when I look back on my career and to a certain extent I view my current role with Iceborne as something of a capstone of sorts I look back on my career and I realize that from the outside, looking in, it might seem as though I've made some rather bizarre choices, because at various stages I could very comfortably have settled in and climbed the proverbial ladder in government or in the management consulting community or the not-for-profit community, you know.
Rob Abbott:Instead, you know, I very intentionally chose to move around because I wanted to look at particular issues and opportunities from multiple perspectives. But the through line, what unites all of this, is that I have had a very longstanding interest in human welfare and how we actually improve human welfare globally, and that has expressed itself through work that I've done related to corporate social responsibility. It's expressed itself through work that I've done as the CEO of the Canadian Genetic Diseases Network and the Canadian Gene Cure Foundation. It's expressed itself through the work that I've done as a management consulting, you know, working for and on behalf of health policy change. But I think the common denominator is that, for me, the relationship between social responsibility on the one hand and business viability on the other, or how we craft policy that's smart, policy that actually improves human welfare. These are the things that are exciting to me. These are the things that make me want to get out of bed in the morning and show up for work.
Ben Comer:Well, it's an important role, maybe particularly right now in the US. Let's get into health economics and outcomes research For listeners who may not be as familiar with what it is. Can you give us a kind of top line explanation of HEOR? And listeners, bear with us. There are some acronyms we're going to be using throughout this conversation. Refer back, you know, to the beginning of the episode if you need to. But HEOR, health economics and outcomes research what is it? What value can it bring to life sciences companies?
Rob Abbott:So I'm going to try and keep the acronyms to a minimum and simply say that health economics and outcomes research is a multidisciplinary field. Firstly and that will become, I think, more interesting to the listeners as we get deeper into this conversation Because when you start thinking about, well, I need to bootstrap an HEOR department at my small biotech, where do I get started? It's not as though you have to hire someone that you know did a degree in health economics necessarily. The reality is that, as a multidisciplinary field, yes, there are economists working here, but so are there epidemiologists and statisticians and others. So, first things first, heor is a multidisciplinary field that uses data to inform decision-making in healthcare. So that's the headline Multidisciplinary, relies on data to inform decision-making in healthcare.
Rob Abbott:Now, if we drop down just a little bit, the idea is to you know, think about you know, cost-effectiveness, real-world effectiveness and patient-centered value. These are kind of the three big things. Is it cost-effective? Does it actually do what you know, we thought it would do? And what is the patient experience in all of this? Not only in terms of the efficacy of the drug or the service, but the ease of use, the drug or the service but the ease of use, et cetera.
Ben Comer:So you know this is very much what is at the heart of health economics when it comes to research, and you know you've talked about this multidisciplinary practice. You also said you know you don't necessarily need a health economics or health economist, you know, hired on to start up, uh, an heor program. Uh, at you know a startup at an early stage company, um, how do you start one up? You know, how do you a company that's hearing you right now and thinking, wow, you know, I'd really like to be able to, you know better elucidate the value of my products, make the case you know to governments, to payers, make sure that you know our medicine is, understand in terms of what it means to individual patients. How do you get started with that else, rob, you might say just about the kind of business case you know for someone at a small company who's saying I really think we should get started on HEOR here and here's why.
Rob Abbott:So I mean, the first thing I would say to you know the listeners, ben, is you know I think that HEOR is crucial and you know it has to be viewed especially from the perspective of a startup or a small to midsize biotech. It has to be viewed, you know, strategically and it has to be scaled appropriately. Experience that resources are tight, data is limited and the priorities generally are focused on proving the science and securing funding Like this is what drives the.
Rob Abbott:You know this is what drives the day-to-day business. Now I do want to just foreshadow something that I hope we get a chance to talk about in a few minutes, which is all about, you know, the investor perspective and how HEOR can support. You know, de-risking and valuing the asset that is the biotech. But before we get there, I would just say that, you know, as a small biotech, you need to understand that payers, investors, prospective business partners, they want evidence of value, not just efficacy. So the mantra that I routinely say is you've got to think beyond approval. Approval is a necessary but insufficient condition for success.
