Virtual ISPOR Panel to Examine Next Steps in Value Assessment

Two of the panelists appearing during the Virtual ISPOR 2020 meeting preview what's needed in improving value assessment: Lou Garrison, PhD, of the University of Washington, and Leah Howard, JD, of the National Psoriasis Foundation.

This year's ISPOR meeting is taking place virtually. One upcoming panel, called Addressing Gaps in Value Assessment, will bring the audience up to date on a stakeholder discussion held on February 27 by the Innovation and Value Initiative, or IVI. The IVI Methods Summit, called Defining Needs and Progress Toward Improving Methods in Value Assessment, focused on priorities for improving methods in value assessment and other future factors.

The American Journal of Managed Care® (AJMC®) recently spoke with 2 of the panelists appearing on the panel: Lou Garrison, PhD, of the University of Washington, and Leah Howard, JD, of the National Psoriasis Foundation.

AJMC®: My name is Allison Inserro, senior editor of The American Journal of Managed Care®. ISPOR 2020 is taking place virtually, and today we're here with some of the panelists who will be talking about addressing gaps in value assessment. Dr Lou Garrison with the University of Washington, and attorney Leah Howard, chief operating officer of the National Psoriasis Foundation.

Thank you for joining us here today. To start out, Dr. Garrison, what are the gaps in value assessment, and haven't they narrowed in recent years?

Lou Garrison: Allison, thanks very much for that question… Let me begin by highlighting a few of the things that we talked about that were brought out as key issues. One is we need we need to really focus on patient-centered outcomes and be able to generate better data on patient-centered outcomes. Another big issue and a big kind of failing in our- and this is my view- in our learning healthcare system is the lack of data on real world outcomes after a product or oeven a practice or a procedure in the field; we have limited ability to collect data and, and, and limited incentives to collect it because it's expensive. So we don't really capture that, and that also makes it difficult difficult for us to deal with the issue of patient heterogeneity and deal with that, which came up at our meeting.“Value” is the buzzword of the day and so, there was a lot of discussion around value-based insurance design and all these things take a lot of time. Tthat discussion has been around a long time and we are making we are closing the gap and making progress. And then I think we also came back to thinking about that real world evidence in terms of longitudinal follow up trials because in the area of medicines, it is somewhat unique that we have a regulated area of benefit risk assessment by the regulators (FDA), and then we want to follow what happens over the rest of a product's life. And so that's a key area. And then, you know, we are the country with the highest percentage GDP [gross domestic product] spending of any country in the world. And there's no doubt that there are many things we're doing that provide clinical benefit, but may not be worth the money. So there may be a lot of low-value care. But we also want to be able to separate low value from high value, identify high-value care, and really incentivize people to move towards high-value care. So those were some of the gaps that were identified, at least my version of the gaps, that were identified in the meeting in February and I think there's progress in every one of those areas. And I can point to specific examples. We have companies that now routinely collect real-world data, and then provide that to manufacturers and payers, but it's very slow, it takes a long time. And so the gaps are being closed, but we really need organizations like IVI, to really push that as a convening to groups, various stakeholders who have a stake in that. We all have a stake in that because we're all patients. But we want to bring that together and see that we can move that forward as a group of stakeholders in a consensus kind of way.

AJMC®: And Leah, how is real world data helping to improve value assessment, especially from the patient point of view?

Leah Howard: You know, real-world data is fascinating. And I think when you look at patient communities, I work with the National Psoriasis Foundation, we represent individuals living with psoriasis and psoriatic arthritis. And what's amazing is we're a community of about just over 8 million people. And when you talk to an individual with a chronic disease, like psoriasis, what you find is that their experience is often different, very different, in some cases, from someone else living with the disease. And so, value assessment is so important, because what we need to be doing is thinking about, at the end of the day, who's really benefiting from the care that we're talking about from the treatments that we're discussing, and that's the end patient. But without looking at the patient and talking to them, a patient directly about what's important and meaningful to them, it's really hard to pursue high-value care and really to be having discussions around value. And so what real-world evidence and real-world data does is it gives us the ability to really draw from what we know about patient communities, what we know about treatment options in certain disease spaces and bring that data to the conversation. So value assessment is certainly a complex issue and one that we want to be drawing in as much data as we can. And I think the more that we're able to pull that data in, ultimately, the more we're able to refine and improve value assessment, to then at the end of the day, bring better outcomes to patients.

