Elaine Siegfried, MD, professor of pediatrics and dermatology, Saint Louis University Health Sciences Center, speaks on step edits and other barriers limiting access to biologic, topical, and other medications for the treatment of atopic dermatitis (AD).
Insufficient clinical data and step edits are among several barriers limiting access to treatment in atopic dermatitis, said Elaine Siegfried, MD, professor of pediatrics and dermatology, Saint Louis University Health Sciences Center.
Can you discuss barriers impeding access to novel therapies in atopic dermatitis?
When we get a new treatment, nobody ever wants to really come to grips with the fact that we can't get access to those treatments, unless they're on label. And even if they are on label, payers often put step edits into place, step edits that are technically illegal for medications that aren't FDA approved for that indication.
So, for example, some insurers want you to give a child cyclosporine or methotrexate, which aren't FDA approved to treat atopic dermatitis. They want a child to fail these treatments before they ever get the FDA-approved biologic agent. And that just doesn't make sense to me. I think it's worth noting, and it's worth all of us being familiar with that and trying to deal with it on a case-by-case basis, but it would be better if there was some legal input into that.
The other thing is our lack of access to certain kinds of topical medications if they're not approved for children. So, for example, there is a corticosteroid-sparing combination treatment that's a topical, relatively potent: betamethasone dipropionate plus calcipotriene. It's FDA approved to treat psoriasis in patients who are 12 and older, but in the adrenal suppression trials, looking at these combination treatments, they appear to be safer, meaning causing less adrenal suppression. So, we can use them longer term with a little bit more safety. But we don't have the data for that in very, very young children.
Because we don't have the data for that, we absolutely can't even get access to that medication. For some patients that I have whose private insurance happens to pay for it, it seems to work pretty well, but it would be better if the providers that have experience in treating these diseases would be able to have access to the medications without so much difficulty.
The other thing is, again, phototherapy is another step edit requirement that is almost impossible for most parents of young children to adhere to. It requires visits 3 times a week for a minimum of 3 to 6 months and then twice a week after that. So, even though those are put in place as step edit requirements by many states, most families just can't really do that. So, that and off-label use of systemic immune suppressants—, t would be really optimal if those were if those step edits were not allowed to be in place.