Cost considerations for monoclonal antibody-targeted therapy in cancer: Focus on trastuzumab

American Journal of Cancer

Volumn 5, Issue 1, 2006, Pages 19-26

  Neyt, Mattias ^a  

^a GHENT UNIVERSITY   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ALEMTUZUMAB; ANTHRACYCLINE DERIVATIVE; CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; INFLIXIMAB; MONOCLONAL ANTIBODY; RITUXIMAB; TRASTUZUMAB;

BREAST CANCER; BUDGET; CANCER; CANCER ADJUVANT THERAPY; CANCER SURVIVAL; CARDIOTOXICITY; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; CROHN DISEASE; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG SAFETY; DRUG TARGETING; ECONOMIC EVALUATION; HEALTH CARE COST; HUMAN; MATHEMATICAL MODEL; METASTASIS; NONHODGKIN LYMPHOMA; PATIENT SELECTION; POPULATION RESEARCH; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW;

EID: 33644967341     PISSN: 11756357     EISSN: 11756357     Source Type: Journal    
DOI: 10.2165/00024669-200605010-00003     Document Type: Review

References (83)

1. Ess SM, Schneeweiss S, Szucs TD. European healthcare policies for controlling drug expenditure. Pharmacoeconomics 2003; 21 (2): 89-103
2. Dubois RW, Chawla AJ, Neslusan CA, et al. Explaining drug spending trends: does perception match reality? Health Aff 2000 Mar-Apr; 19 (2): 231-9
3. Garattini S, Bertele V. Efficacy, safety, and cost of new anticancer drugs. BMJ 2002 Aug 3; 325 (7358): 269-71
4. Lopez BJ, Mossialos E. Pharmaceutical expenditure in Spain: cost and control. Int J Health Serv 2000; 30 (3): 597-616
5. Kohler G, Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975 Aug 7; 256 (5517): 495-7
6. Walsh G. Pharmaceutical biotechnology products approved within the European Union. Eur J Pharm Biopharm 2003 Jan; 55 (1): 3-10
7. Borrebaeck CA. Antibodies in diagnostics: from immunoassays to protein chips. Immunol Today 2000 Aug; 21 (8): 379-82
8. Milstein C. With the benefit of hindsight. Immunol Today 2000 Aug; 21 (8): 359-64
9. Farah RA, Clinchy B, Herrera L, et al. The development of monoclonal antibodies for the therapy of cancer. Crit Rev Eukaryot Gene Expr 1998; 8 (3-4): 321-56
10. Zola H. Introduction. In: Zola H, editor. Monoclonal antibodies: the second generation. Herndon (VA): BIOS Scientific, 1995: 1-16
11. Ross JS. Targeted therapy for cancer. Am J Cancer 2004; 3 (4): 205-14
12. Disis ML, Cheever MA. HER-2/neu protein: a target for antigen-specific immunotherapy of human cancer. Adv Cancer Res 1997; 71: 343-71
13. Perez EA. Her-2 as a prognostic, predictive, and therapeutic target in breast cancer. Cancer Control 1999 May; 6 (3): 233-40
14. Ross JS, Fletcher JA. The HER-2/neu oncogene in breast cancer: prognostic factor, predictive factor, and target for therapy. Oncologist 1998; 3 (4): 237-52
15. Slamon DJ, Clark GM, Wong SG, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 1987 Jan 9; 235 (4785): 177-82
16. Berger MS, Locher GW, Saurer S, et al. Correlation of c-erbB-2 gene amplification and protein expression in human breast carcinoma with nodal status and nuclear grading. Cancer Res 1988 Mar 1; 48 (5): 1238-43
17. Slamon DJ, Godolphin W, Jones LA, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989 May 12; 244 (4905): 707-12
18. Andrulis IL, Bull SB, Blackstein ME, et al. Neu/erbB-2 amplification identifies a poor-prognosis group of women with node-negative breast cancer. J Clin Oncol 1998 Apr; 16 (4): 1340-9
19. Press MF, Bernstein L, Thomas PA, et al. HER-2/neu gene amplification characterized by fluorescence in situ hybridization: poor prognosis in node-negative breast carcinomas. J Clin Oncol 1997 Aug; 15 (8): 2894-904