Rob Abbott:So health economics now comes. Research can, you know, help shape smarter development, it can help reduce risk, it can attract investment. But again, you have to kind of approach this, you know, thoughtfully and strategically. It can strengthen the value proposition. So in particular I would say health economics and outcomes. Research can help quantify, you know, unmet need and the economic burden of disease, which you know directly translates into prospective future business value, directly translates into prospective future business value. And early modeling, particularly cost of illness studies, burden of disease analysis, can justify the relevance of a drug or a medical device to prospective investors and partners. So that's kind of just the. You know the beginning of where HEOR may start to become more relevant for an early stage biotech.
Ben Comer:Yeah, and I think your comment about launch or, excuse me, approval essentially being table stakes is an important one, especially given you know the data we've seen on just how unpredictable success can be with newly launched products. Something like 50% of newly launched products are not meeting their forecast, I think, which just shows how important proving the value of a product to a whole lot of different stakeholders you know might be. Yeah, go ahead.
Rob Abbott:Absolutely. And I think the thing too for listeners is that you know this can sometimes seem like you know this mountain that you have to climb and I would say, look, you can break it down If you're an early stage biotech that's, you know, raising capital, you know, especially beyond Series A, let's say you know the first order of business is, you know, have some basic health economics and outcomes research materials at hand, and I'm thinking of things like cost of illness or burden of disease studies. You know the payer landscape or pricing strategy and probably a reasonably clear sense of what the economic endpoints you know look like. Like that's kind of the foundational piece. You can then build on that and basically say, ok, whench, right now, you know, can I show that I understand how value not efficacy, but how value is assessed, because that's different from efficacy. And if I'm in the pre-revenue stage, health economics, outcomes research can be a proxy of sorts for prospective commercial traction, you know. Then ultimately you need to have a sense of how I can show, you know, a pathway to real-world validation. So what are my plans for patient reported outcomes, real world evidence generation and post launch data collection. So you can kind of break it down into those three stages, let's say.
Rob Abbott:But the first order of business is probably one of saying wait a minute, like what is you know? Ultimately, you know what is the health outcome for dollar spend, you know, and how is our product or service going to shape that positively? I mean, there are a number of things that HEOR brings to a biotech, in my opinion, you know. I think it can serve as a bridge between clinical innovation on the one hand and market success on the other. I think it can help to justify pricing and gain access. But at the end of the day, it's like what is the health outcome per dollar spent? And can this product or service, you know, positively shape that? And you get to begin answering that question when you have the cost of illness or burden of disease studies in hand, when you kind of understand what the payer landscape looks like, you know, when you have a better sense for what those economic endpoints might be.
Ben Comer:Right. And so when, you know, when should a company get started on this? So I'm thinking of maybe it's a, you know, a preclinical company, you know, transitioning from animal studies into their first in human trial, you know. Or maybe it's a company that's, you know, moving into a phase two or even a phase three, you know. I guess my question is do you want to start this process of developing your HEOR dossier for lack of a better word, but you know your, your group of HE data and documents? Do you want to start doing that once you know, or are fairly certain that you know, you've landed on a product that you're going to take all the way into late stages and, hopefully, approval, or is this something that should start, you know, even earlier, even at, you know, the very earliest preclinical stages?
Rob Abbott:you know, the very earliest preclinical stages. So my bias here is that you want to be starting as early as possible. You know there is an adage that you know you begin with the end in mind, and so I think you want to be thinking about okay, what are those foundational pieces of work? I mean, I've spoken of cost of illness or burden of disease, studies and so forth. You know you want to be thinking about that early on, like what is it? What is the science that we're pursuing? What is this company being built around? What is the disease that we're targeting and what is the outcome that we hope to achieve from a from a, you know, health improvement perspective? Certainly, but what is the outcome we hope to achieve from a business perspective? You've got to be thinking about those things early on, Because if you wait too long, you're not going to have the time to generate the real evidence.
