Abstract

Introduction

There are 1.1 billion smokers in the world, and four out of five live in low- and middle-income countries ¹1. World Health Organization. Global Health Observatory data: prevalence of tobacco smoking. http://www.who.int/gho/tobacco/use/en/ (acessado em 03/Mar/2017).
http://www.who.int/gho/tobacco/use/en/... . Smoking is the leading risk factor for death from chronic noncommunicable diseases, accounting for 6 million deaths a year ²2. U.S. National Cancer Institute; World Health Organization. The economics of tobacco and tobacco control. Bethesda: U.S. Department of Health and Services, National Institutes of Health, National Cancer Institute/Geneva: World Health Organization; 2016. (National Cancer Institute Tobacco Control Monograph, 21). (NIH Publication, 16-CA-8029A).. A total of 603 thousand deaths a year are attributable to passive smoking, 28% of which in children ³3. Oberg M, Jaakkola MS, Woodward A, Peruga A, Pruss-Ustun A. Worldwide burden of disease from exposure to second-hand smoke: a retrospective analysis of data from 192 countries. Lancet 2011; 377:139-46.. This risk factor is associated 75% of cases of chronic obstructive pulmonary disease (COPD) and 22% and 10% of deaths in adults from cancer and cardiovascular diseases, respectively ²2. U.S. National Cancer Institute; World Health Organization. The economics of tobacco and tobacco control. Bethesda: U.S. Department of Health and Services, National Institutes of Health, National Cancer Institute/Geneva: World Health Organization; 2016. (National Cancer Institute Tobacco Control Monograph, 21). (NIH Publication, 16-CA-8029A).. Recent epidemiological evidence also indicates that other diseases such as breast and prostate cancer and vascular disorders of the gastrointestinal tract are partly attributable to smoking ⁴4. Carter BD, Abnet CC, Feskanich D, Freedman ND, Hartge P, Lewis CE, et al. Smoking and mortality-beyond established causes. N Engl J Med 2015; 372:631-40..

The total global cost reaches USD 1.4 trillion per year, or 1.8% of the global Gross Domestic Product (GDP) ⁵5. Goodchild M, Nargis N, Tursan d'Espaignet E. Global economic cost of smoking-attributable diseases. Tob Control 2017; 27:58-64.. Approximately 40% of these losses occur in low- and middle-income countries. Four of the five BRICS countries - Brazil, Russia, India, and China -, account for 25% of the global cost attributable to smoking ⁵5. Goodchild M, Nargis N, Tursan d'Espaignet E. Global economic cost of smoking-attributable diseases. Tob Control 2017; 27:58-64.. From the health sector’s perspective, the cost of care represents 15% of total expenditures in some countries, and in seven Latin American countries alone it is the equivalent of 8.3% ⁶6. Pichon-Riviere A, Bardach A, Augustovski F, Alcaraz A, Reynales-Shigematsu LM, Pinto MT, et al. Financial impact of smoking on health systems in Latin America: a study of seven countries and extrapolation to the regional level. Rev Panam Salud Pública 2016; 40:213-21..

Smoking is the third leading risk factor for death and quality-adjusted years of life lost in South American countries ⁷7. Lim SS, Vos T, Flaxman AD, Danaei G, Shibuya K, Adair-Rohani H, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factors and risk factor clusters in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2224-60.. It is associated with a reduction in productivity and heavy expenses for families, factors that contribute to the exacerbation of poverty. The loss of productivity is the result of premature death, which occurs before the individual retires, and also indirectly, with the reduction in productivity due to the chronic diseases associated with smoking ⁸8. Rice DP, Hodgson TA, Sinsheimer P, Browner W, Kopstein AN. The economic costs of the health effects of smoking, 1984. Milbank Q 1986; 64:489-547..

Brazil has an outstanding position in the global scenario with its National Tobacco Control Policy, which incorporates the guidelines of the World Health Organization Framework Convention on Tobacco Control (WHO-FCTC), ratified by Brazil more than 10 years ago (Decree n. 5,658 of 2006). Although Brazil was one of the world leaders in the number of smokers, from 1990 to 2015 it was also one of the countries that showed a significant reduction in smoking prevalence among both men and women (56.5% and 55.8%, respectively) ⁹9. GBD 2015 Tobacco Collaborators. Smoking prevalence and attributable disease burden in 195 countries and territories, 1990-2015: a systematic analysis from the Global Burden of Disease Study 2015. Lancet 2017; 389:1885-906.. These strides are important, but data from 2011 showed that the burden of disease associated with smoking is still high, with some 147 thousand deaths and 2.69 million years of life potential lost per year, in addition to generating an annual cost to the health system of BRL 23.37 billion (USD 6.1 billion) ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97..

