COST-EFFECTIVENESS ANALYSIS OF TRASTUZUMAB IN THE TREATMENT OF METASTATIC BREAST CANCER
Keywords:Metastatic breast cancer, Cost-effectiveness, Trastuzumab
Objective: To perform a cost-effectiveness analysis of pharmacological treatments for MBC in the context of the Brazilian Unified Health System (Sistema Único de Saúde - SUS) by comparing the drugs docetaxel and paclitaxel in isolation and in combination with trastuzumab.
Methods: The results for each treatment were simulated using a Markov model and a hypothetical cohort of 1000 women aged 50 years diagnosed with MBC with overexpression of HER2. The progression of MBC was simulated for 48 months and the transitions between health states occurred monthly. A sensitivity analysis was performed. The discount rate considered was 5% per year.
Results: The addition of trastuzumab allowed a gain of eight to ten months in the average lifespan after a four-year treatment. The increased threshold allows the increased use of trastuzumab combined with paclitaxel in the treatment of MBC. The combination of trastuzumabwith docetaxel and paclitaxel achieved an effective gain in the survival of patients with MBC, and the average survival time doubled compared with monotherapy.
Conclusion: Considering that the costs per quality-adjusted life year (QALY) of these treatment strategies were below the threshold of 3 times the per capita GDP recommended by WHO, both strategies can be considered cost-effective.
World Health Organization. Media center. Cancer. Available from: <http://www.who.int/mediacentre/factsheets/fs297/en/index.html#>. [Last accessed 29 July 2012].
Instituto Nacionalde Câncer José Alencar Gomesda Silva (Brasil). Estimate 2012: incidenceofcancer in Brazil. Rio de Janeiro: INCA; 2011.
Guerra MR, Gallo CVM, Mendonça GAS. Riskofcancer in Brazil: trends and most recent epidemiological studies. J Oncol 2005;51(3):227-34.
Instituto Nacionalde Câncer José Alencar Gomesda Silva (Brasil). Cancer staging. Rio de Janeiro 2012. Available from: <http://www1.inca.gov.br/conteudo_view.asp?ID=54>. [Last accessed 16 Jun 2014].
Rosso S. Up-to-date estimates of breast cancer survival for the years 2000–2004 in 11 European countries: The role of screening and a comparison with data from the United States. Eur J Cancer 2010;46:3351-7.
Stuart-Harris R. Proliferation markers and survival in early breast cancer: a systematic review and meta-analysis of 85 studies in 32, 825 patients. Breast J 2008;17:323-34.
Webb PM. Changes in survival after breast cancer: improvements in diagnosis or treatment? Breast J 2004;13:7-14.
Brasil. Ministryof Health, Secretariatof Science, Technology and Strategic Inputs. Recommendation report of the national commissionof technology incorporation in SUS–Conitec–08. Brasília: Ministry of Health; 2012 (b).
Conass. Technical Note 19/2013, Progestores. Available from: <http://www.co.nass.org.br/Notas%20t%C3%A9cnicas%202013/NT%2019%20-%202013%20-%20%20Trastuzumabe.pdf>.[Last accessed 10 Jan 2014].
Brasil. Ministryof Health, Secretariatof Science, Technology and Strategic Inputs. Ordinance no. 18 from July 25 of 2002 (a). Makes public the decision to incorporate the drug trastuzumab in the Unified Health System (Sistema Único de Saúde-SUS) for the treatment of locally advanced breast cancer. Brasilia: Ministry of Health; 2012.
Data. version, Tree Age Software, Inc Williamstown; 2009. p. 103.
Marty M, Cognetti F, Maraninchi D. Randomized phase II trial of the efﬁcacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer administered as first-line treatment: The M77001 Study Group. J Clin Oncol 2005; 23(19).
Matter-Wasltra KW, Dedes KJ, Schwenkglenks M, Brauchli P, Szucs TD, Pestalozzi BC. Trastuzumab beyond progression: a cost-utility analysis. Ann Oncol 2010;21(11):2161-8.
Brasil. Ministry of health. Secretariat of science, Technology and strategic inputs. Departmentof science and technology. Methodological guidelines: economic assessment studies on health technologies. Brasília: Ministry of Health; 2012.
Neto MC. Handbook of protocols and medications in oncology and hematology 2013. Miguel Cendoroglo Neto, Nelson Hamerschlak, Andreza Alice Feitosa Ribeiro, Rafael Aliosha Kaliks Guendelmann, Valéria Armentano dos Santos (editores). São Paulo: Hospital Albert Einstein; 2013. p. 516.
