Monoclonal Antibody Prior Authorization



Lawrence Eichenfield, MD: Has dupilumab been impactful for kids and teens? It's just revelatory in my practice in terms of what we can offer. I think that the relative efficacy with safety compared to our traditional immunosuppressants, there's much more consistency, but it does raise questions of can we get it for our patients.

Why don't we turn to Elaine. Elaine, how do you handle prior authorization for dupilumab? What are your recommendations to make it easier? Is it more difficult in younger kids as well? What's your sense?

Elaine Siegfried, MD: Access has been difficult since the first of the approval in March of 2017, and we've tried to be creative about that. One of the things, the newer things, because now that we have labeled approval down to age 6, it's kind of a miracle, and many payers base access strictly on labeling. It should be said that that's not legal by the Affordable Care Act. You can't discriminate based on age, but it's something that happens and that requires a lot more of our efforts to communicate that to our colleagues in the insurance world.

Often I think one of the things for practitioners about getting access to this medication is you have to request a peer-to-peer discussion. You have to be able to talk to your colleagues about this specific patient that you're trying to get this medication for. And I find that the most efficient way and the quickest way, and saying that, it's still not quick, it can take weeks to months to get access to this medication for your children, even now that it's on label.

I have to say that in my hands, methotrexate is still a great first option for patients who need systemic treatment. It does take a while to kick in. We don't have wonderful guidelines about the safety and efficacy because it's such an old drug, but we do have 50 years of experience with the safety and efficacy of this drug.

Often I will start methotrexate because I know that ultimately, especially if it's a patient who has a lot of atopic morbidities as well as their skin disease, that ultimately they're probably going to be better off to be on a targeted medication like Dupixent. But I think often I'll just start them on the path of least resistant drug that's easier to get.

Lawrence Eichenfield, MD: It makes your next authorization approval easier if they've already been on it.

Elaine Siegfried, MD: Right.

Lawrence Eichenfield, MD: I try to not have that as a speed bump since it's unapproved; I think we all have our methods. I do think that sometimes when you do peer-to-peers, or you speak to someone and get them to understand why it is this drug makes sense, and I will document body surface area and I do EASI [Eczema Area and Severity Index] scores as well so there are objective measures of the severity. As well, I list every medicine that I can get record of the patient having been on, especially oral prednisone, to make the case for it.

But when you speak to someone and they get it, sometimes the next 4 or 5 become easier, and if the data are there to rationalize it for the individual, and it's not a one-off each time. But ask me tomorrow, and I'll tell you that I'm frustrated that I have to set up peer-to-peers to have to deal with, but it is part of the issue in dealing with the medicine. Anything else on dupilumab before we move back into more topicals and other aspects of care?

Elaine Siegfried, MD: I did want to briefly mention the dosing, because although we have high level 1 evidence for dosing this medication, it still has some gaps. And the data that were just released for the 6-to-11-year-olds, we had 2 dosing arms and the labeling only reflects 1 dosing arm with monthly, with a 600 mg load and 300 mg once a month, mostly for ease of administration, but I think we don't know everything there is to know about dosing adequately.

I also think that the data that we have point to safety, and I particularly tend to go up on the dosing rather than go down because I'm pretty confident about the safety more than the efficacy at the labeled indication.

Lawrence Eichenfield, MD: My read on the data is that the more you give per month, the better patients do. But it's very fascinating. For people just to be clear about what we're talking about, for the younger kids under 30 kg, because they go into monthly dosing, they get a huge load on milligrams per kilogram. We were studying 2 mg, 4 mg, and 6 mg/kg doses, and they're getting a 25 to 30 mg/kg loading dose. They're responding pretty quickly to it, but then they go to monthly dosing, and there's definitely going to be these breaks. There are times where I want to hand a kid a weight on a scale because I want them to be heavier, and there are times I would love them to have a foot off the scale so I can do the Q4 [every 4] week dosing. But it's one of the things we're working on over time.

Transcript Edited for Clarity

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