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“Wilking N, Jönsson B. A pan-European comparison regarding patient access to cancer drugs. Http://ki.se/content/1/c4/33/52/Cancer_Report.pdf (accessed Oct 14, 2012).) ) In the US, where most patients receive adequate initial diagnosis and treatment, new cancer drugs have been shown to account for m…”
The global economic cost of new cancer cases in 2009, including medical and non-medical costs, lost productivity, and the cost of cancer research, is estimated to have amounted to at least $ 286 billion. (1)Economist Intelligence Unit. Breakaway: the global burden of cancer— challenges and opportunities, 2009. http://www.livestrong.Org/pdfs/GlobalEconomicImpact (accessed Aug 14, 2012).
One of the main concerns is that the incidence of cancer is not distributed equally in all the nations of the world. Despite the fact that low- and middle-income countries constitute 84.7% of the world’s population and 61.3% of new cancer cases globally, these areas only represent 6.2% of worldwide financial expenses against cancer, evidencing the large investment deficit that exists. Globally, the cancer fatality rate (death rate / cancer incidence) is higher in low-income countries than in high-income countries. In 2002, the cancer fatality rate for low-income countries (74.5%) was 1.6 times higher than that of high-income countries (46.3%). (2)Economist Intelligence Unit. Breakaway: the global burden of cancer— challenges and opportunities, 2009. http://www.livestrong.Org/pdfs/GlobalEconomicImpact (accessed Aug 14, 2012).
En la introducción, hemos presentado los datos estadísticos sobre la inversión en atención de la salud en América Latina y el Caribe, que se muestran en las figuras 1D y 2D.
In 2011, total health spending in Latin America remained at an average of 7.7% of GDP; however, this percentage varies greatly by country and region. (3)The World Bank. World Bank health nutrition and population statistics statistics. Http://data.worldbank.org/data-catalog/health-nutrition-and-population-statistics (accessed Sept 9, 2012). Bolivia, Jamaica, Peru, and Venezuela spend approximately 5% of their GDP on health care, while Costa Rica spent 10.9% of GDP on health care, higher than spending in Japan (9.5% of GDP) or in the United Kingdom (9.6% of GDP). Nicaragua stands out in the region with a low GDP per capita (only US $ 1,243 per person, an amount that is less than the GDP per capita in Bolivia, Jamaica, Peru and Venezuela), but nevertheless invests 9.1% of GDP in health care. (4)The World Bank. World Bank health nutrition and population statistics database. Http://data.worldbank.org/data-catalog/health-nutrition-and-population-statistics (accessed Sept 9, 2012). Brazil, The most populous country in the region, with an emerging economy, invests 9.0% of GDP in health care, while Mexico, the second most populous country, invests only 6.3% of GDP. (5)The World Bank. World Bank health nutrition and population statistics database. Http://data.worldbank.org/data-catalog/ health-nutrition-and-population-statistics (accessed Sept 9, 2012).
Figure 2D shows total health spending as the sum of public and private health expenditures for some Latin American countries. Public sector financing is 50.2% on average, compared to the world average of 62.8%. Contributions represented 34.3% of health spending in 2011, creating a high risk of catastrophic spending and impoverishment. (6)The World Bank. Working for a world free of poverty. Health indicators. Vienna: The World Bank Group, 2012. The WHO has estimated that it takes only 15% or less out-of-pocket costs to reach a risk low catastrophic expense. (7)Xu K, Evans D, Kawabata K, et al. Household catastrophic health expenditure: a multicountry analysis. Lancet 2003; 362: 111–17 In 12 Latin American countries, the estimated proportion of households with catastrophic health expenditures ranged from 1 to 25%. (8)Knaul F, Wong R, Arreola-Ornelas H, et al. Household catastrophic health expenditures: a comparative analysis of twelve Latin American and Caribbean Countries. Salud Publica Mex 2011; 53 (suppl 2): 85–95.