AJMC®: Do we need different infrastructure to capture patient-reported outcomes, real-world data, that sort of thing, Dr. Garrison?

Garrison: Oh, yes. And again, I'm kind of speaking from academic perspective, I really appreciated what Leah just said about, you know, the challenges ahead and how important it is to kind of measure these things from a patient perspective, the patient-centered kind of approach. We have a limited infrastructure. We've certainly been trying to make improvements in medical records data collection. And certainly I think that the Affordable Care Act supported some innovations in that area. But at the same time for at least from my personal perspective, as an economist, there's, there is a fundamental problem of incentives, that, you know, everybody has kind of an incentive to let other people do the hard work to collect the data. So how do you how do you address that? Well, one way to address that was the Patient Centered Outcomes Research Institute, which is a federal subsidy to collect information, I would just say in my view was, that was a great idea. But even with some dedicated funding, it's not enough because it's very expensive to collect these data. We also see things in the private sector, agreements where outcomes-based agreements or what are called value-based arrangements are agreements between manufacturers and payers to try to collect data. There's some incentive to do that. But again, there are some free rider issues. The infrastructure - there are companies out there that are trying to improve the infrastructure. We've spent a lot of time on trying to do natural language processing and medical records. My impression is — and I'm not an expert on that - that that has been helpful but hasn't solved the problem and that they've kind of moved towards some combination of human-assisted artificial intelligence and so on to try to extract data from the records that we have. And so that's there are room there's room to improve the infrastructure it's needed. There's also it's important to give people the incentive to collect and share the information.

AJMC®: Earlier we briefly referred to the stakeholder meeting that IVI held at the end of February of this year that discussed this topic, and since then, unfortunately, we've all seen the chaotic upheaval due to COVID-19. Given the magnitude of the crisis, financial and otherwise, do you think that the impact for better or worse, will discussions around value assessment change over the coming years?

Howard: I actually believe that the discussions around value assessment are going to become more important in the coming year. So I think as we look at the challenges placed by the current healthcare pandemic on our system, I think these questions around value and whether, for example, one treatment delivers more value to a patient than another, I think is going to become all the more important. We know that patient communities and individuals and families are certainly feeling the financial strain of this crisis. And so as they think about where their limited dollars are going, the dollars that they're intending to put forward for health care, for example, they want to make sure that they're getting the highest value for those dollars. And so I think value assessment is going to be even more meaningful than it has been. Certainly we want it to be scientifically credible, and we want it to be meaningful. And those things are going to be important. And that's why looking at the gaps, looking at the data inputs that are needed, is so important as we move value assessment forward in the next few years.

AJMC® Is there anything else that either one of you want to add about this topic or about the upcoming ISPOR meeting?

Garrison: Well, no, I would just agree with what Leah said. As someone - I think Rahm Emanuel one said - a crisis is a terrible thing to waste, or something to that effect. We have a crisis. In thinking through value questions, we really all have a powerful incentive to see innovation and medicines, for COVID or vaccines. So how are we going to reward that? It's going to you know, [require] additional spending. It's not spending that we had planned, right? And that's going to put pressure on other aspects of the trade-offs that we have around value. So we have to somehow decide, well, what's valuable in those? And how do we reward that? And I think we'll want this broader concept of value. Because I mean, for one thing is, we're talking about an infectious disease. So each person's behavior affects everybody, other people. It's not just an individual taking care of themselves. So you have to think about value from that perspective. And I think that's going to focus that. And, you know, there's also this other dimension of impacts on other aspects of life, your employment, your family, you know, that our broader concept of value than sometimes we've been used to in the past, and we need to think about that, as we think about this next era that we're entering.

AJMC®: Well, thank you so much for joining us here today. We really appreciate it.

Howard: Thanks for having me.

Garrison: And thanks to IVI for moving this forward.

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