COST-EFFECTIVENESS ANALYSIS OF TRASTUZUMAB EMTANSINE IN THE TREATMENT OF METASTATIC BREAST CANCER
DOI:
https://doi.org/10.22159/ijpps.2017v9i6.18741Keywords:
Metastatic breast cancer, Cost-effectiveness, Trastuzumab emtansineAbstract
Objective: To investigate the cost-effectiveness of second-line pharmacological treatments for metastatic breast cancer (MBC) by comparing trastuzumab emtansine (T-DM1) versus a combination of lapatinib and capecitabine (LAP+CAP) from the perspective of the Brazilian health system, the Unified Health System (Sistema Único de Saúde–SUS).
Methods: The results of each treatment were simulated based on a three-state Markov decision model applied to a hypothetical cohort of 1,000 women, aged 50 y old or older, with MBC and HER2 (human epidermal growth factor receptor 2) overexpression. The data on the effectiveness of treatments were taken from reports in the literature. The period considered for simulation was three years subdivided into monthly cycles of transition between health states. A discount rate of 5% per year was applied to costs and outcomes. Possible uncertainty was assessed by means of a sensitivity analysis.
Results: Chemotherapy for women with refractory MBC using T-DM1 monotherapy was ruled out by extended dominance. Treatment with LAP+CAP proved to be the most efficient strategy because the cost in relation to the overall survival (BRL 72,035.43/quality-adjusted life year–QALY) was the lowest and fell within the acceptability threshold, BRL 86,628.00.
Conclusion: T-DM1 demonstrated pharmacological superiority over other agents used for the treatment of MBC in clinical studies. However, the price set for T-DM1 in Brazil is the determinant variable that contraindicates its inclusion in the SUS, in agreement with other international assessments.
Downloads
References
World Health Organization. Media centre. Cancer: Fact sheet N °297. Available from: http://www.who.int/mediacentre/ factsheets/fs297/en/index.html#>. [Last accessed on 29 Jul 2015].
Instituto Nacional de Câncer José Alencar Gomes da Silva (Brasil). Estimativa 2012: incidência de câncer no Brasil. Rio de Janeiro: INCA; 2011.
Guerra MR, Gallo CVM, Mendonça GAS. Risco de câncer no Brasil: tendências e estudos epidemiológicos mais recentes. Rev Bras Cancerol 2005;51:227-34.
Instituto Nacional de Câncer José Alencar Gomes da Silva (Brasil). Estimativa 2016:incidência de câncer no Brasil. Rio de Janeiro: INCA; 2016.
Rosso S, Gondos A, Zanetti R, Bray F, Zakelj M, Zagar T, et al. 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, Caldas C, Pinder SE, Pharoah P. Proliferation markers and survival in early breast cancer: a systematic review and meta-analysis of 85 studies in 32,825 patients. Breast 2008;17:323-34.
Webb PM, Cummings MC, Bain CJ, Furnival CM. Changes in survival after breast cancer: improvements in diagnosis or treatment. Breast 2004;13:7-14.
Dawood S, Broglio KK, Buzdar AU, Hortobagyi GN, Giordano SH. Prognosis of women with metastatic breast cancer by HER2 status and trastuzumb treatment: an institutional-based review. J Clin Oncol 2010;28:92-8.
Solomayer EF, Diel IJ, Meyberg GC, Gollan Ch, Bastert G. Metastatic breast cancer: clinical course, prognosis and therapy related to the first site of metastasis. Breast Cancer Res Treat 2000;59:271-8.
Uncu D, Bayoglu IV, Arslan UY, Kucukoner M, Artac M, Koca D, et al. Trastuzumab-based retreatment after lapatinib in heavily pretreated HER2 positive metastatic breast cancer: an anatolian society of medical oncology study. Asian Pac J Cancer Prev 2015;16:4127-31.
Cameron D, Casey M, Press M, Lindquist D, Pienkowski T, Romieu CG, et al. A phase III randomised comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast câncer that progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat 2008;112:533-43.