Disparities in Health Expenditure Within Countries
Disparities in public spending on health services vary in different Latin American countries, and also within countries and regions. In Brazil, for example, total spending on health services represents 9.0% of GDP, but 53% of this amount (4.8% of GDP) is assumed by the private sector, which covers less than half of all patients. However, public sector expenses in the Brazilian Unified Health System (SUS) represent only 40% of total health care expenses (3% of GDP), but cover 75% of the population. (9)The World Bank. World Bank health nutrition and population statistics database. Http://data.worldbank.org/data-catalog/health-nutrition-and-population-statistics (accessed Sept 9, 2012). This contrasts strikingly with public spending of around 50% in the US and over 75% in the UK, relative to total health spending. Because of this, care in public facilities in Brazil, where overcrowding, lack of access to medicines, limited services and lower quality are frequent, is often inferior to that of private establishments, with large differences linked to the geography and the income of the regions. (10)Paim J, Travassos C, Almeida C, Bahia L, Macinko J. The Brazilian health system: history, advances, and challenges. Lancet 2011; 377: 1778–97 The situation is similar in other Latin American countries. During 2008, Mexico spent 5.9% of its GDP on health care (52% in the private sector, which covers only 5% of the population) (11)Knaul F, Wong R, Arreola-Ornelas H, et al. Household catastrophic health expenditures: a comparative analysis of twelve Latin American and Caribbean Countries. Salud Publica Mex 2011; 53 (suppl 2): 85–95.
Latin American countries have focused their investment in health on the prevention and treatment of infectious diseases, while spending on non-communicable diseases, such as cancer, has not been balanced. (12)Stuckler D, King L, Robinson H, McKee M. WHO’s budgetary allocations and burden of disease: a comparative analysis. Lancet 2008; 372: 1563–69. (13)Ravishankar N, Gubbins P, Cooley RJ, et al . Financing of global health: tracking development assistance for health from 1990 to 2007. Lancet 2009; 373: 2113–24. However, many of these countries are achieving higher life expectancy and adopting a lifestyle similar to that of developed countries, leading to a rapid increase in the number of cancer patients, an economic burden for which they are not prepared. It is estimated that low-income countries globally would have to spend $ 217 billion to meet the global minimum standard for cancer treatment, a figure known as the funding gap. (14)Economist Intelligence Unit. Breakaway: the global burden of cancer— challenges and opportunities, 2009. http://www.livestrong.Org/pdfs/GlobalEconomicImpact (accessed Aug 14, 2012).
There are no country-specific financial resources available for cancer care for all Latin American countries; however, the estimated spending gap for cancer (defined by the projected costs of treatment and care in the country with the lowest case fatality rate for each cancer location) for middle-income countries globally it is between 24–57%, compared to 11% in high-income countries. (15)Unger-Saldana K, Pelaez-Ballestas I, Infante-Castaneda C. Development and validation of a questionnaire to assess delay in treatment for breast cancer. BMC Cancer 2012; 12: 626. It is estimated that the total economic burden of Cancer in Latin America, including medical and non-medical costs, is around US $ 4 billion (Table 4) (16)Economist Intelligence Unit. Breakaway: the global burden of cancer— challenges and opportunities, 2009. http://www.livestrong.org/pdfs/GlobalEconomicImpact (accessed Aug 14, 2012). (17)United Nations. Per capita GNI at current prices. http://data. un.org/Data.aspx?d=SNAAMA&f=grID%3A101%3BcurrID%3AUSD%3BpcFlag%3A1 (accessed Oct 14, 2012). (18)United Nations, Department of Economic and Social Affairs. World population prospects, the 2010 revision. Http://esa.un.org/wpp/index.htm (accessed Oct 16, 2012).
