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Published ahead of print on February 5, 2003, doi:10.1164/rccm.200209-1035OC
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American Journal of Respiratory and Critical Care Medicine Vol 167. pp. 1387-1392, (2003)
© 2003 American Thoracic Society

Cost-Effectiveness Analysis of Augmentation Therapy for Severe {alpha}1-Antitrypsin Deficiency

Thomas R. Gildea, Kenneth M. Shermock, Mendel E. Singer and James K. Stoller

Department of Pulmonary and Critical Care Medicine and Pharmacy, the Cleveland Clinic Foundation; Center for Pharmaceutical Outcomes and Policy, The Johns Hopkins Hospital, Baltimore, Maryland; Department of Epidemiology and Biostatistics, Case Western Reserve University School of Medicine, Center for Quality Improvement Research, Cleveland Department of Veterans Affairs Medical Center, Institute for Public Health Sciences, MetroHealth Medical Center; Division of Medicine and Section of Respiratory Therapy, Department of Pulmonary and Critical Care Medicine, Cleveland, Ohio

Correspondence and requests for reprints should be addressed to James K. Stoller, M.D., M.S., Department of Pulmonary and Critical Care Medicine, A 90, The Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195. E-mail: stollej{at}ccf.org

A Markov-based decision model was created to assess the cost-effectiveness of augmentation therapy (Aug) for severe {alpha}1-antitrypsin deficiency, comparing strategies of: (1) no Aug, (2) Aug for life, and (3) Aug until FEV1 is below 35% predicted. A hypothetical cohort of 46-year-old patients with FEV1 49% predicted was followed over time using Monte Carlo simulation across five possible health states: (1) FEV1 50 to 79% predicted, (2) FEV1 35 to 49% predicted, (3) FEV1 below 35% predicted, (4) status—post-lung transplantation, and (5) dead. Treatment for life yielded 7.19 quality-adjusted life-years (QALYs) and cost $895,243. Treating until FEV1 is below 35% predicted cost $511,930 and produced 6.64 QALYs. "No Aug" cost $92,091 with 4.62 QALYs. The incremental cost-effectiveness ratio was $207,841/QALY for Aug until FEV1 is below 35% predicted and $312,511/QALY for the "Aug for life" strategy. In all sensitivity analyses, the incremental cost-effectiveness ratio for Aug for life exceeded $100,000. The cost of Aug needed to be reduced from $54,765 to $4,900 for the "Aug for life" strategy to be considered cost-effective. We conclude that, compared with other conventionally used health interventions, Aug is relatively less cost-effective. These results should encourage the development of more clinically and cost-effective therapies for {alpha}1-antitrypsin deficiency.

Key Words: cost-effectiveness • {alpha}1-antitrypsin deficiency • decision analysis




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