The objectives of this study were to estimate the burden of disease and economic burden associated with smoking in Brazil in 2015 and to predict the economic and health benefits from increasing excise taxes on cigarettes in a 10-year scenario.

Materials and methods

The study used two models: (i) a model of the burden of disease associated with smoking, which allowed estimating the impact in terms of morbidity, mortality, and cost to society and (ii) an excise tax model to measure how price increases would avoid deaths, illness, and costs to society based on different scenarios of cigarette price increases in 10 years. We also estimated the government’s increase in tax revenue resulting from the excise tax increases.

Model of burden of disease associated with smoking

This is a mathematical model with first-order Monte Carlo microsimulation using a probabilistic simulation of each individual to incorporate the natural history, direct and indirect costs, and loss of quality of life associated with the main tobacco-related diseases. The model has been validated in various countries, as shown by previous studies ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.^,1111. Alcaraz A, Caporale J, Bardach A, Augustovski F, Pichon-Riviere A. Burden of disease attributable to tobacco use in Argentina and potential impact of price increases through taxes. Rev Panam Salud Pública 2016; 40:204-12.^,1212. Pinto M, Bardach A, Palacios A, Biz AN, Alcaraz A, Rodríguez B, et al. Carga de doença atribuível ao uso do tabaco no Brasil e potencial impacto do aumento de preços por meio de impostos. Buenos Aires: Instituto de Efectividad Clínica y Sanitaria; 2017. (Documento Técnico IECS, 21).. The selected diseases were: ischemic and non-ischemic cardiac diseases, COPD, pneumonia and influenza, stroke, and the following types of cancer: lung, mouth and pharynx, esophagus, stomach, pancreas, kidneys and renal pelvis, larynx, uterine cervix, and myeloid leukemia. The model’s methodological development and coding of the diseases by the 10th revision of the International Classification of Diseases (ICD-10) have been presented in detail in previous studies ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.^,1313. Pichon-Riviere A, Augustovski F, Bardach A, Colantonio L. Development and validation of a microsimulation economic model to evaluate the disease burden associated with smoking and the cost-effectiveness of tobacco control interventions in Latin America. Value Health 2011; 14(5 Suppl 1):S51-9.. The model was programmed in Excel (https://products.office.com/) with macros in visual basic.

Initially, for each individual from a hypothetical cohort of non-smokers, we calculated, by age and sex, the baseline risk of occurrence of acute and chronic events that could be related to the disease, its progression or death, and the direct costs (healthcare) and indirect costs (productivity lost to premature death and disability). Individuals were followed in six hypothetical cohorts in which we estimated, in annual cycles, each event’s risk of occurrence, according to demographic characteristics and smoking status (non-smoker, smoker, or former smoker), clinical conditions, and risk equations ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.^,1111. Alcaraz A, Caporale J, Bardach A, Augustovski F, Pichon-Riviere A. Burden of disease attributable to tobacco use in Argentina and potential impact of price increases through taxes. Rev Panam Salud Pública 2016; 40:204-12.^,1313. Pichon-Riviere A, Augustovski F, Bardach A, Colantonio L. Development and validation of a microsimulation economic model to evaluate the disease burden associated with smoking and the cost-effectiveness of tobacco control interventions in Latin America. Value Health 2011; 14(5 Suppl 1):S51-9..