However, the total median medical expense per patient is $ 7.92, compared to $ 183 in the UK, $ 244 in Japan, and $ 460 in the US. Latin American data compares favorably with China (median spending of $ 4.32 per patient) and India ($ 0.54 per patient). The medical costs of cancer treatment in Latin America, adjusted according to income at current exchange rates, represent 0.12% of gross national income (GNI) per capita (ranging from 0.06% in Venezuela 0.29% in Uruguay), compared to 0.51% in the United Kingdom, 0.60% in Japan, and 1.02% in the US; in India, this figure was 0.05%, and in China it was 0.11%. (19)Economist Intelligence Unit. Breakaway: the global burden of cancer— challenges and opportunities, 2009. http://www.livestrong.Org/pdfs/GlobalEconomicImpact (accessed Aug 14, 2012). (20)United Nations. Per capita GNI at current prices. Http://data.Un.org/Data.aspx?d=SNAAMA&f=grID%3A101%3BcurrID%3AUSD%3BpcFlag%3A1 (accessed Oct 14, 2012). (21)United Nations, Department of Economic and Social Affairs. World population prospects, the 2010 revision. Http://esa.un.org/wpp/index.htm (accessed Oct 16, 2012).
Assessing the Cost of Cancer Treatment
To evaluate the cost of any disease, pharmacoeconomic studies that consider the total costs (direct and indirect) that are caused by the disease are necessary. (22)Meltzer MI. Introduction to health economics for physicians. Lancet 2001; 358: 993–98. Direct costs are for medications, medical devices, doctor visits, emergency room visits, diagnostic testing services, education, and research . Indirect costs include lost work days and productivity, travel time and costs, accommodation and waiting times. Complications requiring hospitalization are those that contribute the most to the direct costs of cancer, with drug costs assuming only a small fraction. Avoiding advanced stage IV cancer is essential to reduce costs. The establishment and improvement of prevention, diagnosis, and basic treatment measures, such as surgery and radiation, are likely to be the factors that reduce costs in Latin America. The vast majority of cost-benefit studies in cancer are conducted outside of Latin America. Within Latin America, Augustovski et al. (23)Augustovski F, Melendez G, Lemgruber A, Drummond M. Implementing pharmacoeconomic guidelines in Latin America: lessons learned. Value Health 2011; 14 (suppl 1): 3–7 identify Brazil as the country that has more experience with the use of pharmacoeconomics in decision-making, while Chile, Mexico, Argentina, Colombia, Guatemala, Uruguay and Venezuela are beginning to adopt pharmacoeconomic models in decision-making. At best, however, efforts are rudimentary and urgent development is needed to expand the use of pharmacoeconomics in improving cancer care.
Drug Policies in Latin America and the Caribbean
During the last decade, many Latin American countries have undertaken profound reforms of their health systems in accordance with macroeconomic changes in the region.
Panel 1 shows the pricing policies for medicines in Latin America. Brazil, the largest economy in the region, is expected to have 15–20% annual economic growth in 2012. Argentina, Colombia, Chile and Mexico are also expected to have strong economic growth in 2012 and 2013. There is the need to establish mechanisms that guarantee the efficient allocation of scarce resources in Latin America, as well as to guarantee the provision of health care services based on local needs. At the same time that health systems in Latin America are modernizing and growing, the region is becoming a promising market for medicines and related products. For example, drug spending is projected to increase from 12% of total cancer spending in 2005 to 28% in 2015, despite strong budget constraints that motivate reference price regulation and promotion. of generic substitution. (24)IMS Institute for Healthcare informatics. The global use of medicines: outlook through 2015. http://www.imshealth.com/deployedfiles/ims/Global/Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/Global_Use_of_Medicines_ Report.pdf (accessed Jan 22, 2013).