Rob Abbott:Because this is the other thing that I find fascinating is that in any biotech's journey, you know there is a stage where you are in an iterative dialogue with partners or investors, and the investors have a whole series of questions and they don't all come at the same time, but those questions have a lot to do with. You know, is there a clear pricing and reimbursement pathway? Is there strong market differentiation? Is there proof of value to stakeholders? Is there an understanding of real world use? Is there a sustainable and scalable you know commercial model? Now those are different questions, but they're all legitimate questions that investors have. And I will say the good news is that health economics now comes.
Rob Abbott:Research can help you answer those questions. Because if someone's concerned about pricing and reimbursement, for instance, we might say, ok, here's, here's our budget impact analysis, or early insights we have from payers. You know we've done that homework and it's not one and done, it is iterative. You know we're back and forth with payers or we're back and forth in terms of the budget impact analysis, but we've at least got something. Or we might say here's our comparative, you know, cost effectiveness work. Or here's what we have in terms of patient reported outcomes and the burden of illness data. So for most investor questions there is an HUR signal or an HUR response that fits. But you can't wait until you're, you know, at stage two clinical trials to start answering these questions. You've got to start early.
Ben Comer:So is this something that you know each individual company needs to? And I guess what I'm thinking about here is are there, are there shortcuts to this? Are there shared resources that that I spore can provide, or is does each individual company, you know, given their very different products, different therapeutic areas, different drug mechanisms?
Rob Abbott:different therapeutic areas, different drug mechanisms. Is it something that they have to think about and build themselves, or are there tools, resources? You know that, that I convey the impression that you know one size of evidence, if you will that particularly small and early stage biotech would find enormous value in. So you know, I appreciate that there are, you know, a large number of studies that ISPOR has been involved in and we have those on our website or we have those readily available for folks.
Rob Abbott:And, by the way, I'm increasingly interested in hearing from the biotech community because I would actually like to grow the number of biotech companies that are part of ISPOR. But certainly, you know, we have some resources that you know can help to sort of smooth out that learning curve a little bit. And it's true that because companies are driven by, you know, different boards of directors or different, you know motivations, they're going to have a nuance to their strategy that needs to be respected. So there's a little bit of bespoke work that individual companies will at some stage inevitably need to do. But there's also a lot of work that ISPOR has that we can make available.
Ben Comer:I want to just circle back to something you said earlier and this is sort of continuing on what we're talking about here and this you know, appealing to love to have a robust HEOR program. But you know, I'm trying to keep the lights on right now. What you know, how do you you know what's your argument to a company that says, essentially, you know you're gonna, if you make this investment, and maybe give me a sense of, like, what that early investment might be, but if I'm willing to make this investment in collecting this HEOR, you know how does it come back to me? What's? You know what's the ROI on creating an HEOR program as an early stage company?
Rob Abbott:Well. So again, just to be really transparent, it won't be lost on some of your listeners that you know, over the last two years, let's say, there has been, you know, very significant consolidation quote unquote within global biopharma with respect to HEOR, and I know that you know any global biopharma C-suite representatives that might be listening would say, okay, hang on, we haven't gotten rid of the HUR function, we've simply redistributed it or rearticulated it in various ways, and there's absolutely some truth to that. But the underlying argument, I think and I've written about this and spoken about this, I think that the H-E-U-R community has actually not done itself any favors historically because we've been so focused on the methods and the curation of evidence that we haven't necessarily connected all of the dots and demonstrated how that evidence does generate an ROI. We've basically said look, this is, you know, we've done our work. It's now over to our market access colleagues, or our whatever you know colleagues in medical affairs to, you know, carry the ball forward. And I think that we can and need to do a little better than that. So, although I don't have a definitive answer today, I do want all of your listeners to know that ISPOR is currently sponsoring, you know, a piece of empirical, quantitative research that is focused very squarely on the ROI of HEOR Typically HEOR practitioners, whether they're in the private sector or elsewhere. We've operated to a certain extent like academics and so we point to oh well, we published this many papers or we've done this many studies, and that sort of thing.