20. Toikkanen S, Helin H, Isola J, et al. Prognostic significance of HER-2 oncoprotein expression in breast cancer: a 30-year follow-up. J Clin Oncol 1992 Jul; 10 (7): 1044-8
21. US Department of Health and Human Services. New monoclonal antibody approved for advanced breast cancer. Press release; 1998 Sep 28 [online]. Available from URL: http://www.fda.gov/bbs/topics/NEWS/NEW00655.html [Accessed 2006 Jan 17]
22. Baselga J, Tripathy D, Mendelsohn J, et al. Phase II study of weekly intravenous recombinant humanized anti-p185HER2 monoclonal antibody in patients with HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol 1996 Mar; 14 (3): 737-44
23. Baselga J, Tripathy D, Mendelsohn J, et al. Phase II study of weekly intravenous trastuzumab (Herceptin) in patients with HER2/neu-overexpressing metastatic breast cancer. Semin Oncol 1999 Aug; 26 (4 Suppl. 12): 78-83
24. Cobleigh MA, Vogel CL, Tripathy D, et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol 1999 Sep; 17 (9): 2639-48
25. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of HerceptinTM (trastuzumab, humanized anti-HER2 antibody) as a single agent in first-line treatment of HER2 overexpressing metastatic breast cancer. Breast Cancer Res Treat 1998; 50: 232
26. Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002 Feb 1; 20 (3): 719-26
27. Norton L, Slamon D, Leyland-Jones B, et al. Overall survival advantage to simultaneous chemotherapy plus the humanized anti-HER2 monoclonal antibody Herceptin in HER2-overexpressing metastatic breast cancer [abstract no. 483]. Proc Am Soc Clin Oncol 1999; 18: 127a
28. Pegram MD, Lipton A, Hayes DF, et al. Phase II study of receptor-enhanced chemosensitivity using recombinant humanized anti-p185HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol 1998 Aug; 16 (8): 2659-71
29. Pegram MD, Pienkowski T, Northfelt DW, et al. Results of two open-label, multicenter phase II studies of docetaxel, platinum salts, and trastuzumab in HER2-positive advanced breast cancer. J Natl Cancer Inst 2004 May 19; 96 (10): 759-69
30. Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001 Mar 15; 344 (11): 783-92
31. Osoba D, Slamon DJ, Burchmore M, et al. Effects on quality of life of combined trastuzumab and chemotherapy in women with metastatic breast cancer. J Clin Oncol 2002 Jul 15; 20 (14): 3106-13
32. Ewer MS, Gibbs HR, Swafford J, et al. Cardiotoxicity in patients receiving trastuzumab: primary toxicity, synergistic or sequential stress or surveillance artefact? Semin Oncol 1999 Aug; 26 (4 Suppl. 12): 96-101
33. Perez EA, Rodeheffer R. Clinical cardiac tolerability of trastuzumab. J Clin Oncol 2004 Jan 15; 22 (2): 322-9
34. Seidman A, Hudis C, Pierri MK, et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J Clin Oncol 2002 Mar 1; 20 (5): 1215-21
35. Hortobagyi GN, Perez EA. Integration of trastuzumab into adjuvant systemic therapy of breast cancer: ongoing and planned clinical trials. Semin Oncol 2001 Oct; 28 (5 Suppl. 16): 41-6
36. Sparano JA. Cardiac toxicity of trastuzumab (Herceptin): implications for the design of adjuvant trials. Semin Oncol 2001 Feb; 28 (1 Suppl. 3): 20-7
37. Piccart-Gebhart MJ. Herceptin: the future in adjuvant breast cancer therapy. Anticancer Drugs 2001 Dec; 12 Suppl. 4: S27-33
38. Tan-Chiu E, Piccart M. Moving forward: Herceptin in the adjuvant setting. Oncology 2002; 63 Suppl. 1: 57-63
39. Drummond MF. Economic evaluation of pharmaceuticals: science or marketing? Pharmacoeconomics 1992 Jan; 1 (1): 8-13
40. Johannesson M. Economic evaluation of drugs and its potential uses in policy making. Pharmacoeconomics 1995 Sep; 8 (3): 190-8
41. Annemans L, Genesté B, Jolain B. Early modelling for assessing health and economic outcomes of drug therapy. Value Health 2000; 3 (6): 427-34
