Severe Asthma: New Biologics Improve Standard of Care, Increase Costs

Recent advances in the ability to treat moderate to severe asthma with targeted therapies may change the game for these patients. However, cost considerations could significantly impact budgets as these new agents come to the market. 

Understanding the Burden

Asthma affects 22 million adults and children in the United States—with 5% to 10% of these patients diagnosed with severe asthma. With a patient population of around 1 million, treating and managing severe, uncontrolled asthma represents a significant burden for patients and health care payers.

Numbers from the CDC indicate that Medicaid spends more than $10 billion annually to treat asthma. A recent ICER report estimated the annual medical costs to treat asthma at $50 billion annually. The report also highlighted that of this $50 billion, at least half is spent on patients with severe, uncontrolled asthma. The most recent report from the CDC, published in January 2018, quantified the total cost of asthma—including medical expenditures, missed school and work days, and deaths—as $80 billion annually. The CDC also noted that the costs of asthma are probably higher than $80 billion annually, because their report did not include data from patients who were not diagnosed with or treated for asthma.

Additionally, asthma is associated with increased health care utilization and costs, with significantly increased costs among patients with severe disease. Patients with asthma tend to use the emergency department (ED) more 1.5 times more often than the general population. 

Lack of adherence to medication is often suggested as a reason for high health care costs and utilization among patients with asthma. Asthma is a disease that causes the airways of the lungs to narrow, making breathing difficult. As a result, asthma often requires daily or multiple daily doses of inhaled medication. Patients with severe asthma are therefore thought to be at a higher risk for health care intervention if they have poor adherence.  

However, some studies also suggest that poor adherence is not the primary driver of health care costs among patients with Asthma. A meta-anlysis by Aurel O Iuga, MD, MPH, of the Johns Hopkins Bloomberg School of Public Health, and colleagues studied how nonadherence impacted health care costs among patients with chronic diseases and found that increased adherence in asthma patients was associated with decreased ED use but not decreased health care costs. Furthermore, a study presented at the AAAAI 2017 annual meeting found that despite adherence to inhaled corticosteroids and long-acting beta2-antagonists, patients still had significant health care utilization and work impairment—suggesting an unmet need among these patients.

CDC data showed that of the 15.4 million Americans treated for asthma annually, the cost per patient is estimated to be $3266. This breaks down to an average of $1830 spent on medications, $640 spent on primary care visits, $176 for hospital visits, and $105 for ED visits.

Standard of Care

Severe asthma is usually diagnosed when control of asthma is not achieved through initial use of high-dose treatment with inhaled corticosteroids and add-on therapies, including long-acting inhaled beta2-agonists, montelukast, and/or theophylline.

Standard treatment starts with treating comorbidities, identifying and eliminating triggers, and optimizing medication adherence. Once patients are stabailized, treatment with drugs such as tiotropium, novel subcutaneous agents, and antibiotics may be initiated. 

Xolair (omalizumab; Genentech) is a recombinant humanized monoclonal anti-IgE antibody that inhibits interactions with the IgE receptor. Xolair can cost between $541 to $1000, with an annual treatment cost of more than $10,000. A report in Value in Health Regional Issues concluded that despite Xolair’s effectiveness among patients with severe asthma, the drug did not meet cost-effectiveness thresholds at its current pricing. However, the researchers concluded that Xolair “will remain in the market because it possesses a unique mechanism of action and provides great benefits to patients with severe asthma.” 

Interleukin Inhibitors/Blockers

Additional options for treating severe asthma include biologics, such as the recently approved Interleukin‐5 receptor alpha (IL‐5Rα) inhibitor, Fasenra (benralizumab; Astrazeneca). Fasenra is an add-on maintenance treatment for patients aged older than 12 years. According to a presentation by at AMCP Nexus 2017, the advantage of Fasenra is that it only has to be administered every 8 weeks vs every 4 weeks with competing medications. The drug is a prefilled syringe that cannot be self-administered, requiring a health care visit to receive treatment. Approval for Fasnera was based on clinical trials that found a 51% reduction in exacerbations vs placebo, improved lung function, and low adverse event profile. 

Other available interleukin‐5 inhibitors include Nucala (mepolizumab; GlaxoSmithKline) and Cinqair (reslizumab; Teva). These drugs are both also administered in a physician’s office; however, unlike Fesnera, they must be administered every 4-weeks. All three drugs are priced similarly, at around $35,000 for a year of treatment. 

Additionally, Dupixent (dupilumab; Sanofi/Regeneron), the recently approved interleukin‐4 alpha receptor (IL‐4Rα) blocker for atopic dermatitis, is expected to receive an indication for the treatment of severe asthma based on recent a clinical trial. In these trails, Dupixent reduced severe asthma exacerbations by 46% overall, with better results among patients with high levels of eosinophilic cells, providing patients with the opportunity to reduce the severity of their psoriatic plaques and prevent complications due to the inflammatory nature of the disease. Cost and provider acceptance are both significant challenges in adequately managing this disease.

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