Rob Abbott:Honestly, investors and C-suite executives don't care as much about that sort of thing. That might be a necessary but insufficient set of conditions. You know they actually care about the fact that, ok, if I'm spending $50 million a year as a global biopharma company on HEOR, you know what am I getting on the other end, because I can say with some certainty that if I spend that same amount on, you know, advertising or marketing and communications, I can measure, you know what that return is. We're not there yet with HEOR generally, whether it's small, mid or large scale, but I know that the work we're currently sponsoring is going to contribute pretty significantly to, I think, a refreshed debate about the business value of H-E-O-R.
Rob Abbott:Now, you know, in the meantime, for the early stage or startup biotechs that are listening, I would say look, you know, if you want to understand some of those foundational things that I mentioned earlier the cost of illness or the burden of disease, for instance. You know you should reach out to ISPOR and we can. I don't want to suggest that we're in a position yet, as a not-for-profit, to become your fractional HEOR department, but I think in many respects you know some of the resources that we have can help to bridge that gap. So you know it's a complex and layered question.
Rob Abbott:When we start talking about the value, I think the most important thing, as it usually is, is just to begin to get started. And for the early stage or startups, then I would suggest, hey, don't fight this drama as if you're all alone. Don't fight this drama as if you're all alone. You know, reach out to us. We are the Professional Society for Health, economics and Outcomes Research. If you reach out to us, we have an interest in helping you. And chances are some of the questions the early stage biotechs have. We've probably already answered many of those questions.
Ben Comer:Right Right. Ispor's science strategy identifies on an ongoing basis emerging themes that impact HEOR and how it's used. Ispor also publishes a top 10 trends report. You know there have been a lot of technological changes, just for one example since, since 1995, when the organization began. You know what are, what are some of those, those topics or technologies that that ISPOR has identified as being important to you know collecting and using HEOR effectively now collecting and using HEOR effectively now.
Rob Abbott:So I'm going to maybe mention three things, and, you know, can expand on any of them as we see fit. No surprise artificial intelligence and the use of artificial intelligence in health economics. No-it-comes research. Obviously, the use of AI in healthcare decision-making more generally Massively important trend, quote-unquote. At the same time, real-world evidence and the use of real-world evidence to inform decision-making. What's most interesting to me, though, ben, is, you know, the third big trend that I think has been gathering a lot of momentum is patient-centered research and patient centricity.
Rob Abbott:Now, patient centricity is one of those things that's a little bit like corporate social responsibility. Everybody likes to talk about it, but you know, when you get right down to it, I think that you know Patient centricity is fundamentally important and it's not well understood. I think there is a lot of what I would characterize as tokenism that takes place under the umbrella of patient centricity, and I think it's really important for all companies, but especially for early stage companies, to think about patient centered work as a strategic business decision and to understand that patients and the views that patients have are every bit as important, if not more so, than what that health economist down the hallway might have to say or what that statistician might have to say. So in my mind, we're going to continue to hear a lot about artificial intelligence and, to be sure, helping with systematic literature reviews, synthesizing data, helping to tailor treatment protocols and so forth. I think there's a lot of promise there, to be sure, and we still need human intelligence to complement that With real-world evidence.
Rob Abbott:We're kind of getting more into the realm of patient centricity, because we're basically saying what has the actual experience with that drug or medical device been? What are patients actually telling us? What are we seeing from electronic health records and so forth? And then we get into patient centricity writ large. And this is where I see tremendous opportunity because and I know some of the early stage biotechs that are listening might be going, yeah, but that's like down the road.
