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Peter L. Salgo, MD: What do we learn now, because we’re making a turn here with AD? But we’ve already made this turn with other diseases, right? And everybody has been talking about psoriasis. Does psoriasis have anything to teach us about this shift from topical to injectable and paradigm shifts in the way you think about this disease?
Ed Pezalla, MD, MPH: Psoriasis does in several ways. One is that, as Jeff pointed out earlier, we controlled the psoriasis drugs much more tightly when they first became available than we do now because we’ve seen that, you know what, their use seems to be pretty appropriate. And one of the things that we’ve learned—and we learn this all the time about new drugs, but it takes a little while—is who’s prescribing them. Is it somebody who really is on top of how these drugs are used, has enough patients to know that? We find that almost always, psoriasis drugs, when it’s a biologic, are being prescribed by a dermatologist or occasionally by a rheumatologist because the patient’s primary presentation was psoriatic arthritis. And so, for most of those patients then, now it’s just a matter of which psoriasis drug do we tell people to use first because we’ve got a contract about it. But it’s not really an argument about using psoriasis drugs.
The other thing we’ve learned is that it’s really hard to get the guidelines to keep up with practice. And so, for example, the dermatology guidelines for psoriasis usually say that patients should go through UV therapy unless there’s some contraindication like it’s on the palms and soles, and a couple of other things like that. We almost never see UV therapy being used much anymore because a lot of patients really don’t like it. It’s hard to get to the doctor’s office. People don’t want to have giant light boxes in their homes, which they have to pay some portion of for anyway. So, there’s a lot more movement toward biologics. The clinical practice has moved more toward biologics, and the guidelines haven’t quite caught up. And that’s another important thing to know, that we really do need to see guidelines get caught up. But, generally, the most important thing has been that we learned that appropriateness of prescribing is happening, it’s the right kind of prescribers, and the drugs don’t need the tight control we started with. And that’s probably how this is going to go. But this is our version of what the Europeans call “managed market entry,” which is you start out with a very circumscribed group of providers, patients, and circumstances in which something can be used. And, as we all learn what happens, we can expand that. One way you expand that is by loosening up on the criteria and not getting so excited about it as it goes along.
That helps the payers because we really do go into this without knowing how many patients are going to be seeking this therapy. On the one hand, we have our own data, which we think is rather flawed in this area. We don’t know that we know all the patients. On the other hand, we’ve got investment houses saying that they’re pumping up the stock of the guys that are producing it because they say, “Oh, this is really going to be great.” And the companies are cringing because on the one hand, they love it that the investors think it’s great and, on the other hand, they know it’s setting expectations that can’t be met.
Peter L. Salgo, MD: I don’t know this, but have the psoriasis drugs moved out from the specialty drugs or are they still there?
Cheryl Allen, BS Pharm, MBA: Many of the psoriasis drugs are still with the specialty.
Peter L. Salgo, MD: So, they’re still controlled, at least in part. The biologics are controlled by the specialty pharmacies?
Cheryl Allen, BS Pharm, MBA: Yes, the biologics.
Peter L. Salgo, MD: So, it’s likely that these new drugs…
Jeffrey D. Dunn, PharmD, MBA: They’re not limited distribution drugs. And that’s probably the nuance difference. Limited distribution drugs will go through specialty. Nonlimited distribution—like the MS (multiple sclerosis), RA (rheumatoid arthritis), and psoriasis drugs—they’ll go through retail.
Peter L. Salgo, MD: Okay, but specialty pharmacies are going to be playing a large part in the foreseeable future for this?
Jeffrey D. Dunn, PharmD, MBA: Yes. And with these, I believe, initially for a period.
Peter L. Salgo, MD: Jonathan, what’s been your experience with regard to the level of support that you get as a clinician from the specialty pharmacies?
Jonathan Silverberg, MD, PhD, MPH: For atopic dermatitis, it hasn’t been a huge issue so far because we haven’t had these biologics. But now we do, and so I think we’re going to need that support unquestionably.
Peter L. Salgo, MD: But you have had other diseases. Psoriasis again, we keep coming back to that. What’s the interactions with the clinicians and the specialty pharmacies?
