Unscripted – The AMCP Podcast: IBD: Innovations, Challenges, and the Future of Managed Care

Fred Goldstein 00:01

Welcome to Unscripted, the AMCP podcast. A look inside Managed Care Pharmacy. Listen in as experts explore the challenges, innovations, and opportunities shaping healthcare for millions of patients. This episode of Unscripted, the AMCP podcast, is sponsored by AbbVie, Inc. AbbVie. We find answers that make life better for patients in our world. Our guest today is Casey Koch, PharmD, Clinical Pharmacy Coordinator at Select Health. We'll be discussing IBD and some of the approaches to the clinical management and pharmaceutical management of this disease. Welcome Casey.

Casey Koch 0:38

Thanks Fred. Yeah, thanks for having me. Really happy to be here.

Fred Goldstein 00:41

Yeah. It's a pleasure to have you on today. So why don't we begin, Casey? Could you give us an overview of IBD?

Casey Koch 00:46

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 01:21

So, obviously, there's been a lot of advancements. How has our understanding of IBD changed over the past decade, and what are some of the most significant breakthroughs that we've seen in research and treatment?

Casey Koch 01:29

Yeah, there has been quite a few changes over the last decade. There's a, first of all, there's a lot of new drugs. So we're thinking about, different mechanisms of action. more targeted types of therapies, just a lot more options. So, really, 10 years ago, we only had a few options when patients were getting to that later line of therapy. whereas today, you have, and it's a, it's a nice problem to have, but we have, different mechanisms of action, different drugs that can be used. and we're also starting to think about different targets. So, I know we're going to get into it, but we're thinking about, not only that the patient is symptomatically better, but also that we can see objectively that the patient has responded to therapy.

Fred Goldstein 02:09

So obviously with all these options, you know, as with other disease states, we see current guidelines, treatment guidelines out. So what are the current treatment guidelines?

Casey Koch 02:18

Yeah, so we are seeing, more rapid updates now, which is actually a very thing to have as well, because of some, so many of the advancements. So I'm primarily looking at kind of two bodies of guidelines for the ACG and the AGA. And the most recent updates. really have been even in the last six months to a year, and the AGA has stated they're going to update, at least every six months or at least re-review every six months, as the landscape continues to change so rapidly. So this is a disease state where, we can actually have modern guidelines that incorporate new therapies as they come out. whereas in a lot of other therapies, you might have dated guidelines and, kind of left. out in the open with what, what to do with the new drugs that haven't yet been reviewed.

Fred Goldstein: 03:07

So when you look at these guidelines, sort of how are they looking at treatment and the approach? Are they stepped or things like that?

Casey Koch 03:14

Yeah, absolutely. So, I think we're seeing some new guideline recommendations. So, there is a thought to sort of treat earlier with biological therapies. So we're thinking about, More, well, so let's say the AGA guidelines have put therapies into more buckets now of how efficacious they are. So they're not necessarily thinking about mechanism of action as much. So it's more about, being highly efficacious, moderately efficacious or  lower efficacy. and then from there,  because there are so many options. It opens up more choices, for patients.

Fred Goldstein 03:54

And when we think about that in choices, what are some of the unmet needs we're, we're dealing with now?

Casey Koch 03:58

Yeah, there's definitely still unmet needs. So I think we, we've seen a lot of advancement. patients are, are doing better with, with so many options, but there are, yes, there are still unmet needs. So I think we're still missing, areas where we can, personalize the therapy, have a better idea of whether or not a patient's going to respond. We also have unmet needs in particular in that late line setting. So if patients have exhausted a lot of the options,  we really don't have kind of a last-line therapy. So what we've seen in that spot is a lot of dose escalation. And so that's been something where, your mate, your providers are going off label or, more frequent dosing and in the hopes to get patients back into remission.

Fred Goldstein 04:41

And when we think of these and these newer approaches and technologies, you just mentioned personalized care. Are we getting close there? And how about the use of biomarkers and other things such as targeted treatment?

Casey Koch 04:53

I think we're still a ways away as we are in a lot of therapy, therapeutic areas. We are seeing some kind of algorithms to try and determine whether or not a patient would be a better responder to certain therapy over another. We're definitely using lab values to guide therapy, and I am seeing more and more drug levels being used, so if a patient is maybe only having a partial response or not responding to a drug, providers can pull actual drug levels from the patient and determine if maybe they're an ultra-rapid metabolizer and the drug is getting removed from the body too quickly. And that's another spot where we do see the dose escalation as well.

Fred Goldstein 05:31

So it sounds like this is fairly complex. Is it really something as you're getting the data and looking at it from your angle or side, you're trying to, in essence, assist the physicians or providers with that care? Or how does that sort of work?

