Speaker: Richard Stanford

This study examined the effectiveness of two widely prescribed fixed-dose combinations for asthma in the U.S.: Fluticasone Propionate/Salmeterol (FP/SAL) and Budesonide/Formoterol (BUD/FOR). Both are recommended in GINA (Global Initiative for Asthma) treatment Steps 3 to 5, but there are differences in their use. FP/SAL and BUD/FOR are among the most commonly prescribed asthma treatments in the U.S., with FP/SAL also available in generic forms. The choice between these options often depends on factors such as formulary access and patient population responses. Notably, BUD/FOR is not labeled for rescue use in the U.S., limiting its application primarily to maintenance therapy. The study aimed to compare the effectiveness of these products in managing asthma exacerbations and outcomes. Preliminary findings included an assessment of how these treatments are prescribed and used, providing insights into their comparative effectiveness in the U.S. market.

This study was a retrospective observational analysis utilizing claims-clinical integrated data from the US Optum database. Optum, a division of UnitedHealth Group, is a major health insurer in the United States, providing access to extensive healthcare data. This data encompasses physician office visits, emergency room visits, and hospital stays, typically covered by third-party payers, including Medicare. The health plan adjudicates claims generated from these healthcare services and links to patients' medical records. The study aimed to analyze real-world data from a large insurer, linking claims data to patient health records. The research focused on an index period where patients' exposure to inhaled corticosteroids/long-acting beta-agonists (ICS/LABA) was identified, specifically evaluating treatments such as FP/SAL or BUD/FOR. Historical data on disease severity was examined, although the study acknowledged limitations in the depth of disease severity information, relying mainly on coding and past treatment histories. The observation period was at the end of 2019 to avoid potential biases introduced by the COVID-19 pandemic, which reduced hospitalizations and emergency room visits for asthma. The study included a 12-month baseline period followed by a subsequent follow-up period. 

In the study, a protocol with inclusion-exclusion criteria akin to those in clinical trials, was employed to analyze claims data for dispensing. This dataset included records of pharmacy dispenses and physician office visits related to asthma. The study focused on patients with at least one prescription claim for FP/SAL or BUD/FOR between July 1, 2011, and December 31, 2018. Inclusion criteria included asthma treatment aligned with GINA Steps 3–4, age over 18 years, continuous medical and pharmacy enrollment coverage for over 12 months pre- and post-index, and a minimum of one asthma diagnosis code on a medical claim at baseline. Baseline demographics were largely similar across the study groups. The baseline demographics showed minimal differences between the groups analyzed. A key metric evaluated was the asthma medication ratio, which combines controller and albuterol use to assess risk, a measure commonly employed in the U.S. using claims datasets. A greater proportion of patients treated with BUD/ FOR had experienced an exacerbation, been treated with oral corticosteroids, or refilled short-acting beta-2-agonists (SABA) prescriptions ≥3 times before the index date compared with those treated with FP/SAL. The proportion of patients experiencing asthma exacerbations (at 12 months follow-up) was slightly lower in the FP/SAL group (22.36%) compared to the BUD/FOR group (23.44%) and somewhat higher use of oral corticosteroids and more frequent SABA refills than the FP/SAL group.

The study concluded that the pre-weighting results demonstrated a trend towards fewer exacerbations and reduced rescue medication use in patients with moderate-severe asthma on FP/SAL than BUD/ FOR. However, this difference was not statistically significant (p>0.05). 

The Q&A session discussed adherence data for two groups using asthma medications, focusing on the Asthma Medication Ratio (AMR) for FP/SAL and BUD/FOR. The adherence rates for both groups were found to be relatively similar. This finding is crucial, as using BUD/FOR often aligns with the MART (Maintenance and Reliever Therapy) strategy, which typically involves reduced inhalation dosages compared to other treatments. The analysis, however, did not account for the actual dosage used but rather the frequency of medication dispensing over time. 

European Respiratory Society Congress (ERS) 2024, 7–11 September, Vienna, Austria.