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Clinical Effectiveness and Cost Effectiveness of Tailoring Chronic Hepatitis C Treatment with Peginterferon Alpha-2b Plus Ribavirin to HCV Genotype and Early Viral Response

A Decision Analysis Based on German Guidelines

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Abstract

Background: Recently developed German guidelines for antiviral treatment in patients with chronic hepatitis C recommend basing drug dosage, intended treatment duration and early stopping rules on the genotype of the hepatitis C virus and early viral responses to treatment.

Objectives: To evaluate effectiveness and cost effectiveness of different antiviral treatment strategies including the German guidelines, for chronic hepatitis C.

Methods: A validated lifetime Markov model was used to project life expectancy, QALYs and lifetime costs for the following strategies: (i) no antiviral therapy (NoAVT); (ii) interferon-α-2b plus ribavirin for 48 weeks (IFN + R); (iii) peginterferon-α-2b plus weight-based ribavirin for 48 weeks (PEG + R); (iv) peginterferon-α-2b plus ribavirin according to German guidelines with genotype-dependent treatment duration, dosage and 12-week viral response evaluation (GUIDE). Clinical and resource utilization data were derived from a clinical trial, the published literature and a survey of German hepatologists. Incremental cost-effectiveness ratios (ICERs) were calculated adopting the German societal perspective. Costs (in €, year 2005 values) and health outcomes were discounted at 3% annually. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses.

Results: Compared with NoAVT, PEG+R increased undiscounted life expectancy by 5.0 life-years (5.2 QALYs) and GUIDE increased undiscounted life expectancy by 4.9 years (5.1 QALYs). Compared with PEG + R, GUIDE saved 13% of hepatitis C virus-related lifetime costs per patient. GUIDE dominated IFN + R. Compared with NoAVT, discounted ICERs were €1500 per QALY for GUIDE and €3200 per QALY for PEG + R.

Conclusion: Administering GUIDE should allow tailoring treatment efficiently to genotype, bodyweight and early viral response in patients with chronic hepatitis C, and appears cost effective compared with other well accepted medical interventions.

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Acknowledgements

Further members of the following research groups participated in this study:

Participating members of the German Hepatitis C Model (GEHMO) Group: F. Buchner (Munich Re); M. Bullinger (University of Hamburg, Berlin); Annette Conrads-Frank (Harvard Medical School, Boston, MA); W. Greiner (University of Hanover); F. Hessel (University of Duisburg-Essen); Bärbel M. Kurth (Robert Koch-Institute, Berlin); Georg Marckmann (University of Tübingen); J.M. Graf von der Schulenburg (University of Hanover); Ulrike Ravens-Sieberer (Robert Koch-Institute, Berlin), Silke Siebert (University of Munich, Germany).

