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Biomarkers–Diagnostic Tool for Optimal Therapy
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Biomarkers–Diagnostic Tool for Optimal Therapy

A discussion on the biomarkers used to determine efficacy with specific biologics.
 


Peter L. Salgo, MD: If we are using now some of these biologics and we’re going to track them by using expensive laboratory tests, eosinophil counts notwithstanding, at some point you’ve got to pay the bill. Is this going to break the bank? Should everybody be tracking them? Is it already sloping up?

Louis Christos, RPh: I don’t think it’s going to break the bank. We would love to have better ways of identifying the appropriate product for the appropriate patient. So we’re always asking for ways to biomarker genetic tests, whether here [or] across all therapeutic areas. We would prefer to have a test that will positively or at least preferentially identify patients who will respond to certain products.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: But you figure it out pretty quickly. You look at their claims data 6 months before they get on drug, and the claims data costs to your system go down. I mean it’s very….

Louis Christos, RPh: What do you mean the claims?

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: When you’re doing analysis of cost, you have, or you should be able to have access to all the claims data.

Peter L. Salgo, MD: Is that a claims analysis?

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Yes, and you can look at all the costs that were involved in that patient’s care before and then after treatment. And you will see that it’s effective.

Don A. Bukstein, MD: I think those costs are very difficult to get in a managed care system.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: We did it in the Florida Medicaid population, [it] showed huge cost savings.

Don A. Bukstein, MD: They did. There’s 2 studies in Medicaid.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: But that’s because you capture all the claims, the comorbid.

Louis Christos, RPh: I wouldn’t say the costs go dramatically down.

Don A. Bukstein, MD: No.

Louis Christos, RPh: You know, I think costs still continue to go up maybe at a slower pace per se. But costs are not going like this [has hand in a diving down motion] with the availability of the biologics.

John J. Oppenheimer, MD: And presently our tests for phenotyping are very inexpensive. I mean, the tests we’re talking about are all quite inexpensive. The medicines are much more expensive.

Louis Christos, RPh: That’s the whole point.

John J. Oppenheimer, MD: Yes.

Louis Christos, RPh: I’d rather pay for the test to offset whether somebody is going to respond to a more expensive medication.

John J. Oppenheimer, MD: And one of the things I always wonder is maybe if we can meld these analyses, we could determine better phenotypic discrimination. So it could be two-thirds eosinophil count and one-third ENO [exhaled nitric oxide] or something like that. But we need to figure out better fits.

Don A. Bukstein, MD: And, unfortunately, we are right now stuck because the way the trials were designed were based on certain eosinophilic counts with the exception of IL-4 [interleukin-4]. Unfortunately, that’s what we go by.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: I sit on a national pharmacy and therapeutics committee on the kind of other side of sales. So we do all, whether it’s an essential medication and what not. And if it’s related to respiratory, I’m one of the people consulted. And they’re always designing these inclusion criteria that strictly go off the clinical trials. And I said that’s crazy because when they design a trial, they wanted to get the sickest patients, so they had the most dramatic effect. But, in real life, there’s a larger population with the 150 or 300 eosinophils that just….

Don A. Bukstein, MD: And that’s really important, the population.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: I get them to stop doing it, thank God.

Louis Christos, RPh: It’s not the size of the population, it’s whether you’re identifying the appropriate patient, whether that’s 20% of the asthmatic population or 3%.

Don A. Bukstein, MD: But it’s more than that because in different communities you’re going to have different percentages of different phenotypes. In the community I work in now, inner city, 28%, 29% of my patients that have asthma are smokers, active smokers. Well, we know inhaled steroids, oral steroids don’t work as well in smokers. And many of those have an eosinophilic phenotype. They may have had asthma for years. So it gets to be very confusing with these other comorbidities, depending on the community that you’re in. Therein lies that huge range in severe asthma. When you have a community like inner city Milwaukee where 25% of children have asthma, whereas the rest of Wisconsin, it’s 8% or 9%.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: That’s huge.

Don A. Bukstein, MD: It’s the same number in New York, or Chicago.

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

Peter L. Salgo, MD: I don’t think that’s widely…I didn’t know that.

Linda S. Cox, MD, FAAAAI, FACAAI, FACP: Florida was 11%.

Peter L. Salgo, MD: Twenty-five percent.

Don A. Bukstein, MD: Beyond that their level of severity is much higher. They have more [emergency department] visits, more hospitalizations. And managed care and insurance companies know that, that there are these pockets of very significant asthma. We’ll talk later about some very interesting studies trying to deal with this. A lot of times they get their ongoing care in emergency [departments], and urgent care centers, and in hospitals. So, again, it’s very different in different communities, the percentages of severe uncontrolled asthma as opposed to milder uncontrolled asthma.

 
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