Atopic Dermatitis: Determining Utilization Management Criteria for Long-Term Systemic Therapies

Peter L. Salgo, MD: Stepwise, let’s come back. That goes back to what I was asking you. We can all dive in on this. How do you recognize who gets them? In other words, you said “stepwise.” They’ll try somebody who’s tried A, tried B, tried C, but then you said, “If I see somebody really bad, I’ll jump right to D.” And he’s going to jump right down your throat.

Jonathan Silverberg, MD, PhD, MPH: Again, we’re not going to jump straight to that systemic agent. I take a generally very stepwise approach, so even when I have a sense that they’re going to require a systemic agent, I do recognize that there’s at least a subset, even of those most severe, that can respond well to topical agents first. It’s certainly worth giving that effort before committing them to long-term systemic management. Right now, there certainly are providers out there who are using pulse dosing of systemic steroids or pulse prednisone as a quick fix when someone comes in with a flare before a wedding or things like that. And so, I think that even in those scenarios, no one is going to jump to using dupilumab for a year when you’re trying to get that quick fix. I think it’s recognizing when patients have a really chronic disease, where automatically you’re going to run into real safety issues with the current systemic agents out there. So, that chronicity is a big issue. And that’s, again, going to be a smaller subset because so many of the patients have just seasonal flares, and things like that, or those who really have failed other options.

Peter L. Salgo, MD: Okay. Let me make it more difficult, unless you wanted to add something here. Go right ahead.

Cheryl Allen, BS Pharm, MBA: Well, I think as we get drugs that are approved by the FDA to treat mild to moderate—as crisaborole comes out, and we’ve got that as a mild to moderate—in my mind, maybe it’s just too simplistic to say to use topical corticosteroids or TCIs (topical calcineurin inhibitors) as a first step above all of the bathing and the hygiene purposes. And then, for a patient who doesn’t respond to topical steroids, there’s a topical nonsteroidal new agent that’s indicated. Then, dupilumab comes on as the moderate to severe alternative to that. That is the first, or should be the first, approved in moderate to severe.

Jeffrey D. Dunn, PharmD, MBA: I think the topical PDE-4 inhibitor, that’s probably even a less clear place in therapy.

Cheryl Allen, BS Pharm, MBA: Well, it’s nonsteroidal. In my mind, it works when steroids don’t. Do you step through that?

Jonathan Silverberg, MD, PhD, MPH: That’s an interesting one. I think for dupilumab, almost everyone would agree that it’s certainly reasonable to step through a topical steroid first. I do agree. I think this is a little less clear with the crisaborole because in a perfect world, we would never have to deal with topical steroids. If we had some cheap nonsteroidal options out there, we would all just like to throw topical steroids away. So, this is not going to necessarily be cheap to start with. But, in theory, if it had the efficacy comparable to a midpotency topical steroid, we’d love to see it used in everyone. Obviously, that’s a scary statement, but what do we do with these, do we step through these or not?

Jeffrey D. Dunn, PharmD, MBA: Is it a replacement or is it another step? I think that’s what we’re seeing, and we don’t know.

Peter L. Salgo, MD: I’m going to keep this away from you for a minute. Let me ask Ed. Do you think that payers are going to recognize that it isn’t just the size of the rash or body surface area affected, but all these other comorbidities? And I come back to sleep, itching, quality of life, just a general annoyance of this thing. Are they going to recognize those as markers for approval of these newer drugs?

Ed Pezalla, MD, MPH: I think they can, but this is something that the dermatologists, and other specialists who are treating these patients, are going to have to help us with. And there are a couple of different ways to do it. In some disease states, we have a list of things, you check off two of them, and you get the drug. And in others, we look for a more global type of assessment. Not necessarily the things we’re calling global assessment, any specific ones, but looking for more of how bad off is this particular patient. And so what we’re really looking for here is, who are the patients who should go right to this drug? Then, perhaps, the patients don’t have all of those symptoms or maybe they didn’t score so high on that, but they’re resistant to other therapies, so they have nowhere else to go. I think that the payers would take that into account. But we’re going to need to have some way of measuring and some way of tracking it back to the clinical trial, even if it’s just to say, “Well, in the clinical trial, 30% or 40% of patients reported they slept better at night.” That’s fine. And then you can add sleeping better at night as one of the ways of adjusting this medication for the patient and figuring out if we’re going to use it.

Cheryl Allen, BS Pharm, MBA: I think the other point, too, to bring out in this area—because that’s what we’re really talking about—is the criteria for utilization. And for mild to moderate, for crisaborole, the drug was studied in those 2 years old and up. But, in dupilumab, these are adults with moderate to severe. They are in, I think, that part of the population, that 1% to 3% of the population.

Jonathan Silverberg, MD, PhD, MPH: It’s probably eczema in the overarching sense, a little more common in adults than we may have realized before. But the moderate to severe atopic dermatitis population is going to be way less than 1%. You’re talking about a much, much smaller segment of the population. What gets interesting is, fast-forward 5 years from now, if dupilumab gets approved for kids, that’s a whole different conversation. But we’re nowhere near there at this point.

Peter L. Salgo, MD: And just to be clear, it seems to me that what we’re talking about with these two new agents, with crisaborole and dupilumab, is disease modification, not symptom modification, right? That’s huge. Again, we come back to, “I can manage your symptoms. I’m going to give you this, I’m going to give you that.” But these two drugs—one topical, one injectable—change the disease, at least theoretically, right?

Jonathan Silverberg, MD, PhD, MPH: Right.

Peter L. Salgo, MD: That’s got to be enormous change.

Jonathan Silverberg, MD, PhD, MPH: Absolutely. Not only are we talking about the potential of really minimizing flares, minimizing between flares, itching symptoms, everything else, and keeping the skin clear, there’s the potential of really taking it down a notch long term as you really intervene on that mechanism. And we need to see more data about that, but that’s a very interesting and exciting principle that comes out of this.