Rob Abbott:I'm an early stage biotech Like how important is this for me? And I would say look, by engaging patients early and often, because it's an iterative process, you're going to heighten your possibilities of designing better drugs, running smarter trials, building trust and differentiation and ultimately accelerating market access and adoption. So you know, the patient centricity piece as a trend for me is hugely important because I think, done well, that can be a game changer, and I think that there's, even in this rather interesting climate in which we find ourselves in the US and elsewhere. Quite honestly, I think there's an appetite for listening to patients in ways that we haven't historically, and I think that for those companies that do it well, it holds tremendous promise.
Ben Comer:Do you think that technology is playing a role in helping to improve this? You know patient, real, patient-centered research approach. Obviously there's you, there's the ePro that's been out now for a few years electronic patient-reported outcomes. I wonder if you have a sense, rob, of if more companies are starting to incorporate that into their trials, if you're seeing any sort of trend. I hope that's moving up, up toward more. I don't know, though. I mean, what are you seeing in terms of how patient-centered research is being conducted in the context of a clinical trial, and whether you know there is emerging technology that can help with that?
Rob Abbott:So I think I would say maybe five things. I think that, yes, overall, the arrow is pointing upward in terms of increased awareness, understanding and use dare I say, if that's the right word for patient-centered research and patient-centered work. And the five things I wanted to highlight would be validating unmet need. This is especially prevalent in rare diseases, because patients define success often, anyway you know, quite differently than regulators or physicians, and so validating unmet need is one important area that we're actually seeing, you know, change around Informing, target product profiles and development strategies. So what features matter most to a patient, you know, is it the mode of administration? So it makes you know. Ultimately, you need to know whether this injectable drug that you're working on is actually going to matter to the patient. If the patient actually prefers a pill, that's a problem, and you want to hear about that early. That's a problem and you want to hear about that early. And the same would be true for, you know, frequency of dosage, tolerability, that sort of thing. So you know, informing TPPs and development strategy is a sort of second area in which patient-centered engagement is starting to change. Of course, enhancing clinical trial design. Are there barriers to participation? Are we articulating meaningful endpoints? You know, are we seeing, you know, patient-reported outcomes that are truly, you know, meaningful and material. You know building trust and I would say building trust and possibly even building, you know, advocacy and advocates, because patients, alongside their experience and their expertise, you know, if you can get patients advocating on behalf of your product, advocating on behalf of your company, I mean that's gold and that's gold to the company. I mean that's gold and that's gold to the company, it's gold to prospective investors and partners. You know. And then, ultimately, you know, I think patient engagement, you know, is very actively linked to, you know, what I would broadly characterize as payer and HTA engagement. So you know, how do we actually do this and what are we seeing? Well, I think what I'm observing is that you know patient advisory boards, qualitative work, and that can include one-on-one interviews with individual patients or patient groups, surveys and social listening sessions, protocol design.
Rob Abbott:These are all things that are happening now and the sort of how to do it piece is, again, you have to start early and, by the way, I spoke to an investor last year and you know, his company, you know, does not invest in companies that are not actively engaging patients. You know, at that early stage, because it's really a signal, I think, of the attitude and approach that the company itself has. Like. If you, you know, if you place the patient truly at the center of what you're doing, then you're going to engage them early to help shape the trajectory of the drug or the product that you're developing, and being respectful in terms of hey, you know, are you compensating, you know, patients for their participation? Are you creating multiple pathways for them to participate?
Rob Abbott:And also, you have to as a company. You have to realize that you know patient engagement is an iterative process. This is not a check the box Okay, I spoke to these patients at you know this stage and we're done. No, you circle back and you want to be targeted as well, like, you really want to be thinking, and this comes back to thinking about this in a strategic business context. You want to come back to, okay, what is the burden of disease, what are the endpoints, what is the usability of the drug or the device and so forth. How do patients perceive this? So you know, again, there's just an element of how aware am I as an early stage biotech or late stage biotech for that matter how aware am I of you? Know who my customer quote unquote ultimately is. You know, that's the population I need to be in communication with.
