AMCP Podcast Series - Listen Up: Elizabeth Powers on Real-World Evidence (RWE) - IQVIA

Fred Goldstein 00:01

Hello and welcome to the AMCP Podcast Series - Listen Up as we take a deep dive into the challenges, trends and opportunities in managed care pharmacy. Follow the show's social hashtag at #AMCPListenUp and to learn more about AMCP, visit amcp.org I'm your host. Fred Goldstein, on this episode, my guest is Elizabeth Powers, Vice President, General Manager, regulatory science and study innovation at IQVIA. Today, we'll talk about Real World Evidence. Welcome, Elizabeth.

Elizabeth Powers 00:31

Hi. How are you, Fred?

Fred Goldstein 00:33

I'm doing great. It's a pleasure to get you on. So tell us a little bit about your background and IQVIA.

Elizabeth Powers 00:38

So IQVIA, I'll start there is the world's largest clinical research outsourcer. We have done we run an enormous number of clinical trials. We do real world research, and then we also do extensive commercial analysis for pharma and life sciences companies. People all over the globe. We, as my husband, likes to say, we have your data. We have your healthcare data.

Fred Goldstein 01:11

Fantastic. So tell me, as the General Manager, Vice President for regulatory science and study innovation, what does that mean, and what do you do?

Elizabeth Powers 01:17

What does that mean? My team, I've got a team of about 50 people, and they focus on sourcing clinically rich data in ways that reduce the burden on health care providers, because that's where the data comes from, really. And then we look at ways of turning that data into evidence that is fit for purpose, whether it's for a regulatory support, for supporting a regulatory submission, or for submission to payers, or for publication, to educate physicians or even to educate patients on what does a drug or a treatment or a device do in a particular disease.

Fred Goldstein 02:04

So one of the areas I know you're rather deep into is real world evidence. Talk about that, and what's the status of its current use.

Elizabeth Powers 02:11

So real world evidence has actually been around for a while. The initial real world evidence were really safety studies. So real world evidence is evidence that is generated outside the realm of clinical trial. It doesn't have the controls, it doesn't have the inclusion and exclusion criteria. People are not perfectly adherent, and it looks at what happens to different types of treatments, whether it's drugs or devices or what have you in that real world setting. You know, back in about 2009/2010 as Obamacare was beginning to take off, pharma companies were trying to really submit a lot of evidence to payers. Increasingly, what's happened is the center of gravity has begun to shift a bit over the last five years or so, with guidances from the FDA and the EMA about how they want to use real world evidence and how they want to see it and what defines good. And so we now see a much bigger focus of pharma companies and life sciences companies on generating evidence for regulators beyond safety studies. But the question has come up in the last couple of years, you know what is really going on with real world evidence and payers, and how are payers using real world evidence? And IQVIA sponsors a work across industry working group called The Real World Leaders Forum, and it has somewhere around 20 leading executives from life sciences companies who work exclusively in real world evidence. That forum did research into what is going on with US payers and their use of real world evidence. And what we found out was that 100% of US payers interviewed. We interviewed about 20 of them actually think that real world evidence has value for informing reimbursement decision making, but none of them, zero of them, are actually doing it routinely. Which is a really interesting conundrum. They think there's value in this, but it turns out that they don't know how to unlock that value. And the challenges they had is that they really weren't clear on what is the best use of RWE. What should they be looking at? Comparative Effectiveness, should be they be looking at safety. There are no common standards for defining what's good. Even with all the guidances from regulators, there aren't really common standards that work for the payer environment. You don't need to have the same level of traceability and that sort of thing for a payer, you can be a bit more pragmatic for a payer, and they don't themselves have the expertise to really dig into how to understand a real world evidence study. So we saw that all of these things were barriers, and over the better part of 2024, IQVIA and AMCP, really, AMCP has been in, you know, spearheading this, and IQVIA has been collaborating on actually developing standards for US payers to outline what sort of studies should they expect to see at what point in a drugs life cycle, and then what are the criteria that they can use to assess is this quality evidence? is this objective? Can we believe this, given that we're getting competitive studies from different sponsors and manufacturers,

Fred Goldstein 06:27

Yeah, I think it would be critically important, obviously, because we've seen you have the clinical trial very controlled and everything, and then, as a population health person, I think, well, then it goes out into the real world,

Elizabeth Powers 06:36

yeah,

Fred Goldstein 06:37

and here's what happens. And so that information is perhaps, in the long run, much more important than the first information that establishes product works. Would you agree with something like that?