Due to the lack of information of good quality on the population incidence of the target diseases, a method was determined backed by data from the Brazilian Mortality Information System (SIM. http://datasus.gov.br) for 2015. This option has been adopted in economic and epidemiological models ¹⁴14. World Heath Organization. Systematic review of the link between tobacco and poverty. Geneva: World Heath Organization; 2011.^,1515. Barendregt JJ, Van Oortmarssen GJ, Vos T, Murray CJ. A generic model for the assessment of disease epidemiology: the computational basis of DisMod II. Popul Health Metr 2003; 1:4.^,1616. Gail MH, Kessler L, Midthune D, Scoppa S. Two approaches for estimating disease prevalence from population-based registries of incidence and total mortality. Biometrics 1999; 55:1137-44.^,1717. Lauer JA, Rohrich K, Wirth H, Charette C, Gribble S, Murray CJ. PopMod: a longitudinal population model with two interacting disease states. Cost Eff Resour Alloc 2003; 1:6.^,1818. Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer 2001; 94:153-6.^,1919. Pisani P, Bray F, Parkin DM. Estimates of the world-wide prevalence of cancer for 25 sites in the adult population. Int J Cancer 2002; 97:72-81. and allows estimating the absolute risks by age and sex for acute or chronic events. It is acknowledged internationally that national statistics underestimate mortality from COPD ²⁰20. Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest 2002; 121(5 Suppl):121S-6S.^,2121. Stang P, Lydick E, Silberman C, Kempel A, Keating ET. The prevalence of COPD: using smoking rates to estimate disease frequency in the general population. Chest 2000; 117(5 Suppl 2):354S-9S., so the estimates for COPD risk, incidence, and progression were taken from the international literature ²⁰20. Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest 2002; 121(5 Suppl):121S-6S.^,2222. Hoogendoorn M, Rutten-van Molken MP, Hoogenveen RT, van Genugten ML, Buist AS, Wouters EF, et al. A dynamic population model of disease progression in COPD. Eur Respir J 2005; 26:223-33.. Case-fatality was estimated from hospitalizations in the Brazilian Hospital Information System of the Brazilian Unified National Health System (SIH/SUS. http://www.datasus.gov.br). Although the etiology of pneumonia and influenza is infectious, the inclusion of both is justified by evidence of increased risk in smokers suffering severe episodes of exacerbation and higher mortality when compared to non-smokers.

The model captured the outcomes’ frequency to the extent that each individual could present no events or multiple events, since acute events and chronic conditions were not mutually exclusive. We also calculated years of potential life lost (YPLL), with two components - YPLL due to premature morality (YPLL-PM) and YPLL due to reduced quality of life (YLL-QL), the direct and indirect costs associated with tobacco-related diseases. Since the model did not include a direct estimate of the effects of passive smoking and perinatal diseases (low birthweight, low birth stature, respiratory distress syndrome, and sudden infant death syndrome), we used an approximation based on the literature to calculate mortality. The additional burden from these causes was 13.6% in males and 12% in females ²³23. Centers for Disease Control and Prevention. Smoking-attributable mortality, years of potential life lost, and productivity losses - United States, 2000-2004. MMWR Morb Mortal Wkly Rep 2008; 57:1226-8..

Calibration, internal consistency, and validation of the model of burden of disease associated with smoking

The following methodological steps were performed: internal consistency to identify errors related to the incorporation of data and the model’s programming syntax in the software; calibration to ensure reproducibility of the results in relation to the incidence and mortality indicators; and external validation, in which the model’s results were validated via comparison with epidemiological and clinical studies that did not use the same data sources to estimate the risk equations. This process allowed verifying the model’s reliability. For calibration specifically, we selected all the mortality rates except for mortality from COPD, since it is underestimated in national statistics. The results by age and sex were compared to rates presented in national statistics, and we proceeded to the analysis of deviations. The mean rates of events simulated by the model that were within +/- 10% of the mean reference rate of events (national statistics and databases) were considered acceptable. In case of larger deviations, the risk equation for this specific event was modified (the case-fatality and survival values varied in the +/- 15% range) to provide for a better fit in the results.

Data collection

The parameters used in the model were backed by Brazil’s demographic structure and by the individual risk of death by cause, age, and sex, and the prevalence of smoking based on smoking status ²⁴24. Instituto Brasileiro de Geografia e Estatística. Pesquisa Nacional de Saúde 2013: percepção do estado de saúde, estilos de vida e doenças crônicas. Brasil, grandes regiões e unidades da Federação. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística; 2014.. The demographic data were obtained via projection of the population to 2015 by the Brazilian Institute of Geography and Statistics (IBGE. Projeção da população brasileira por sexo e idade: 2000-2060. https://www.ibge.gov.br/estatisticas-novoportal/sociais/populacao/9109-projecao-da-populacao.html?=&t=o-que-e, accessed on 20/Apr/2016), considering each individual in the cohorts by sex and age from 35 to 100 years. Overall population mortality and disease-, age-, and sex-specific mortality were incorporated into the estimated risk of death ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.^,1313. Pichon-Riviere A, Augustovski F, Bardach A, Colantonio L. Development and validation of a microsimulation economic model to evaluate the disease burden associated with smoking and the cost-effectiveness of tobacco control interventions in Latin America. Value Health 2011; 14(5 Suppl 1):S51-9.. The following adjustments were made to the data from the SIM: (i) correction of the under-recording of deaths by application of the adjustment factor for coverage of deaths ²⁵25. Departamento de Análise de Situação em Saúde, Secretaria de Vigilância em Saúde, Ministério da Saúde. Saúde Brasil 2010: uma análise da situação de saúde e de evidências selecionadas de impacto de ações de vigilância em saúde. Brasília: Ministério da Saúde; 2011.; (ii) imputation of missing values for age and sex, replaced respectively by median age and the most frequent sex calculated by considering the records with the same underlying cause; and (iii) redistribution of garbage codes and ill-defined causes that did not allow the precise classification of cause of death for the diseases included in the model (Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz. Projeto Carga de Doença. http://www4.ensp.fiocruz.br/projetos/carga/downloads1.htm, accessed on 05/Apr/2017).

