Cost-effectiveness of protease inhibitor based regimens for chronic hepatitis C: A systematic review of published literature

Expert Review of Pharmacoeconomics and Outcomes Research

Volumn 14, Issue 3, 2014, Pages 387-402

  San Miguel, Ramón ^a   Gimeno Ballester, Vicente ^b   Mar, Javier ^c  

^a Universidad Pública de Navarra   (Spain)

^b HOSPITAL UNIVERSITARIO MIGUEL SERVET   (Spain)

^c Hospital Alto Deba   (Spain)

Author keywords

boceprevir; chronic hepatitis C; cost effectiveness; disease related costs; pegylated interferon; protease inhibitors; ribavirin; telaprevir; treatment burden

Indexed keywords

BOCEPREVIR; INTERLEUKIN 28B; PEGINTERFERON; RIBAVIRIN; TELAPREVIR; N-(3-AMINO-1-(CYCLOBUTYLMETHYL)-2,3-DIOXOPROPYL)-3-(2-((((1,1-DIMETHYLETHYL)AMINO)CARBONYL)AMINO)-3,3-DIMETHYL-1-OXOBUTYL)-6,6-DIMETHYL-3-AZABICYCLO(3.1.0)HEXAN-2-CARBOXAMIDE; OLIGOPEPTIDE; PROLINE; PROTEINASE INHIBITOR;

CLINICAL EFFECTIVENESS; CLINICAL EVALUATION; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DISEASE ASSOCIATION; DRUG COST; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; HEALTH CARE UTILIZATION; HEPATITIS C; HUMAN; PROTEIN POLYMORPHISM; QUALITY ADJUSTED LIFE YEAR; REVIEW; SYSTEMATIC REVIEW; TREATMENT OUTCOME; TREATMENT PLANNING; UNSPECIFIED SIDE EFFECT; ANALOGS AND DERIVATIVES; DRUG LABELING; ECONOMICS; HEPATITIS C, CHRONIC;

COST-BENEFIT ANALYSIS; DRUG LABELING; HEPATITIS C, CHRONIC; HUMANS; OLIGOPEPTIDES; PROLINE; PROTEASE INHIBITORS; QUALITY-ADJUSTED LIFE YEARS;

EID: 84900824954     PISSN: 14737167     EISSN: 17448379     Source Type: Journal    
DOI: 10.1586/14737167.2014.906307     Document Type: Review

References (63)

1. Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis 2005;5(9): 558-67
2. Armstrong GL, Alter MJ, McQuillan GM, Margolis HS. The past incidence of hepatitis C virus infection: implications for the future burden of chronic liver disease in the United States. Hepatol 2000;31(3): 777-82
3. European Association of the Study of the Liver. 2011 European Association of the Study of the Liver hepatitis C virus clinical practice guidelines. Liver Int 2012; 32(Suppl 1):2-8
4. European Association of the Study of the Liver. EASL International Consensus Conference on Hepatitis C, Paris, 26-28 February 1999. Consensus statement. J Hepatol 1999;30(5):956-61
5. Wong JB, Bennett WG, Koff RS, Pauker SG. Pretreatment evaluation of chronic hepatitis C: risks, benefits, and costs. JAMA 1998;280(24): 2088-93
6. Su J, Brook RA, Kleinman NL, Corey-Lisle P. The impact of hepatitis C virus infection on work absence, productivity, and healthcare benefit costs. Hepatol 2010;52(2):436-42
7. Wong JB. Hepatitis C: cost of illness and considerations for the economic evaluation of antiviral therapies. Pharmacoeconomics 2006;24(7):661-72
8. Ge D, Fellay J, Thompson AJ, et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 2009;461(7262):399-401
9. Ahlenstiel G, Booth DR, George J. IL28B in hepatitis C virus infection: translating pharmacogenomics into clinical practice. J Gastroenterol 2010;45(9):903-10
10. European Medicines Agency. Victrelis: EPAR-Product Information. Available from: www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/medicines/ 002332/human-med-001464.jsp& mid=WC0b01ac058001d124&murl=menus/ medicines/medicines.jsp
11. European Medicines Agency. Incivo: EPAR-Product Information. Available from: www.ema.europa.eu/ema/index.jsp? curl=pages/medicines/human/medicines/ 002313/human-med-001487. jsp&mid=WC0b01ac058001d124
12. Tungol A, Rademacher K, Schafer JA. Formulary management of the protease inhibitors boceprevir and telaprevir for chronic hepatitis C virus. J Manag Care Pharm 2011;17(9):685-94
13. Italian Association for the Study of the Liver (AISF). Triple therapy with first-generation Protease Inhibitors for patients with genotype 1 chronic hepatitis C: recommendations of the Italian Association for the Study of the Liver (AISF). Dig Liver Dis 2013;46(1):18-24
14. Agencia Espanola de Medicamentos y Productos Sanitarios. Criterios y recomendaciones generales para el tratamiento con Boceprevir y Telaprevir de la hepatitis crónica C (VHC) en pacientes monoinfectados. Available from: www.msssi. gob.es/profesionales/farmacia/pdf/TRATAMIENTO-HEPATITIS-CRONICA-C.pdf
15. Aronsohn A, Jensen D. Distributive justice and the arrival of direct-acting antivirals: who should be first in line? Hepatol 2011; 53(6): 1789-91
16. Drummond MF, Jefferson TO. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party. BMJ 1996;313(7052) :275-83
17. Laupacis A, Feeny D, Detsky AS, et al. How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations. CMAJ 1992;146(4): 473-81
18. Donaldson C, Baker R, Mason H, et al. The social value of a QALY: raising the bar or barring the raise? BMC Health Serv Res 2011;11:8
19. Sacristan JA, Oliva J, del Llano J, et al. What is an efficient health technology in Spain? Gac Sanit 2002;16(4):334-43
20. National Institute for Clinical Excellence. Guide to the Methods of Technology Appraisal. NICE. 2004. Available from: www.nice.org.uk
21. Younossi ZM, Singer ME, Mir HM, et al. Impact of Interferon Free Regimens on Clinical and Cost Outcomes for Chronic Hepatitis C Genotype 1 Patients. J Hepatol 2013;60(3):530-7
22. Sroczynski G, Siebert U. Viral hepatitis: cost-effectiveness of direct-acting antivirals for chronic hepatitis C. Nat Rev Gastroenterol Hepatol 2013;10(10):572-4
23. McEwan P, et al. The impact of timing and prioritization on the cost-effectiveness of birth cohort testing and treatment for hepatitis C virus in the United States. Hepatol 2013;58(1):54-64
24. Blazquez-Perez A, San Miguel R, Mar J. Cost-effectiveness analysis of triple therapy with protease inhibitors in treatment-naive hepatitis C patients. Pharmacoeconomics 2013;31(10):919-31
25. Cammà C, Petta S, Enea M, et al. Cost-effectiveness of boceprevir or telaprevir for untreated patients with genotype 1 chronic hepatitis C. Hepatol 2012;56(3): 850-60
26. Chan K, Lai MN, Groessl EJ, et al. Cost effectiveness of direct-acting antiviral therapy for treatment-naive patients with chronic HCV genotype 1 infection in the veterans health administration. Clin Gastroenterol Hepatol 2013;11(11):1503-10
27. Cure S, Bianic F, Gavart S, et al. Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in previously untreated chronic hepatitis C genotype 1 patients. J Med Econ 2014;17(1):65-76
28. Ferrante SA, Chhatwal J, Brass CA, et al. Boceprevir for previously untreated patients with chronic hepatitis C Genotype 1 infection: a US-based cost-effectiveness modeling study. BMC Infect Dis 2013; 13(1):190
29. Liu S, Cipriano LE, Holodniy M, et al. New protease inhibitors for the treatment of chronic hepatitis C: a cost-effectiveness analysis. Ann Intern Med 2012;156(4): 279-90
30. Elbasha EH, Chhatwal J, Ferrante SA, et al. Cost-effectiveness analysis of boceprevir for the treatment of chronic hepatitis C virus genotype 1 infection in Portugal. Appl Health Econ Health Policy 2013;11(1): 65-78
31. Odhiambo R, Chhatwal J, Ferrante SA, et al. Economic evaluation of boceprevir for the treatment of patients with genotype 1 chronic hepatitis C virus infection in Hungary. JHEOR 2013;1(1):62-82
