Challenges of Biologics in the Treatment Plan

John J. Oppenheimer, MD: One of the other things worth talking about in biologics is not just who to start but who to stop. One of the things we also don’t know is what is an indicator that somebody is responding. Do we wait a year because of exacerbations?

Peter L. Salgo, MD: Yes, I was going after that. In other words, you give the drug, you look for an indicator, boom, it goes down or what?

Don A. Bukstein, MD: When I started with omalizumab, we started the clinical studies probably almost 20 years ago, my partner and I decided we couldn’t tell a patient this is forever therapy. We had to give them some endpoint, something to shoot for. So we said we’re going to continue this biologic once a month for 5 years, and then we’ll evaluate. We’ll sit down with you and do something. Since there is such an overlap of biologics, I’m going to say something that’s extraordinarily important, when there’s gray areas in chronic disease, whether it be cancer, whether it be rheumatoid arthritis, we have to do something called shared decision making with our patients. We have to use shared decision-making tools, decisional aids to help us so that the patient can understand the perspectives there are to his treatment or her treatment, and what the options are, and make that informed decision. They know what’s best for them. We may know the science and can explain and answer their questions. But in gray areas where there’s such overlap with these biologics, it comes down oftentimes to a patient decision made with the physician consulting.

Peter L. Salgo, MD: But taken as a group, what is the experience you guys have, that clinicians as a group have, with the biologics in the treatment plan? And what are the challenges when you use these biologics? You want to start in a very broad sense?

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: The challenge is getting preauthorization approval.

Louis Christos, RPh: Unfortunately, that’s sort of the process when you have a newly launched, very expensive therapy indicated for a specific patient population.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Well, one of them has been on the market since 2003.

Peter L. Salgo, MD: He’s been using it for 20 years.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Omalizumab.

Don A. Bukstein, MD: You know, I’m going to differ a little bit in that I understand, I worked in managed care for almost 40 years.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Well, there you go.

Don A. Bukstein, MD: I understand the perspective, and it is difficult. Certainly, we want the right therapy for the right patient, right time. That’s easy to say. But, in my practice in the inner city, I often will see patients that come in. I just published a study that for a year-and-a-half, I followed every patient that came in with severe uncontrolled asthma. And we looked at the records and we saw whether they had ever had any biologic discussed with them. And we found, I had to go to 31 patients before I found 1 patient that had ever had it discussed.

Louis Christos, RPh: Discussed by whom?

Don A. Bukstein, MD: By any physician, was in any records or the patient said nobody’s ever told me about that. The average number of hospitalization, ER visits in this group was over 4, 4.5, I think. So lots of hospitalization, lots of ER [emergency department] visits. And oftentimes, I’ll see patients that come in like that. In my private practice before I was in the inner city, I’d see patients that came in, maybe 1 or 2 ER visits or hospitalization. And it was kind of a hard call. It’s not a hard call when somebody is in the hospital 4 or 5 times a year, is on maximum medication. All they do is keep switching them from 1 inhaled steroid LABA [long-acting beta agonist] to another inhaled steroid LABA. But I think, in both groups, you sit down with the patient, you go over why. And here I think it’s really important to talk to the patient. You want to get good adherence. You use the I words. I think that I would like your asthma to be better, OK? I think we need, we can have hope that it will get better, but I think it’s not getting better. Instead of trying to give them some false sense that you know that if they take this drug, they’re going to get better.

Peter L. Salgo, MD: What would cause you to switch off some of these older treatments and move toward biologics in terms of age and population?

Don A. Bukstein, MD: Usually it’s exacerbations, and that’s a huge problem. Because we don’t have a good way to track exacerbations. Right now we track them by asking the patient. That’s as reliable as asking them about albuterol. OK? Not very reliable. So I think that we need a better way to track those bursts of oral steroids they get on the phone or in the ER, or they get called in in the middle of the night. Once we have that, that’s the key. Because the best indicator of future exacerbations, which managed care would love, is past exacerbations. So when we see that pattern of exacerbations, that usually, and a Th2 phenotype, that pushes us to start talking about biologics.

John J. Oppenheimer, MD: And we can really work together by the way, managed care and doctors.

Don A. Bukstein, MD: Yes.

John J. Oppenheimer, MD: I mean you have the data that we need. Number 1, you know how many controller therapies they’re really using. At least filling, how many relievers they’re filling. You also can see the exacerbation rate. If we can work together and identify those patients, it’s going to be cost effective for you to think about biologics in them. But also if they’re not adherent, we’re going to have to figure out new mechanisms to gain their adherence.

Don A. Bukstein, MD: But we need it at the point of service.

John J. Oppenheimer, MD: Yes.

Don A. Bukstein, MD: We can’t have it 3 weeks later in a report of 20 of our patients that may not….

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Is this helpful?

Don A. Bukstein, MD: You have to work with us, we have to use digital technology in the future. [It is] are going to be built into inhalers, so we can tell if they’re taking the inhaler properly and how many times they took it, where they took it. We need better ways to track those oral steroid bursts. And those things will happen in the digital world.

John J. Oppenheimer, MD: And also, we as physicians have to be partners with you. And that is, sometimes part of being a physician is we want to make people better. And the mistake we’re making is when we see somebody in poor control, if they don’t have the phenotype that’s going to respond to the biologic, we need to feel our pulse and say, “this isn’t going to work for you.”

Don A. Bukstein, MD: Yes.

John J. Oppenheimer, MD: And to put them on an expensive medicine, that we’d make maybe forever, I think we have to really hold off on that.

Louis Christos, RPh: You brought up the good word, switching from your traditional products to the biologics. They’re not switching. This is on top of standard of care.

Peter L. Salgo, MD: Is that right?

Louis Christos, RPh: Yes.

Peter L. Salgo, MD: So you’re not going to decrease the LABA, SABAs [short-acting beta agonists].

Louis Christos, RPh: No, that is the other rationale for initially trying to manage these therapies. This is not intended to replace.

John J. Oppenheimer, MD: Although some theorize that these would be cheaper. And as we move off to every 2 and maybe every 6 months in the future, this may be the standard of care in the future.

Louis Christos, RPh: Maybe, in the future, but not at that.

Don A. Bukstein, MD: And it may be that there’s a prevent; if you start these, some of these therapies young enough, there may be a preventive aspect. But I think you hit a real important point. Yours is a great point. When we looked at all the patients, we had over 300 that were on omalizumab, was the only biologic, we found they fell into 3 categories, which made sense after we saw it. And 30% of them, oh wow, they didn’t need any of their medication, they threw them all out, they stopped, they felt great.

Thirty percent of them still needed a fair amount of medication but they decreased, there’s no question there. And 30% of them still needed a fair amount of medication to maintain control. So it’s not always, “Oh my God,” because there’s that bell shaped curve.