Replacing epinephrine with budesonide-formoterol as the OTC option for self-management of mild asthma would save $70.29 billion, study authors estimated.
Over-the-counter (OTC) inhaled budesonide-formoterol would be a safer and more cost-effective option than inhaled epinephrine for patients with mild asthma, and even removing OTC epinephrine from the market without offering another OTC option would benefit patients, investigators reported in the Annals of Allergy, Asthma & Immunology.
Use of inhaled epinephrine, the only currently approved OTC inhaler for managing asthma, is generally discouraged by physicians due to concerns regarding its safety and efficacy. The researchers sought to evaluate the cost and effectiveness of OTC as-needed budesonide-formoterol as a possible OTC alternative to inhaled epinephrine for underinsured adults with mild asthma. The investigators also sought to calculate the cost-benefit of not having an OTC inhaler option available to patients (ie, removing OTC inhaled epinephrine from the marketing and having no other OTC option).
The researchers created a probabilistic Markov cohort model with weekly cycles to assess costs and quality-adjusted life-years (QALYs) for scenarios that included no HCP management; HCP management; severe exacerbation; recovery from severe exacerbation; and death. A microsimulation with 100,000 patients was conducted, with projections based on the assumption that 5,250,000 underinsured individuals in the US had mild asthma. A discount rate of 3% per annum for costs and QALYs was used, and costs were reported in 2022 US dollars.
The investigators found that budesonide-formoterol was superior (ie, more effective and less costly) than inhaled epinephrine, with incremental cost-savings of $13,371, QALY gains of 0.022 per-patient, and an incremental net monetary benefit [INMB] of $15,541. The no OTC inhaler option also was superior to inhaled epinephrine, with a cost savings of $497, QALY gains of 0.006 per-patient, and an INMB of $1023.
Budesonide-formoterol, compared with inhaled epinephrine, was associated with 145 more well-controlled asthma days, 2.79 severe exacerbations avoided, and an absolute risk reduction of 0.23% for asthma-related death. The no OTC inhaler option led to 4 more well-controlled asthma days, less than 0.01 more severe exacerbations, and an absolute risk reduction of 0.13% for asthma-related death.
The probability that budesonide-formoterol was cost-effective vs no OTC inhaler and inhaled epinephrine was 100% for all willingness-to-pay (WTP) thresholds assessed. The no OTC inhaler option also was superior compared with inhaled epinephrine for all WTP thresholds.
From the public payer perspective, the INMB for budesonide-formoterol was reduced to $13,061, and the INMB for no OTC inhaler option increased to $1047 vs inhaled epinephrine, although budesonide-formoterol continued to be the preferred strategy.
Among several limitations, the study authors assumed that the costs of budesonide-formoterol as an OTC product would be the same as contemporary prescription costs, and they used an asthma-fatality risk of unopposed beta-agonist use to model inhaled epinephrine monotherapy. Also, the participants had mild asthma and were not receiving care from an HCP.
If inhaled budesonide-formoterol were to supplant inhaled epinephrine as the OTC option for self-management of mild asthma, said study authors, “it would be cost-effective and improve asthma control, decrease asthma exacerbations, and reduce asthma fatalities, resulting in $70.29 billion in savings to society over the lifetime of this population,” even at its current price. Even without a new OTC option, the study authors added, “removing inhaled epinephrine from the market and offering no OTC option would still result in significant health and economic benefits. This underscores how potentially harmful inhaled epinephrine is as a treatment option.”
Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
References: Ho JK, Shaker M, Greenhawt M, et al. Cost-effectiveness of budesonide-formoterol versus inhaled epinephrine in United States adults with mild asthma. Ann Allergy Asthma Immunol. Published online October 23, 2023. doi:10.1016/j.anai.2023.10.024