Elizabeth Powers 06:50

Well, I'm not going to discount the importance of a clinical trial,

Fred Goldstein 06:54

sure

Elizabeth Powers 06:55

it establishes the baseline safety and efficacy of a drug, but in terms of value a drug brings, what does that really look like? You know, I've seen examples of, you know, cancer drugs, and in the clinical trial, and within the scope of a clinical trial for a cancer drug, you see that a certain drug will increase progression free survival for nine to 12 to 18 months. But out in the real world, when a patient is using it, you begin to see examples in certain types of cancer where people are living for years longer, and you don't get that within the scope of the clinical trial, because it's so it's relatively short,

Fred Goldstein 07:55

yeah, and that makes sense, where you can see that longer period of time and get a much better sense of its true potential for that product?

Elizabeth Powers 08:02

Yeah,

Fred Goldstein 08:02

absolutely, a great example. And I think about it sometimes that when I look at it, that it may be have nothing to do with the product, but it may have to do with the environment that the individuals living in, etc. And so these are things that the health plans or payers need to consider to improve the product and bring it back to the level you might have seen the clinical trial for effectiveness, because there are other things impacting it.

Elizabeth Powers 08:22

I mean, the other thing. So as part of AMCP work, we've been doing focus groups and surveys with US payers and with pharma. And one of the things that's really come out is that payers are interested in seeing the outcomes. They're interested in seeing safety and effectiveness, but they're also really interested in seeing what is the adherence rate on a certain drug. Are people really taking their medication? And if not, why not? Or if so, why so? Because that informs the overall value proposition,

Fred Goldstein 09:03

absolutely and so you talked about some of the potential barriers to it. So how do we overcome some of those? Or what are some of those barriers and things that could be done to fix those?

Elizabeth Powers 09:12

Let's start with the big one, which is standards. What AMCP is doing is now embedding two things into their dossiers. So they are embedding a framework that says, okay, at you know, before a drug gets launched, you should expect to see natural history studies. At launch you might expect to see, say, an external comparator, a real world assessment of, you know, it might be a benchmark. It doesn't have to be a full on comparator, but a real world view of the current standard of care. Then maybe a couple of years later, then, then you actually see real world effectiveness, comparative effectiveness studies between the drug and other standards of care, and then eventually you might also see real world evidence supporting new uses, so labeling, expansion, new indications, that kind of thing. So there's a framework that looks at that and says, here's what you can expect across a product's life cycle, and here are the end points that payers really want to see. Then there's in the second piece of this is criteria. So what does good look like in a study, and what's reasonable? We've had both payers and pharma at the table, because it's important to kind of manage the expense and the burden you're putting on evidence generation. You don't want to make this all so expensive that we're basically creating a new realm of clinical drive. But you know those criteria then help payers understand how well has a study been conducted? So between that and then an education program to educate us payers, on the standards, on the framework, on the criteria, and on what's going on from the pharma side. How do they actually get access to that evidence? Because this is something that varies by pharma company in terms of how they engage with payers, and it creates some mystery for payers. So, you know, AMCP is really working to kind of open up the black box, as it were.

Fred Goldstein 11:41

yeah, and this really is the merging of data. Typically, the plans looked at claims data. You've got all the clinical data over in the, you know, in the repository for the in the EMR, and bringing that stuff together

Elizabeth Powers 11:51

exactly

Fred Goldstein 11:51

is really critical.

Elizabeth Powers 11:52

That's exactly right.

Fred Goldstein 11:54

So what do you see as potential outcomes for this market?

Elizabeth Powers 11:57

Well, I think our hope is that payers are making more informed choices based on clinical outcomes, as much as they are making them on financial outcomes, and that they're helping. It is very difficult to keep up with certain therapeutic areas. It is next to impossible to keep up with oncology right now, and what is the best treatment and who should get what disease we're going to see it happening in psychiatry. We're going to see it happening in Alzheimer's. But if Payers can use real world evidence, they can then work better with the sponsors and the physicians so that the right patients actually really do have access to the right medicines that will help them.

Fred Goldstein 12:58

That's really fantastic. Is there anything else you'd like to add on to the end here and talk about real world evidence or anything

Elizabeth Powers 13:04

Well, I mean, ultimately, I think my hope is that we are helping the world move to a true learning healthcare system where where everyone is using the evidence that's in front of them in one way or another to make the best possible health care decisions. So this is just one step in that, in that whole journey. ,

Fred Goldstein 13:35

Well I'd like to thank you Elizabeth and IQVIA for the work in real world evidence, and really appreciate you coming on the show today.

Elizabeth Powers 13:40

Oh, thank you, Fred. It's been a pleasure,

Fred Goldstein 13:43

and thank you for joining us today. If you like this show, you can find all our episodes at amcp.org/podcast, on our show page at healthcarenowradio.com or on your favorite listening platform by searching Healthcare NOW Radio, you can follow our show's social hashtag at #AMCPListenUp and don't forget to share, like and follow AMCPorg on LinkedIn, Twitter, Instagram and Facebook. I'm Fred Goldstein for AMCP. Until next time