Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-23T07:37:34.573Z Has data issue: false hasContentIssue false
  • English
  • Français

IMPLICATIONS OF GLOBAL PRICING POLICIES ON ACCESS TO INNOVATIVE DRUGS: THE CASE OF TRASTUZUMAB IN SEVEN LATIN AMERICAN COUNTRIES

Published online by Cambridge University Press:  20 May 2015

Andres Pichon-Riviere ,
Osvaldo Ulises Garay ,
Federico Augustovski ,
Carlos Vallejos ,
Leandro Huayanay ,
Maria del Pilar Navia Bueno ,
Alarico Rodriguez ,
Carlos José Coelho de Andrade ,
Jefferson Antonio Buendía  and
Michael Drummond
Andres Pichon-Riviere
Affiliation:
IECS – Institute for Clinical Effectiveness and Health Policy; School of Public Health, University of Buenos [email protected]
Osvaldo Ulises Garay
Affiliation:
IECS – Institute for Clinical Effectiveness and Health Policy
Federico Augustovski
Affiliation:
IECS – Institute for Clinical Effectiveness and Health Policy; School of Public Health, University of Buenos Aires
Carlos Vallejos
Affiliation:
Universidad de La Frontera
Leandro Huayanay
Affiliation:
Universidad Peruana Cayetano Heredia
Maria del Pilar Navia Bueno
Affiliation:
Universidad de San Andrés
Alarico Rodriguez
Affiliation:
Fondo Nacional de Recursos (FNR)
Carlos José Coelho de Andrade
Affiliation:
Brazilian National Cancer Institute-INCA
Jefferson Antonio Buendía
Affiliation:
Department of Pharmacology, School of Medicine, University of Antioquia
Michael Drummond
Affiliation:
Centre for Health Economics, University of York
Get access Rights & Permissions [Opens in a new window]

Abstract

Objectives: Differential pricing, based on countries’ purchasing power, is recommended by the World Health Organization to secure affordable medicines. However, in developing countries innovative drugs often have similar or even higher prices than in high-income countries. We evaluated the potential implications of trastuzumab global pricing policies in terms of cost-effectiveness (CE), coverage, and accessibility for patients with breast cancer in Latin America (LA).

Methods: A Markov model was designed to estimate life-years (LYs), quality-adjusted life-years (QALYs), and costs from a healthcare perspective. To better fit local cancer prognosis, a base case scenario using transition probabilities from clinical trials was complemented with two alternative scenarios with transition probabilities adjusted to reflect breast cancer epidemiology in each country.

Results: Incremental discounted benefits ranged from 0.87 to 1.00 LY and 0.51 to 0.60 QALY and incremental CE ratios from USD 42,104 to USD 110,283 per QALY (2012 U.S. dollars), equivalent to 3.6 gross domestic product per capita (GDPPC) per QALY in Uruguay and to 35.5 GDPPC in Bolivia. Probabilistic sensitivity analysis showed 0 percent probability that trastuzumab is CE if the willingness-to-pay threshold is one GDPPC per QALY, and remained so at three GDPPC threshold except for Chile and Uruguay (4.3 percent and 26.6 percent, respectively). Trastuzumab price would need to decrease between 69.6 percent to 94.9 percent to became CE in LA.

Conclusions: Although CE in other settings, trastuzumab was not CE in LA. The use of health technology assessment to prioritize resource allocation and support price negotiations is critical to making innovative drugs available and affordable in developing countries.

