Evidence and Outcomes in Atopic Dermatitis

Peter L. Salgo, MD: Jeff, we have all this. We have the drugs which promise, at least theoretically, to change the disease itself. So, how impactful does the evidence need to be for you to warrant coverage? What do payers take into consideration when they look at this?

Jeffrey D. Dunn, PharmD, MBA: Well, the typical algorithm is, is it more efficacious than the standard of care, what we already have? Is it safer? The third thing we’re looking at is cost. And then, there’s everything else, which is route of administration, utilization, those kind of things. So, it’s in that order. Even payers, even insurance companies, look at efficacy and safety first. These drugs will be covered because they’re better, and they’re being studied on top of the standard of care. To me, the issue becomes what are the utilization management criteria that are put in place and who’s the appropriate patient? That’s everything we’ve been talking about, which again might be a moot point. Because if physicians are not using these out of the shoot for mild to moderate, and there’s a history of these other drugs being used in their system, then it will shake out. But, initially, because of the cost, we just need to make sure that the first little while that we have these drugs, it fits the evidence that’s available.

Peter L. Salgo, MD: Does the mechanism of action (MOA) of these drugs affect your willingness to pay for them?

Jeffrey D. Dunn, PharmD, MBA: Usually, no. It only does if we have multiple drugs with the same MOA, and then it comes down to contracting, pricing, and things like that. But there’s an old adage that I like. We tend to care if a drug works, not how it works. So, we’re going to look at the data. Just because one works differently, if it’s inferior, we’re not going to pick it because it has a certain MOA. It comes down to the efficacy and the safety of the drug.

Ed Pezalla, MD, MPH: I totally agree that we don’t choose to cover a drug based on that. We’re looking for the outcome. What does it do for the patient? The MOA does matter in the sense that you look at it in terms of potential drug interactions. And also, what are rational drug combinations? Two drugs with the same mechanism of action is not generally a rational way of going about treating a patient. But it’s nonsteroidal, and you add it to a steroidal. That might make a difference for patients who need more therapy than just one or the other. So, MOA matters not in our coverage decision, but basically in some of the utilization management. What we’re really looking for here is efficacy.

Peter L. Salgo, MD: I guess MOA might matter if the mechanism is such that it affects the natural course of the disease. So, is long-term better even though short-term may have the same outcome?

Jeffrey D. Dunn, PharmD, MBA: Well, again, that’s a reflection of the efficacy. I don’t care how we get there. I care if I get there.

Jonathan Silverberg, MD, PhD, MPH: It’s an interesting part about MOA that starts to play in—and it’s a little early to say because we don’t have all the data yet—but when you think about, let’s say, Th2 blockade, there are active programs now to look at dupilumab for asthma, nasal polyps. Presumably from a mechanism standpoint, it will probably help for hay fever and all this other stuff. So, when you have these patients who, right now, are on omalizumab for their asthma and I’m putting them on cyclosporine, the two are not exactly cheap and I don’t like that combination so much. You have this potential value-add of like 2-for-1, so to speak, or a 3-for-1. While it’s early on the efficacy, that’s where MOA may play a role for some of these things because there are some other biologics that may not have that same breadth in terms of covering that.

Peter L. Salgo, MD: Note to self, not to viewers: he’s not recommending you use these for nasal polyps.

Jonathan Silverberg, MD, PhD, MPH: No, I’m not. I think that’s an interesting story to watch. We have to see the data.

Peter L. Salgo, MD: Sure.

Jonathan Silverberg, MD, PhD, MPH: But if the data do come out and you get that indication for these drugs, that could be a great decision maker. Same idea with psoriasis, where the same treatment is being used for psoriasis and the psoriatic arthritis cutaneously, and you’re getting that 2-for-1. No dermatologist in their right mind thought 20 years ago that they would be helping a patient’s psoriatic arthritis, but they are now. And so, you have this idea that you can really get a bunch of disorders treated with one agent and still have the precision without the side effects.

