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A Multinational Economic Evaluation of rhDNase in the Treatment of Cystic Fibrosis

Published online by Cambridge University Press:  10 March 2009

Joseph Menzin ,
Gerry Oster ,
Linda Davies ,
Michael F. Drummond ,
Wolfgang Greiner ,
Carlo Lucioni ,
Jean-Louis Merot ,
Franco Rossi ,
J. Graf Schulenburg  and
Eric Souêtre
Joseph Menzin
Affiliation:
Policy Analysis Inc.
Gerry Oster
Affiliation:
Policy Analysis Inc.
Linda Davies
Affiliation:
University of York
Michael F. Drummond
Affiliation:
University of York
Wolfgang Greiner
Affiliation:
Universitat Hannover
Carlo Lucioni
Affiliation:
Istituto Economia Sanitaria
Jean-Louis Merot
Affiliation:
Benefit International
Franco Rossi
Affiliation:
Istituto Economia Sanitaria
J. Graf Schulenburg
Affiliation:
Universitat Hannover
Eric Souêtre
Affiliation:
Benefit International
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Abstract

Economic evaluations of Pharmaceuticals are increasingly being conducted in conjunction with randomized phase III clinical trials to meet the demand for pharmacoeconomic data when new products are launched. While the need for such data is often global, the trials in which relevant information may be collected are often conducted in only one or a limited number of countries. A critical issue is how data from pivotal clinical trials in one setting can serve as the basis for pharmacoeconomic evaluations in others. We address this issue and report on four economic evaluations that we undertook in conjunction with a recent U.S. phase III clinical trial of recombinant human deoxyribonuclease (rhDNase), which is used to improve pulmonary function in patients with cystic fibrosis (CF). The objective of these evaluations was to estimate the potential impact of rhDNase therapy in France, Germany, Italy, and the United Kingdom on the direct costs of medical care for the treatment of respiratory tract infections (RTIs) in patients with CF. Analyses of economic impact were undertaken

Type
General Essays
Information
International Journal of Technology Assessment in Health Care , Volume 12 , Issue 1 , Winter 1996 , pp. 52 - 61
Copyright
Copyright © Cambridge University Press 1996

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References

REFERENCES

1.Anders, G. Doubts are cast on cost studies by drug makers. Wall Street Journal, 06 28, 1994, section B, 1.Google Scholar
2.Commonwealth of Australia. Guidelines for the submission of data to the Pharmaceutical Benefits Advisory Committee (PBAC) including economic analysis. Canberra, 1992.Google Scholar
3.Cystic Fibrosis Foundation Patient Registry. Annual data report, 1991, Cystic Fibrosis Foundation, Bethesda, MD: 1992.Google Scholar
4.Drummond, M. F.Cost-effectiveness guidelines for reimbursement of Pharmaceuticals: Is economic evaluation ready for its enhanced status? Health Economics, 1992, 1, 85–92.Google Scholar
5.Drummond, M. F., Bloom, B. S., Carrin, G. et al. Issues in the cross-national assessment of health technology. International Journal of Technology Assessment in Health Care, 1992, 8, 671–82.Google Scholar
6.Drummond, M. F., & Davies, L.Economic analysis alongside clinical trials: Revisiting the methodological issues. International Journal of Technology Assessment in Health Care, 1991, 7, 561–73.CrossRefGoogle ScholarPubMed
7.Drummond, M. F., & Stoddart, G. L.Economic analysis and clinical trials. Controlled Clinical Trials, 1984, 5, 115–28.CrossRefGoogle ScholarPubMed
8.FitzSimmons, S. C.The changing epidemiology of cystic fibrosis. Journal of Pediatrics, 1993, 122, 1–9.Google Scholar
9.Fuchs, H. J., Borowitz, D. J., Christiansen, D. H. et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. New England Journal of Medicine, 1994, 331, 637–42.CrossRefGoogle ScholarPubMed
10.Organization for Economic Cooperation and Development. National accounts, vol. 1: Main aggregates, 1960–92. Paris: OECD. 1994, 155.Google Scholar
11.Ramsey, B. W., Astley, S. J., Aitkey, M. L. et al. Efficacy and safety of short-term administration of aerosolized recombinant human deoxyribonuclease in patients with cystic fibrosis. American Review of Respiratory Disease, 1993, 148, 145–51.Google Scholar
12.Ranasinha, C., Assoufi, B., Shak, S. et al. Efficacy and safety of short-term administration of aerosolized recombinant DNase I in adults with stable stage cystic fibrosis. Lancet 1993, 342, 199–202.Google Scholar
13.Reglementation, Monatsliste, abed Spezialitdten Nachtrag zum Katalog. Geneva. 1994, 15.6, 1.Google Scholar
14.Shak, S., Capon, D. J., Hellmiss, R. et al. Recombinant human DNase I reduces the viscosity of cystic fibrosis sputum. Proceedings of the National Academy of Science USA, 1990, 87, 9188–92.Google Scholar