Keywords

Cost-effectivenessCost utilitytrastuzumabdrug pricingLatin America
Type
Assessments
Information
International Journal of Technology Assessment in Health Care , Volume 31 , Issue 1-2 , 2015 , pp. 2 - 11
Copyright
Copyright © Cambridge University Press 2015 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. United Nations. General Assembly. Prevention and control of non-communicable. Report of the Secretary-General 2011. http://www.un.org/ga/search/view_doc.asp?symbol=A/66/83&Lang=E (accessed March 15, 2013).Google Scholar
2. World Health Organization. Preventing chronic diseases: A vital investment: WHO global report. WHO Library Cataloguing-in-Publication Data 2005. http://www.who.int/chp/chronic_disease_report/contents/foreword.pdf (accessed March 15, 2013).Google Scholar
3. Howitt, P, Darzi, A, Yang, GZ, et al. Technologies for global health. Lancet. 2012;380:507–535.Google Scholar
4. World Health Organization. Research and development to meet health needs in developing countries: Strengthening global financing and coordination. Report of the consultative expert working group on research and development: Financing and coordination. 2012. http://www.who.int/phi/CEWG_Report_5_April_2012.pdf (accessed March 15, 2013).Google Scholar
5. World Health Organization. Report of the Workshop on Differential Pricing & Financing of Essential Drugs. 2001. http://apps.who.int/medicinedocs/en/d/Jh2951e/ (accessed March 15, 2013).Google Scholar
6. Morel, CM, McGuire, A, Mossialos, E. The level of income appears to have no consistent bearing on pharmaceutical prices across countries. Health Aff (Millwood). 2011;30:1545–1552.Google Scholar
7. Gelders, S, Ewen, M, Noguchi, N, Laing, R. Price, availability and affordability. An international comparison of chronic disease medicines. Background report prepared for the WHO Planning Meeting on the Global Initiative for Treatment of Chronic Diseases held in Cairo in December 2005 2006. http://apps.who.int/medicinedocs/index/assoc/s14135e/s14135e (accessed March 10, 2013).Google Scholar
8. Tobar, F, Charreau, J. Comparación internacional del precio de los medicamentos de alto costo. Argentina, Países del Cono sur, España e Inglaterra. 2011. http://www.fsg.org.ar/publicaciones/Precio%20de%20los%20medicamentos%20de%20alto%20costo.pdf (accessed March 15, 2013).Google Scholar
9. World Health Organization. The World Health Report–Health Systems Financing: The path to universal coverage. 2010. http://www.who.int/entity/whr/2010/whr10_en.pdf (accessed March 15, 2013).Google Scholar
10. Parkin, DM, Bray, F, Ferlay, J, Pisani, P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001;94:153–156.Google Scholar
11. Lozano-Ascencio, R, Gomez-Dantes, H, Lewis, S, Torres-Sanchez, L, Lopez-Carrillo, L. [Breast cancer trends in Latin America and the Caribbean]. Salud Publica Mex. 2009;51 (Suppl 2):s147–s156.Google Scholar
12. Plosker, GL, Keam, SJ. Trastuzumab: A review of its use in the management of HER2-positive metastatic and early-stage breast cancer. Drugs. 2006;66:449–475.CrossRefGoogle ScholarPubMed
13. Liao, N, Zhang, GC, Li, XR, Yao, M, Wang, K. [A meta-analysis of neoadjuvant chemotherapy combined with trastuzumab for HER2-positive breast cancers]. Nan Fang Yi Ke Da Xue Xue Bao. 2009; 29:943–945.Google Scholar
14. Chan, AL, Leung, HW, Lu, CL, Lin, SJ. Cost-effectiveness of trastuzumab as adjuvant therapy for early breast cancer: A systematic review. Ann Pharmacother. 2009;43:296–303.CrossRefGoogle ScholarPubMed