Ben Comer:Right, that's the population. I need to be in communication with Right. I want to ask a question before we move on on real world evidence, which is not a new idea. It's been around for a number of years now and I remember a time period it's probably been five or six years ago where there was a lot of excitement about anonymizing patient data. You know from big health insurers Optum, for example, created a group where they had, you know, millions and millions of patient records based on claims data and the idea was, you know, this is going to open up a brand new area of research where we can really understand, you know, not just the safety and efficacy of a drug but, you know, a patient with a comorbidity and how this drug is going to impact them.
Ben Comer:All these different things outside of a traditional clinical trial could potentially be gleaned by doing deep analysis on things like claims data. I'm just I'm curious to get your thoughts, rob, on kind of the state of real world evidence right now. You know it's easy to imagine that AI could absolutely revolutionize the use of real world evidence by making the analysis. You know, maybe, some of the ways that it's being used now, how it's changed, I guess, in the last few years.
Rob Abbott:OK, so that that's a, that's a PhD. I can respond from a, let's say, of the world's leading experts on real-world evidence, particularly in the context of healthcare decision-making. So rest assured that if there's a nuanced question about real-world evidence, you know we have within our membership, you know the people that can answer that question. This also, by the way, allows me to put a plug in for the fact that you know, ispor is actually convening a real world evidence summit later this month in Tokyo, actually because of the importance of real world evidence within the Asia Pacific region. So I think that real world evidence has been very, very consistently in the top three trends that we have been tracking for many, many years now as part of our top 10 trends work.
Rob Abbott:I think it's important for listeners to note that we actually, at ISPOR, release a top 10 trends report every two years, release a top 10 trends report every two years, and, for several iterations now, real world evidence has been in the top three, and I think that's a reflection of the fact that, okay, the clinical trial gives us critical insights in terms of the efficacy of a drug, and that's fundamental in terms of ultimate approval and, you know, access to the market. Real world evidence, though, is the backbone of the outcomes research piece of HEOR. We actually, with very clear intention, get the patient experience, whether that's through electronic health records, whether that's through patient-reported outcomes, whether that's through individual interviews and so forth, and so I would say real-world evidence needs to be, and be seen to be, as important as the outcomes of the clinical trial itself. At a minimum, it needs is likely going to be alongside AI and patient-centered research. This is something that's going to be with us and viewed with increasing importance over the next five to 10 years.
Ben Comer:Great, I want to move on. I have a question about health technology assessment, rob, you know you've worked at the nonprofit health technology assessment international. Does not, you know, consider HTA, or doesn't have a formalized HTA program, as a component of drug approval or of decision making generally? But we have seen in recent years private insurers, you know, increasingly using HTA like information to make coverage decisions, you know, collaborating in some cases with groups like ICER, the Institute for Clinical and Economic Review. My question is do you think, rob, that that FDA or CMS, in the context of Medicare and Medicaid, should consider formally adopting an HTA framework, underscored, of course, by the quality, the quality adjusted life year, what, what are your thoughts there?
Rob Abbott:So that's, that's a. On the one hand, that's a great question, ben. It's also, you know, a loaded question, because I know that, you know, many of my colleagues have very strong opinions on this, you know. I think I would say the following and it is important, I suppose, to acknowledge what the FDA's current remit is, and the reality is that you know that current remit really doesn't extend into the evaluation of quality.
Ben Comer:I mean, it's very much centered around efficacy or cost. It doesn't talk you know the FDA does not talk about cost or economics right.
