Jeffrey D. Dunn, PharmD, MBA: Let me go down that path a little further and bring Dr Epstein into this. From a payer perspective, how do we go about evaluating this disease state and the role of drugs and things like that when we’re not only talking about indirect things, but we may struggle with real-world evidence in this particular disease state? How is a payer supposed to use these tools?

David Epstein, MD, MBA: I don’t know that it’s much different from other disease areas. In looking up our policies, there are standards of care. Right now, the 1 drug I found was Protopic. There’s PUVA [psoralen plus ultraviolet light A] and light treatments and what have you. At least from my payer perspective, it’s acknowledged as a disease. The steroids are covered and Protopic is covered. Basically, the coverage for the treatment of the disease is going to come from where all the others come: what are the KOLs [key opinion leaders] and society experts [saying]? At this point, I don’t think payers are pushing back and saying this isn’t a disease. They’re obviously going to look at the symptoms. It’d be nice to have something like a PASI [Psoriasis Area and Severity Index]–related score for this in terms of looking at the coverage of all this.

Jeffrey D. Dunn, PharmD, MBA: We generally view this as a disease, this isn’t cosmetic. I agree with you there. Part of the challenge though—I know I’m jumping the gun here, we’re going to come back to this—is that a lot of therapies in this area are relatively inexpensive. There’s off-label biologic use in other things, but largely, we have a lot of generics in this space. When we get other therapies that are labeled and expensive in the future, the lens on this will be very different. The challenge is going to be that from a formulary perspective and even a prior authorization perspective, we have to use these tools, and if they aren’t used in clinical practice, we’re going to have to figure out how to work together as payers and providers on understanding who the appropriate patient is, if a drug is working, and ways to quantify that. Great comments. Please jump in.

David Epstein, MD, MBA: Jeff, you’re absolutely on the right track, and I’m sure you’ve seen this over the years too, that in a lot of instances, you get an initial authorization for a period for drugs and then basically need reauthorization. It basically has to show that the patient has stayed the same or not gotten worse. It can be fairly vaguely defined, but it’s physician attestation in a lot of these arenas.

Brett King, MD, PhD: Yes. I heard you both say, “We’d like to have documentation that somebody is better.” When I think about our patients with psoriasis and our patients with atopic dermatitis, a couple of things come to mind. I get that you guys are looking at enormous expenditures over millions of people. It would be very uncommon that I’d want to keep somebody on a medicine if they weren’t improving. Not only that, but it’s fairly uncommon that a patient wants to continue putting cream or ointment on their skin or taking a systemic medicine if they aren’t getting better. But I agree with you wholeheartedly. You want to be able to see in a note a physician attestation. However this works, you want to know that somebody is getting better.

In vitiligo, payers or formulary managers are going to need to be thoughtful about when vitiligo is likely to get better and when vitiligo is unlikely to get better, and develop decision trees around those parameters. It makes complete sense that somebody would want to see at a 6-month visit or at an appropriate amount of time [that the patient is getting better].

This is part of the complex decision-making that faces the payers. What’s that appropriate amount of time? You want to see documentation that the patient is having a meaningful clinical response. I don’t think that’s going to come in the form of outcomes from hardcore research instruments, but everybody can document, “The amount of vitiligo on this person’s face has decreased by 50% in X amount of time.” Then the question is, what are you going to determine needs to be done in the next X amount of time before you say, “OK, we’re going to continue down this path,” or decide to cut back?

Jeffrey D. Dunn, PharmD, MBA: That’s a great example. As a teaser, I’ll throw out a scenario to frame what could happen in the future. Let’s say we have a $40,000 treatment and a $70,000 treatment. Maybe the $70,000 treatment is slightly better than the $40,000 one. We aren’t clinicians, we aren’t trying to practice medicine, but we have a fiduciary responsibility to implore groups and other people who are using us for insurance to use the most cost-effective therapy first. That’s where I was going with that. Is there a way for us to ask from a value perspective or a cost-effectiveness perspective to use something that’s a little more objective when we’re influencing the first therapy choice? But we aren’t trying to overstep our bounds in determining if a drug works. That seems to be fairly clear based on the example you just gave. I appreciate that.

Transcript edited for clarity.