15. Skedgel, C, Rayson, D, Younis, T. The cost-utility of sequential adjuvant trastuzumab in women with Her2/Neu-positive breast cancer: An analysis based on updated results from the HERA Trial. Value Health. 2009;12:641–648.Google Scholar
16. Lidgren, M, Jonsson, B, Rehnberg, C, Willking, N, Bergh, J. Cost-effectiveness of HER2 testing and 1-year adjuvant trastuzumab therapy for early breast cancer. Ann Oncol. 2008;19:487–495.CrossRefGoogle ScholarPubMed
17. Liberato, NL, Marchetti, M, Barosi, G. Cost effectiveness of adjuvant trastuzumab in human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2007;25:625–633.Google Scholar
18. Garrison, LP Jr, Lubeck, D, Lalla, D, et al. Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer. Cancer. 2007;110:489–498.Google Scholar
19. Shiroiwa, T, Fukuda, T, Shimozuma, K, Ohashi, Y, Tsutani, K. The model-based cost-effectiveness analysis of 1-year adjuvant trastuzumab treatment: Based on 2-year follow-up HERA trial data. Breast Cancer Res Treat. 2008;109:559–566.Google Scholar
20. Norum, J, Olsen, JA, Wist, EA, Lonning, PE. Trastuzumab in adjuvant breast cancer therapy. A model based cost-effectiveness analysis. Acta Oncol. 2007;46:153–164.Google Scholar
21. Fagnani, F, Colin, X, Arveux, P, Coudert, B, Misset, JL. [Cost/effectiveness analysis of adjuvant therapy with trastuzumab in patients with HER2 positive early breast cancer]. Bull Cancer. 2007;94:711–720.Google Scholar
22. Hedden, L, O’Reilly, S, Lohrisch, C, et al. Assessing the real-world cost-effectiveness of adjuvant trastuzumab in HER-2/neu positive breast cancer. Oncologist. 2012;17:164–171.Google Scholar
23. Purmonen, TT, Pankalainen, E, Turunen, JH, Asseburg, C, Martikainen, JA. Short-course adjuvant trastuzumab therapy in early stage breast cancer in Finland: Cost-effectiveness and value of information analysis based on the 5-year follow-up results of the FinHer Trial. Acta Oncol. 2011;50:344–352.Google Scholar
24. Hall, PS, Hulme, C, McCabe, C, et al. Updated cost-effectiveness analysis of trastuzumab for early breast cancer: A UK perspective considering duration of benefit, long-term toxicity and pattern of recurrence. Pharmacoeconomics. 2011;29:415–432.CrossRefGoogle ScholarPubMed
25. Sullivan, R, Peppercorn, J, Sikora, K, et al. Delivering affordable cancer care in high-income countries. Lancet Oncol. 2011;12:933–980.Google Scholar
26. Banta, D. Health technology assessment in Latin America and the Caribbean. Int J Technol Assess Health Care. 2009;25 (Suppl 1):253–254.CrossRefGoogle ScholarPubMed
27. Pichon-Riviere, A, Augustovski, F, Rubinstein, A, et al. Health technology assessment for resource allocation decisions: Are key principles relevant for Latin America? Int J Technol Assess Health Care. 2010;26:421–427.Google Scholar
28. Di Ruggiero, E, Zarowsky, C, Frank, J, et al. Coordinating Canada's research response to global health challenges: The Global Health Research Initiative. Can J Public Health. 2006;97:29–31.Google Scholar
29. Caro, JJ, Briggs, AH, Siebert, U, Kuntz, KM. Modeling good research practices–overview: A report of the ISPOR-SMDM Modeling Good Research Practices Task Force–1. Value Health. 2012;15:796–803.Google Scholar
30. Sachs, JD. Macroeconomics and health: Investing in health for economic development. Report of the Commission on Macroeconomics and Health. WHO Library Cataloguing-in-Publication Data 2001. http://whqlibdoc.who.int/publications/2001/924154550x.pdf (accessed March 10, 2013).Google Scholar
31. Barajas, RE, Ríos, PR. Guía de Evaluación de Insumos para la Salud. In: Dirección General Adjunta de Priorización Comisión Interinstitucional del Cuadro Básico y Catálogo de Insumos del Sector Salud, editor. Mexico; 2011. http://www.csg.salud.gob.mx/descargas/pdfs/cuadro_basico/guia_eval_insumos11052011.pdf (accessed March 10, 2013).Google Scholar
