Retrospective Claims Study of Fluticasone Propionate/Salmeterol Fixed-Dose Combination Use as Initial Asthma Controller Therapy in Children Despite Guideline Recommendations

Background: According to current asthma treatment guidelines, single-entity inhaled corticosteroids (ICSs) should be used as initial controller therapy in children with mild to moderate persistent asthma. Long-acting beta(2)-agonists (LABAs) can be added to therapy for those patients whose asthma is not well controlled with a single-entity ICS. Objectives: The goal of this study was to examine whether the claims history for children in a US insured population indicate proper fluticasone propionate/ salmeterol (FPS) fixed-dose combination use in accordance with recommended asthma guidelines and a US Food and Drug Administration (FDA) advisory and black box warning regarding LABA use. A comparison of study-drug charges was also conducted. Methods: Data from a US commercial insurance database were used in this retrospective study to evaluate pharmacy and medical claims for children between October 2004 and September 2006 (ie, the index period). An index date corresponding to the date of the first FPS claim was assigned to each patient. Eligible patients were aged 4 to 11 years and had >= 1 pharmacy claim for FPS during the index period. Those patients receiving 1 FPS prescription dose strength on the index date who were continuously enrolled for benefits during the preindex period (ie, the 365 days before the index date) were included in the study. Disease severity was assigned based on asthma-related pharmacy (frequency and/or incidence of oral corticosteroid, LABA, montelukast, and >365 doses of a short-acting beta(2)-agonist) and medical (asthma-related urgent care clinic or emergency department visits or hospitalizations) claim histories during the preindex period. Results: A total of 13,306 patients between the ages of 4 and 11 years on the index date were included in the study; their mean (SD) age was 8.9 (1.9) years. The majority of the patients were male (60.7%). Of the total FPS claims, 55.2% were for patients with no evidence of pharmacy or medical claims in the 365 days before the first FPS claim that would warrant ICS/LABA combination therapy according to asthma treatment guidelines. There were no large changes in preindex ICS claims over the course of the study in response to an FDA-issued advisory and black box warning regarding the use of LABAs. Median drug charges for single-entity ICS use were $98 compared with $1.68 for FPS therapy. Conclusions: ICS/LABA combination treatment was used as initial therapy in 55.2% of children with mild to moderate asthma in this claims database population, contrary to the recommendations of current asthma treatment guidelines. The FDA advisory and black box warning for LABA use had little observed impact on the number of single-entity ICS claims. (Clin Ther. 2009;31:1056-1063) (C) 2009 Excerpta Medica Inc.