Casey Koch 05:43

Yeah, I think ideally the payer is more hands off. I mean, we definitely want providers to be able to assess their patients, make choices on which therapy to use, and guide that therapy with the clinical presentation that they're seeing. I think we've been, with how many therapies we have now, we have more options to be able to do that. We, we've seen,  launch of low-cost biosimilars, and that also gives additional options for providers and patients. And I think the best thing that we can do moving forward is to just give additional options.

Fred Goldstein 06:19

And when, when you're looking at that, what do you consider as a positive outcome? I know that there's a range, and as you say, some people are, are further along, require higher dose and things like that, but what do you look for as a positive outcome?

Casey Koch 06:32

Yeah, absolutely. So in clinical trial setting, we are generally looking at clinical response, clinical remission, and some of the newer therapies are also now looking at endoscopic response and remission. so that, that would be more of an objective marker. whereas the clinical, response to remission would be more symptomatic. In, in practice, we are seeing both coming in, when we, when we do chart notes, I know providers are, are looking at, um.  lab values. They're also looking at, you know, patient, attestation of how they're doing, but they're also looking at the response on the, on the scope. So, really I think it's a totality of all of that in terms of what an actual good response looks like. But if you get a patient that's into remission on a drug, that that's a great spot to be in. and then another  part that's really coming up and it's kind of going back to the unmet need is. When can a patient come off of therapy? So if a patient is in remission, they're doing well. we don't have a lot of data on, feasibility of a patient coming off maintaining their response long term.

Fred Goldstein 07:42

And do we have a sense of,  as patients consider this, how many might be achieving remission yet?

Casey Koch 07:48

Yeah, we do. I think that's kind of come out of the clinical trial setting. we are seeing, pretty impressive rates, and it sort of depends on a number of factors. So, what's the disease presentation? is it mild, moderate, or severe? what, what therapies have the patient, has the patient already attempted? so the more therapies a patient has attempted, it's generally, we're generally seeing that they're less likely to respond to additional therapies, which kind of goes back to that initial, top-down approach where we want to really find a therapy that works early on for a patient, get them lasting, remission that, can well, can last long term for them while still having additional options if they have a relapse.

Fred Goldstein 08:29

And in terms of remission, are we seeing longer periods of time with that when we consider that or where are we in understanding that? 

Casey Koch 08:32

Yeah, I don't know that we really know for sure on that and clinical trials were generally going out to a year, seeing maintain responses in a lot of cases.  historically, you mean a certain amount of patients are going to fall off every year, whether it be to just loss of efficacy. There's also issues potentially with non adherence or other problems that can arise. so I do think that we. have drugs that have long remission periods. But I don't know that we have a great cross-comparison to know that certain drugs Do actually last longer than others.

Fred Goldstein 09:10

And this episode is sponsored by AbbVie Inc. Our guest is Casey Koch. So Casey, as you look at a pipeline of new products, what do you see as the most promising therapies and how might that change the standard of care?

Casey Koch 09:21

Yes, I think we are sort of seeing some of the pipeline come to fruition right now. So we have a number of new products in the last year, a year or two in colitis. primarily seeing, we have at least, we have three IL 23 inhibitors now. they're approved in one and or the other, Jack inhibitors are, coming out. We also have, S1P receptor modulators. so we have new mechanisms that I think are still getting  fully fleshed out in the real world on, use, what kind of responses we're going to see. and I think it's maybe a little too soon to tell, until we really get a lot of real world utilization on how patients are ultimately going to, respond.

Fred Goldstein 10:05

So Casey, obviously fairly complex issue. How do health plans or PBMs take a look at this and consider it from a pharmacy management approach?

Casey Koch 10:14

Yeah, I think that's that's a great question. So we have, an extremely complex area of pharmacy management. We really can't think about I. B. D. without also thinking about rheumatology and dermatology because there's so much overlap in the indications of the products and the use. and so really, I think an ideal.

Way of managing this offers coverage for not only, but also those other disease states gives a significant amount of offering.  I had mentioned earlier that some of the thinking is moving away from mechanism of action and and more towards the level of efficacious.  In those other areas, it's still more mechanism of action focused, so we really feel like we have to have an offering, that spans the mechanisms of action, while still giving adequate options to providers and patients.

Fred Goldstein 11:03

And it, so does that mean you're really looking at sort of more broadly allowing for these various agents so providers are able to have choices and, and mix and match things to try and deal with the, with solving the IBD issue?