Rob Abbott:What I would suggest, and you know it's become a very live and important conversation, especially, as you know, the US administration has talked about international reference pricing and a host of other approaches to drug pricing and I think, in the wake of the executive order, in particular that came out in May around reference pricing, you know some of my colleagues have said look, there are probably better approaches that could be taken, and that's where HTA has started to emerge as a you know, perspective, you know option. I think what I would say is that, you know, historically the United States has not necessarily been friendly, you know, towards the concept of HTA for a number of reasons. We don't necessarily need to debate those reasons right now. I think that there's a renewed interest in what this could look like and I'm glad you mentioned our friends at ICER because I think they would say well, we're kind of doing this.
Rob Abbott:And I think that that's a good platform and a good place to begin, because what I would suggest is that the FDA and CMS, you know, would benefit from closer collaboration with HTA and payer bodies, with HTA and payer bodies, better alignment on data needs and promotion of value-based evidence generation. And that can happen, you know, without any change to the, you know, remit of the FDA and CMS, like that can happen right now. So I think what I would, you know, what I would, you know, suggest is that, rather than jumping straight to you know, the FDA should formally adopt. Or, you know, I would just say, actually, you know, there's room and space right now to collaborate, you know, more closely with HTA bodies and payers and align around some common gaps, and that then could establish a foundation for further work that could be done down the road, that could conceivably lead to something more formal. I think that I would not want to advocate, you know, an immediate shift towards formal adoption.
Ben Comer:Yeah, and I agree with you that we don't have anywhere close to the time to get into the pros and cons of a quality adjusted life year. But I will just mention because ICER ran into this I believe has worked on their methodology to try to improve it. But just one example worked on their methodology to try to improve it. But just one example.
Ben Comer:You know rare disease patients have criticized, you know, the quality adjusted life year calculation. You know used by regulators like ICWIG in Germany or NICE, the National Institute for Health and Care Excellence in England, which of course provides guidance, you know, on drug coverage to the National Health Service. But rare disease patients, you know, have said the QALY metric doesn't adequately consider drug attributes that are meaningful for patients. Getting back to this, you know patient directed research. So you know we won't debate the QALY. But I will ask you, ask you rob, if you could describe ispore's value flower and if this is a kind of spin off of quality, if it's similar to what icer's doing, or maybe just give kind of an overview of what that is, if you would so I want to say maybe a couple things here.
Rob Abbott:Firstly, for your listeners, at the end of 2023 and into early 2024, ispor developed and released a new strategy for the society as a whole. It's our 2030 strategy, and I'm mentioning that because, firstly, I'd like as many of your listeners as possible to go to the ISPOR website and have a look at it. But I'm also mentioning it because it really is anchored by two goals. One of those goals has a lot to do with ISPOR becoming, you know, the trusted HEOR authority that is helping to shape health policy globally. You know, the trusted HEOR authority that is helping to shape health policy globally. The other goal has a lot to do with value, and this is where the value flower, I think, is important a particular way. If you're an investor, you think about value maybe in a slightly different way, and if you're a patient, you think about it in a very different way as well. The flower, you know it attempts to, you know, tease out what are these dimensions of value and from that perspective, it's been, I think, an incredibly important intellectual and pedagogic contribution to the field In practice.
Rob Abbott:You know, the reality is that, as health economists, we have tended to think about value quite narrowly and we know that if we talk to patients or we talk to, you know, people that you know aren't currently a patient, you know we hear things like well, what matters most to my health is access to affordable housing, access to nutritious food, social networks and connection employment. You know some pretty foundational, fundamental things. And, again, you know, our conception of health and our conception of value in health has been much more narrowly focused. So it's been focused around quality, adjusted life years, for instance, and what we're wanting to do increasingly is say well, wait a second, how do we factor in some of these things that patients and people and people are telling us matter to them? So the value flower, you know, is important and we are very deliberately wanting to, you know, undertake the work and we're doing that right now at ISPOR. We're undertaking the work to expand and broaden our definition of value to explicitly reference what is now, I think, increasingly and popularly referred to as whole health.
