Key Takeaway: New biologics offer important options for members with severe asthma, but high-cost therapy requires more than coverage. A sound PBM strategy confirms clinical fit, optimizes lower-cost treatment first where appropriate and monitors outcomes over time.
Why Severe Asthma Matters for Self-Funded Plans
As spring allergy season begins, asthma control often becomes more difficult for members already managing chronic respiratory disease. Pollen, mold, weather changes, and air quality shifts can worsen symptoms, increase rescue inhaler use, and contribute to flare-ups.
For brokers and self-funded groups, that makes this a timely moment to ask a bigger question: are respiratory medications being managed in a way that protects both the member and the plan?
Asthma affects millions of people in the U.S. and remains a meaningful driver of avoidable medical utilization. According to the CDC, approximately 24.9 million people in the U.S. have asthma, representing about 7.7% of the population. Severe asthma affects a smaller share of people with asthma, but for those members, the impact can be significant: recurring flare-ups, emergency department visits, hospitalizations, missed work, and rising medical and pharmacy costs.
That’s especially true for severe eosinophilic asthma, a form of asthma associated with elevated eosinophils, a type of white blood cell that can contribute to airway inflammation. For members whose asthma remains uncontrolled despite inhaled therapies, biologic medications may help reduce inflammation and prevent exacerbations.
Several biologic treatments are already FDA-approved for asthma, including Dupixent® (dupilumab), Xolair® (omalizumab), Nucala® (mepolizumab), Fasenra® (benralizumab), Tezspire® (tezepelumab), and Cinqair® (reslizumab).
One of the newest additions to the severe asthma biologic market is Exdensur® (depemokimab-ulaa).
What Brokers Should Know About Exdensur® and Asthma Biologics
Exdensur® (depemokimab-ulaa) was approved by the FDA in December 2025 as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients ages 12 and older. It’s not used to treat sudden breathing problems or acute asthma attacks.
Its key differentiator is its dosing. Exdensur® is administered by subcutaneous injection once every six months, making it the first FDA-approved ultra-long-acting biologic for severe asthma with twice-yearly dosing. Less frequent administration may improve treatment adherence.
Exdensur®’s approval was based on two Phase 3 clinical studies, SWIFT-1 and SWIFT-2. These studies looked at patients with severe asthma whose symptoms were not fully controlled with standard asthma therapy. Researchers evaluated whether adding Exdensur® helped reduce asthma exacerbations compared with standard therapy alone. In both studies, Exdensur® significantly reduced the rate of asthma exacerbations over 52 weeks.
That data matters, but it doesn’t make Exdensur® an automatic answer for every member with asthma.
Why High-Cost Asthma Drugs Require Clinical Oversight
At an estimated cost of about $62,000 per year, Exdensur® may affect a relatively small number of members, but each case can carry meaningful financial and clinical implications.
For plans, the question should not simply be whether the drug is covered. The better question is whether the member is clinically appropriate for therapy, whether existing inhaler therapy has been optimized, whether exacerbation history supports escalation, and whether the treatment is likely to improve disease control without creating unnecessary cost.
That’s where clinical oversight becomes critical.
A clinically disciplined PBM strategy should evaluate severe asthma biologics through clear coverage criteria, including confirmation of disease severity, eosinophilic phenotype, documented flare-up history, and adherence to appropriate controller therapy. It should also consider whether a member’s current treatment pattern suggests poor control, inappropriate inhaler use, or gaps in therapy that should be addressed before escalation.
How PBMs Should Manage Severe Asthma Biologic Coverage
At PharmPix, we evaluate therapies like Exdensur® through the whole pharmacy picture: clinical appropriateness, member access, treatment continuity, and plan cost.
The goal is never to block access to innovative therapies, but to make sure the right members receive the right therapy at the right time, with the right clinical safeguards in place. That means asking practical questions before the claim becomes an unnecessary cost driver or the member is placed on a therapy that may not be the right fit.
Four Questions Plans Should Ask Before Covering a New Asthma Biologic
- Is the member a strong clinical fit for a severe asthma biologic? Coverage criteria should confirm that the therapy is appropriate for the member’s disease severity, clinical profile, and exacerbation history, so the right patients can access advanced therapy when it is likely to help.
- Has standard inhaler therapy been optimized first? Before moving to a high-cost biologic, plans should understand whether daily controller therapy has been used consistently and appropriately, and whether symptoms remain uncontrolled despite that treatment.
- Could the therapy help prevent avoidable medical costs? For the right member, improved asthma control may reduce exacerbations, emergency department visits, hospitalizations, and other avoidable plan costs.
- Can the plan support appropriate use over time? A biologic strategy shouldn’t end at approval. Plans need visibility into utilization, adherence, outcomes, and ongoing clinical appropriateness to protect both the member and the plan.
Why Respiratory Drug Management Is a Cost-Containment Issue
For brokers advising self-funded clients, severe asthma biologics are a good example of why pharmacy strategy cannot be reduced to unit cost alone. A low PMPM estimate may make a therapy look manageable on paper. But if coverage criteria are weak, if members escalate before lower-cost therapies are optimized, or if the plan cannot monitor outcomes over time, costs can grow without clear clinical value.
The reverse is also true. If a member is appropriate for therapy and the drug helps prevent severe exacerbations, access may protect both the patient and the plan from avoidable medical spend. That’s the balance plans need from a PBM: not reflexive restriction, and not open-ended approval, but clinically disciplined management.
The Bottom Line: Better Asthma Management Protects Patients and Plans
Exdensur® adds a new option for patients with severe eosinophilic asthma. Its twice-yearly dosing may reduce treatment burden, and clinical trial data support its role in reducing exacerbations for appropriate patients.
But for plans, the broader consideration goes beyond any single drug.
As respiratory therapies become more targeted and more expensive, the plans that manage them best will be the ones with clinical oversight built into the pharmacy benefit. That means identifying the right patients, confirming appropriate use, monitoring therapy over time, and protecting access without allowing avoidable cost to go unchecked.
For brokers and self-funded groups, that’s the question worth asking this spring: does your PBM simply process new therapies as they enter the market, or does it have the clinical discipline to make sure those therapies are used where they can do the most good?
FAQs
What should a health plan’s coverage criteria include for severe asthma biologics?
Coverage criteria should confirm disease severity, eosinophilic phenotype where relevant, exacerbation history, appropriate use of controller therapy and the member’s clinical fit for treatment.
What is Exdensur, and who is it for?
Exdensur is a twice-yearly biologic approved as an add-on maintenance treatment for patients age 12 and older with severe eosinophilic asthma. It is not intended to treat sudden breathing problems or acute asthma attacks.
Can severe asthma biologics lower total healthcare costs?
For clinically appropriate members, effective treatment may reduce severe exacerbations, emergency department visits and hospitalizations. Value depends on selecting the right therapy for the right member and monitoring outcomes over time.
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