Dr Matthew J. Zirwas Discusses Step Therapy in Patients With Atopic Dermatitis

Ohio dermatologist Matthew J. Zirwas, MD, offers his view on what step therapy would look like in patients with atopic dermatitis.

Transcript

As new therapies come online, what sorts of concerns, if any, do you have about patient access and issues around prior authorization or maybe step therapy?

It is one of the things that I spend a lot of time thinking about. And I always put it in terms of, who deserves these medications, because whenever we look at them from a safety and efficacy perspective, 100% they are better than every other option for atopic dermatitis. They both work better and are safer.

Now, on the other hand, they are extremely expensive. So dupilumab is around $37,000 a year; I'm guessing that the new medications are going to be priced relatively similarly. And so the question becomes, who deserves these? And I think the payers have gotten it completely wrong here. So far, the step therapy for dupilumab has been primarily topical agents—tacrolimus, pimecrolimus and crisaborole—and the patients have to fail those. I've seen some requirements that patients have to have failed an off-label immunosuppressant, something like methotrexate or cyclosporine.

All of that is—I have no idea who told the insurers or the payers to use those steps because they’re just ridiculously stupid. The topicals literally cannot work. You cannot give patients enough topical to cover the body surface area that's involved. The oral immunosuppressants—no where near effective enough, way too dangerous, and not FDA approved [for atopic dermatitis].

The only step therapy that should be is, a patient should have to have had systemic steroids. So the only therapy that really makes sense [is] you need to have had a trial of systemic steroids to calm your disease down, and then, you know, be transitioned to a topical regimen. And I've not seen a set of criteria anywhere that require that patients have failed systemic steroids prior to going on to these biologics. That's really what step therapy should be is systemic steroids.

You know, they've needed those in the past, and really they've needed them more than once. The way that we really should be managing these patients, if they're a new patient, new to a dermatologist, it should be, "Here’s some oral steroid to calm your disease down. It's going to be a short course, a few weeks, and we're going to transition you to the topical therapy." If you then need systemic steroids again, that by definition means you're not adequately controlled by topical therapy, and therefore you now should be somebody who's a candidate for one of these biologics or oral medications.

So, to me, the rational step therapy is, has this person needed systemic steroids more than once? The other things don't make any sense, either from a patient safety perspective, a cost perspective, any perspective, and the number of patients I see who are on biologics, who are on dupilumab who've never been on a systemic steroid is incredible. And they shouldn't be, they really shouldn't be. Because if maybe you could just give them the 1 course of steroids, systemic steroids transitioned to the topicals, and they'd be okay. But they never got that trial. And they should have.