Lack of Access to High-Cost Cancer Drugs
Money and access to health care delivery are associated with the results of cancer treatment. 5-year breast cancer survival ranges from 80% in high-income countries to 40% in low-income countries. (25)Coleman MP, Quaresma M, Berrino F, et al. Cancer survival in five continents: a worldwide population-based study (CONCORD). Lancet Oncol 2008; 9: 730–56. This is partly due to differences in access to cancer care and medications. In Europe, where patients generally receive timely and adequate initial diagnosis and treatment, there is a difference in cancer survival between countries that have a rapid approval process for new cancer drugs and those that require more time to the approval. (26)Wilking N, Jönsson B. A pan-European comparison regarding patient access to cancer drugs. Http://ki.se/content/1/c4/33/52/Cancer_Report.pdf (accessed Oct 14, 2012).) ) In the US, where most patients receive adequate initial diagnosis and treatment, new cancer drugs have been shown to account for more than 50% of the improvement in survival rates at 5 years of cancer patients between 1975 and 1995, contributing to more than 10% of the total improvement in life expectancy for US citizens. Furthermore, the number of cancer drugs available has been associated with the 1-year and 5-year survival of cancer patients. (27)Lichtenberg FR. The impact of new drug launches on longevity: evidence from longitudinal, disease-level data from 52 countries, 1982–2001. Int J Health Care Finance Econ 2005; 5: 47–73. These figures should be interpreted With precaution. Cancer medications can improve residual risk only after other preventive, diagnostic, and primary care measures have been optimized. In Latin America, where the main cause of cancer mortality is the discovery of advanced stage disease at the time of diagnosis, more emphasis should be placed on the provision of advanced diagnostic services, primary surgery, and radiation treatment. Otherwise, increased drug spending is unlikely to change national morbidity and mortality statistics.
The supply of new cancer drugs may be beyond the reach of developing countries. Over 90% of cancer drugs approved in the US since 2004 cost more than $ 20,000 over 12 weeks of treatment. The use of these new drugs in Latin America would lead to an estimated 15% increase in the cost of cancer drugs per year. Therefore, despite the fact that Latin America is considered to be an expanding market for the pharmaceutical industry, 88% of the new medicines launched in the period 2005–09 were used in North America, Europe and Japan. (8 European Federation of Pharmaceutical Industries and Associations. The pharmaceutical industry in figures: 2011. http://www.efpia.eu/sites/www.efpia.eu/files/EFPIA%20Figures%202012%20Final.pdf (accessed Feb 13 , 2013). Access to high-cost medicines and technologies is restricted in Latin American public health systems, while patients with private insurance (or private funds) have access to many of the expensive treatments.
Cancer Treatment in the Public Health Field Compared to the Private Field: The Case of Brazil
In Brazil, most breast cancer patients who receive adjuvant chemotherapy in public institutions receive first-generation chemotherapy regimens (cyclophosphamide, methotrexate, and fluorouracil) compared to less than a third of these patients in private institutions. The Brazilian Ministry of Health reported in 2009 that adding antibody therapies to the list of drugs covered by the public health system would increase expenses for lymphoma treatment by 900%, which was a prohibitive expense. (28)ANVISA. Rituximabe no treatment for diffuse large cell Não-Hodgkin lymphoma B. Boletin Brasileiro de Avaliação de tecnologia em Saúde. 2009 (december), nº IV Diário Oficial da União. Portaria nº 720, December 20, 2010. http://portal.saude.gov.br/portal/arquivos/pdf/Brats10.pdf (accessed Sept 1, 2012). In 2011, rituximab was added to the list of included drugs, but its use is restricted to first-line treatment of diffuse large B-cell lymphomas. (29)Ministério da Saúde. Portaria no 720 of December 20, 2010. http://www.brasilsus.com.br/legislacoes/sas/106840-720.html?q=. (Accessed Oct 15, 2012).) ) Until recently, HER2-positive breast cancer patients receiving treatment through the Brazilian public health system had to sue the government for access to trastuzumab, a common situation in almost all Latin American countries. (30)Contreras-Hernández IPF, Alvis-Gúzman N, Stefani SD. The use of economic evaluation for decision-making in oncological interventions: the experience of Mexico, Colombia and