32. Ministerio de Salud de Chile. Guía Metodológica para la Evaluación Económica de Intervenciones en Salud en Chile. In: Departamento de Economía de la Salud Subsecretaría de Salud Pública, editor. Santiago de Chile; 2013. http://desal.minsal.cl/wp-content/uploads/2013/09/EE_FINAL_web.pdf (accessed October 4, 2013).Google Scholar
33. Instituto de Evaluación Tecnológica en Salud (IETS). Manual para la elaboración de evaluaciones económicas en salud. Bogotá; 2014. http://www.iets.org.co/manuales/Manuales/Manual%20evaluacio%CC%81n%20econo%CC%81mica%20web%2030%20sep.pdf (accessed October 14, 2013).Google Scholar
34. George, B, Harris, A, Mitchell, A. Cost-effectiveness analysis and the consistency of decision making: Evidence from pharmaceutical reimbursement in australia (1991 to 1996). Pharmacoeconomics. 2001;19:1103–1109.Google Scholar
35. Augustovski, F, Garay, OU, Pichon-Riviere, A, Rubinstein, A, Caporale, JE. Economic evaluation guidelines in Latin America: A current snapshot. Expert Rev Pharmacoecon Outcomes Res. 2010;10:525–537.Google Scholar
36. Gianni, L, Dafni, U, Gelber, RD, et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: A 4-year follow-up of a randomised controlled trial. Lancet Oncol. 2011;12:236–244.Google Scholar
37. Smith, I, Procter, M, Gelber, RD, et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: A randomised controlled trial. Lancet. 2007;369:29–36.Google Scholar
38. Piccart-Gebhart, MJ, Procter, M, Leyland-Jones, B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353:1659–1672.Google Scholar
39. Paul, Kind, Richard, Brooks, Rabin, R, editors. EQ-5D concepts and methods: A developmental history. New York: Springer; 2005.Google Scholar
40. Calvert, MJ, Freemantle, N, Cleland, JG. The impact of chronic heart failure on health-related quality of life data acquired in the baseline phase of the CARE-HF study. Eur J Heart Fail. 2005;7:243–251.CrossRefGoogle ScholarPubMed
41. International Agency for Research on Cancer. Globocan 2008 Cancer Incidence, Mortality and Prevalence Worldwide in 2008. http://globocan.iarc.fr/ (accessed March 10, 2013).Google Scholar
42. Bland, KI, Menck, HR, Scott-Conner, CE, et al. The National Cancer Data Base 10-year survey of breast carcinoma treatment at hospitals in the United States. Cancer. 1998;83:1262–1273.Google Scholar
43. Paik, S, Bryant, J, Tan-Chiu, E, et al. HER2 and choice of adjuvant chemotherapy for invasive breast cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-15. J Natl Cancer Inst. 2000;92:1991–1998.Google Scholar
44. Prieto, MM, Torres, CS. Situación epidemiológica del cáncer de mama en Chile 1994–2003. Epidemiologic situation of breast cancer in Chile 1994–2003. Rev Méd Clín Condes. 2006;17:142–148.Google Scholar
45. Piñeros, M, Sánchez, R, Cendales, R, et al. Características sociodemográficas, clínicas y de la atención de mujeres con cáncer de mama en Bogotá. Social, Demographic and Clinical Features in Women with Breast Cancer attending Health Services in Bogotá. Rev Colomb Cancerol. 2008;12:181–190.Google Scholar
46. Solidoro, Andrés. Cáncer en el Perú del 2000: hechos, cifras, realidades DIAGNOSTICO. 2001;40:306–317. http://www.fihu-diagnostico.org.pe/revista/numeros/2001/novdic01/306-317.html (accessed March 10, 2013).Google Scholar
47. Juarez, AM. Edad y estadio de la mujeres con cancer de mama, hospitales públicos, Córdoba 1998/2003. Age and stage of the with breast cancer. Public hospitals, Cordoba 1998–2003. Rev Esc Salud Pública. 2009;13:33–42.Google Scholar