Brasil. Ministério da Saúde. Secretaria de Atenção à Saúde. Portaria n ° 1008, de 30 de setembro de 2015. Aprova as Diretrizes Diagnósticas e Terapêuticas do Carcinoma de Mama. BrasÃlia: Ministério da Saúde; 2015.
Giordano SH, Temin S, Kirshner JJ, Chandarlapaty S, Crews JR, Davidson NE, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2–positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol 2014;32:1–23.
Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367:1783-91.
Garrison LP, Lubeck D, Lalla D, Paton V, Dueck A, Perez EA. Costâ€effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2â€positive breast cancer. Cancer 2007;110:489-98.
Hoyle MW, Henley W. Improved curve fits to summary survival data: application to economic evaluation of health technologies. BMC Med Res Methodol 2011;11:139.
Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia e Insumos Estratégicos. Departamento de Ciência e Tecnologia. Diretrizes Metodológicas, Diretriz de Avaliação Econômica. BrasÃlia: Ministério da Saúde; 2014.
von Minckwitz G, Du Bois A, Schmidt M, Maass N, Cufer T, de Jongh FE, et al. 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.
Callahan R. Ado-Trastuzumabe emtansine in metastatic HER-2 positive breast cancer. J Adv Pract Oncol 2014;5:134-9.
Krop IE, Kim SB, González-MartÃn A, LoRusso PM, Ferrero JM, Smitt M, et al. Trastuzumab emtansine versus treatment of physician’s choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol 2014;15:689–99.
Neto MC. Guia de protocolos e medicamentos para tratamento em oncologia e hematologia 2013. Neto MC, Hamerschlak N, Ribeiro AAF, Guendelmann RAK, Santos VA. editores. São Paulo: Hospital Albert Einstein; 2013. p. 516.
Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006;355:2733-43.
Gasparini G, Gion M, Mariani L, Papaldo P, Crivellari D, Filippelli G, et al. Randomized phase II trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with her-2 positive advanced breast cancer. Breast Cancer Res Treat 2007;101:355-65.
Lloyd A, Nafees B, Narewska J, Dewild S, Watkins J. Health state utilities for metastatic breast cancer. Br J Cancer 2006; 95:683-90.
Sigtap-Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos e-OPM do SUS. Available from: http://sigtap.datasus.gov.br/ [Last accessed on 14 Apr 2016]
Comprasnet–Portal de compras do governo federal. Available from: http://www.comprasnet.gov.br/. [Last accessed on 14 Apr 2016]
Instituto Brasileiro de Geografia e EstatÃstica–IBGE. Brasil. Contas nacionais: PIB–per capita. Available from: http://brasilemsintese.ibge.gov.br/contas-nacionais/pib-per-capita. [Last accessed on 17 Apr 2016]
Agência Nacional de Vigilância Sanitária: Câmara de Regulação do Mercado de Medicamentos (CMED). Lista de preços. Available from: http://portal.anvisa.gov.br/listas-de-precos [Last accessed on 25 Apr 2016]
National Institute for Health and Care Excellence. Technology appraisal guidance: Trastuzumab emtansine for treating HER2-positive, unresectable locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane. Inglaterra; 2015. Available from: https://www.nice.org.uk/ guidance/ta371/documents/breast-cancer-her2-positive-unresectable-trastuzumab-emtansine-after-trastuzumab-taxane-final-appraisal-determination-document. [Last accessed on 25 Jun 2016].
Le QA, Bae YH, Kang JH. Cost-effectiveness analysis of trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2): positive advanced breast cancer. Breast Cancer Res Treat 2016;159:565-73.
Romero PM, Gil RM. Trastuzumab emtansine in locally advanced or metastatic HER2 positive breast cancer; GENESIS-SEFH drug evaluation report. Farm Hosp 2015;39:171-5.
Bandeira TFGS, Mosegui GBG, Vianna CMM, Araujo RL, Rodrigues MPS, do Valle PM. Cost-effectiveness analysis of trastuzumab in the treatment of metastatic breast cancer. Int J Pharm Pharm Sci 2015;7:307-12.