Neil B. Minkoff, MD: Let me ask you to hold that thought for 30 seconds, because we’re going to come right back to exacerbations. I have some questions about how we measure those and the proper way of doing so. But before I do that, I want to just finish the last topic with you in terms of—not just you, but as an industry—do you think this is allowing for a LAMA [long-acting muscarinic antagonist] or LABA [long-acting beta-agonist] to be started together and then add therapies? Does it have to be 1, and then 2, and then 3? What are you seeing out there?

Maria Lopes, MD, MS: What I’m seeing is this is a disease with pretty significant consequences and very high costs. I don’t see the appetite for payers to really prior authorize. You know, start with 1, and move to 2, and move to 3, and sequence. I see choice within each category, which I think speaks to the need to be able to somewhat individualize therapy. I see greater opportunities certainly on, “Let’s make the diagnosis,” and the unmet need in terms of even understanding who has the disease and who does not.

I also see that real-world data help us all understand the magnitude of benefit of what triplets may bring, particularly for a moderate to severe population. That’s what I see—the opportunity, and really some of the discussion around maybe an algorithm that cuts through the chase in terms of how you medically optimize someone. That’s what I think the appetite is. It’s around, how do we impact total cost of care as well?

Neil B. Minkoff, MD: We keep coming back to exacerbations.

Maria Lopes, MD, MS: Yes.

Neil B. Minkoff, MD: I’m curious about a number of different things. Can you identify ahead of time who you think is at increased risk? Whose definition of exacerbation are you using? Does the patient have to be hospitalized? Do they have to have gone to urgent care? Can it just be their description of a really bad day at home? How do you define exacerbation as you’re saying things like, “Well, if they have more than X number of exacerbations, we should consider adding an ICS [inhaled corticosteroid].”

Frank C. Sciurba, MD, FCCP: We’ve had these intellectual debates onstage that the COPD [chronic obstructive pulmonary disease] Foundation has sponsored with patients in the audience. If you give the patient the chance to go to the microphone, they’ll say, “You know, you guys can debate all you want what an exacerbation is, but I’ll tell you when I’m having one. I know it.” That’s probably right. When they call in and say, “I’m having a flare-up. I’m more short of breath.” Or “I’m bringing up more sputum and coughing more. What can you do for me?” That’s an exacerbation. It’s a change in symptoms. And the pure definition usually correlates with that—a change in symptoms for at least 2 days that warrants an escalation in therapy.

Neil B. Minkoff, MD: There are 2 paths to look at that, right? One is, what is that effect on lung function in terms of clinical progression? But the other is the effect on quality of life. And trying to pair those together. What do you concentrate on and focus on in the office?

Byron Thomashow, MD: Well, we do understand that exacerbations are bad things. The more frequent they are, the worse it is. They have more airway inflammation, there’s more rapid deterioration of lung function, and in those who are frequently exacerbated—2 or more a year—there is a mortality risk over the course of time. It’s certainly something we aggressively need to treat. Indeed, we have medicines that are available that can make a difference, whether it’s a combination of bronchodilators and inhaled corticosteroids. Or if you’re continuing to exacerbate, consideration of things like roflumilast, which is an oral drug that’s available, or erythromycin, which potentially is an immune modulator.

It’s important for everyone to understand that we actually have a number of different therapies available. Being aggressive and trying to prevent those exacerbations is really a critical issue, not just from the standpoint of cost—although it’s a critical issue from that standpoint—but from the issue of quality of life, continued quality of life, and length of life as well.

Neil B. Minkoff, MD: We’ve talked about lung function and, in general, quality of life. What is your ability to look at exacerbation rate and things like improvements in activities of daily living with the data that you have in terms of helping to support or deny different types of therapies?

Maria Lopes, MD, MS: Well, we have claims data. We have utilization data on the pharmaceutical side. We have claims data on hospitalizations, on ER [emergency department] visits. What I find fascinating is, there’s a lot of interest in patient-reported outcomes [PROs]. Can the PRO, in this case, predict an exacerbation? And if we actually were able to capture this data? Perhaps it’s more real-time tools like mobile apps that can integrate into disease management and, hence, define the protocol or the referral, or when the patient is actually seeing a provider.

Neil B. Minkoff, MD: To see if they’re active.

Maria Lopes, MD, MS: Exactly. I find the elements of PROs that actually have a predictive ability and are meaningful and potentially impactful on what can be done to prevent that exacerbation to be sort of at the forefront of what we can then do to translate these PROs into better care at the right time to prevent that exacerbation.

Neil B. Minkoff, MD: Just to reiterate something you said, to make sure we’re getting it, absenteeism is reasonably easy to measure. Productivity is very hard to measure, and presenteeism is very hard to measure.

Maria Lopes, MD, MS: And the payer may not have that data at all.

Neil B. Minkoff, MD: OK.

Maria Lopes, MD, MS: The employer may, but it’s very hard to merge. They exist with different entities. The health plan, unless it’s their own employee, may not have absenteeism data, for example.