Peter L. Salgo, MD: And when do patients typically come to you and get care anyway, Ed? What triggers somebody to say, “I’ve been living with this; it’s been itching. I’ve had all this, but today I’m coming for medical care”?
Ed Pezalla, MD, MPH: Well, as Jonathan said, it’s really going to depend on the age of the patient. Parents pretty much get alarmed about anything that happens with a small child. They’re not aware of all the different diagnoses of skin disorders. And so, the pediatrician is on the frontline. The family practice physician who’s doing well-child visits, they are also going to see the child for these sorts of things. There are many, many skin conditions in children, and so they’re going to have to make a distinction here between the seborrheic dermatitis and eczema atopy. They’re going to need to take a family history.
It starts with the primary care doctor and especially a pediatrician for the younger children—but it really can come from anywhere. Somebody might be ignoring it or self-treating, but they’re seeing an allergy specialist for something else. They’re seeing a pulmonologist for their asthma, and those physicians are well aware that atopic dermatitis goes along with those other conditions that they are treating. So, we’re going to see these patients come from a number of different places, including going to see their internist and just saying, “I give up. I can’t self-medicate enough to make this work. I’m taking antihistamines over the counter. I’m using various creams and it’s not working.” Ultimately, these patients will see the dermatologist if they fall into the moderate-to-severe category. And they need to if we’re going to see management with new medications, because all of those other specialists and primary care physicians are not going to be familiar with the new medications.
Peter L. Salgo, MD: At least, not at first. It would percolate out.
Ed Pezalla, MD, MPH: Right. It may take a while.
Peter L. Salgo, MD: But it will, at some point. Yes, parents are going to bring little kids. I thought that as a doctor, when I had little kids, I’d be immune to this, but no, my kid’s got a hangnail and they’re going to the pediatrician. Sorry, it’s true. That being said, a grownup who’s been living with this, is there some trigger where the grownup says, “That’s it. I’ve had enough”? What typically brings them to a dermatologist?
Ed Pezalla, MD, MPH: There are those triggers, and Jonathan sees this all the time. They finally go, “I just can’t take it that I can’t sleep,” or their spouse says, “I’m going to push you out of bed because I can’t sleep.” So, those sorts of things happen. And sometimes they’re just fed up or sometimes there is a particular instance, like “I really want to learn to scuba dive, but I can’t stand being outside in a bathing suit because people will see this.” There are all sorts of things that bring people to the doctor, but a lot of times it’s because they just can’t stand those symptoms and, especially, the pruritus.
Peter L. Salgo, MD: I can imagine. My kids get mosquito bites, they’re scratching all night. It’s terrible. Imagine this if it doesn’t go away. It’s a chronic condition that stays with you forever, and the medications aren’t working. So, it comes back to you, Jeff, because you’re talking about the pipeline and you’re talking about the expense. But we’re talking about direct and indirect costs of this disease; not just money, but the social cost, the psychological cost, and the psychosocial cost. This is a big deal. What about comorbid conditions and all this affecting the cost?
Jeffrey D. Dunn, PharmD, MBA: This is not a focus right now for payers. It’s off the radar screen—because, again, of the generic and over-the-counter versions—but it speaks to the unmet need and around education on what this is. And with that is, what do those outcomes mean? Because payers generally don’t focus on indirect costs and quality of life in their analyses when it comes to formulary management. So, right now, most of the cost of this disease is indirect or really low direct. But that is going to change, and so that’s the need right now: what are those direct costs? We don’t want to be told that this helps sleep. We have inexpensive sleeper medications that we can use, right? It really comes down to, how does this treat the disease? And if we get those extra benefits, that’s fantastic. Hopefully, those are the outcomes that we’re getting with the drugs, but we cannot prioritize that way.
Cheryl Allen, BS Pharm, MBA: But, don’t we think that there will be times patients will seek additional treatment when they have flares? This is a disease that the patient is up and down, and most likely it’s going to be the adults who are going to come more so to seek that treatment. And it’s not 30 million; it’s probably two-thirds of those are mild to moderate, and most could be controlled, for the most part, by over-the-counter or topical steroids. It’s going to be a small subset of those patients who really have issues.
Jeffrey D. Dunn, PharmD, MBA: It’s never the full amount.
Cheryl Allen, BS Pharm, MBA: Right.
Jeffrey D. Dunn, PharmD, MBA: It’s never the case. There’s going to be a lot of analogies here with psoriasis. So, a decade ago when we had the biologics that were launched for psoriasis, there was major concern. Those were tightly managed. We were asking about body surface areas, and we were doing all kinds of things. And now I think the approach is generally more open because we’re comfortable, a little bit more, with who that patient is. I think we’re going to see a similar approach here. But my point is, when we’re talking about a value proposition of these new drugs, it cannot be around some of the quality of life. It has to be more around functionality and direct cost because that’s what we’re …
Ed Pezalla, MD, MPH: But some things that are sometimes lumped into these quality-of-life questionnaires and things like that actually are really about patient symptoms, and so that’s really part of the clinical story here. When payers hear quality of life, sometimes what they’re thinking about is, is this some convenience factor or something that fits into some social mold that’s not quite what they normally deal with? But patients have symptoms; patients can’t sleep. These are important symptoms, and you can put that more into a clinical context and don’t lump them in with a bunch of other things.
Jeffrey D. Dunn, PharmD, MBA: If they’re disease-specific and they’re related to outcomes, then we’ll look at those, absolutely.
Peter L. Salgo, MD: Let me be a devil’s advocate here, and a little bit mean, because I heard you say, “Well, if it’s about sleep, we’ll cover a sleeping pill or some sleep medicine.” But it’s not about sleep, is it? It’s about the fact that you’re itching and sleep is only the byproduct of that.
Jeffrey D. Dunn, PharmD, MBA: Absolutely. So, the message is that sleep and all these other things improve because we’re affecting the disease state, the inflammation, and the itching. Again, it’s the value prop. I don’t want to discount this, but we’re not using these medications to treat sleep. We’re using them to treat atopic dermatitis, which helps these other things.
Peter L. Salgo, MD: Okay. That’s fair, I guess. We’re all on board with that. You’re not going to break it down into various slices of symptoms and treat one individually. You’re going to say the whole picture here affects sleep. So, if we treat A, we’ll get that as a side benefit. Is that worth it to the insurance companies?
Jeffrey D. Dunn, PharmD, MBA: Again, my point is, though, you have to be talking about direct cost and objective. And if we can accomplish that and we can show an improvement in the disease state, then these things … absolutely.
Peter L. Salgo, MD: Absolutely. Then they all fall out.
Jeffrey D. Dunn, PharmD, MBA: But, if not, then no.
Cheryl Allen, BS Pharm, MBA: Do you think that it would be better to look at the subsets of those patients? These are the mild to moderate and then moderate to severe. And what about for a patient who’s moderate to severe who has incurred all of these additional costs to the health plan related to sleep aids and skin issues?
Jeffrey D. Dunn, PharmD, MBA: I don’t think payers will have as big of an issue in that population. That completely makes sense. But I think that speaks to the difficulty in the payer environment of who’s mild, who’s moderate, and who’s severe? We don’t have good tools for that, and we’re never going to get that in claims data. It’s like asthma: when you have six stages of asthma, we can’t determine. That’s a clinician’s perspective. So, we really need, again, objective measures that we all agree on. How do we determine who is a candidate for these types of drugs, when do you start, when do you stop, what are the algorithms? It really is about the appropriate patient.