Clinicians and a payer review current treatment guidelines for chronic obstructive pulmonary disease and discuss how often they refer to and utilize current recommendations when making decisions for coverage and treatment.
Neil Minkoff, MD:Dr Mahler, you were the one who started to bring us back to the GOLD [Global Initiative for Chronic Obstructive Lung Disease] guidelines. Dr Drummond mentioned how, as pulmonologists, you might be seeing sicker patients. How closely can you adhere to a treatment guideline, such as a GOLD guideline? How do you deal with a stepwise approach and when do you vary?
Donald A. Mahler, MD:That’s an important question. Historically, the emphasis used to be on lung function: treating and using medicines to improve lung function. So I give credit to the GOLD Scientific Committee. These global experts were focusing on relief of symptoms—mainly shortness of breath—and reducing the risks of future exacerbations. Clearly the science supports that approach.
On the other hand, the GOLD committee has recommended a stepwise approach to treating COPD [chronic obstructive pulmonary disease] similar to the stepwise approach to treating asthma. I do not follow this stepwise approach. For example, Dr Drummond mentioned the data that support 2 different bronchodilators in those who are very symptomatic. I’ll give you an example of a vignette that I included in a book I wrote several years ago. It’s an educational book for patients with COPD. In that vignette, the doctor takes a history, examines the patient, and says, “Mr Jones, you have COPD. I can prescribe 1 bronchodilator in an inhaler that would help you breathe better, or I can prescribe 2 different bronchodilators in a single inhaler that will help you breathe even more. Which one would you prefer?”
I think that very simple, silly example illustrates, why hold back? Why not give the patient the best treatment we have for relieving symptoms? As Dr Drummond described, for people who have high symptoms and low risk of exacerbation, I would prescribe dual bronchodilators because of the improved benefit. That’s even supported by the American Thoracic Society, which in May of 2020 published guidelines and basically said that 2 bronchodilators are better than 1 for people who are short of breath or have exercise limitation.
For Group D, who are symptomatic, high symptoms, and at high risk of future exacerbations, 2 studies were published in 2020. The IMPACT and ETHOS studies—different companies, different molecules, different medicines—show that 3 medicines in a single inhaler, called triple therapy, is not only more effective in reducing the risk of future exacerbations, but also shows a mortality benefit compared to 2 bronchodilators. In my perspective, people who have been hospitalized for a COPD exacerbation should be on triple therapy unless there’s a strong reason to avoid a medicine because of possible [adverse] effects, such as the possibility of pneumonia associated with inhaled corticosteroids.
Neil Minkoff, MD: So that would be the rationale for supporting the withdrawal of the ICS [inhaled corticosteroids]?
Donald A. Mahler, MD: Yes. If someone’s on an inhaled corticosteroid, and they have 1 or more episodes of pneumonia, which typically cause an exacerbation, I would sit down and talk with the patient. I would say, “Here’s one of the risks. You’re on a medicine that may increase the risk of pneumonia.” I would recommend a trial of discontinuing it and seeing how they go.
As Dr Drummond mentioned, I’d certainly want to look at their blood eosinophil count. If that’s low and they’re having episodes of pneumonia, I would definitely recommend withdrawing the inhaled corticosteroid and following their clinical course.
Neil Minkoff, MD: Dr Lopes, we spent a lot time talking about payers trying to follow guidelines to help keep everybody on the same page so it decreases the conflict between good clinical practice, what the clinicians are trying to accomplish with their patients, and what the coverage decisions are. What are you doing around utilization management for COPD in general? Is there anything around stepwise therapy and following the guidelines? How closely do you have to follow the guidelines?
Maria Lopes, MD, MS: I think what Dr Mahler just outlined is critically important for payers. We want to be evidence-based. I think we react to published literature, especially if there are data around reductions of mortality and reductions in events, hospitalizations, emergency department [ED] visits, and exacerbations. We recognize how this connection between the convenience of combination treatments for the right patient can really optimize outcomes. I think that’s significant. When we’re in a P&T [pharmacy and therapeutics] committee, we’re looking at the degree of clinical differentiation. Is this just convenience, or does it really connect with better outcomes, especially in the short term? With COPD, you don’t have to wait long for this to have inherent value if you can see an exacerbation has occurred and you can prevent the next event.
I think it certainly is about choice. It’s also about helping practitioners have enough choice. It’s also becoming about convenience, with a recognition that convenience matters, and there’s a cost if you introduce steps, encounter agents that are more challenging, or you have steps before you can get to something that’s more convenient or appropriate to avoid a costly event.
Going back to your question—I think the data are there to support matching individual patients with the right approach. The cost of the treatment pales in comparison to a hospitalization or an ED visit. And so, generally speaking, these drugs are available. There’s not a lot of prior authorization or scrutiny around their use. There may be preferred agents and nonpreferred agents, but I think we generally recognize the value of the treatment, the convenience, and the ease of administration that then links to better adherence.
This activity is supported by an educational grant from Boehringer Ingelheim.