Hostname: page-component-586b7cd67f-l7hp2 Total loading time: 0 Render date: 2024-11-26T05:10:48.405Z Has data issue: false hasContentIssue false
  • English
  • Français

Evaluation of the cost-effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in the United Kingdom

Published online by Cambridge University Press:  27 February 2006

Colin Green ,
Jacqueline Dinnes ,
Andrea L. Takeda  and
Brian H. Cuthbertson
Colin Green
Affiliation:
University of Southampton
Jacqueline Dinnes
Affiliation:
University of Southampton
Andrea L. Takeda
Affiliation:
University of Southampton
Brian H. Cuthbertson
Affiliation:
University of Aberdeen
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: The aim of this study was to assess the cost-effectiveness of drotrecogin alfa (activated) compared with best supportive care in a UK cohort of adult intensive-care patients with severe sepsis.

Methods: A systematic review of evidence on the clinical- and cost-effectiveness of drotrecogin alfa (activated) was undertaken, and a decision-analytic model was developed to estimate the cost-effectiveness of treatment in the United Kingdom. Trial data from the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study have been synthesized with other data, including UK data on severe sepsis, to estimate the costs and consequences of treatment over time.

Results: For patients with severe sepsis and multiple organ dysfunction, the estimates of cost per life year and cost per quality-adjusted life year (QALY) are £4,931 and £8,228, respectively. For patients with severe sepsis alone, the cost per life-year and cost per QALY are £5,495 and £9,161, respectively.

Conclusions: Whereas the therapeutic cost for drotrecogin alfa (activated) appears high (at around £5,000 per patient) and the potential impact on the provider budget is considerable, drotrecogin alfa (activated) is clinically effective, represents a cost-effective use of resources, and is a significant advance in the treatment of severe sepsis in patients requiring intensive care.

Keywords

SepsisSevere sepsisDrotrecogin alfa (activated)Activated protein CCost-effectiveness
Type
GENERAL ESSAYS
Information
International Journal of Technology Assessment in Health Care , Volume 22 , Issue 1 , January 2006 , pp. 90 - 100
Copyright
© 2006 Cambridge University Press

