Understanding Emerging Therapies in Atopic Dermatitis

Peter L. Salgo, MD: Before we move on, I just want to get a benchmark. Where do we stand right now in terms of levels of awareness of this problem with AD among the community, its patients, among physicians? Specialty pharmacies, are they aware at all that this is coming their way, that there’s a train coming down the track? And what about health plans? You’ve talked about health plans, but what else? Where’s the level of awareness here with all these?

Jeffrey D. Dunn, PharmD, MBA: I’d say it’s pretty low, generally speaking, except for those people who are specifically watching the pipeline and are managing budgets and managing formularies. But generally, no. And there’s a misperception that this is eczema. Some people think that this is cosmetic and so there’s an unmet need.

Cheryl Allen, BS Pharm, MBA: I think you’re spot on there. I think eczema, it’s been around. You treat it with over-the-counter steroids. And for a payer thinking about atopic dermatitis, there’s not the awareness that really this is this large issue.

Ed Pezalla, MD, MPH: And payers really have a data problem here. It’s like we don’t know the whole sphere of patients who have all of this. We can’t find it all in claims. And one of the things that would really help here would be to start thinking about, is there an algorithm you can use on claims to find the most severe patients as sort of a starting point? Because those are patients who probably have a proper coded diagnosis and who are receiving some sort of therapy that we’re paying for. They’re not just using a moisturizing cream. They’re on an expensive fluorinated topical steroid, and they’re getting it in gallon drums. So, at some point, we should be able to at least figure out who the severe population is. And right now, nobody is tracking that, but it’s doable. But, if you said, “Well, I want to figure out the entire atopic dermatitis group and then segment them into this or that,” you’re not going to find all of those folks, because for most of them, we don’t have a claim for them.

Jeffrey D. Dunn, PharmD, MBA: And there will be some self-selection here. And also to Cheryl’s earlier point: we’re not talking about 30 million people. There will be some self-selection because these are not oral once-a-day tablets and they’re expensive. They’re going to be in specialty tiers for the most part. So, there will be some self-selection.

Peter L. Salgo, MD: We’re going to get to all of these medications. But if I take a look at your body language, at least early on, it was like, be careful; that light at the end of the tunnel is the headlight of an ongoing train and that’s expensive.

Jeffrey D. Dunn, PharmD, MBA: Yes. We tend to overreact to things that are coming, and it settles out. But we have to have some comfort level that these drugs are being used appropriately.

Peter L. Salgo, MD: Okay. Let’s move on just a little bit and shift gears. Let’s talk about a little science. What’s known about the causes, the pathophysiology of AD, and how has this evolved over time?

Jonathan Silverberg, MD, PhD, MPH: There has actually been a big shift right now in the dogma. There has been this existential debate about whether or not atopic dermatitis is a disease of the skin barrier, where the skin barrier is impaired and, as a result, that allows junk from the outside world in and, eventually, inflammation.

Peter L. Salgo, MD: That’s a technical term, junk?

Jonathan Silverberg, MD, PhD, MPH: It is a Northwestern term versus this idea that inflammation may be at the heart of it and that there’s something wrong with the immune system as the underlying trigger. And then that causes, secondarily, this dry skin phenomenon and the rash. For the past decade, we’ve seen a ton of development with over-the-counter agents and some of these prescription emollient devices that have really focused on the barrier story. But now we’re starting to see a whole lot of development in the inflammatory side of things, where we’re seeing that you can really get this targeted treatment of inflammation and get outstanding results.

Peter L. Salgo, MD: So, let’s turn to these because he’s already beginning to shiver on the side over there.

Jeffrey D. Dunn, PharmD, MBA: That’s what gets back to the indirect versus direct cost. That’s what we want. We want to have a discussion around inflammation and those kinds of things.

Peter L. Salgo, MD: We’re going to get there, yes. Cheryl, bring us up to speed. Now, these emerging therapies, he’s afraid of them from a cost-perspective standpoint. But, in fact, they might be effective, which would make it even worse because you have to pay for them. What have we got? What are some of the targets being investigated?

