Cheryl Allen, BS Pharm, MBA: So, there’s caregiver and disease burden. I think it’s extremely difficult when we start to think about, what is the cost of this disease? Because through looking at the past studies, we can’t really get our arms around what the cost is. One of the things I think we need to look at is quality of life, not only in the patients themselves, but the caregiver, as well.
Jeffrey D. Dunn, PharmD, MBA: But if you look at payers, though, and the ultimate purchaser of insurance, it’s employer groups or health plans. They don’t understand how to value this.
Peter L. Salgo, MD: I was going to ask you about that.
Jeffrey D. Dunn, PharmD, MBA: We tend to focus more on direct costs and, within quality of life, functionality. But presenteeism, absenteeism, and sleep, we don’t know how to value. We tend to not include much of that in a review. I think this whole thing underscores one of the main key issues with this disease state, which is that there is a huge unmet need in terms of education. Because when we talk about these numbers and we talk about symptoms and everything else, it scares us as payers.
Peter L. Salgo, MD: Well, sure. Twenty percent would scare me.
Jeffrey D. Dunn, PharmD, MBA: This disease is not necessarily on a “radar” screen because it’s treated with generics and over-the-counters, and it’s cyclic. And so, when we hear millions and millions of patients, and if the value prop is you sleep better by using a potentially very expensive biologic medication, that’s a little concerning.
Cheryl Allen, BS Pharm, MBA: Yes, I absolutely think that. And when we look at these types of things and talk about return on investment, we have to look at the overall absenteeism, presenteeism for the workforce. Because if you have three children and you have a child who’s affected, it’s not only affecting that one child, it’s your whole household.
Peter L. Salgo, MD: A parent would say, “Please, leave my kid alone. Give this to me.” But then the parent doesn’t go to work.
Jeffrey D. Dunn, PharmD, MBA: If you’re an employer and you’re providing insurance to employees, we’re talking about something like that, where it’s rolled up under PTO (paid/personal time off). Or we don’t know what’s going on with the patient and you may be an employer who has hourly employees, for example. It’s really hard to make that as the key justification for covering expensive medications.
Peter L. Salgo, MD: You mentioned expensive medication, as opposed to over-the-counters. Currently, right now, without using biologics, without using these new expensive things, what are the go-to drugs?
Jonathan Silverberg, MD, PhD, MPH: A starting point, pretty much for everyone, would be they’re all going to get over-the-counter moisturizers, things that will soothe the skin, soften the skin, help retain moisture. And that’s something that’s going to be a patient cost 99 out of 100 times. And then for the really mild cases, that may be enough, actually, as a primary treatment alone. But when you start getting into the ones where they’re on the high end of the mild spectrum, certainly for the moderate to severe, that’s never enough. And so then we would go to our prescription topical steroids or topical calcineurin inhibitors, which nowadays actually aren’t quite so cheap anymore. There has been this big cost explosion over the past few years where things are getting a lot more expensive, but still, I guess, relatively cheap in the grand scheme of things. And there are all different levels of potency for the topical steroids, ranging from mild stuff for sensitive areas to super strong stuff for tougher lesions or refractory areas.
Peter L. Salgo, MD: But can you apply all of these medicines with almost wanton abandon to all areas where this disease affects you?
Jonathan Silverberg, MD, PhD, MPH: That’s the big challenge. Absolutely not. Because while they have efficacy in many, or most, cases, it’s the long-term safety that precludes us from being able to use this long term. So, the concerns about thinning of the skin—the so-called steroid withdrawal or steroid phobia that patients have, where then they get a rebound effect when they come off of the steroids—fragility of the skin, and poor wound healing, these are major issues. And they’re certainly not just cosmetic ones. They’re major functional ones, as well.
Peter L. Salgo, MD: Right. Well, you were commenting about healthcare phobia. That is, to say, expensive stuff may work better—but that’s 20% of people. That’s a lot of money. So, what are you tracking?
Jeffrey D. Dunn, PharmD, MBA: Pipeline.
Peter L. Salgo, MD: What does that mean, “pipeline”?
Jeffrey D. Dunn, PharmD, MBA: Right now, these medications are generic over-the-counter, so we’re not managing it. That’s why I bring up the point that we’re going to need education as we move into other areas: who the appropriate patient is, sequencing, how we apply these medications because we can’t pay for expensive future medications in that many of patients. It doesn’t financially make sense. So, when I say “pipeline,” we’re looking out in the future to see what is being studied, particularly in phase III trials; what we’re going to be seeing within the next 1, 2 years.
Jonathan Silverberg, MD, PhD, MPH: Can I just say one point? I think this is an excellent point, in terms of the candidate patient. When we throw those numbers around, a lot of that is based on population-based reports. The overwhelming majority of those are going to be really on the mild end of the spectrum, and there’s actually a substantial proportion that don’t even utilize healthcare for their atopic dermatitis.
Peter L. Salgo, MD: Let me stop you there. Do they even know they have atopic dermatitis?
Jonathan Silverberg, MD, PhD, MPH: That’s a big question in and of itself. But, at least based on the self-reported data, the answer is pretty much yes. They’re reporting that they have it.
Jeffrey D. Dunn, PharmD, MBA: And we understand that. Not all 20 million patients with eczema or atopic dermatitis are going to be candidates for this. We get that. But that’s where we start when we’re talking about the potential exposure to these medications.
Jonathan Silverberg, MD, PhD, MPH: Right, I understand.
Peter L. Salgo, MD: I’ve got to tell you. Yes, it’s going to sound facetious, but when you were talking about what you would do for this, I recall back in medical school the standard dogma of dermatology was if it’s dry, wet it; if it’s wet, dry it; and for everybody else, it’s steroids. And that really hasn’t changed until right now. Has it been effective for atopic dermatitis, honestly, in the past?
Jonathan Silverberg, MD, PhD, MPH: Well, certainly the idea of “if it’s dry skin with atopic dermatitis, we want to keep it moist” is true. And the idea that we use topical steroids in atopic dermatitis a lot, yes, that certainly has been the paradigm. We had a breakthrough with topical calcineurin inhibitors, going back over a decade ago. But with the introduction of a black box warning, it’s been challenging for a lot of providers to use it. So, yes, we’re left with very limited options.
Peter L. Salgo, MD: I guess that’s what I was getting at. Until right now, there hasn’t been a lot in the armamentarium.
Jonathan Silverberg, MD, PhD, MPH: Right. And the end result of that has been that the standard of care for our moderate to severe patients has really been gross undermanagement, where many of these patients really have been suffering with very little that can actually get them better.
Peter L. Salgo, MD: Not the fault of the clinicians?
Jonathan Silverberg, MD, PhD, MPH: No, not at all.
Peter L. Salgo, MD: Just nothing out there to do this.
Jonathan Silverberg, MD, PhD, MPH: Exactly.