PHARMACOECONOMIC OUTCOMES OF LEVALBUTEROL AND RACEMIC ALBUTEROL IN HOSPITALIZED PATIENTS REQUIRING NEBULIZATION THERAPY (POLARIS)

Author(s)

Raymond Claus, MS, Associate Director of Biostatistics1, Les Noe, RPh, MPA, Vice President of Health Economics2, David Pasta, MS, Vice President, Statistics & Data Operations2, Kendyl Schaefer, MSc, Executive Director, Medical Affairs1, Williams Andrews, MD, Sr. Medical Director, Medical Affairs1, James Roach, MD, Senior Vice President, Medical Affairs11Sepracor Inc, Marlborough, MA, USA; 2 Ovation Research Group, San Francisco, CA, USA

OBJECTIVES: Studies in patients with asthma and COPD have demonstrated that levalbuterol (LEV) treatment resulted in significantly fewer nebulizations and/or decreased total cost of care compared with racemic albuterol (RAC). This was a prospective, multicenter, open-label study in patients hospitalized for acute bronchospasm that evaluated the cost-effectiveness of the two treatments. METHODS: Patients were randomized to either LEV 1.25 mg (N=241) Q8h or RAC 2.5 mg (N=238), administered per routine standing hospital order. The primary endpoint was the total number of nebulizations (scheduled plus rescue) during hospitalization. Secondary endpoints included length and cost of hospital stay. Cost-effectiveness (CE) analyses were conducted using patient costs from billing records, and three different effectiveness measures [all based on a 0 (worst) to 100 (best) scale]. The primary CE analysis used Subject General Well Being score (SGWB), which was a general health assessment question. Two other effectiveness measures were ß-mediated treatment effect (BMTE) and Disease Symptom Assessment (DSA) scores. RESULTS: LEV patients required fewer total nebulizations (median 10 vs 12; p=0.031), and the two groups were not statistically different with respect to the number of rescue nebulizations, length of hospital stay, and total hospital cost. For the primary CE analysis, LEV was as effective (70.0 vs 68.3) and cost $164 less per patient compared with RAC. For CE analyses using BMTE and DSA, LEV was again as effective (86.9 vs 79.0 and 59.2 vs 57.2, respectively) and cost $174 less per patient. Bootstrap re-sampling analyses found that approximately 65%-77% of the 10,000 simulations for LEV fell within the dominant quadrant on a CE plane. CONCLUSION: In this study, LEV patients required significantly fewer total nebulizations without an increased need for rescue nebulizations. CE analysis indicated that LEV was at least as effective as RAC with a $164 savings in costs.

Conference/Value in Health Info

2007-05, ISPOR 2007, Arlington, VA, USA

Value in Health, Vol. 10, No.3 (May/June 2007)

Code

PAA7

Topic

Economic Evaluation

Topic Subcategory

Cost-comparison, Effectiveness, Utility, Benefit Analysis

Disease

Respiratory-Related Disorders

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