42. Eddy DM. Technology assessment: the role of mathematical modelling. In: Committee for evaluating medical technologies in clinical use, Institute of Medicine: assessing medical technologies. Washington, DC: National Academy Press, 1985: 144-54
43. Russell LB. Modelling for cost-effectiveness analysis. Stat Med 1999 Dec 15; 18 (23): 3235-44
44. Hjelmgren J, Berggren F, Andersson F. Health economic guidelines: similarities, differences and some implications. Value Health 2001 May-Jun; 4 (3): 225-50
45. Norum J, Risberg T, Olsen JA. A monoclonal antibody against HER-2 (trastuzumab) for metastatic breast cancer: a model-based cost-effectiveness analysis. Ann Oncol 2005 Jun; 16 (6): 909-14
46. Neyt MJ, Albrecht JA, Clarysse B, et al. Cost-effectiveness of Herceptin®: a standard cost model for breast-cancer treatment in a Belgian university hospital. Int J Technol Assess Health Care 2005 Winter; 21 (1): 132-7
47. Chrischilles EA, Scholz DA. Dollars and sense: a practical guide to cost-analysis for hospital epidemiology and infection control. Clin Perform Qual Health Care 1999 Apr-Jun; 7 (2): 107-11
48. Baselga J, Carbonell X, Castañeda-Soto N-J, et al. Phase II study of efficacy, safety, and pharmacokinetics of trastuzumab monotherapy administered on a 3-weekly schedule. J Clin Oncol 2005 Apr 1; 23 (10): 2162-71
49. Cobleigh M, Frame D. Is trastuzumab every three weeks ready for prime time? J Clin Oncol 2003 Nov 1; 21 (21): 3900-1
50. Montemurro F, Faggiuolo R, Redana S, et al. Continuation of trastuzumab beyond disease progression. J Clin Oncol 2005 Apr 20; 23 (12): 2866-8
51. Fountzilas G, Razis E, Tsavdaridis D, et al. Continuation of trastuzumab beyond disease progression is feasible and safe in patients with metastatic breast cancer: a retrospective analysis of 80 cases by the Hellenic cooperative oncology group. Clin Breast Cancer 2003 Jun; 4 (2): 120-5
52. Tripathy D, Slamon DJ, Cobleigh M, et al. Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. J Clin Oncol 2004 Mar 15; 22 (6): 1063-70
53. Hortobagyi GN. In reply on: Montemurro F, Faggiuolo R, Redana S, et al. Continuation of trastuzumab beyond disease progression. J Clin Oncol 2005 Apr 20; 23 (12): 2866-8
54. Vogel CL, Tan-Chiu E. Trastuzumab plus chemotherapy: convincing survival benefit or not? J Clin Oncol 2005 Jul 1; 23 (19): 4247-50
55. HerA trial: F. Hoffmann-La Roche Ltd. HerA, Herceptin® adjuvant trial [online]. Available from URL: http://www.heratrial.com [Accessed 2006 Jan 17]
56. Harries M, Smith I. The development and clinical use of trastuzumab (Herceptin). Endocr Relat Cancer 2002 Jun; 9 (2): 75-85
57. Slamon D, Pegram M. Rationale for trastuzumab (Herceptin) in adjuvant breast cancer trials. Semin Oncol 2001 Feb; 28 (1 Suppl. 3): 13-9
58. Elkin EB, Weinstein MC, Winer EP, et al. HER-2 testing and trastuzumab therapy for metastatic breast cancer: a cost-effectiveness analysis. J Clin Oncol 2004 Mar 1; 22 (5): 854-63
59. Fornier M, Risio M, Van Poznak C, et al. HER2 testing and correlation with efficacy of trastuzumab therapy. Oncology 2002 Oct; 16 (10): 1340-8
60. Mass R, Press M, Anderson S, et al. Improved survival benefit from Herceptin® (trastuzumab) and chemotherapy in patients selected by fluorescence in situ hybridization (FISH). Proc Am Soc Clin Oncol 2001; 20: 22a
61. Tanner M, Gancberg D, Di Leo A, et al. Chromogenic in situ hybridization: a practical alternative for fluorescence in situ hybridization to detect HER-2/neu oncogene amplification in archival breast cancer samples. Am J Pathol 2000 Nov; 157 (5): 1467-72
