Neil B. Minkoff, MD: I want to address some of the things we’ve been talking about here, in terms of a lot of payer formularies are based on guidelines. In this case, GOLD [Global Initiative for Chronic Obstructive Lung Disease] is the most common. So how does the GOLD guideline or anything else affect your formulary in terms of stepwise management, and going from 1 to 2 to 3? And do you even approve triple therapy?

Maria Lopes, MD, MS: We try to be evidence based. The role of national guidelines plays a role to the extent that they outline what categories—what LAMA/LABA [long-acting muscarinic antagonist/long-acting beta-agonist] combinations or ICS [inhaled corticosteroid] combinations based on mild, moderate, and severe disease. Obviously that’s overarching. When we’re in a P&T [Pharmacy and Therapeutics] committee and we’re looking at a drug, we’re starting with: What’s the category? What’s the mechanism of action? But we’re also looking at what the efficacy is in clinical trials, particularly around exacerbations.

We’ve moved beyond FEV1 [forced expiratory volume in 1 second], and we really are looking at what the impact is on exacerbations. In the end, that’s also the big impact on total cost of care. We’ll certainly also look at safety, including black box warnings. Obviously, if 1 drug has a black box warning and another does not, that’s an area of differentiation. We do have pulmonologists who are practicing, also part of that committee, to give us exactly the kind of feedback that we’re getting here in this discussion. In the end, generally speaking, in the area of COPD [chronic obstructive pulmonary disease], it’s about choice. And 1 of the things I heard from both the thought leaders here is there needs to be choice to be able to individualize what that patient needs based on symptoms. Although not everything is tier 2, unrestricted—tier 2 is typically nonpreferred—there are usually options on a preferred tier that satisfy, if you will, the need for some individualized choice across different classes.

Some payers are actually covering the triple combination. I think we all recognize that for some patients—and probably those who are most severe, in order to keep them out of the hospital, out of the ER [emergency department], and better controlled—that convenience and adherence may tie together. That’s what success is going to look like if we’re going to manage to total cost of care. Others may put some more restrictions or perhaps move the triplet to a nonpreferred tier, which has cost-share implications for patients, but I think you’re seeing some also recognize there’s value in choice and maybe also an opportunity for contracting. That said, I think we’ve recognized the importance of managing COPD [chronic obstructive pulmonary disease] and doing a better job in choice and access to remove barriers to patient adherence.

Neil B. Minkoff, MD: Let me just throw out 1 thing, which is 1 of the things we found across a number of my roles. A lot of times when these switches happen, it wasn’t that the plan was switching. It was that the employer was carving out to a new pharmacy manager. There was nothing we could do. They made a business decision. I know that from your point of view, it’s all just the insurance company, right? I understand that, but sometimes it’s taken away from us.

Byron Thomashow, MD: Wherever the decision is made in the pathway, we’re all in this to try to improve the care of the people we’re taking care of. I think it’s just really important to understand that if you don’t know how to use the devices you’re using, that’s problematic.

It’s also, by the way, extremely frustrating when we get a request to say that this LAMA/LABA isn’t available and 1 of the choices is Combivent [ipratropium/albuterol], which is a short-acting LAMA/LABA but is not part of a maintenance therapy. It doesn’t provide many of the other things. When you get the request form from wherever it’s coming and it says you can switch to, and this is 1 of your options, it suggests a lack of understanding, which is problematic.

Maria Lopes, MD, MS: Yes. But also, like Byron said, I think it is our problem when we’re paying for a drug and patients aren’t taking it correctly. So [we go] back to the point of training. And if there is a switch, what can we do? We have disease management. We have clinical pharmacists. We now have technology that can do maybe a Skype video to help train patients appropriately. I would actually put the onus on us, collectively, to say, “What are some ways we can overcome some of these training issues?”

Byron Thomashow, MD: And having inhaler videos available within the app or a different portion, perhaps. Potentially getting pharmacists who work in CVS and Walgreens to show the person how to use the different devices. But we have to get away from this issue of somebody has changed their drug and they’re not using it.

Before we leave this issue, I do have a question for Frank. There are data suggesting that, particularly in people who have more severe disease, they don’t have the inspiratory force to get some of these drugs in. Should that play a role in the decisions we’re making?

Frank C. Sciurba, MD, FCCP: I would broaden that a little to say that different patients seem to sync with different devices. Some of it is cognitive related, dexterity related—severe arthritis. Some of it is inspiratory flow rate. To answer your specific question, there has been some discussion that particularly the more severe patients—small, petite women in particular—may have trouble activating some of the dry powder inhalers.

I can tell you that there’s truth in that, and it has to be recognized. But as in many things, it may have gone too far and needs to be pulled back. I think some of the patients with more severe disease, especially with variable rates and especially if they’re not educated on how to use the devices, can get below the inspiratory thresholds. In some cases, nebulized therapy is indicated in patients who can’t coordinate with devices in general or who are particularly arthritic.

In general, dry-powder inhaler devices actually are preferred by patients, and they’re the easiest to use. So you have to balance this contradiction. And so the answer to that is, if the medicine doesn’t get down in your lungs because you don’t know how to use the device, it’s not going to do well. And different patients sync with different devices. I’m a big fan of a redundant formulary, and I always make that argument to have at least a couple of choices.

Byron Thomashow, MD: Let me just follow up on that, because I think it’s really important. It’s our job, as providers, at whatever level we’re providing, to provide something that works best for our patients. While we have a limited number of types of drugs that are available, there are a number of different ways they can be delivered. If you find someone who’s struggling, you can often find a different approach that can work with a different variation of the drug using a different device. Over the last year or 2, there have been a couple of nebulized LAMAs that have finally gotten into the formulary. So there are options available. Clearly, a single device—you know, once a day—would be ideal. It may not be ideal for every one of the patients we’re dealing with.