32. Cammà C, Petta S, Cabibbo G, et al. Cost-effectiveness of boceprevir or telaprevir for previously treated patients with genotype 1 chronic hepatitis C. J Hepatol 2013;59(4):658-66
33. Chhatwal J, Ferrante SA, Brass C, et al. Cost-effectiveness of boceprevir in patients previously treated for chronic hepatitis C genotype 1 infection in the United States. Value Health 2013;16(6):973-86
34. Cure S, Bianic F, Gavart S, et al. Cost-effectiveness of telaprevir in combination with pegylated interferon alpha and ribavirin in treatment-experienced chronic hepatitis C genotype 1 patients. J Med Econ 2014;17(1):77-87
35. Mendes D, White K, Cooper K, Bryant J. Boceprevir for the treatment of genotype 1 chronic hepatitis C. Southampton Health Technology Assessments Centre. 2011. Available from: www.hta.ac.uk/erg/reports/2609.pdf
36. Jones J, Hartwell D, Baxter L, Harris P. Telaprevir for the treatment of genotype 1 chronic hepatitis C. Southampton Health Technology Assessments Centre. 2011. Available from: www.hta.ac.uk/erg/reports/2782.pdf
37. Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011; 364(13): 1195-206
38. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364(25): 2405-16
39. Poordad F, Bronowicki JP, Gordon SC, et al. Factors That Predict Response of Patients With Hepatitis C Virus Infection to Boceprevir. Gastroenterol 2012;143(3): 608-18
40. Jacobson IM, Catlett I, Marcellin P, et al. Telaprevir substantially improved SVR rates across all IL28B genotypes in the ADVANCE trial. J Hepatol 2011;54: S542-3
41. Planas R, Ballesté B, Alvarez MA, et al. Natural history of decompensated hepatitis C virus-related cirrhosis. A study of 200 patients. J Hepatol 2004;40(5): 823-30
42. Salomon JA, Weinstein MC, Hammitt JK, et al. Empirically calibrated model of hepatitis C virus infection in the United States. Am J Epidemiol 2002;156(8):761-73
43. Victrelis prescribing information. Available from: www.merck.com/product/ usa/pi-circulars/v/victrelis/victrelis-pi.pdf
44. Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1207-17
45. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364(25): 2417-28
46. Siebert U, Sroczynski G, Rossol S, et al. Cost effectiveness of peginterferon-2b plus ribavirin versus interferon-2b plus ribavirin for initial treatment of chronic hepatitis C. Gut 2003;52(3):425-32
47. Ghany MG, Nelson DR, Strader DB, et al. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatol 2011;54(4):1433-44
48. Shepherd J, Jones J. A systematic review of the cost-effectiveness of peginterferon alfa-2b in the treatment of chronic hepatitis C. Expert Rev Pharmacoecon Outcomes Res 2007;7(6):577-95
49. Briggs AH, Weinstein MC, Fenwick EA, et al. ISPOR-SMDM Modeling Good Research Practices Task Force. Model Parameter Estimation and Uncertainty: a Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-6. Med Decis Making 2012;32(5):722-32
50. Gold M, Siegel JE, Russell LB, et al. Cost-effectiveness in health and medicine. Oxford University Press; NY, USA: 1996
51. Bennett W, Inoue Y, Beck J, et al. Estimates of the cost-effectiveness of a single course of interferon-2b in patients with histologically mild chronic hepatitis C. Ann Intern Med 1997;127(10):855-65
52. Cardoso AC, Moucari R, Figueiredo-Mendes C, et al. Impact of peginterferon and ribavirin therapy on hepatocellular carcinoma: incidence and survival in hepatitis C patients with advanced fibrosis. J Hepatol 2010;52(5): 652-7
53. Veldt BJ, Heathcote EJ, Wedemeyer H, et al. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Ann Intern Med 2007;147(10):677-84
54. Townsend R, McEwan P, Kim R, et al. Structural frameworks and key model parameters in cost-effectiveness analyses for current and future treatments of chronic hepatitis C. Value Health 2011;14(8): 1068-77
55. Hézode C, Fontaine H, Dorival C, et al. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC)-NCT01514890. J Hepatol 2013;59(3): 434-41
56. Agencia Española de Medicamentos y Productos Sanitarios. Tratamiento con boceprevir y telaprevir de la hepatitis crónica C (VHC) en pacientes monoinfectados, co-infectados por el VIH y trasplantados hepáticos: nuevas recomendaciones: 31 de julio de 2013. Available from: www.aemps. gob.es/informa/notasInformativas/medicamentosUsoHumano/2013/docs/NI- MUH-16-2013-boceprevir-telaprevir.pdf
57. Karnon J, Stahl J, Brennan A, et al. ISPOR-SMDM Modeling Good Research Practices Task Force. Modeling using discrete event simulation: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force - 4. Value Health 2012;15(6):821-7
58. Caro JJ, Briggs AH, Siebert U, et al. ISPOR-SMDM Modeling Good Research Practices Task Force. Modeling good research practices - overview: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force - 1. Value Health 2012;15(6):796-803
59. Au JS, Pockros PJ. Novel therapeutic approaches for hepatitis C. Clin Pharmacol Ther 2013;95(1):78-88
60. Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013;368(20):1867-77
61. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013; 368(20):1867-77
62. Fried MW, Buti M, Dore GJ, et al. Once-daily simeprevir (TMC435) with pegylated interferon and ribavirin in treatment-näive genotype 1 hepatitis C: the randomized PILLAR study. Hepatol 2013; 58(6):1918-29
63. You DM, Pockros PJ. Simeprevir for the treatment of chronic hepatitis C. Expert Opin Pharmacother 2013;14(18):2581-9