Casey Koch 11:15

Yes, it does. And I think that's probably what you're going to see in most health plans is,  some sort of offering, that may, may or may not be specific to the actual disease state, but still,  keeps the disease state in mind so that you're still offering, adequate coverage and options for patients, and all those sorts of things. Another thing that's going to come up, and it's starting to happen now is. I mentioned the biosimilars that have come out, so we are seeing, we now have two, TNF inhibitors that are biosimilar availability. We're going to have an IL 1223, starting essentially now, so you'll start to see some, availability of biosimilars in that space.  And that really is going to be,  the thought moving forward is if we have some low cost options that are still guideline recommended, how do we, from a population health standpoint, Get those therapies to the right patients, while still then offering some additional therapies, for the patients that those may not be appropriate as well.

Fred Goldstein 12:20

And you mentioned this a little bit earlier, getting in a little earlier, starting a little earlier, and there's some talk of a top down approach. How might that look to health plans?

Casey Koch 12:29

Yeah, so I think historically we've seen, more of a step up approach, which would be using maybe some small molecule products, see if there's a response from the patient, if there's not over time, then maybe starting sort of a later line of therapy with a, either a biologic or a specialty, medication. Some of the thinking now has, has flipped that. So we're thinking that maybe early on, if you're,  able to get a patient on a more effective biologic or specialty therapy, then you will not see that downstream,  relapse of the disease. so that's, the difference in the thinking. I do think that especially with those low cost biosimilars we've got from, even from a population health standpoint, I think we've got some cost effective options, to where that becomes a much more. You know, satisfactory way of treating patients and you get, you can get treatment on early and hopefully prevent things like surgeries and hospitalizations down the road.

Elizabeth Powers 13:29

And you mentioned earlier real world evidence and, you know, we think about that. We run the clinical trial. It's got a period of time you get the results, but then it's put out there and we see it for a while. So are you beginning to look at those kinds of data sets more? And if so, what evidence might you be looking for in the rural bringing in this real world evidence?

Casey Koch 13:47

We are. And when we look at our own data, a lot of it is, just utilization of the drugs. So our patients adherent to medication,  we, we do track things like, hospitalizations. And, those pieces, when they do come out, in, in like a publication with real world evidence can really play in, and especially as we're thinking about, the cost of the drug  in a lot of cases was maybe more expensive than something like a, a surgery, in the past, but if we have lower cost options now, that script can kind of flip and the drugs may be, able to be cost effective if they're able to prevent, Things like hospitalizations and surgeries. So I think we're going to be looking towards, publications of real world evidence to show that that actually is the case. And I think that really pushes towards using more of a top down approach and getting biologics on board early.

Fred Goldstein 14:44

And it sounds like health plans in general are looking at the utilization data downstream as these products are used to begin to get a sense of how it's impacting their populations.

Casey Koch 14:53

Yes, absolutely. So I think the drugs themselves, you're, you really are going to have a focus on, on the, utilization of, of the actual drug. but yes, you can look downstream, see the effects, see if patients are able to maintain on the drug. I think that's a good sign by itself. The patient stays on the drug long term. We can sort of assume they're doing fairly well or they wouldn't still be taking the drug.

Fred Goldstein 15:14

And one of the issues we've faced quite a bit is this issue of health disparities. And can you discuss that in this, in this area of IBD and how that might be addressed?

Casey Koch 15:22

Yeah. So I think, something I haven't mentioned yet is primary population for this is kind of the young adult. so we probably do have,  You know, some disparities in the data on in the pediatric setting and really in the geriatric setting. So those are areas that have probably not been studied as much as we ideally would like. therapies are still being used in those patient populations. we maybe don't have quite the, level of data and rigor of the clinical trials to know, the exact outcomes. Another spot, that is, is rural health. So, a lot of these therapies are IV administrations or have an IV loading dose. So, patients do need to get into some sort of site of service to receive that dose.  and that can be really burdensome for a patient that, does not live near a center. the, the infusions themselves take time. And so, be an entire day of a, it's life to go get, The drug administered, so those are some areas of,  kind of the social determinants of health that we've been thinking about.

Fred Goldstein 16:26

So things like access, availability, et cetera, are the ones you're most focused on?

Casey Koch 16:30

Yeah, and if you, you know, you're thinking from a formulary standpoint,  it kind of lends itself to having more options. So if you're thinking an IV therapy might be the best drug for a patient, but they can't get in to use it,  and, the provider would rather use either a self injectable or an oral product. making an allowance for that, I think, is something that, can help with the health disparities.

Fred Goldstein 16:55

Well, thanks so much, Casey, for joining us today on Unscripted, the AMCP podcast and sharing your expertise.

Casey Koch 17:00

Thanks, Fred. Appreciate it.

Fred Goldstein 17:03

And thank you for listening to this episode of Unscripted, the AMCP podcast. This episode was sponsored by AbbVie, Inc. For more information about AbbVie, go to abbvie.com.