Uncontrolled Severe Asthma and Difference among Biologics

Peter L. Salgo, MD: There’s a phrase out there. Is it a term of art, “unmanaged severe asthma”? What does that mean to you as a payer?

Louis Christos, RPh: I mean, clinically speaking, our managers, they’re not, they still continue to have exacerbations and hospitalizations while on their controller medication.

Don A. Bukstein, MD: See, I don’t think that’s a great term.

Peter L. Salgo, MD: That’s a term that’s out there, right?

Louis Christos, RPh: That’s a term that’s out there.

Don A. Bukstein, MD: Yeah, I know. Unmanaged means I can have a severe asthmatic that’s doing great. Okay? He’s taking his inhaled steroid and LABA [long-acting beta agonist]; they take it twice a day on 1 burst of steroids a year, I’m not worried. I don’t control.

Louis Christos, RPh: We don’t use the term “unmanaged.” We do use the term “uncontrolled.”

Don A. Bukstein, MD: Uncontrolled or “difficult to control.”

Louis Christos, RPh: Yeah.

Don A. Bukstein, MD: Those are the patients that we really care about.

Peter L. Salgo, MD: Very quickly, before we move on to these specific drugs, do the biologics, all the biologics, require prior authorization?

Louis Christos, RPh: Yes.

Linda S. Cox, MD, FAAAI, FACAAI ACP: Yes.

Peter L. Salgo, MD: Okay. And are patients required to follow a stepwise treatment plan prior to biologics. in your view?

Louis Christos, RPh: We require that they have tried maximum-tolerated controller medications prior to using, and they identify, identification [as] a severe asthmatic by diagnosis, that’s physician at the station. But we do require that stepwise approach, so I’d say yes.

Don A. Bukstein, MD: Yeah, there’s no insurance company today that doesn’t require they have failed on an inhaled steroid LABA. Some require additional therapy, a leukotriene antagonist, LAMA, long-acting muscarinic agent, that had been approved for asthma.

Louis Christos, RPh: Well, we don’t say fail. We say that they continue to have exacerbations that are uncontrolled.

Don A. Bukstein, MD: Yes.

Louis Christos, RPh: Even on, and the assumption is they’re compliant but….

Peter L. Salgo, MD: Yes.

Don A. Bukstein, MD: But you already said, he’s presented very good data that a lot of them aren’t compliant, and the question there is…

John J. Oppenheimer, MD: Yeah, Jeffries, a recent study shows scarily that well over 40% of these people haven’t been taking their ICS [inhaled corticosteroid] with regularity prior the year before.

Don A. Bukstein, MD: And the question there is….

Louis Christos, RPh: You can make the case for me to make it more difficult because I can say confirm it.

John J. Oppenheimer, MD: Part of the reason is why are they not using it?

Don A. Bukstein, MD: Right. Maybe it’s because it doesn’t work.

John J. Oppenheimer, MD: Correct.

Don A. Bukstein, MD: I had a patient not long ago that says, “I cannot,” and he’s smart enough to say, “Every time I go to the pulmonologist, okay, I get a different inhaled steroid LABA. They all don’t work. Don’t give me another brand. I need something else.”

Peter L. Salgo, MD: What is the difference in mechanism of action in the current and the emerging biologics? Who wants to tackle that?

John J. Oppenheimer, MD: I’ll do the current. So we really, we talked about them before. We have really 3 major classes. We have the anti-IgEs [immunoglobulin E], that would be omalizumab. We have the anti—IL-5s [interleukin 5], as Don said. Two of them are direct blockers. That would be reslizumab and mepolizumab. And then we have an indirect program cell death, so to speak, in the benralizumab. And then finally, that’s all the anti–IL-5s. We move to IL-4–receptor alpha blockade, which blocks both IL-4 and IL-13, and that would be dupilumab. Now what’s interesting is when you look at all of their data, they’re looking at largely the same population in all of the studies.

Don A. Bukstein, MD:One thing you have to understand about these biologics: They don’t alter the natural history of the disease as much as we know. They don’t…they’re not a true immune modulator in the sense that they’re going to change your immune system.

Linda S. Cox, MD, FAAAI, FACAAI ACP: Like allogeneic therapy.

Don A. Bukstein, MD: Exactly.