Inside Compendia: Expanding Intended Use Populations
Summary
In the second installment of our Inside Compendia series, Avalere Health Advisory experts discuss how compendia can support clinical decision-making and medication access, highlighting a case study on GLP-1s.Transcription
Laura Housman, MPH, MBA, DrPH: Hi, I'm Dr. Laura Housman. I'm a Practice Director here at Avalere Health, and I'm joined today by a colleague and excellent mentor in oncology, a registered pharmacist and our clinical team lead here at Avalere Health, Amy Schroeder. We're here today for the second in our series discussing compendium. In our first conversation, we discussed the background of compendia and provided an overview of their utility in the life sciences market. In today's discussion, we'll be taking a deeper dive into the ways that compendia can be beneficial for supporting clinical decision-making and access for patients and providers. Hi Amy, good to see you today. Amy Schroeder, RPh: Hi, Laura. Nice to see you as well. Laura: In your experience working with three of the major compendia organizations and through your work here at Avalere Health with a broad range of compendia organizations, how have you seen compendia be useful to life sciences organizations? Amy : That is a really interesting question, Laura. And one of the things that I've seen just over time is really understanding how compendia came to be. Compendia have been in existence, some of them for over 100 years. And if we think back to when they first started looking at actual uses of medications, which is around the 1950s, we started seeing them really incorporate that almost as an encyclopedia. And really thinking about evidence and what that evidence looks like. So, if we think about FDA approvals, we know that the FDA looks at the safety and the efficacy of medications, and then they decide whether or not to approve a product. So, it's basically a yes or no. What's really nice about compendia is they actually look at the evidence behind that use of a medication, and they actually write that. Some of the compendia do also rate the on-label uses from the FDA and the off-label uses, and some focus more on reading the off label. But what I find that's been really helpful over time is that these compendia actually step in where we do not have FDA approved uses and actually look at all of that evidence. And so if we think about how evidence changes over time, one thing that's really important is that healthcare providers are making decisions and so are health plans every day about whether or not to select a medication for use and also whether or not to pay for it. And what's really nice about compendia is that they really come in and there's sort of like that gap filled for all of the situations where a patient's situation might not exactly fit with an FDA approved use and determine if that use is actually medically appropriate and should be selected and should be paid for. So that's something that we've definitely seen over time is how compendia have really come in and actually helped with patient access to needed medications. Laura: Well, you're speaking beautifully about a topic that's very near and dear to my heart, evidence and evidence generation. As I’m seeing the increased challenges to budgets, funding, added considerations that payers are seeking for coverage decisions, I have been observing more emphasis being placed on evidence generation as a support for inclusion in compendia. Sounds like you've been seeing these dynamics as well, but it feels even more acute in this moment. How might organizations navigate that? Amy: Sure. So, we think about a product's first approval. One thing that's really important that we actually talked about in the last session is making sure that that information is getting in the right hands and also in compendia’s hands at the time of FDA approval, because compendia can also help with interpretation of all that evidence. So, if you're thinking about a health plan or a healthcare provider that's deciding to use a medication just based on FDA approval, that's a little bit easier to do just from the FDA approved prescribing information. But for those that are really looking to compare medications, what's really nice about compendia is that by engaging with compendia right from the beginning is that that also helps with that better understanding of the evidence and how those products can actually be reviewed by compendia compared to each other to really help make those decisions. So, for instance, if a health plan is like, I would like to select the drugs with the highest level of evidence, and I would like to pick, you know, two or three medications in this space. Compendia can really help health plans decide what those two or three medications are if it's a situation where a health plan might not be using a medication just based on the fact that it's FDA approved, if they want to be a little more narrow. What's also nice about healthcare providers is they're also looking for that highest level of evidence, right, because they want to do what's best for the patient. And so, the compendia also helps them understand which products have better evidence than others. So that's something that we've definitely seen compendia help with is decision making on both sides. Laura: I have a specific question for you about GLP-1s. I read a recent Avalere Health Insight that you contributed to regarding the constricting levels of coverage for GLP-1s among commercial and Medicaid plans. And I wonder to what extent, as the clinical evidence continues to build for GLP-1s, can or should patients and providers use compendia as a way to have payers reconsider those coverage decisions? Amy: Yeah. So, one thing that I've seen actually more recently about compendia is that even in the situation of an FDA approved use, sometimes the FDA approved indication is not really exactly clear on the population to use a medication. It can be very broad and sometimes health plans can look that look back to the clinical trial and say, well, in the clinical trials for the FDA approval, a certain population was not included in that trial, so therefore we're going to restrict coverage for that population. What's really nice about compendia is if there are other data that have come out since then that actually show evidence in those populations, compendia can actually provide that additional clarification that the broad FDA approved indication is based on the clinical trials, but also the supporting evidence that's come out more recently since then, it really is a broader population that can benefit from the product. So in thinking about GLP-1s, specifically, with all the new data that's coming out and the broader and broader uses, one thing that's very interesting about compendia is the review of the off-label uses that come out after FDA approved uses, because we know that healthcare providers trust that information and compendia, and so do health plans. This is actually a way to really generate real world evidence of use in these other uses. And so what we end up with is real data that's not in a clinical trial setting that shows that when these products are supported for use by compendia and they're actually utilized in the real world, we actually have that real evidence generation from patients in everyday life who are using GLP-1s. So that's something that I think is really important to think about is not only the FDA approved strategy for new indications for GLP-1s, and also other medications, but also thinking about that off-label strategy as well, because it's very it's very beneficial because it's real data Laura: That’s such an important point. The number of real-world pragmatic users of GLP-1s is extraordinarily high compared to what the number was in the clinical trial. So, that just has the benefit of demonstrating clear, intended use in real world populations of large numbers and magnitude, to support the findings. That’s great. Amy, I loved talking with you again today. Thanks for your time, and I'm looking forward to our next conversation. Amy: Yes, I'm looking forward to this one. Thanks, Laura. Laura: Thank you.
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