Brazil. PharmacoEconomics 2012; 9: 117–32. women with HER2-positive breast cancer are ten times more likely to receive trastuzumab if they have private insurance (only 6% of patients with HER2-positive breast cancer receive trastuzumab in the public system compared to 56% in the private sector) . (31)Lee BL, Liedke PE, Barrios CH, Simon SD, Finkelstein DM, Goss PE. Breast cancer in Brazil: present status and future goals. Lancet Oncol 2012; 13: e95–102. In 2012, trastuzumab started to be available for women with HER2-positive early breast cancer, but not for metastatic disease. This approval will take effect in 2013, 8 years after its broad approval for adjuvant therapy in the United States. ((Ministério da Saúde, Secretary of Science, Technology and Strategic Supplies. Report of the recommendation of the National Commission for Incorporation of Technologies not SUS-CONITEC-08: trastuzumab for treatment of advanced breast cancer. Http://portal.saude.gov.br/portal/saude/Gestor/visualizar_texto.cfm?idtxt=40351&janela=1 (accessed Dec 28, 2012). (32)Ministério da Saúde, Secretary of Science, Technology and Inputs. Report of National Recommendations of Comissão de Incorporação de Tecnologias no SUS – CONITEC – 07: trastuzumab e for treatment of initial breast cancer http://portal.saude.gov.br/portal/saude/Gestor/visualizar_texto. cfm?idtxt=40351&janela=1 (accessed Dec 28, 2012). 3 The picture is similar in other Latin American countries, such as Mexico, Argentina and Colombia. (33)Augustovski F, Melendez G, Lemgruber A, Drummond M. Implementing pharmacoeconomic guidelines in Latin America: lessons learned. Value Health 2011; 14 (suppl 1): 3–7. (34)Contreras-Hernández IPF, Alvis-Gúzman N, Stefani SD. The use of economic evaluation for decision-making in oncological interventions: the experience of Mexico, Colombia and Brazil. PharmacoEconomics 2012; 9: 117–32.
Participation in clinical trials sponsored by the pharmaceutical industry may be a favorable option for patients in Latin America, facilitating access to high-cost medications that cannot be obtained in any other way. In fact, many Brazilian clinical trial centers have higher participation rates than those in the US or Europe. (35)Schwartsmann G. Breast cancer in South America: challenges to improve early detection and medical management of a public health problem. J Clin Oncol 2001; 19 (suppl 18): 118–24. This situation raises ethical issues, however , since most patients in Latin America do not have access to new treatments, even if they have been approved. One view is that participation in trials in low- and middle-income countries is a convenient way for wealthy countries and pharmaceutical companies to obtain rapid approval of drugs for use in richer markets and to increase business profits at the expense of exploitation of the lower income countries. (36)Lee BL, Liedke PE, Barrios CH, Simon SD, Finkelstein DM, Goss PE. Breast cancer in Brazil: present status and future goals. Lancet Oncol 2012; 13: e95–102. (37)Campbell D, Chui M . Pharmerging shake-up: new imperatives in a redefined world. Http://www.imshealth.com/pharmerging (accessed Jul 1, 2011).
Lack of access to high-cost medicines and the low implementation of new technologies is an issue that must be addressed in Latin America, but should not have priority over access to primary care. Increased government spending and major structural changes are necessary to decrease inequality in countries where most people do not have access to a minimum level of health services, and only a small proportion have access to the highest standards. . Financial support from developed countries is also important to help Latin America close the financing gap, which is the cause of inequalities in cancer outcomes between developing countries and rich countries.
High-quality research, including cost-effectiveness studies, is needed to understand the optimal allocation of scarce resources. In this sense, Brazil has made great progress with the creation of the Health Technology Assessment Institute (Instituto de Avaliação Tecnologiaem de Saúde), an institute that collaborates with more than 80 researchers from ten universities in different regions of the country. (38)IATS (Instituto de Avaliação de Tecnologia em Saúde). Http://www.Iats.com.br/instituto.php?id_cms_menu=1 (accessed Feb 13, 2013).
Mexico, Colombia, Argentina, Uruguay and Venezuela are also developing similar initiatives. It may not be feasible for all Latin American countries to develop their own cost-effectiveness studies, but a regional approach is likely to be more useful than adopting European and North American guidelines.