The relative risks of developing each disease in smokers and former smokers compared to non-smokers were obtained from the Cancer Prevention Study II (CPS-II) ²⁶26. Centers for Disease Control and Prevention. Smoking-attributable mortality, morbidity, and economic costs (SAMMEC). Atlanta: Centers for Disease Control and Prevention; 2008.. Case-fatality was calculated by the model for certain conditions such as acute myocardial infarction (AMI), angina pectoris, and stroke and compared to the available national statistics for ischemic coronary disease or cerebrovascular diseases. By dividing the data on deaths grouped according to ICD-10 codes by the Brazilian population, it was possible to obtain the absolute mortality risk by cause, sex, and age. For the cancer case-fatality rates, we obtained data on specific prognoses by type of cancer, age, and sex using Globocan ¹⁹19. Pisani P, Bray F, Parkin DM. Estimates of the world-wide prevalence of cancer for 25 sites in the adult population. Int J Cancer 2002; 97:72-81.^,2727. Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer 2013; 132:1133-45.. Due to the unavailability of hospitalizations by sex, age, and ICD-10 in Brazil’s supplementary health system (private plans), a correction was performed in the data from the SIH/SUS in order to include all hospitalizations in 2015 in the country ²⁸28. Azambuja MI, Foppa M, Maranhão MF, Achutti AC. Economic burden of severe cardiovascular diseases in Brazil: an estimate based on secondary data. Arq Bras Cardiol 2008; 91:148-55..

Estimated burden of disease associated with smoking

The burden was estimated by analysis of differences in the occurrence of acute and chronic events, deaths, and costs between the results predicted by the model, according to current data on smoking prevalence ²⁴24. Instituto Brasileiro de Geografia e Estatística. Pesquisa Nacional de Saúde 2013: percepção do estado de saúde, estilos de vida e doenças crônicas. Brasil, grandes regiões e unidades da Federação. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística; 2014., and the results predicted for a cohort of non-smokers. Estimated burden of disease was expressed in YPLL in population terms, through two components: YPLL-PM and YPLL-QL. YPLL-PM were calculated via a standardized methodology ²⁹29. Fox-Rushby JA, Hanson K. Calculating and presenting disability adjusted life years (DALYs) in cost-effectiveness analysis. Health Policy Plan 2001; 16:326-31. and measures of state-of-health utility were used for each disease to estimate the YPLL-QL.

Cost calculation

We adopted society’s perspective, including the direct cost of care and the indirect cost associated with loss of productivity due to premature death and disability. Costs are shown in Brazilian Reais (BRL) for 2015, with no adjustment for inflation.

A 5% annual discount rate was applied for all the health outcomes and for the costs ³⁰30. Departamento de Tecnologia e Insumos Estratégicos, Secretaria de Ciência, Tecnologia e Insumos Estratégicos, Ministério da Saúde. Diretrizes metodológicas: estudos de avaliação econômica de tecnologias em saúde. Brasília: Ministério da Saúde; 2014.. The discount was necessary in order for these results estimated over the years to express present values.

Direct cost

We estimated the mean unit cost per disease to the SUS (public) and the supplementary health sector (private) through the micro-costing and cost-per-procedure technique. This cost was incorporated into the model, which simulated the likelihood of occurrence of the events over the individual’s life to estimate the total cost of care. The Delphi technique was used, consulting specialists in oncology, cardiology, pulmonology, and neurology to identify and quantify the health resources. The costs items included: medical consultations, tests, hospitalizations, and surgical and non-surgical procedures.

