The Use of Biologics for the Treatment of Asthma - Episode 5
Peter L. Salgo, MD: What about the GINA [Global Initiative for Asthma] guidelines, the NHLBI [National Heart, Lung, and Blood Institute] guidelines?
Linda S. Cox, MD, FAAAAI, FACAAI, FACP: One class we forgot. Well, that’s a good lead-in because more recently, we called them the long-acting muscarinic [antagonists], LAMAs, and they have been added to the GINA guidelines, which get updated every year or 2 years. Whereas, NHLBI or NHI [National Institutes of Health] guidelines haven’t been updated since ’07 and they’re not going to be.
Peter L. Salgo, MD: That’s a long time ago.
Don A. Bukstein, MD: Well, even before that, the research that was included in those guidelines occurred years before that. So we’re talking about guidelines that are, especially with our national, US guidelines, they’re old and outdated.
Linda S. Cox, MD, FAAAAI, FACAAI, FACP: And they won’t be updated.
Peter L. Salgo, MD: Why won’t they be updated?
Linda S. Cox, MD, FAAAAI, FACAAI, FACP: When I was president of the American Academy of Allergy, [Asthma & Immunology], we met, several meetings with them and it’s too onerous a process because they have….
Don A. Bukstein, MD: It’s very expensive and onerous.
Linda S. Cox, MD, FAAAAI, FACAAI, FACP: They have multiple stakeholders and then it has to go out for review, revision, and it ends up being a 500-page document that takes 4 years to make.
Peter L. Salgo, MD: And nobody is going to read 500 pages.
Don A. Bukstein, MD: They are going to have this next year, some updates. So there’s some major areas of controversy.
Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Oh yeah, they decided to focus.
Don A. Bukstein, MD: Controversy that they’re trying to approach. But the fact is there are multiple guidelines out there in all different chronic diseases. But most of them don’t have a system where they’re updated, so you really have to, especially when they’re controversial areas, really try to get some consensus. And we have very good consensus right now in asthma, we call [it] the Asthma Yardstick, for both children and adults, which takes the newer data and tries to put them in a clinical format through the American College of Allergy, Asthma & Immunology.
Peter L. Salgo, MD: So we’ve got all these drugs out there, the LABAs [long-acting beta agonists], the SABAs [short-acting beta agonists]. Cromolyn is out there somewhere. We’ve got steroids. Are there any restrictions on any of these agents based on the guidelines from the payer’s perspective? And what about step therapy?
Louis Christos, RPh: It depends on the payer, but I would say, for the most part, your traditional products, the ones you mentioned, there are not. And I think we just heard the guidelines are so old that it would sort of defeat the purpose of trying to adhere to the guidelines because they’re so outdated.
The thing to understand within each one of these categories you mentioned, there are multiple options available. So there are agents that are preferred for the patient because I don’t know how many ICS [inhaled corticosteroid] LABAs are out there, how many ICSs are out there, and how many SABAs are out there.
Peter L. Salgo, MD: A lot.
Louis Christos, RPh: There are a lot.
John J. Oppenheimer, MD: What’s interesting, if you look at all the guidelines, there really is consensus to some degree. As you pointed out earlier, Linda, you move from a reliever medicine initially as monotherapy, you begin adding some form of controller therapy, and then dial it up. You do add-on therapy. It can be a LABA, once you fill an ICS, a LAMA/LABA, once you fill that. And then we move finally to biologics.
Louis Christos, RPh: Which I get when you’re talking with the specialists. But we were talking about patients being adherent to medication. I wonder how many PCPs are adherent to the guidelines and following that stepwise approach.
Peter L. Salgo, MD: Before we leave the traditional meds [medications], because we’re going to go on to the newer meds.
Don A. Bukstein, MD: And I want to talk about the traditional meds.
Peter L. Salgo, MD: Go ahead.
Don A. Bukstein, MD: Because it’s not as easy as just stepping up. Having asthma myself, [I think] we know a lot more than we used to. And for many asthmatics, we can use what we call smart therapy. Maybe it’s not such smart therapy in some patients.
Linda S. Cox, MD, FAAAAI, FACAAI, FACP: That’s the name of the Canadian studies.
Don A. Bukstein, MD: But, basically, it’s not taking our controller twice a day every day. It may be taking it once a day and having 1 inhaler and stepping it up or stepping it down. Because many of the combination therapies have a LABA, long-acting beta agonist, that works very quickly, as fast as albuterol really. So we’re starting to understand that there may be phenotypes, certain patients that do better with this intermittent therapy. So I think in today’s world, it’s very confusing. And many times, depending on that patient’s background and predictability of being nonadherent, there are certain factors that give you predictability of nonadherence, you may want to start with a combination therapy and step down if the patient is doing well.
Linda S. Cox, MD, FAAAAI, FACAAI, FACP: That’s usually what I do.
Don A. Bukstein, MD: Or give them the incentive. Listen, I’m going to start you on this more expensive therapy. It’s 2 agents but if you do really well, take it every day, maybe we’ll be able to step down.
Peter L. Salgo, MD: Let me ask you one quick question, then we’re going to change gears a bit. If they start high and move low, that’s like an anti-step therapy. That bother you at all?
Louis Christos, RPh: It doesn’t. If that’s what is done in practice, then it doesn’t bother us. But like I said, we don’t really manage your traditional products. I would be concerned if you start using biologics a lot earlier.
John J. Oppenheimer, MD: May I just add one other comment? We talked about phenotypes. One of the phenotypes that’s worth mentioning, and it’s important for us to remember, we make asthma out to be a simple illness. It’s not, it’s a very complex illness. And one of the phenotypes that’s most frightening is the poor perceiver of dyspnea. And identifying them is hard as a specialist. As a primary-care doctor, I have no idea how you do this, but an Israeli study showed about 20% to 25% of people are poor perceivers of their level of dyspnea, and this translates to death.
Don A. Bukstein, MD: One of the ways to highlight that patient, the pharmacy databases can, is a patient that’s having exacerbations but not using a lot of albuterol. At Kaiser [Permanente], they picked the poor perceiver out because they don’t feel the obstruction, so they’re not using albuterol, but they’re having lots of exacerbations. So, when I see that pattern, right away I’m starting to think is that a poor perceiver.