Instituto Nacional De Câncer José Alencar Gomes Da Silva (Brasil). Oncology: routines for treatment of breastcancer. Rio De Janeiro; 2001.
Hye-Suk Han, Jungsil Ro, Keun Seok Lee, Byung-Ho Nam, Jung Ae Seo, Dae Hee Lee, et al. Analysis of chemotherapy-induced amenorrhea rates by three different anthracycline and taxane containing regimens for early breast cancer. Breast Cancer Res Treat 2009;115(2):335-42.
Gasparini G, Gion M, Mariani L, Papaldo P. Randomized phase II trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy for patients with her-2 positive advanced breast cancer. Breast Cancer Res Treat 2007;101:355-65.
Seidman AD, Berry D, Cirrincione C, Harris L. Randomized phase iii trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer with trastuzumab for all HER-2 Overexpressors and random assignment to trastuzumab or not in HER-2 Nonoverexpressors: Final results of cancer and leukemia group B Protocol 9840. J Clin Oncol 2008;26(10):1642-9.
Seidman AD, Fornier MN, Esteva FJ. Weekly trastuzumab and paclitaxel therapy for metastatic breast cancer with analysis of efficacy by HER2 Immunophenotype and gene amplification. J Clin Oncol 2001;19(10):2587-95.
Esteva FJ, Valero V, Booser D, Guerra LT. Phase II study of weekly docetaxel and trastuzumab for patients with her-2-Overexpressing metastatic breast cancer. J Clin Oncol 2002;20(7):1800-8.
Compras net-Compras Net-Shopping portal of the federal government. Available from: <http://www.comprasnet.gov.br/>. [Last accessed 10 Oct 2014].
Banco Central Do Brasil. Available from: <http://www4.bcb.gov.br/pec/conversao/conversao.asp>[Last accessed 9 May 2014].
von Minckwitz G, du Bois A, Schmidt M. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a german breast group 26/Breast International Group 03-05 Study. J Clin Oncol 2009;27:1999–2006.
Garrison LP, Veenstra DL. The economic value of innovative treatments over the product life cycle: the case of targeted trastuzumab therapy for breast cancer. Value Health 2009;12(8):1118-23.
Mass RD, Press M, Anderson S. Improved survival benefit from Herceptin (trastuzumab) in patients selected by fluorescence in situ hybridization. Proc Am Soc Clin Oncol 2001;20:22a.
Elkin EB, Weinstein MC, Winer EP, Kuntz KM, Schnitt SJ, Week JC. HER-2 testing and trastuzumab therapy for metastatic breast cancer: A Cost-Effectiveness Analysis. J Clin Oncol 2004;22:854-63.
Slamon DJ, Leyland-Jones B, Shank S. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001;344:783-92.
Slamom DJ, Clark GM, Wong SG. Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Sci 1987;235:177-82.
Lloyd A, Nafees B, Narewska J. Health stateutilities for metastaticbreastcancer. Br J Cancer 2006;95:683-90.
Instituto Brasileiro De Geografia E Estatística-IBGE. Brasil. Information on the Brazilian GDP. Available from: http://brasilemsintese.ibge.gov.br/contas-nacionais/pib-valores-correntes.[Last accessed 3 Sep 2014].
AthanasakisK, Kyriopoulos J. A cost-effectiveness analysis of trastuzumab plus docetaxel vs. docetaxel alone for the treatment of HER2-positive metastatic breast cancer in the Greek healthcare setting. J Clin Oncol 2012;3(4):28-34.
Poncet B, Bachelot T, Colin C, Ganne C, Jaisson-Hot I, Orfeuvre H, et al. Use of the monoclonal antibody anti-HER2 trastuzumab in the treatment of metastatic breast cancer: a cost-effectiveness analysis. Am J Clin Oncol 2008;31(4):363-8. Erratum in: Lenoir, Véronique Trillet [corrigido para Trillet-Lenoir, Véronique]. Am J Clin Oncol 2009;32(1):98.
Kanagathara N, Kavitha K. Evaluation of HER 2/Neu over expression in breast cancer. Int J Pharm Pharm Sci 2014;6(2):898-900.
Puiggròs C. El Karnofsky index as predictor of mortalidad en patients con the home enteral nutrición. [The Karnofsky index as a predictor of mortality in patients with home enteral nutrition.] Nutr Hosp 2009;24:156-60.
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;16:909–14.
Instituto Nacional De Câncer José Alencar Gomes Da Silva (Brasil). National program for the control of Breast cancer. Rio de Janeiro; 2010.