Experts Examine Biologic Coverage in Asthma and COPD

Biologic therapy has expanded the options for patients with severe asthma and chronic obstructive pulmonary disease (COPD) with type 2 inflammation, but payer requirements increasingly determine which patients receive which agent. Recent approvals include dupilumab and mepolizumab for eosinophilic COPD and depemokimab, a twice-yearly anti-interleukin (IL)-5 agent, for severe asthma.1-4 For advanced practice providers (APPs) who manage much of this population, documentation and coverage now shape treatment as much as biomarkers do.

In October 2026, MeiLan Han, MD, MS, chief of the Division of Pulmonary and Critical Care Medicine at the University of Michigan and a member of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) committee, moderated a virtual clinical forum on biologic therapy in asthma and COPD. Participants included nurse practitioners, a physician assistant, and a nurse scientist from outpatient and inpatient pulmonary practices in Michigan, Ohio, Montana, Oregon, and Alabama. The discussion covered biomarkers, oral corticosteroid (OCS) tracking, agent selection, and coverage barriers.

Type 2 Biomarkers and OCS Tracking in Asthma

Participants said they review the most recent blood eosinophil count for every patient with asthma and repeat it when control worsens, and several have access to fractional exhaled nitric oxide. The most common challenge they described was interpreting eosinophil counts in patients who cycle on and off systemic steroids, including injectable corticosteroids from primary care. Participants said patients frequently receive steroids for unrelated conditions such as gout or back pain, and some described patients who keep leftover prednisone and self-treat.

To capture outside courses, participants described reviewing external prescription records, pharmacy dispense reports, and multiple health systems' records, often manually. In 1 participant's practice, a 12-month calendar of steroid courses is shown to patients, who are often surprised by the total. Participants also noted that steroids prescribed by phone or urgent care may not reflect a confirmed exacerbation.

Biologic Selection and Coverage in Severe Asthma

Participants said patients must typically reach Global Initiative for Asthma step 3 or 4 on moderate- to high-dose inhaled corticosteroids before payers approve a biologic, and that meticulous documentation of 2 or more OCS-treated exacerbations in 12 months can support approval when eosinophils are suppressed. In polling, 40% cited biomarkers, 30% cited phenotype, and 30% cited insurance coverage as the main driver of biologic choice. Han said biomarkers often determine eligibility while coverage determines the final agent, and she described a general framework of IL-5 agents for very high eosinophils, IL-4/IL-13 blockade for elevated eosinophils with elevated fractional exhaled nitric oxide, and tezepelumab for low eosinophils.

Several participants described frequent use of dupilumab and strong patient-reported responses, while others reported arthralgias leading to discontinuation and, in 2 patients with psoriasis, flares after initiation. Other participants described anti-IL-5 agents as their preferred class for severe eosinophilic asthma, with dosing interval guiding choice among them, and 1 participant described pushing for an IL-5 agent over a payer-preferred alternative in a patient with an eosinophil count of 5700 cells/µL and concern for vasculitis. Participants described tezepelumab as an option for patients with lower eosinophil counts or inadequate response to other agents.

Participants who have prescribed depemokimab said patients who travel frequently value twice-yearly dosing, and others cited potential benefit for children, patients averse to needles, and patients who spend months away from home.

COPD Biologics and Payer Preferences

Han noted that an estimated 20% to 40% of patients with COPD have type 2 inflammation. In BOREAS and NOTUS, dupilumab reduced exacerbations and improved lung function, with symptom improvement in BOREAS, in patients with eosinophil counts of 300 cells/µL or higher, and in MATINEE, mepolizumab reduced exacerbations in patients with counts of 300 cells/µL or higher.2-4 Han said the mepolizumab label references both 150 and 300 cells/µL thresholds but that she views the totality of evidence as supporting 300 cells/µL, the threshold GOLD uses.

Participants who prescribe mepolizumab in COPD cited once-monthly dosing as an advantage, though several reported recent payer denials directing them to dupilumab even when eosinophil counts fell between 150 and 300 cells/µL. According to 1 participant, a regional payer now requires documented specialist consultation before APPs can order biologics for asthma or COPD. Han said differences in trial populations may explain some differences in secondary outcomes between agents.

Han said she understands that trials of depemokimab and tezepelumab in COPD are underway and that an IL-33 inhibitor has reported positive results.

"For me it's super helpful to kind of hear what all of you have to say because that way I can have a better and broader perspective when I go back to the committee and we're talking about how to improve the management strategy," she said.

References

1. Jackson DJ, Wechsler ME, Jackson DJ, et al. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype. N Engl J Med. 2024;391(24):2337-2349. doi:10.1056/NEJMoa2406673

2. Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. N Engl J Med. 2023;389(3):205-214. doi:10.1056/NEJMoa2303951

3. Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with blood eosinophil evidence of type 2 inflammation. N Engl J Med. 2024;390(24):2274-2283. doi:10.1056/NEJMoa2401304

4. Sciurba FC, Criner GJ, Christenson SA, et al. Mepolizumab to prevent exacerbations of COPD with an eosinophilic phenotype. N Engl J Med. 2025;392(17):1710-1720. doi:10.1056/NEJMoa2413181