Changes in Inhaled Steroid Dispensing to Children After Withdrawal of Brand-Name Fluticasone Propionate

To evaluate whether the withdrawal of brand-name fluticasone propionate (Flovent) was associated with discontinuation of inhaled steroid therapy in children who had previously used the brand-name drug.The prescription data included more than 3.2 million person-years of children aged 0 to 18 years with 1 or more dispensed steroid prescription in Q4 of 2021, 2022, and/or 2023. The treatment group included 1 980 963 person-years of prescription data, and the control group included 1 237 802 person-years of prescription data.This was a retrospective difference-in-differences analysis of the IQVIA Longitudinal Prescription Database, which captures 92% of US pharmacy prescriptions. The treatment group consisted of children whose only inhaled steroid prescription in the index quarter was brand-name fluticasone, and the control group consisted of children who received only other inhaled steroid prescriptions (including the authorized generic). The outcome was whether the child discontinued therapy in the following 9 months. Linear models assessed whether changes between 2021-2022 and 2023 differed between the treatment and control groups, and controlled for age, sex, payer type, state, year, and days supplied.Compared with the control group, children who had previously used only brand-name fluticasone experienced a 6.0-percentage-point greater increase in the probability of having no inhaled steroid dispensing. This increase was larger among children aged 0 to 5 years and those with Medicaid. Difference-in-difference analyses were positive across varying levels of prior medication use.The withdrawal of brand-name fluticasone propionate was associated with increased treatment discontinuation among children, particularly in young children and Medicaid patients, 2 groups with more risk for asthma complications. The findings suggest that elimination of the Medicaid rebate cap was potentially associated with unintended consequences. This raises concerns about drug pricing policy changes when alternatives become less accessible due to a lack of insurance coverage or high cost-sharing.This study highlights an important relationship between drug pricing policy and pediatric health outcomes and underscores the importance of ensuring access to equivalent medications, especially for Medicaid patients. The strengths of the study include the large national sample and the thorough statistical analysis. A potential weakness is the absence of health outcome data, such as asthma morbidity. These data could strengthen the interpretation of real-world impacts of rebate cap eliminations.