Document Detail

Resource use, costs, and utility estimates for patients with cystic fibrosis with mild impairment in lung function: analysis of data collected alongside a 48-week multicenter clinical trial.
MedLine Citation:
PMID:  22433759     Owner:  NLM     Status:  In-Data-Review    
OBJECTIVES: Transport of ions to generate epithelial rehydration (TIGER)-1 was a randomized trial conducted to evaluate the safety and efficacy of denufosol versus placebo in patients with cystic fibrosis with mild impairment in lung function. The trial met its primary end point at 24 weeks, but a subsequent trial did not show a sustained effect of denufosol at 48 weeks. By using the 48-week data, we characterized resource use, direct medical costs, indirect costs, and utility estimates.
METHODS: Data on medications, outpatient and emergency visits, hospital admissions, tests, procedures, and home nursing were captured on study case report forms. Sources for unit costs included the Medicare Physician Fee Schedule, the Nationwide Inpatient Sample, and the Red Book. Health utilities were derived from the Health Utilities Index Mark 2/3. We used multivariable regression to evaluate the impact of baseline covariates on costs.
RESULTS: Characteristics of the 352 participants at enrollment included mean age of 14.6 years, history of Pseudomonas aeruginosa colonization in 45.2%, use of dornase alfa in 77.0%, and long-term use of inhaled antibiotics in 37.2%. Over 48 weeks, 22.4% of participants were hospitalized and, on average, participants missed 7.4 days of school or work. Mean total costs (excluding denufosol) were $39,673 (SD $26,842), of which 85% were attributable to medications. Female sex and P. aeruginosa colonization were independently associated with higher costs.
CONCLUSIONS: Prospective economic data collection alongside a clinical trial allows for robust estimates of cost of illness. The mean annual cost of care for patients with cystic fibrosis with mild impairment in lung function exceeds $43,000 and is driven by medication costs.
Esi Morgan Dewitt; Chelsea A Grussemeyer; Joëlle Y Friedman; Michaela A Dinan; Li Lin; Kevin A Schulman; Shelby D Reed
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Publication Detail:
Type:  Journal Article     Date:  2012-01-27
Journal Detail:
Title:  Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research     Volume:  15     ISSN:  1524-4733     ISO Abbreviation:  Value Health     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-03-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100883818     Medline TA:  Value Health     Country:  United States    
Other Details:
Languages:  eng     Pagination:  277-83     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.
Division of Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA; James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
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