Participating members of the International Hepatitis Interventional Therapy (IHIT) Group: F.H. Anderson (Vancouver General Hospital, Vancouver, BC, Canada); S. Arora (University of New Mexico, Albuquerque, NM, USA); B. Bacon (St. Louis University School of Medicine, St. Louis, MO, USA); L. Balart (Center for Digestive Diseases, New Orleans, LA, USA); K.G. Benner (Oregon Health Sciences University, Portland, OR, USA); M.-A. Bigard (Hopital de Brabois Adultes, Vandoeuvre Les Nancy, France); H.C. Bodenheimer (Mt. Sinai Medical Center, New York, NY, USA); M. Bourliere (Hopital Saint Joseph, Marseille, France); C. Brechot (Hôpital Necker, Paris, France); H. Brunner (KH Lainz der Stadt Wien, Vienna, Austria); S. Caldwell (University of Virginia, Charlottesville, VA, USA); W. Carey (Cleveland Clinic Foundation, Cleveland, OH, USA); R.L. Carithers Jr (University of Washington, Seattle, WA, USA); G.L. Davis (University of Florida, Gainesville, FL, USA); J. Dienstag (Massachusetts General Hospital, Boston, MA, USA); J. Donovan (University of Nebraska, Omaha, NE, USA); R. Esteban-Mur (Hospital Valle d’Hebron, Barcelona, Spain), M. Buti (Hospital Valle d’Hebron, Barcelona, Spain); G.T. Everson (University of Colorado, Denver, CO, USA); S. Feinman (Mount Sinai Hospital, Toronto, ON, Canada); S. Flamm (Northwestern Memorial Hospital, Chicago, IL, USA); P.R. Galle (Klinikum der Johannes-Gutenberg-Universität, Mainz, Germany); R. Gish (California Pacific Medical Center, San Francisco, CA, USA); N. Gitlin (Emory University, Atlanta, GA, USA); T. Goeser (Medizinische Einrichtungen der Universität Köln, Germany); S. Gordon (William Beaumont Hospital, Royal Oak, MI, USA); H. Greten (Universitäts-Krankenhaus Eppendorf, Hamburg, Germany); S. Hadzyiannis (Hippokration Hospital, Athens, Greece); I. Hokeberg (Akademiska Hospital, Uppsala, Sweden); I. Jacobson (Cornell University, New York, NY, USA); P. Kwo (Indiana University School of Medicine, Indianapolis, IN, USA); D.R. LaBrecque (University of Iowa Hospital and Clinic, Iowa City, IA, USA); W.M. Lee (University of Texas Southwestern Medical Center, Dallas, TX, USA); S. Lindgren (University Hopital MAS, Malmö, Sweden); K.L. Lindsay (University of Southern California, Los Angeles, CA, USA); M.P. Manns (Medizinische Hochschule Hannover, Hannover, Germany); P. Marcellin (Hôpital Beaujon, Clichy, France); P. Marotta (London Health Sciences Centre, University, London, ON, Canada); T. McGarrity (Pennsylvania State University, Hershey, PA, USA); J.G. McHutchison (Scripps Clinic, La Jolla, CA, USA); R. Moreno (Hospital de la Princesa, Madrid, Spain); T.R. Morgan (VA Medical Center, Long Beach, CA, USA); R. Perrillo (Ochsner Clinic, New Orleans, LA, USA); M. Poliquin (Centre Universitaire de l’Universite de Mtl, Montreal, QC, Canada); Thierry Poynard (Hôpital Pitié-Salpiêtrière, Paris, France); J. Rakela (University of Pittsburgh, Pittsburgh, PA, USA); R. Reindollar (Charlotte Clinic for GI and Liver Diseases, Charlotte, NC, USA); J.L. Rodriguez-Agullo (Hospital Clinico Universitario San Carlos, Madrid, Spain); R. Rouzier-Panis (Centre CAP, Nime, France); V. Rustgi (Metropolitan Research, Fairfax, VA, USA); J.M. Sanchez-Tapias (Hospital Clinic I Provincial, Barcelona, Spain); E.R. Schiff (University of Miami School of Medicine, Miami, FL, USA); D. Schuppan (Klinikum der Universität Erlangen-Nürnberg, Erlangen, Germany); M. Sherman (The Toronto Hospital, Toronto, ON, Canada); M.L. Shiffman (Medical College of Virginia, Richmond, VA, USA); M. Silva (Fundacion Favaloro, Buenos Aires, Argentina); C. Smith (Minnesota Clinical Research Center, St. Paul, MN, USA); H. Tanno (Clinica del Higado, Rosario, Argentina); C. Trepo (Hospital Hotel Dieu, Lyon, France); W. Vogel (Leopold-Franzens-University Innsbruck, Innsbruck, Austria); T. Wright (University of California San Francisco, San Francisco, CA, USA); S. Zeuzem (Klinikum der J.W. Goethe Universität, Frankfurt, Germany).

Panel of expert German hepatologists participating in the survey of German practice: C.H. Antoni (University Hospital, Mannheim); T.H. Berg (University Hospital Charite, Berlin); N. Demmel (Teaching Hospital of the University of Munich, Städtisches Krankenhaus München-Neuperlach); D. Hüppe (Herne); B. Kallinowski (University of Heidelberg); C. Kölbel (Teaching Hospital of the University of Mainz, Trier); S. Mauss (Düsseldorf); B. Moeller (Berlin); M.K. Müller (Marienhospital, Osnabrück); C. Niederau (Academic Teaching Hospital of the University of Essen, St. Josefs Hospital, Oberhausen); G. Teuber (University Hospital, Frankfurt); L. Theilmann (Städtisches Klinikum, Pforzheim); E. Will (Mannheim); R. Zachoval (Großhadern Medical Center, University of Munich); A. Zipf (Mannheim).

