Abstract
OM-85 BV, an immunostimulant made from bacterial extracts, has been shown to reduce the risk of hospitalization for acute exacerbation in patients with chronic obstructive pulmonary disease, as well as to reduce the length of stay for all hospitalizations. In conjunction with a placebo controlled, randomized clinical trial, a cost effectiveness analysis was carried out to assess the economic impact of using OM-85 BV. In the analysis, effectiveness was defined as the difference in the number of severe acute exacerbations, assessed by the number of hospitalizations for a respiratory problem, between the placebo and OM-85 BV-treated groups. The median cost to prevent one day of hospitalization for a respiratory condition was CDN$45, with a 95% CI of CDN$18 to CDN$210. Bootstrap of the study population and sensitivity analyses showed that the results were robust and not likely due to random fluctuation; 98.8% of the cost effectiveness and 96.8% of the cost-benefit ratios favoured the use of OM-85 BV. Indirect costs, defined as a need for help, were reduced by 36% in the group treated with OM-85 BV: 779 h of help compared with 1212 h in the placebo group. This trend, while not significant, is consistent with other results and suggests a decrease in the severity of exacerbations in the OM-85 BV-treated group. Given the high prevalence of chronic obstructive pulmonary disease worldwide and the high cost of acute exacerbations, immunostimulants may become a key element in the improved control of this condition.
Highlights
ORIGINAL ARTICLEJean-Paul Collet MD PhD1,2, Thierry Ducruet MSc1, Seema Haider MSc3, Stan Shapiro PhD1,2, Ann Robinson RN1, Paolo M Renzi MD4,5, André-Pierre Contandriopoulos PhD5,6, Pierre Ernst MD FRCPC2,3
The length of hospital stay for a respiratory problem was much shorter in the group treated with OM-85 BV than in the group treated with placebo (P=0.058)
The lower cost of hospitalization for a respiratory condition in the group treated with OM-85 BV (Table 4) is not likely to be related to a difference in the comorbidity between the two treatment groups because patients were similar at baseline (Table 1) and the number of comorbid conditions associated with hospitalizations was similar between the two groups [11]
Summary
Jean-Paul Collet MD PhD1,2, Thierry Ducruet MSc1, Seema Haider MSc3, Stan Shapiro PhD1,2, Ann Robinson RN1, Paolo M Renzi MD4,5, André-Pierre Contandriopoulos PhD5,6, Pierre Ernst MD FRCPC2,3. J-P Collet, T Ducruet, S Haider, et al Economic impact of using an immunostimulating agent to prevent severe acute exacerbations in patients with chronic obstructive pulmonary disease. In a recent double-blind, placebo controlled, randomized clinical trial [11], patients treated with an immunostimulating agent (OM-85 BV) were found to have a lower risk of hospitalization for a respiratory cause and a shorter hospital stay. This resulted in a substantial reduction in the total number of days of hospitalization in the treated group compared with that in the placebo group – 287 days versus 642 days, respectively. To the best of our knowledge, this is a rare description of the burden related to acute exacerbations in patients with COPD and the first economic trial addressing the impact of an immunostimulating agent on the prevention of their occurrence
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