OTC Budesonide-Formoterol Would Be Cost-Effective Alternative to Inhaled Epinephrine for Mild Asthma
An over-the-counter (OTC) as-needed budesonide-formoterol inhaler would improve outcomes and reduce costs compared with inhaled epinephrine for adults with mild asthma, according to a cost-effectiveness analysis using a lifetime modeling approach. The findings address a gap in OTC options for asthma management, where inhaled epinephrine remains the only nonprescription therapy in the United States.
Investigators developed a probabilistic Markov model from a US societal perspective to compare OTC as-needed budesonide-formoterol with inhaled epinephrine in adults with mild asthma. Model inputs were drawn from the SYGMA trials, published data, and commercial cost estimates. Outcomes included quality-adjusted life-years (QALYs), severe exacerbations, well-controlled asthma days, and asthma-related deaths.
Inhaled epinephrine was “dominated” by both as-needed budesonide-formoterol and a no-OTC inhaler strategy, meaning it was associated with lower QALYs at higher cost. Compared with inhaled epinephrine, as-needed budesonide-formoterol provided 145 additional well-controlled asthma days, 2.79 fewer severe exacerbations, and an absolute risk reduction of 0.23% for asthma-related death over a lifetime horizon.
At a willingness-to-pay threshold of $100,000 per QALY, as-needed budesonide-formoterol generated an incremental net monetary benefit of $15,541. Sensitivity and scenario analyses consistently favored budesonide-formoterol, with a 100% probability of cost-effectiveness in probabilistic simulations.
The authors concluded that “if made available, OTC as-needed budesonide-formoterol for treating mild asthma in underinsured adults without HCP management improves asthma outcomes, prevents fatalities, and is cost-saving.” They noted that inhaled epinephrine without an inhaled corticosteroid may increase the risk of asthma death, underscoring the rationale for combination therapy.
Reference
Ho JK, Shaker M, Greenhawt M, et al. Cost-effectiveness of budesonide-formoterol vs inhaled epinephrine in US adults with mild asthma. Ann Allergy Asthma Immunol. 2024;132(2):229-239.e3. doi:10.1016/j.anai.2023.10.024