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Angus DC, Carlet J. 2003 Surviving intensive care: A report from the 2002 Brussels Roundtable. Int Care Med. 29: 368– 377.Google Scholar
Angus DC, Laterre PF, Helterbrand J, et al. 2002 The effects of drotrecogin alfa (activated) on long-term survival after severe sepsis. Chest. 122 (Suppl): 51S.Google Scholar
Angus DC, Linde-Zwirble WT, Clermont G, et al. 2003 Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis. Crit Care Med. 31: 1– 11.Google Scholar
Angus DC, Linde-Zwirble WT, Lidicker J, et al. 2001 Epidemiology of severe sepsis in the United States: Analysis of incidence, outcome, and associated costs of care. Crit Care Med. 29: 1303– 1310.Google Scholar
Angus DC, Musthafa AA, Clermont G, et al. 2001 Quality-adjusted survival in the first year after the acute respiratory distress syndrome. Am J Respir Crit Care Med. 163: 1389– 1394.Google Scholar
Anti-Infective Advisory Committee. FDA Clinical Review: Drotrecogin alfa (activated) [recombinant human activated protein C (rhAPC)] Xigris, BLA# 125029/0. 12-9-2002. Rockville, MD, Food and Drug Administration.
Bernard GR, Vincent JL, Laterre PF, et al. 2001 Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 344: 699– 709.Google Scholar
Bernard GR, Margolis B, Shanies HM, et al. 2002 Efficacy and safety of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis: Report from a single open-label trial in the United States. Chest. 122 (Suppl): 50S.Google Scholar
Bernard GR, Macias WL, Joyce DE, et al. 2003 Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis. Crit Care. 7: 155– 163.Google Scholar
Briggs AH. 2000 Handling uncertainty in cost-effectiveness models. Pharmacoeconomics. 17: 479– 500.Google Scholar
Brun-Buisson C, Doyon F, Carlet J, et al. 1995 Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 274: 968.Google Scholar
Coughlin MT, Angus DC. 2003 Economic evaluation of new therapies in critical illness. Crit Care Med. 31: S7– S16.Google Scholar
Davies A, Hutton J, Ridley S, Chinn C, Barber B. 2002 Cost-effectiveness of drotrecogin alfa (activated) in treating severe sepsis in the UK [abstract]. Intensive Care Med. 28: 623.Google Scholar
Department of Health (UK). NHS Reference Costs 2002. Available at: http://www.doh.gov.uk/nhsexec/refcosts.htm. Accessed 2003.
Department of Health statistics (UK). Total NHS expenditure on hospital and community health services (HCHS) for 2002/3. Available at: www.doh.gov.uk/HPSS/TBL_E1.htm. Accessed 2003.
Department of Health (UK). Hospital Episode Statistics 2001–2002. Available at: www.doh.gov.uk/hes. Accessed 2003.
Dhainaut JF, Laterre PF, Janes JM, et al. 2003 Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: Data from the PROWESS trial. Intensive Care Med. 29: 894– 903.Google Scholar
Drabinski A, Williams G, Formica C. 2001 Observational evaluation of health state utilities. Abstract. Value Health. 4: 128.Google Scholar
Ely EW, Laterre PF, Angus DC, et al. 2003 Drotrecogin alfa (activated) administration across clinically important subgroups of patients with severe sepsis. Crit Care Med. 31: 12– 19.Google Scholar
Food and Drug Administration. Product approval information—Licensing action: Drotrecogin alfa (activated) Xigris. BLA# 125029/0. 21-11-2001. Washington, DC: FDA.
Fowler R, Hill-Popper M, Stasinos J, et al. 2003 Cost-effectiveness of recombinant human activated protein C and the influence of severity of illness in the treatment of patients with severe sepsis. J Crit Care. 18: 181– 191.Google Scholar
Frampton JE, Foster RH. 2004 Drotrecogin alfa (activated). A pharmacoeconomic review of its use in severe sepsis. Pharmacoeconomics. 22: 445– 476.Google Scholar
Gold MR, Siegel JE, Russell LB, Weinstein MC. 1996. Cost-effectiveness in health and medicine. New York: Oxford University Press;
Government Actuary's Department. Life tables for England and Wales, interim life tables 1999–2001 Available at: http://www.gad.gov.uk/Life_Tables. Accessed July 2003.
Green C, Brazier J, Deverill M. 2000 Valuing health-related quality of life. A review of health state valuation techniques. Pharmacoeconomics. 17: 151– 165.Google Scholar
Green C, Dinnes J, Takeda A, et al. 2005 Clinical and cost-effectiveness of drotrecogin alfa (activated) (Xigris) for the treatment of severe sepsis in adults: A systematic review and economic evaluation. Health Technol Assess. 9 (11): 1– 126.Google Scholar
Laterre PF, Levy H, Ball D, Helterbrand J, Angus D. 2002 The effects of drotrecogin alfa (activated) on hospital mortality, length of stay and discharge location. Chest. 122 (Suppl): 51S.Google Scholar
Launois R, Riou-Franca L, Guidet B, et al. 2002 Cost effectiveness analysis of drotrecogin alfa (activated) as a treatment for severe sepsis. Abstract. Intensive Care Med. 28: 624.Google Scholar
Lucion C, Guidi L, Mazzi S, Chinn C. 2002 The treatment of sepsis patients with drotrecogin alfa (activated): An economic evaluation with reference to Italy. Abstract. Value Health. 5: 562.Google Scholar
Manns BJ, Lee H, Doig CJ, Johnson D, Donaldson C. 2002 An economic evaluation of activated protein C treatment for severe sepsis. N Engl J Med. 347: 993– 1000.Google Scholar
National Institute for Clinical Excellence (NICE). Drotrecogin alfa (activated) for severe sepsis—appraisal (project). Available at: www.NICE.org. Accessed 2003.
2004. National Institute for Clinical Excellence. Drotrecogin alfa (activated) for severe sepsis. Technology Appraisal 84. Available at: www.NICE.org.
Neilson AR, Burchardi H, Chinn C, et al. 2003 Cost-effectiveness of drotrecogin alfa (activated) for the treatment of severe sepsis in Germany. J Crit Care. 18: 217– 227.Google Scholar
Padkin A, Goldfrad C, Brady AR, et al. 2003 Epidemiology of severe sepsis occurring in the first 24 hours in ICU in England, Wales and Northern Ireland. Crit Care Med. 31: 2332– 2338.Google Scholar
Padkin A, Rowan K, Black N. 2001 Using high quality clinical databases to complement the results of randomised controlled trials: The case of recombinant human activated protein C. BMJ. 323: 923– 926.Google Scholar
Quartin AA, Schein RM, Kett DH, Peduzzi PN. 1997 Magnitude and duration of the effect of sepsis on survival. Department of Veterans Affairs Systemic Sepsis Cooperative Studies Group. JAMA. 277: 1058– 1063.Google Scholar
Ridley S. 2002. Outcomes in critical care. Boston: Butterworth Heinemann;
Sacristan JA, Prieto L, Huete T, et al. 2004 Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis in Spain. Gac Sanit. 18: 50– 57.Google Scholar
2003. UK Government. Population statistics for England and Wales, by age (ONS, Census 2001 data). Available at: www.statistics.gov.uk/census2001. Accessed July 29
Wright JC, Plenderleith L, Ridley SA. 2003 Long-term survival following intensive care: Subgroup analysis and comparison with the general population. Anaesthesia. 58: 637– 642.Google Scholar