Cheryl Allen, BS Pharm, MBA: Well, there’s some close target agents that we’re monitoring in the pipeline. Pfizer has crisaborole. This is at acquisition through the Anacor. This is going to be a topical PDE-4, so we’ll see this as a small molecule, and it’ll probably be priced as that small molecule. I think some of the financial analysts are saying somewhere around $12,000 per patient per year.

Peter L. Salgo, MD: Stop for a minute. Is that big or small?

Jeffrey D. Dunn, PharmD, MBA: Medium.

Peter L. Salgo, MD: This is an ointment?

Cheryl Allen, BS Pharm, MBA: This is a topical ointment.

Jeffrey D. Dunn, PharmD, MBA: It’s still a concern in a generic and over-the-counter space. It will still be a concern.

Peter L. Salgo, MD: Okay. Tell me about the data. Does it work?

Cheryl Allen, BS Pharm, MBA: Well, the data looks good initially. The study came out, and it’s used twice daily. The study was for 28 days and the data was reviewed on day 29. What we would like to see is a little bit more on that data to show some efficacy.

Peter L. Salgo, MD: Is this phase III data? What kind of data is this?

Cheryl Allen, BS Pharm, MBA: It is phase III data. The FDA will review that, and we’ll see what happens with that agent. But we’re pretty excited about dupilumab. So, that’s a Sanofi-Regeneron. This is going to be a biologic, so this is really something that’s coming in and going to help to really get to the cause of this. As Dr. Silverberg said, now we’re, with the newer drugs, looking at really going into the immune system and targeting that therapy. This is going to work on IL-4 and IL-13, so we’re very excited about the studies that are coming out there and the true markers that we’re seeing; when you look at the body surface area, the improvement is there. The EASI scores are better, so it’s very exciting.

One of the things that we’re a little bit concerned with is the loading dose and injection on this. So, whereas the topical agents, right now, are used in mild to moderate—even the crisaborole is going to be used mild to moderate, and that’s for ages 2 years old and up—dupilumab is going to be for adults and is injectable. This is something new for this patient population, so a lot of education around this.

Peter L. Salgo, MD: And so, we have data. As I understand, it’s SOLO-1, SOLO-2. Those are the two studies?

Cheryl Allen, BS Pharm, MBA: Yes, SOLO-1, SOLO-2. Efficacy was shown in both in those key measures that we’re looking for. I think those are going to be some of the things that will speak to the health plans.

Peter L. Salgo, MD: This goes to what you pointed out, too. By the time you’re ratcheting up to some of these newer therapies, there’s a lot more patient investment because it’s an injection.

Jeffrey D. Dunn, PharmD, MBA: It is. Again, there’s a lot of need for patient education. The out-of-pocket, financially to the member or patient, is a lot higher. So, they themselves have to decide if it’s worth it to spend this money.

Peter L. Salgo, MD: It’s a self-selection thing. Not necessarily for money, but, in fact, for inconvenience in pain and injections.

Jeffrey D. Dunn, PharmD, MBA: But the nice thing about these studies, from what I understand, is it’s on top of standard of care. So, it’s on top of the steroids and TCIs and other things. It’s not as monotherapy, where we’re really struggling to see where does this fit versus an inexpensive topical.

Cheryl Allen, BS Pharm, MBA: It’s being studied as both, so we’ll see if it’s monotherapy. But one of the ways it could be used is in these times of flare, where we’re trying to control the patients.

Jeffrey D. Dunn, PharmD, MBA: Which, when you start talking about compliance programs and what specialties pharmacies do, that’s an issue. Because understanding that, if you talk about psoriasis and other things, we track adherence and persistence. And if that’s not applicable here, then we’re going to need to understand that.

Peter L. Salgo, MD: But, again, it’s on you to work out the model, right, or not? The financial model?

Jeffrey D. Dunn, PharmD, MBA: It falls on us, unfortunately. It shouldn’t be that way, but it falls on us, yes.