PURPOSE:To determine incremental cost-efficacy of Fluticasone Propionate/Salmeterol 250/50mcg (FSC) relative to Salmeterol 50mcg (SAL) in terms of cost per exacerbation avoided.
METHODS:Cost-efficacy analysis using randomized clinical trial data. This was one of two replicate, similarly designed trials (SCO40043 and SCO100250). Total within trial costs were calculated for each treatment. Cost included study drugs, concomitant medications, antibiotics, oral corticosteroids, office visits, emergency department visits, and hospitalizations evaluated over a one year time horizon by assigning cost weights to utilization data obtained from the trial. All costs were inflated to 2007 dollars and standard published costs were used for both medication and medical interventions. Efficacy was the difference in any exacerbation or moderate/severe exacerbation rate between the two treatment groups, which was the primary endpoint of the trial. An incremental cost-efficacy ratio (ICER) of FSC versus SAL for exacerbations avoided was calculated by taking the difference in total cost divided by the differences in exacerbation rates. 95% confidence intervals around the ICER point estimate were calculated using a Bootstrapping technique.
RESULTS:There were 391 FSC patients and 385 SAL patients in the intent-to-treat sample used for the analysis. The rates of any exacerbations per year were 4.98 for FSC and 5.83 for SAL (p=0.002), while the rates per year of moderate/severe exacerbations were 1.32 for FSC and 1.99 for SAL (p<0.001). Total mean (SD) cost per year for FSC was $5,277.96 ($4,738.35) compared to $4,591.20 ($4,672.48) for SAL (p<0.001). Incremental cost per “any” exacerbation avoided (ICER) for FSC vs SAL ICER was $807.95 (95% CI: FSC dominate to $22,627.70) and incremental cost per moderate/severe exacerbation avoided for FSC vs SAL (ICER) was $1,025.01 (95% CI: FSC dominate to $16,719.50).
CONCLUSION:Using exacerbations avoided, the use of FSC is cost-effective compared to the use of SAL in patients with COPD. The cost-efficacy ratios (ICER) are considered to be well below most willingness to pay thresholds.
CLINICAL IMPLICATIONS:Advair reduces exacerbations and is cost-effective treatment in terms of cost per exacerbation avoided.
DISCLOSURE:Anand Dalal, Employee Anand Dalal is currently employed by GlaxoSmithKline (GSK); Consultant fee, speaker bureau, advisory committee, etc. Chris Blanchette was a consultant at LRRI who received funding from GSK to complete this analysis. Analysis was done independently and without any direction from GSK. Kathy Manavi, Hans Petersen and Megan St. Charles were also involved in analysis of the study.; No Product/Research Disclosure Information