gms | German Medical Science

49. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds)
19. Jahrestagung der Schweizerischen Gesellschaft für Medizinische Informatik (SGMI)
Jahrestagung 2004 des Arbeitskreises Medizinische Informatik (ÖAKMI)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie
Schweizerische Gesellschaft für Medizinische Informatik (SGMI)

26. bis 30.09.2004, Innsbruck/Tirol

Clinical Effectiveness and Cost-Effectiveness of the New Genotype-specific Guidelines for Chronic Hepatitis C Treatment

Meeting Abstract (gmds2004)

  • corresponding author presenting/speaker Uwe Siebert - Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, USA
  • Gaby Sroczynski - Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, USA
  • Pamela Aidelsburger - Alfried Krupp von Bohlen und Halbach-Chair for Medical Management, University of Duisburg-Essen, Duisburg-Essen, Deutschland
  • Siegbert Rossol - Department of Internal Medicine, University of Heidelberg, Hospital of Ruesselsheim, Ruesselsheim, Deutschland
  • Jürgen Wasem - Alfried Krupp von Bohlen und Halbach-Chair for Medical Management, University of Duisburg-Essen, Duisburg-Essen, Deutschland
  • Michael Manns - Department of Gastroenterology and Hepatology, Medical School of Hanover, Hannover, Deutschland
  • John McHutchison - Scripps Clinic, La Jolla, USA
  • John Wong - Division of Clinical Decision Making, Department of Medicine, Tufts University School of Medicine, Boston, USA
  • German Hepatitis C Model (GEHMO) Group - Deutschland

Kooperative Versorgung - Vernetzte Forschung - Ubiquitäre Information. 49. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie (gmds), 19. Jahrestagung der Schweizerischen Gesellschaft für Medizinische Informatik (SGMI) und Jahrestagung 2004 des Arbeitskreises Medizinische Informatik (ÖAKMI) der Österreichischen Computer Gesellschaft (OCG) und der Österreichischen Gesellschaft für Biomedizinische Technik (ÖGBMT). Innsbruck, 26.-30.09.2004. Düsseldorf, Köln: German Medical Science; 2004. Doc04gmds119

Die elektronische Version dieses Artikels ist vollständig und ist verfügbar unter: http://www.egms.de/de/meetings/gmds2004/04gmds119.shtml

Veröffentlicht: 14. September 2004

© 2004 Siebert et al.
Dieser Artikel ist ein Open Access-Artikel und steht unter den Creative Commons Lizenzbedingungen (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.de). Er darf vervielf&aauml;ltigt, verbreitet und &oauml;ffentlich zug&aauml;nglich gemacht werden, vorausgesetzt dass Autor und Quelle genannt werden.


Gliederung

Text

Introduction

Chronic hepatitis C is an emerging problem in public health. As the most common blood-borne infection, it imposes a significant personal and social burden on those infected, as well as substantial costs to society. Antiviral combination therapy for chronic hepatitis C (CHC) is effective and cost-effective. However, antiviral therapy is costly, imposes the risk of severe adverse events, and not all patients benefit from treatment.

The recently developed German guidelines for antiviral treatment (AVT) in patients with CHC recommend to base drug dosage, intended treatment duration and early stopping rules on the genotype of the hepatitis C virus (HCV). The objective of this study was to evaluate the lifetime clinical effectiveness and cost-effectiveness of different AVT strategies using the new German guidelines.

Methods

The German Hepatitis C Model (GEHMO) [1], [2], [3], a validated and previously published Markov model, was adapted to the new guidelines and used to project life expectancy, quality-adjusted life years (QALY), and lifetime costs for the following AVT strategies: (1) no AVT (NoAVT), (2) Interferon alfa-2b plus ribavirin for 48 weeks (IFN+R), (3) Peginterferon alfa-2b plus ribavirin for 48 weeks (PEG+R), (4) Peginterferon alfa-2b plus ribavirin according to the German guidelines with genotype-dependent AVT duration, dosing and early stoppage in HCV-positive patients after 12 weeks (GUIDE). Utilities were based on a German quality-of-life survey in patients with chronic hepatitis C. Clinical and drug utilization data were derived from a clinical trial [4] and from a survey of German hepatologists. Incremental cost-effectiveness ratios (ICER) were calculated from a societal perspective using a 3% annual discount rate.

