David Epstein, MD, MBA: Vitiligo isn’t necessarily unlike some other diseases in that the payers might limit coverage of the treatments to these “sensitive” areas of the body, such as the head and neck and maybe fingers. I wonder whether they may restrict the coverage for only those areas.

Brett King, MD, PhD: I hear you completely, but my greatest wish is that if those sorts of decisions are made, which make sense to some degree, let’s be sure these are data-driven decisions. We’ve got great data for the face. Let’s think about topical calcineurin inhibitors or ruxolitinib 1.5% cream. We have data that say the face does well but the hands don’t do well. In a perfect world, if somebody is going to come back to me and say, “I approve of this, but I don’t approve of that,” I want it to be data driven and not that somebody hazarded a guess about what works and what doesn’t, because we now have good data.

David Epstein, MD, MBA: I was headed back there with that. I’m not taking anything off the table with the payers and the manufacturers anymore because it has gotten so bad, but at some point, would the payers consider the rest of the body cosmetic and therefore not cover treatment for that?

Jeffrey D. Dunn, PharmD, MBA: Dr Epstein, let’s build on that a little. It makes sense to dive into that. You alluded to your policies a few minutes ago. It sounds as if you aren’t doing those kinds of things, and we’ll get into what changes in the future in a minute. But is there any integration between medical and pharmacy, or does each thing have its own policy? What challenges have you seen to date in your policy development for vitiligo? Do you have any comments on the challenges, issues, or approaches?

David Epstein, MD, MBA: Medical and pharmacy are separated. There has obviously been overlap. I just pulled up…Protopic. This may have driven what I said before. The coverage criteria includes 16 years of age and older. It’s being prescribed for psoriasis on the face, genital, or skin folds or for vitiligo on the head or neck.

Jeffrey D. Dunn, PharmD, MBA: That infers some cosmetic issues and some other things, right?

David Epstein, MD, MBA: Yes.

Brett King, MD, PhD: The thing is that the face and the neck are hugely important. In a perfect world, Dr Rosmarin and I would advocate that if vitiligo anywhere is in some sense disabling somebody or impairing their quality of life, we’re going to advocate for the patient to get treatment. You all understand that. None of us can argue with the data. If the data for agent X say that it works particularly well on this location and it doesn’t work particularly well on another location, let me give it to my patient for the areas for which the data say it works. I don’t mind if you then burden me with making the argument to use it someplace else, because in this case, the burden on the patient is X. Give me that burden. I don’t struggle with that at all. But make the first decision very data driven. That to me is a gift.

David Epstein, MD, MBA: That’s where I was going. That’s where the payers are going to go, and they will control the so-called off-label use in the other areas by basically putting quantity limits in terms of how much drug is going to be authorized.

David Rosmarin, MD: I completely agree about the importance of being data driven. Of course, as a provider, we’re going to advocate for our patients. The challenge is when you look at certain areas. For example, ruxolitinib cream, which hopefully will be the first medicine approved shortly, has a significant effect over vehicle in all the different areas that have been measured, including the hands, feet, trunk, and upper and lower extremities. But the challenge is that it doesn’t work nearly as well for the face. But what does? That becomes quite challenging if we have a patient who wants to be repigmented there.

We lack evidence that calcineurin inhibitors work in those locations. We have data that they work for the face, but we don’t have the data that they work on the hands. But for this cream, we do. Even though it may not work nearly as well, and it may take more time and medication, should it be covered by the payers? I’m still of the hope that we’ll be able to broadly have it, but I realize there are going to have to be some limitations on how things are done. My hope is so that we have more broad access for patients, but it’s challenging.

Jeffrey D. Dunn, PharmD, MBA: This discussion has been super interesting and valuable because, as Dr Epstein talked about the policies, there are probably a lot of payers that have similar policies limiting this to the face and hands. Those are the things people see. It goes back to what we talked about at the beginning. If somebody is interacting with somebody with vitiligo and they see it on their face, they’re going to freak out. But does that mean we don’t treat somebody’s vitiligo on their trunk? Then the issue is, would we have any expectation that these drugs are going to work differently on the face than they are on the trunk? You’re saying that maybe they do. Is that right?

David Rosmarin, MD: We have published data on this from the phase 2 that ruxolitinib cream works on all those different subgroups of body parts, but they don’t work as well. It works best for the head and neck, as is true for all our treatments. It still works for the other locations, but not quite as well. We don’t see as robust a response, but we still see a response nonetheless.

Transcript edited for clarity.