Rob Abbott:So you know health beyond the purely physical, and health you know beyond simply the treatment of a particular disease.
Ben Comer:You mentioned the Real World Evidence Conference coming up in Tokyo at the end of this month, but what else is on your agenda? Rob at ISPOR, you know what are your top priorities for the rest of this year and maybe the start of next year.
Rob Abbott:So I'm really, really excited about the fact that we have our European conference coming up very, very shortly as well. So we're in Tokyo at the end of September for a real world evidence summit, and in mid-November we'll be in Glasgow, scotland, for our annual European conference. And this is the important thing about these conferences. So we have an annual North American conference and an annual European conference. At present, these are the largest conferences in the community together and welcome, you know, those that are new to health economics.
Rob Abbott:Now comes research and new to ISPOR. But I think what excites me most, though, is that we're on a journey right now where I think it's fair to say we've acknowledged that for most of its 30-year history, ispor was focused on the definition of the field and the articulation of methods and so forth, and that was necessary. Now, increasingly, we want to drive increased awareness, use and impact of health economics. Now comes research, and that means we need to be stepping into the policy arena in ways that we haven't or haven't done as much historically. And that's what really excites me, because, honestly, on the back of every ISPOR business card, it says improving healthcare decisions.
Rob Abbott:Well, the only way we're going to improve health care decisions is if we're actually engaging with decision makers and bringing our evidence to bear and helping they, in their capacities, make better, more informed decisions grounded in data and evidence, and, at the same time, what really excites me is the possibility to have conversations like this and, through you know, your listeners, you know, reach new audiences and help them, you know, become aware of ISPOR firstly, and hopefully to help them understand that, hey, I'm an early stage biotech or I'm a late stage biotech and I have questions about, you know, the value of my product and how I communicate that value. Well, this is where this is, or indeed seek to be acquired having that impact on health policy, but also having that impact on stakeholders within the healthcare ecosystem.
Ben Comer:Rob, we have covered a lot of topics during this hour. You've been a really good sport and I very much appreciate that. I know that this conversation is going to be valuable the operative word for this conversation to our listeners. You've already given some, I think, excellent advice, but I just want to maybe end with are there any final messages that you would like to leave with our listeners? Thinking of startups, early stage companies who are looking for ways to grow their business and get medicines excuse me to the patients that need them.
Rob Abbott:So thank you, ben. It's been a real pleasure for me to be part of this conversation and I would say to the early stage companies especially, you heard me say it early in the conversation so I'll bookend it now. You know, think beyond the approval. You know there's a real, you know, adoption reimbursement and that flow of return. So that's one thing. The other thing is that I really want you know listeners to understand that health economics now comes.
Rob Abbott:Research can, which can sound or appear to be a rather dry and arcane topic, but this is ultimately about how we deliver a greater patient experience. You know, all of us have been patients or will be patients at some point in our lives. All of us know people that are patients or will be patients, and so it's in our self-interest to improve the healthcare system to the best of our abilities and make it accessible so it's there when we need it. Make it effective so we actually get what we need. Make it efficient. Hey, I'm an economist, you know I look for efficiency, you know, but I also care passionately about affordability, and so you know what ISPOR is continually animated by is this quest for accessibility, effectiveness, efficiency and affordability. And we're a big tent and I want to make that tent bigger. So anyone who's listening you know I want them to know that the door is always open at ISPOR and I welcome anyone that wants to reach out to me or any of my staff to learn more about ISPOR and health economics when it comes to research.
Ben Comer:Thank you so much for being here.
Rob Abbott:It's been a real pleasure, ben, thank you for having me.
Ben Comer:We've been speaking with Rob Abbott, ceo at Ispor. I'm Ben Comer and you've just listened to the Business of Biotech. Find us and subscribe anywhere you listen to podcasts and be sure to check out new weekly videocasts of these conversations every Monday under the Business of Biotech tab at Life Science Leader. We'll see you next week and thanks, as always, for listening.
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