The discontinuation of the popular asthma inhaler Flovent by GlaxoSmithKline in 2024 led to a significant decrease in the number of children using steroid inhalers to manage their asthma, according to a recent study published in the Journal of the American Medical Association. This withdrawal, while accompanied by the continued availability of a chemically identical “authorized generic,” created barriers for many families due to insurance coverage issues and higher out-of-pocket expenses. Consequently, researchers observed a 6 percentage point increase in the likelihood of children not having a steroid inhaler readily available to prevent potentially life-threatening asthma attacks.
The study, conducted by researchers at the University of Michigan Health C.S. Mott Children’s Hospital, examined the trend in asthma inhaler access among patients aged 18 and younger who had been prescribed Flovent (fluticasone). The findings revealed a concerning drop in access from nearly 41% between 2021 and 2023 to approximately 35% following Flovent’s market withdrawal. This decline starkly contrasts with the consistent access to inhalers, hovering around 38%, observed in young asthma patients prescribed other inhaled corticosteroids during the same period.
Dr. Kao-Ping Chua, the lead researcher and a pediatrician at the University of Michigan, emphasized the potential ramifications of these findings. “Our findings suggest the withdrawal of Flovent disrupted inhaled steroid therapy in children, potentially increasing their risk of asthma attacks,” he stated in a news release. Regular use of inhaled steroids is a cornerstone of asthma management in children, helping to reduce inflammation in the airways and prevent the onset of debilitating and sometimes fatal asthma exacerbations. A disruption in this preventative therapy can have serious health consequences for young patients.
The researchers shed light on the likely reason behind GlaxoSmithKline’s decision to pull Flovent from the market. They pointed to changes in the Medicaid rebate program, specifically the elimination of a cap on rebates that manufacturers must pay to secure drug coverage under Medicaid. Historically, these rebates had a ceiling, providing a degree of predictability for pharmaceutical companies. However, the American Rescue Plan Act of 2021, enacted in January 2024, removed this cap.
This policy change had significant financial implications for drugs like Flovent, for which GSK had implemented substantial price increases over time. With the rebate cap lifted, the rebates the company would have been required to pay to Medicaid could have exceeded the drug’s sales price, particularly due to a provision that applies when a drug’s price increases outpace inflation. This unfavorable economic landscape likely prompted the manufacturer to discontinue the brand-name Flovent while continuing to offer the authorized generic.
While the authorized generic contained the same active ingredient (fluticasone), its accessibility was not uniform. Many families encountered difficulties obtaining this alternative due to their insurance plans either not covering it or imposing higher out-of-pocket costs compared to the original Flovent. This highlights a critical issue: the mere availability of a generic equivalent does not guarantee equitable access for all patients, especially when insurance coverage and cost become significant barriers.
Dr. Chua underscored the broader implications of this situation. “Our findings suggest that the elimination of the Medicaid rebate cap had unintended consequences for children with asthma,” he noted. He further pointed out that Flovent is not the only medication that has triggered the rebate cap, citing drugs used to treat diabetes and infections as other examples. This raises concerns about potential future disruptions in therapy for patients relying on other brand-name medications.
In light of these findings, Dr. Chua urged policymakers to proactively address potential therapy disruptions that may arise from the withdrawal of other brand-name drugs due to the elimination of the rebate cap. He suggested interventions such as ensuring that insurance plans adequately cover alternative medications to maintain continuity of care for patients. This proactive approach is crucial to safeguarding the health and well-being of vulnerable populations, particularly children with chronic conditions like asthma.
The study’s findings serve as a stark reminder of the complex interplay between pharmaceutical pricing, insurance coverage, and patient access to essential medications. While policies like the elimination of the Medicaid rebate cap aim to control drug costs, their unintended consequences can create significant challenges for patients and healthcare providers. Ensuring seamless transitions and affordable access to alternative treatments is paramount to mitigating the negative impacts of drug discontinuations on patient health outcomes. Further research and policy adjustments may be necessary to strike a balance between cost containment and ensuring equitable access to necessary medications for all individuals.
More information
KFF has more on the elimination of the Medicaid prescription drug rebate cap.
SOURCE: University of Michigan, news release, April 26, 2025