48. Vázquez, T, Krygier, G, Barrios, E, et al. Análisis de sobrevida de una población con cáncer de mama y su relación con factores pronósticos: estudio de 1.311 pacientes seguidas durante 230 meses: trabajo de equipo multidisciplinario. Survival analysis i a population with breast cancer and its pronostic factors: 230 months-follow up in 1.311 women. Rev Méd Urug. 2005;21:107–121.Google Scholar
49. Kurian, AW, Thompson, RN, Gaw, AF, et al. A cost-effectiveness analysis of adjuvant trastuzumab regimens in early HER2/neu-positive breast cancer. J Clin Oncol. 2007;25:634–641.Google Scholar
50. Ministério da Saúde do Brasil. Secretaria de Ciência, Tecnologia e InsumosEstratégicos. Relatório de recomendação da ComissãoNacional de Incorporação de Tecnologias no SUS–CONITEC–07: trastuzumabeparatratamento do câncer de mama inicial. 2012. http://portal.saude.gov.br/portal/arquivos/pdf/Trastuzumabe_cainicial_final.pdf (accessed March 15, 2013).Google Scholar
51. Danzon, PM, Towse, A, Mulcahy, AW. Setting cost-effectiveness thresholds as a means to achieve appropriate drug prices in rich and poor countries. Health Aff (Millwood). 2011;30:1529–1538.Google Scholar
52. Goss, PE, Lee, BL, Badovinac-Crnjevic, T, et al. Planning cancer control in Latin America and the Caribbean. Lancet Oncol. 2013;14:391–436.CrossRefGoogle ScholarPubMed
53. World Health Organization. WHO Guideline on Country Pharmaceutical Pricing Policies. 2013: Geneva. http://www.who.int/childmedicines/publications/WHO_GPPP.pdf?ua=1 (accessed October 2014).Google Scholar
54. Knaul, FM, Frenk, J, Shulman, L. Closing the cancer divide: A blueprint to expand access in low and middle income countries. Global Task Force on Expanded Access to Cancer Care and Control in Developing Countries. Boston, MA: Harvard Global Equity Initiative; 2011.Google Scholar
55. Instituto de Efectividad Clínica y Sanitaria (IECS). Base de datos de Costos Sanitarios Argentinos. 2011. http://www.iecs.org.ar/iecs-buscador-costos.php (accessed March 10, 2013).Google Scholar
56. Chile. Ministerio de Salud. Subsecretaría de Salud P. Estudio costo-efectividad de intervenciones en salud: informe final. 2010. http://desal.minsal.cl/wp-content/uploads/2013/09/01CostoEfectividad.pdf (accessed March 15, 2013).Google Scholar
57. Martinez, JI DJ, Diaz, S. et al. Costos del uso de trastuzumab para cáncer de mama metastásico en el Instituto Nacional de Cancerología. Serie de casos. Rev Colomb Cancerol. 2007;11 (3):189–192.Google Scholar
58. Sánchez-Castillo, JO. Estudio de costo-efectividad del uso de trastuzumab como tratamiento adjuvante del cáncer de mama temprano HER 2 positivo en el Instituto Nacional de Cancerología, desde el punto de vista del pagador (tesis). Bogota, D.C.: Universidad Nacional de Colombia; 2008.Google Scholar
59. Instituto Nacional de Enfermedades Neoplasicas “Dr. Eduardo Caceres Graziani”. Tarifario INEN. 2012. http://www.inen.sld.pe/portal/documentos/pdf/tarifario_institucional/31012012_Tarif_Instit_2012.pdf (accessed March 11, 2013)Google Scholar
Supplementary material: File

Pichon-Riviere supplementary material

Figure S1

Download Pichon-Riviere supplementary material(File)
File 14.9 KB
Supplementary material: File

Pichon-Riviere supplementary material

Figure S2

Download Pichon-Riviere supplementary material(File)
File 18.1 KB
Supplementary material: File

Pichon-Riviere supplementary material

Figure S3

Download Pichon-Riviere supplementary material(File)
File 23.6 KB
Supplementary material: File

Pichon-Riviere supplementary material

Table S1

Download Pichon-Riviere supplementary material(File)
File 22.1 KB