Results

Compared to NoAVT, both PEG+R and GUIDE reduced the 20-year risk for decompensated cirrhosis, hepatocellular carcinoma, liver transplantation, and liver-related death by more than 50%. PEG+R increased life expectancy by 5.0 life years and GUIDE by 4.9 years. When compared to IFN+R, PEG+R resulted in higher clinical effectiveness at higher costs and had an incremental cost-utility ratio of €4,400/QALY gained, whereas GUIDE was less costly and more effective than IFN+R (i.e., GUIDE dominated IFN+R by strong dominance). Compared to NoAVT, discounted ICERs were €1500/QALY for GUIDE and 3300 €/QALY for PEG+R. GUIDE reduced costs by €3,950 per patient compared to IFN+R.

Discussion

This is the first cost-effectiveness analysis of that considers the recently developed German guidelines for antiviral treatment of CHC.

Our study has several limitations, our results assume that the efficacy of peginterferon plus ribavirin observed in a subgroup of individuals who received >10.6 mg/kg ribavirin daily would be achievable for the entire study population. Although this assumption requires confirmation from ongoing prospective clinical trials, increased viral response rates observed in logistic regression analysis [4] support the rationale behind weight-based ribavirin dosing in European labelling.

Our economic analysis likely underestimates disease-related costs for several reasons. First, we used variable costs (the cost to treat one additional patient with a disease) and did not consider fixed costs (such as buildings, maintenance, and administrative personnel) nor indirect or productivity costs. Second, we did not consider the cost of future liver biopsies and further therapy for non-responders. Third, we did not consider reduced incidence of hepatocellular carcinoma in non-responders, nor histologic normalisation in responders. Our analysis applied average age, gender distribution and histologies to avoid potential biases related to patient level variation in the different treatment groups of the trial and applied a consistent resource utilisation structure in the model and institutional assignment (where different institutions or countries may vary in their economic efficiencies and accounting practices) [5], [6].

In conclusion, administering combination therapy with peginterferon and ribavirin in accordance with the new German guidelines should be cost-effective compared to other medical interventions and should allow tailoring treatment efficiently to HCV genotype, body weight, and early viral response in patients without substantial loss of effectiveness.


References

1.
Siebert U, Sroczynski G. Antivirale Therapie bei Patienten mit chronischer Hepatitis C in Deutschland. Medizinische und ökonomische Evaluation der initialen Kombinationstherapie mit Interferon / Peginterferon und Ribavirin. Köln: Deutsche Agentur für Health Technology Assessment des Deutschen Instituts für Medizinische Dokumentation und Information, 2003.
2.
Siebert U, Sroczynski G, Rossol S, Wasem J, Ravens-Sieberer U, Kurth BM, et al. Cost effectiveness of peginterferon alpha-2b plus ribavirin versus interferon alpha-2b plus ribavirin for initial treatment of chronic hepatitis C. Gut. 2003;52(3):425-32.
3.
German Hepatitis C Model (GEHMO) Group. Klinische und Ökonomische Evaluation der antiviralen Therapie bei chronischer Hepatitis C. Public Health Forum. 2002;10(35):12-13
4.
Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358(9286):958-965.
5.
Drummond MF, Davies L. Economic analysis alongside clinical trials. Revisiting the methodological issues. Int J Technol Assess Health Care 1991;7(4):561-73.
6.
Ellwein LB, Drummond MF. Economic analysis alongside clinical trials. Bias in the assessment of economic outcomes. Int J Technol Assess Health Care 1996;12(4):691-97.