The authors also acknowledge the advice of members of the Advisory Board of the German Hepatitis C Model (GEHMO) Group: R. Holle (Institute of Health Economics and Health Care Management, GSF-National Research Centre for Environment and Health, Neuherberg, Germany); N. Mühlberger (University of Munich, Germany); B. Gibis (Institute of Health Economics, Edmonton, AL, Canada).

The authors received an unrestricted research grant from Schering Plough Corporation, Kenilworth, NJ, USA and funding for a national Health Technology Assessment commissioned by the Agency of Health Technology Assessment at the German Institute for Medical Documentation and Information (DAHTA@DIMDI) [No. 05/01.2.] This study was sponsored by an unrestricted research grant from Schering Plough Corporation, Kenilworth, NJ, USA. The authors had complete and independent control over study design, analysis and interpretation of data, report writing and publication, regardless of results.

U. Siebert and G. Sroczynski have received funding from different health technology assessment agencies to perform health technology assessments related to hepatitis C. (i.e., DAHTA@DIMDI — German Agency for Health Technology Assessment at the German Institute Medical Documentation and Information, German Federal Ministry of Health; CADTH — Canadian Agency for Drugs and Technologies in Health; ITA — Institute for Technology Assessment at the Austrian Academy of Sciences, LBIHTA, Ludwig Boltzmann Institute for Health Technology Assessment, Austria). They have both also received unrestricted research grants from Schering Plough and Roche to perform studies related to hepatitis. C.J. Wasem has received grants/honoraria from a number of pharmaceutical companies, including Schering Plough, Novartis and Valeant. He did not receive any specific funding for this paper. J. McHutchison has acted as a consultant and scientific advisor for Schering Plough, and has received grant support from Schering Plough. M. Manns has received grants from and acted as a consultant to a number of pharmaceutical companies including Schering Plough, Novartis, Roche and Valeant.

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Authors and Affiliations

  1. Department of Public Health, Medical Decision Making and Health Technology Assessment, UMIT-University of Health Sciences, Medical Informatics and Technology, Eduard Wallnoefer Center I, A-6060, Hall i.T., Austria

    Uwe Siebert (Professor of Public Health (UMIT), Professor of Health Policy and Management (Harvard School of Public Health) & Gaby Sroczynski

  2. Institute for Technology Assessment, Massachusetts General Hospital and Department of Radiology, Harvard Medical School, Boston, Massachusetts, USA

    Uwe Siebert (Professor of Public Health (UMIT), Professor of Health Policy and Management (Harvard School of Public Health) & Gaby Sroczynski

  3. Program in Health Decision Science, Department of Health Policy and Management, Harvard School of Public Health, Boston, Massachusetts, USA

    Uwe Siebert (Professor of Public Health (UMIT), Professor of Health Policy and Management (Harvard School of Public Health)

  4. Institute for Health Services Management, University of Duisburg-Essen, Essen, Germany

    Pamela Aidelsburger & Jürgen Wasem

  5. Medical Clinic I, Krankenhaus Nordwest, University of Frankfurt, Frankfurt am Main, Germany

    Siegbert Rossol

  6. Department of Gastroenterology and Hepatology, Medical School of Hanover, Hanover, Germany

    Michael P. Manns

  7. Scripps Clinic, La Jolla, California, USA

    John G. McHutchison

  8. Division of Clinical Decision Making, Department of Medicine, Tufts-New England Medical Center, Tufts University School of Medicine, Boston, Massachusetts, USA

    John B. Wong

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  1. Uwe Siebert
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Correspondence to Uwe Siebert.

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Siebert, U., Sroczynski, G., Aidelsburger, P. et al. Clinical Effectiveness and Cost Effectiveness of Tailoring Chronic Hepatitis C Treatment with Peginterferon Alpha-2b Plus Ribavirin to HCV Genotype and Early Viral Response. Pharmacoeconomics 27, 341–354 (2009). https://doi.org/10.2165/00019053-200927040-00006

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