62. Zhao J, Wu R, Au A, et al. Determination of Her2 gene amplification by chromogenic in situ hybridization (CISH) in archival breast carcinoma. Mod Pathol 2002 Jun; 15 (6): 657-65
63. Johannesson M, Weinstein MC. On the decision rules of cost-effectiveness analysis. J Health Econ 1993 Dec; 12 (4): 459-67
64. Karlsson G, Johannesson M. The decision rules of cost-effectiveness analysis. Pharmacoeconomics 1996 Feb; 9 (2): 113-20
65. 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 Feb 15; 146 (4): 473-81
66. Ubel PA, Hirth RA, Chernew ME, et al. What is the price of life and why doesn't it increase at the rate of inflation? Arch Intern Med 2003 Jul 28; 163 (14): 1637-41
67. Raftery J. NICE: faster access to modern treatments? Analysis of guidance on health technologies. BMJ 2001 Dec 1; 323 (7324): 1300-3
68. Orlewska E, Mierzejewski P. Proposal of Polish guidelines for conducting financial analysis and their comparison to existing guidance on budget impact in other countries. Value Health Jan-Feb 2004; 7 (1): 1-10
69. Mauskopf J, Earnshaw S, Mullins D. Budget impact analysis: review of the state of the art. Expert Rev Pharmacoeconomics Outcomes Res 2005 Jan; 5 (1): 65-79
70. Sendi PP, Briggs AH. Affordability and cost-effectiveness: decision-making on the cost-effectiveness plane. Health Econ 2001 Oct; 10 (7): 675-80
71. Sendi P, Al MJ, Gafni A, et al. Optimizing a portfolio of health care programs in the presence of uncertainty and constrained resources. Soc Sci Med 2003 Dec; 57 (11): 2207-15
72. Puig-Junoy J. Incentives and pharmaceutical reimbursement reforms in Spain. Health Policy 2004 Feb; 67 (2): 149-65
73. Danzon P, Towse A. The economics of gene therapy and of pharmacogenetics. Value Health 2002 Jan-Feb; 5 (1): 5-13
74. Mason J, Drummond M. Biotechnology: a special case for health technology assessment? Health Policy 1997; 41: 73-81
75. Private Stichting Kankerregister. Absolute numbers of tumours by site and age group (Belgium, year of incidence 1998, females) [online]. Available from URL: http://www.webweaver.be/nkr/www/NKRtabellen1998/Belgique%2019 98_vrouwenaantalinvasief.pdf [Accessed 2006 Jan 17]
76. Berkowitz N, Gupta S, Silberman G. Estimates of the lifetime direct costs of treatment for metastatic breast cancer. Value Health 2000; 3 (1): 23-30
77. Cox MC, Figg WD. No rational theory for drug pricing. J Clin Oncol 2004 Mar 1; 22 (5): 962-3
78. Cancer facts. Targeted cancer therapies: questions and answers [online]. Available from URL: http://cis.nci.nih.gov/fact/7_49.htm [Accessed 2005 Aug 22]
79. Gorman C. Rethinking breast cancer: new detection techniques and treatments are exciting and confusing: a guide to saving lives. Time 2002 Feb 18; 159 (7): 52
80. Hodge MJ, Battista RN. Erythropoietin: taking the pulse of innovation and product launch of a recombinant biological. In: OECD. The economic aspect of biotechnologies related to human health. Part 1: biotechnology and medical innovation: socio-economic assessment of the technology, the potential and the products. Paris: Organisation for Economic Co-operation and Development, 1997: 219-36
81. Noble I, Brown RE. Granulocyte colony-stimulating factor: a successful biotechnology. In: OECD. The economic aspect of biotechnologies related to human health. Part 1: biotechnology and medical innovation: socio-economic assessment of the technology, the potential and the products. Paris: Organisation for Economic Co-operation and Development, 1997: 237-56
82. Romeo AA, Wagner JL, Lee RH. Prospective reimbursement and the diffusion of new technologies in hospitals. J Health Econ 1984 Apr; 3 (1): 1-24
83. Sibbald B. Making a case for a $2700-a-month drug. CMAJ 1999 Nov 2; 161 (9): 1173