Peter L. Salgo, MD: Let me put it this way then: if we’re going to take the insurers at their word, and why not, I like you, we like you, it’s not fair necessarily to make them the judge and the jury on all of this. And we get to a word that you used, Cheryl, which is “stakeholders.” You did use it. I heard you use it. How do we get this thing going? How do you get the shareholders and stakeholders together to work together to measure real world success of these drugs? Give these guys and women some guidelines to say, “Look, here’s what we think and here’s what we think you ought to be doing, here’s what should be covered.” How do you do that?

Cheryl Allen, BS Pharm, MBA: I think it goes back to something Ed said before. He said that you take that study population and you continue it out. Maybe it’s phase IV studies, where we begin to monitor these patients and, basically in the real world, come out looking at what happens over the natural history. And then, as the stakeholders begin to venture out into the world, we see how that works. Are we truly seeing that we’re having better outcomes from a medical claims data perspective? Are we having less doctor visits? Are we seeing more clear skin and less itch time? Maybe antidepressants or sleep therapies? Are we seeing less of those over time?

Peter L. Salgo, MD: Well, how is that happening? This all sounds great, but how—physically, mechanically—do you get all the stakeholders talking to all the other stakeholders? Do you have them get in a room and lock the door?

Cheryl Allen, BS Pharm, MBA: That’s the tough part.

Ed Pezalla, MD, MPH: We can’t really do that.

Peter L. Salgo, MD: Why not?

Ed Pezalla, MD, MPH: Well, for one thing, the payers can’t have this discussion together because we can’t have a discussion about how much we’ll pay for something, or whether we’ll pay for something or not, because it violates antitrust laws and we want to maintain those laws here. But one way to deal with this, and a great way to get these started, is for a professional society to create an evidence-based guideline. They’re the experts, right? Then they can also talk to patients, which helps with the risk-benefit and with asking patients what are the most important symptoms and problems to address. But we take guidelines very, very seriously when they’re evidence-based and they come from the appropriate professional society. That helps us a lot to get things done, and it’s something that we can all start to talk about even if we’re not all in the same room talking about it.

Peter L. Salgo, MD: Okay. So, they just kicked the ball into your court, which is, “We’re helpless. Doctor, give us some evidence-based guidelines.” Are you willing to do that?

Jonathan Silverberg, MD, PhD, MPH: We’re working on it. The American Academy of Dermatology (AAD) recently put out a four-part guideline series, which finished about a year or two ago, and it’s a little early because we didn’t have the biologics. We didn’t have all these data, and we don’t have FDA approval yet for any of these. So, there needs to be a revision. There’s recognition of that. It’s a costly and timely process, but there are many advocates who are pushing that the AAD go that route and really get a revision. There’s also a number of other international consensus groups that are working on position statements, etc, to try to provide a little more refinement to the guidelines.

Cheryl Allen, BS Pharm, MBA: And I think that’s going to be extremely helpful. I think there will be a lag time, though, as these couple of products, the first wave, get approved, and then the guidelines will be updated. But I think going back, while payers, as a group of stakeholders, can’t get together and make the decision, each individual payer can look at a segment of its population and do its own internal return on investment studies, its own internal sort of phase IV study. Because you have your own pharmacy claims, medical claims, crunch that. See what happens at the end because that’s where the real world analysis comes out.

Peter L. Salgo, MD: Is that what you do now, Jeff?

Jeffrey D. Dunn, PharmD, MBA: We do, depending on the disease state. I would argue, though, that it’s rare that decisions are made on real world retrospective data like that. A lot of it still comes from the randomized controlled trials. But I agree. The two words I’m going to throw into this discussion are data and risk. So, collaboration on long-term studies and who the appropriate patient is, it’s hugely important to see what some of those offsets are, and in terms of direct cost. And the other is risk. If a drug doesn’t work, who should be paying for it? There should be some shared responsibility in that, and I’m not necessarily talking about an outcomes-based contract. I’m not big fans of those because they’re super hard to measure and operationalize, but some kind of discussion around shared risk.