The Evolving Treatment Landscape of Atopic Dermatitis and Other Dermatological Conditions - Episode 8

Selecting Appropriate Patient Populations for Ruxolitinib

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Dr Butrus leads a discussion on the ideal patient population for treating atopic dermatitis with ruxolitinib.

Casey Butrus, PharmD: I think we noticed that ruxolitinib [Opzelura] is definitely a novel therapy. It hasn’t been on the market for too long. So I’m interested to see your perspectives of what patient populations are you prescribing this for? Are they trying other therapies before, or do you have new patients that you’re starting directly on topical ruxolitinib?

Michael Cameron, MD, FAAD: Yes. A lot of new patients. I think from my perspective, the issue is that the label is a bit restrictive. And so, if you look at the label, some payers are not allowing it when they’re already on Dupixent [dupilumab], for example. One of my biggest issues with Dupixent is residual facial dermatitis and sometimes rarely new onset facial dermatitis from Dupixent. And so, both of those types of facial rashes would be perfect candidates for Opzelura because it’s a nonsteroidal that goes nicely on the face. But some payers are not allowing that given they’re already on Dupixent.

If you read the label for Opzelura, it says it’s not recommended to be used concomitantly with Dupixent. And so, that’s one thing I would like to comment on. But yes, if you look at the label, it’s for intermittent therapy for mild-to-moderate AD [atopic dermatitis]. It is a great candidate therapy for your mild-to-moderate patient that wants a nonsteroidal that didn’t respond to a topical steroid or tacrolimus, or maybe they aren’t ready to go on something like Dupixent, but they want something that works really rapidly that’s not a steroid.

But for me, forgetting about the label and forgetting about the insurance payers, I would like it for a lot of my eczema patients because I think there’s no reason I can’t give it to a severe patient, for example, or a patient that’s on Dupixent from a clinical perspective. But sometimes, it’s not just about what I think. It’s about the label and it’s about the insurance payers.

Casey Butrus, PharmD: Dr Keegan, do you use topical ruxolitinib in the same place in therapy or do you have a differing opinion?

Brian Keegan, MD, PhD: I think I agree with all the above that we use a lot. We love it for the ability to apply it in some of those “more sensitive areas.” Otherwise, because of the landscape now with paying for it, and again, I recognize that if I prescribed ruxolitinib to every patient that had irritated skin when they walked in the door, I see about 40 patients a day, I’d probably be sending 20 prescriptions out a day and I would quickly bankrupt medicine. So I recognize that we need to make choices on who would be the best patients to use it in, and the topical steroids from the cost perspective can offer a lot of bang for your buck for patients and can be very helpful. And so, I do start with topical steroids first for that reason.

I’m willing to use other nonsteroid anti-inflammatories because that’s often a requirement for me where I practice in order to get onto the next step and get to something like a topical ruxolitinib. But one of the challenges I might still run into is a patient who comes to me and has failed both of these medicines. And again, flipping back to Amy, if they haven’t failed them within the last 90 days, sometimes that means that I have to prescribe them again in order to be able to get through to that next step. It’s not always per se what have you done, but it’s what have you done lately that might also be another challenge as well.

Amy Brennan: And I think that’s where the patient advocate comes in key to this whole process. You drive this as the prescribers, of course, you are the ones choosing the medications, but then it really is up to a lot of times the office staff to advocate for you and for the patient on your behalf to the insurance company and explain how they’re meeting those criteria that may be in place if there’s step therapies or step edits explaining how the patient may not meet the criteria, but why you feel that those criteria shouldn’t apply to them. Because, of course, there are so many different situations for all of these patients where the prior authorization goes through the process that that’s the point. That’s why it’s there. But it shouldn’t necessarily be limiting access to patients. It should essentially be opening doors, just opening doors the right way for the right patients.

Casey Butrus, PharmD: And I think we brought up the intermittent nature of this disease where one topical may be appropriate, and then they won’t need the topical consistently to manage the disease state. I’m wondering, Dr Cameron, your thoughts on topical ruxolitinib and its durability of response. I know the label, as you mentioned, is only for intermittent therapy for a certain duration. Even after patients that you’ve experienced discontinue this medication, do they still have that lasting response, or do you see them needing more of an acute treatment to maintain their disease response?

Michael Cameron, MD, FAAD: Yes. So it’s not disease-modifying, meaning once they stop therapy, it will eventually come back. But when they stay on therapy, I find it to be highly durable. And I would say that the 8 weeks and stop thing makes no sense from the agency. I hate to say that to the FDA, but the half-life is less than 10 hours. So why do I have to stop applying it after 8 weeks? It’s not like it’s continuously accumulating in their body. Clearly, they’re breaking it down and excreting it. And so, for me, if they’re applying it twice daily, or BID PRN [pro re nata], there’s no reason from a clinical perspective that they can’t continue to do that on an ongoing basis. It’s not a steroid, remember. It’s not going to thin their skin with chronic use or anything like that. From my perspective, yes, I wanted them to use it as needed intermittently, but this whole notion that you can only do it for an 8-week or 12-week period to me really doesn’t make any good scientific sense.

Brian Keegan, MD, PhD: Do you feel though, or at least I feel like some of my patients in the office, when we can finally get their disease under control, they have a better chance of maintaining clarity? I use what I sometimes call the campfire analogy. If you only get the campfire partway out and then you walk away, there is a chance that the fire sparks back up and things do get back out of control again. And if we can really use them, to your point, whether that’s 2 weeks, 8 weeks, or 12 weeks, if we can really get them all the way to better, my intuition has always been that those patients will have a better chance of staying better longer by using these skin hygiene products as opposed to patients that you only get mostly there and then flare right back up again.

Michael Cameron, MD, FAAD: Yes. I totally agree with that. For sure.

Casey Butrus, PharmD: I agree. I think it’s interesting to think about what the label says vs how these are being used in clinical practice. I know a lot of managed care organizations will implement things like quantity limits to only allow a certain tube to be dispensed per duration. Maybe it’s 8 weeks, maybe it’s 365 days. So they have to look back in there where patients may need additional tubes, depending not only on how long they’re using the medication, but how much body surface area they have affected. As you mentioned, you may even consider topical ruxolitinib for your more moderate to severe patients. I know the body surface area for moderate to severe definitely differs from the mild population. I think these are really great considerations to see what we might be experiencing in the real world, not exactly reflecting what’s in the FDA labeling.

Transcript edited for clarity.