Jonathan Silverberg, MD, PhD, MPH: It’s really been psoriasis at the forefront, and then more recently, hidradenitis suppurativa, as well, with Humira being approved for that. But it’s been good overall, and I think we need to have a dialogue, and we need the support in terms of the education. This was something you mentioned. Early education is so important on disease state for patients, but for providers, as well; proper usage, who the appropriate patients are, and how to navigate whatever restrictions there will be.
Peter L. Salgo, MD: And then, we get the payers in this mix yet again. How do they work with the specialty pharmacies to manage patients and manage costs at the same time?
Jeffrey D. Dunn, PharmD, MBA: I think specialty pharmacies bring a large value to how we manage patients. Just like every plan is not great, there are variations in specialty pharmacies. What we try to avoid is the emphasis on auto refills and things like that, and we really want to have a discussion around managing the patient holistically. You brought this up earlier. What are we doing with the depression, and the sleep, and other things in some of these patients, and how is that fitting with our care management programs? It really is about data and integration, but it’s aligning incentives. A lot of times everybody in this room has different incentives and unless those are aligned, we’re going to have problems. So, if it really is about driving drugs out of the specialty pharmacy, that’s probably different than what we’re trying to accomplish.
Peter L. Salgo, MD: But you know what it sounds like to me, you’re talking about specialty pharmacies, you’re talking about specialty pharmacies, you’re talking about specialty pharmacies, and you’re sitting here right in the center. We talked about stakeholders all getting together and managing all of this. Why am I hearing, in the back of my brain, it’s all going to come down to you and specialty pharmacies?
Cheryl Allen, BS Pharm, MBA: We touch the patient, right? So, we have wonderful manufacturers that bring amazing technologies to the forefront. We have prescribers who are prescribing those drugs. We have the payers. But we are the ones who are ultimately touching those patients, and quite often, we’re the ones preparing the case for appropriate utilization.
Peter L. Salgo, MD: Well, that’s what we need.
Jeffrey D. Dunn, PharmD, MBA: Yes, and that’s the issue. Most payers, PBMs, and health plans have their own pharmacy and therapeutics committee. They’re the ones setting the utilization management criteria, and these are the ones that are implementing it on the patient side. So, that’s why that communication has to be there.
Peter L. Salgo, MD: Right. But, you’re communicating with doctors, you’re communicating with payers, you’re communicating with patients. It seems to me that you are right there. You are that stakeholder hub.
Cheryl Allen, BS Pharm, MBA: Which makes it very, very exciting when we start thinking about patient-reported outcomes, particularly when we talk about atopic dermatitis. How can we get this real world information? We can do this through specialty pharmacies.
But you talk about the right patient, right drug, right time, and making sure that we’re not auto refilling medications. One of the things that we do is call our patients. Generally, patients get a 1-month supply, so on or about 7 days before, we’re calling them. Many times, it’s in this call that we discover overutilization of drug therapy, underutilization, maybe underutilization because of financial issues. Maybe if they’re supposed to get an injection every other week, we ask them, we take an inventory check. How many do you have? “Oh, well, I really can’t afford it, so I’m stretching it.” So, then we really begin to get involved. We work with the manufacturers for co-pay assistance or if we can’t go there for government payers, we work with 501(c)(3) organizations. It is, I believe, the specialty pharmacy folks on the forefront. It’s working with the payers on utilization management to make sure that it’s the right patient, it’s the right drug, and it’s timed appropriately, and that we’re helping that patient through any financial barriers to get that patient on drug therapy. And, again, it’s the specialty pharmacy who, over time, is creating that supportive environment to help patients stay compliant with their therapy.
Peter L. Salgo, MD: Do we all agree with her? Is this what they’re doing? Are they doing it well?
Jeffrey D. Dunn, PharmD, MBA: Cheryl’s company does.
Cheryl Allen, BS Pharm, MBA: Independent specialty pharmacy.
Jeffrey D. Dunn, PharmD, MBA: Yes. End of the day though, again, payers can’t give up the control of their UM (utilization management) criteria and the decision making. It’s their money, but we understand that specialty pharmacies can bring value to helping manage patients.