Impact of New Atopic Dermatitis Treatments on Formulary Decision Making

Payers and pharmacy benefit managers face challenges with the arrival of several new drugs in the atopic dermatitis space. Dr Ed Pezalla, CEO of Enlightenment Bioconsult and former VP of pharmaceutical policy and strategy for Aetna, shares how new approvals are affecting formulary decision making and what payers should keep in mind as drugs continue being developed.

With several new treatments approved for atopic dermatitis in the last year, how do you think the expansion of treatment options is impacting formulary decision making?

New drugs always expand formularies, especially if you are getting access to treatments that have new mechanisms of action or new modes of delivery.

One of the standard things we have had for a long time are oral treatments for atopic dermatitis, and we also have simple things like antihistamines for itching. For patients with more severe symptoms, before we had dupilumab (Dupixent), we had other kinds of immunomodulators. We have had topical treatments for a very long time. And we have had injectables since the introduction of Dupixent. Now we are getting treatments with different mechanisms of action.

The goal for most pharmacy benefit managers and health plans is to cover all mechanisms of action and most modes of delivery because that gives options for physicians, and it generally will cover the needs of most patients. But it does not mean PBMs and payers have to cover everything because, of course, they are going to aim for lower prices.

You can prefer one agent over another, but where you have an agent that is the first of its kind, then you are a bit stuck and will want to have that agent on the formulary. But once there are 2 agents, then things can get interesting.

Upadacitinib (Rinvoq) is an effective medication for atopic dermatitis and is already on formularies for rheumatoid arthritis. It is more expensive than many other rheumatoid arthritis drugs, but between the manufacturer’s portfolio and good contracting for Rinvoq itself, in many places, it is a preferred agent for rheumatoid arthritis.

And if it is preferred, then it is going to be on a preferred setting for other indications as well—not that you cannot put another agent in front of it, but the manufacturer is probably not happy about too many step edits. Rinvoq is 1 example that has impacted formulary decision making because of the rheumatoid arthritis indication.

Thank you, Ed. What outcomes are most important when payers evaluate a new treatment for atopic dermatitis?

The outcomes that the Institute for Clinical Effectiveness Research (ICER) found important in the development of Dupixent have become standards in atopic dermatitis.

Treatment of itch, or pruritus, is important. There was a tendency toward the treatment of the rash, of the skin manifestations, and that is what payers would have prioritized if it were not for successful pruritus treatment with Dupixent.

The reason why I say that is because payers were already primed to think about itchy rashes because of psoriasis. We had etanercept (Enbrel) and adalimumab (Humira) and all kinds of other things for psoriasis and psoriatic arthritis for a while, and we became used to percentage clearing—PASI scores and such. Dupixent arrived, and the quality assigned by health technology assessment authority groups like ICER focused on itch.

The other thing new agents brought to light is atopic dermatitis can be painful. Everybody knew it was itchy and caused rash. But I think very few people understood there was some pain associated with atopic dermatitis, either because of constant scratching or for various other reasons. I would say itch, pain, and the skin clearing itself are your 3 big outcomes.

In addition, we see outcomes that are derivatives of those three—principally, sleep measures, because if you are itching, you are not sleeping. Sleep impacts everybody's quality of life, and, of course, payers pay for sleeping pills of various sorts and insomnia treatments already. So sleep would be the fourth outcome, but it is a derivative of itch.

What else should payers keep in mind as new treatments hit the market?

Oftentimes, payers do not rank quality of life metrics as highly as other metrics. There is good reason for that because if you are successful in treating the disease, the patient's quality of life should follow. And if one drug has better quality of life scores than some other brand, but it did not score as well on itch, pain, skin clearing, sleep, or other outcomes, then how did it impact quality of life? Quality of life is not really a good standalone measure.

However, in getting access to more advanced medications, beyond standard, older topicals and antihistamines, we should keep in mind that quality of life does matter to patients. We also do not consider social factors. For children and adolescents, if they are having problems with an itchy rash, then they may have difficulty getting to school. This can have long-term consequences, which are not medical problems, so we do not see them as payers, but I think it is something we need to keep in mind.

Quality of life and the ability to participate in school are important. That does not mean one drug is going to be better than another drug at improving these issues, but we need make sure patients have access to more advanced therapies.

Thank you for that insight. Is there anything else you would like to add today?

Patients and physicians will find that not everything is covered by everybody. There will be some tradeoffs, and there will be payers who do not cover everything or who prefer one product over another to manage cost. This also manages costs borne by the patient and their families too, so patients play the game with payers.

The other thing I think is important is providers can help by advocating for up-to-date guidelines. We have guidelines in atopic dermatitis, but many are general and not up to date.

For example, we do not know the place of tralokinumab vs ruxolitinib. Which one comes first, or how do you choose between one or the other? As we are getting into covering these complicated things, having some guidelines to help us understand how to sequence or choose between drugs for certain kinds of patients will be important.

We are also going to have to keep an eye out for a lot of drugs in development. There are more JAK inhibitors of different kinds and more IL-13 inhibitors. Other subcutaneous, oral, and topical agents are all going to hit the market. Up-to-date guidelines are going to clarify where to put topicals vs orals vs subcutaneous agents. Guidelines are going to be key in ensuring we cover a range of mechanisms of action and modes of administration, in different combinations.

Getting all drugs on the formulary is just not practical. But how can we get the right combination of treatments on the formulary so doctors and patients can choose appropriately?

About Dr Pezalla

Edmund Pezalla, MD, MPH, is a physician and chief executive officer of Enlightenment Bioconsult, LLC. He holds a degree in public health and was formerly vice president of pharmaceutical policy and strategy for Aetna.