To assess the resources for the SUS, we consulted: (i) Management System for Table of Procedures, Medicines, and Orthoses, Prostheses, and Special Materials (SIGTAP. http://sigtap.datasus.gov.br/tabela-unificada/app/sec/inicio.jsp, accessed on 20/Sep/2017); (ii) Database on Prices in Health (BPS. http://aplicacao.saude.gov.br/bps/login.jsf, accessed on 22/Sep/2016); and (iii) Chamber for Regulation of the Pharmaceuticals Market (CMED. http://portal.anvisa.gov.br/cmed, accessed on 25/Sep/2016). We also reviewed the reports on approval of incorporation of technologies by the SUS by the National Committee for Health Technology Incorporation since 2011 (CONITEC. http://conitec.gov.br/, accessed on 04/Oct/2016). The cost of cancer of the larynx and cancer of the esophagus for the SUS was obtained in the literature ³¹31. Pinto M, Uga MA. Custo do tratamento de pacientes com histórico de tabagismo em hospital especializado em câncer. Rev Saúde Pública 2011; 45:575-82.. The procedures tables for the national health insurance market and the Brazilian Hierarchical Classification of Medical Procedures published by the Brazilian Medical Association (CBHPM. https://amb.org.br/cbhpm/, accessed on 30/Sep/2017) were consulted to calculate the costs to the supplementary health system.

Indirect cost

The theory of human capital was used to estimate the cost from premature death and disability ³²32. Krol M, Papenburg J, Koopmanschap M, Brouwer W. Do productivity costs matter?: the impact of including productivity costs on the incremental costs of interventions targeted at depressive disorders. Pharmacoeconomics 2011; 29:601-19.^,3333. Nyan JA. Productivity costs revisited: towards a new US policy. Health Econ 2012; 21:1387-401.. We assumed that the value for society of the loss of productivity can be measured as the current values of the individuals’ lost work time, according to their market wages, and to which was assigned a productivity equal to a worker’s marginal productivity in a perfectly competitive market ³⁴34. Zhang W, Bansback N, Anis AH. Measuring and valuing productivity loss due to poor health: a critical review. Soc Sci Med 2011; 72:185-92..

Presenteeism was used to estimate the disability’s cost, a concept that refers to the decrease in work productivity when an individual is reincorporated into work after the disease. The decrease in productivity as a consequence of the illness can be expressed as a shorter workday and lower level of production per hour of work, or both ³⁵35. Krol M, Brouwer W, Rutten F. Productivity costs in economic evaluations: past, present, future. Pharmacoeconomics 2013; 31:537-49..

The current value of a person’s future income depends on their life expectancy, participation in the labor market, and income from work. The human capital value of an individual of a given sex and age is the current value of this income in the future, according to the actuarial formula of the value of a statistical life (VSL):

In which prob(alive) is the probability that an individual will be alive the next year (Instituto Brasileiro de Geografia e Estatística. Projeção da população brasileira por sexo e idade: 2000-2060. https://www.ibge.gov.br/estatisticas-novoportal/sociais/populacao/9109-projecao-da-populacao.html?=&t=o-que-e, accessed on 20/Apr/2016); wages is an estimate of the individual’s annual income from work ³⁶36. Instituto Brasileiro de Geografia e Estatística. Pesquisa Nacional por Amostra de Domicílios. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística; 2015.; and the last term considers two parameters assumed as constants: a growth rate over time in income from work (parameter g), the premise of which is that this growth is equal to the mean annual growth rate for Brazil’s per capita GDP, or 2.25% per annum, from 1960 to 2015 (World Bank. http://data.worldbank.org/indicator/), and a 5% discount factor for future income (parameter r). Calculation of the VSL associated with an individual of a given sex and age is the sum of the products for each age.

It was necessary to adopt alternative models for the reduction of work productivity ³⁵35. Krol M, Brouwer W, Rutten F. Productivity costs in economic evaluations: past, present, future. Pharmacoeconomics 2013; 31:537-49.^,3737. Knies S, Severens JL, Ament AJ, Evers SM. The transferability of valuing lost productivity across jurisdictions. differences between national pharmacoeconomic guidelines. Value Health 2010; 13:519-27.^,3838. Mattke S, Balakrishnan A, Bergamo G, Newberry SJ. A review of methods to measure health-related productivity loss. Am J Manag Care 2007; 13:211-7. using an indirect estimation criterion: it was assumed that individuals’ work productivity decreased due to smoking at the same proportion as the reduction of quality of life attributed to it ¹⁶16. Gail MH, Kessler L, Midthune D, Scoppa S. Two approaches for estimating disease prevalence from population-based registries of incidence and total mortality. Biometrics 1999; 55:1137-44.. We also estimated the probability of an individual surviving from year t to year t + 1 according to the life table by age and sex in 2015, published by the IBGE (http:www.ibge.gov.br, accessed on 18/Mar/2017).

The Mincer ³⁹39. Harberger AC, Guillermo-Peón S. Estimating private returns to education in Mexico. Lat Am J Econ 2011; 49:1-35.^,4040. Lemieux T. The "Mincer equation" thirty years after schooling, experience and earnings. In: Grossbard S, editor. Jacob Mincer: a pioneer of modern labor economics. Boston: Springer; 2006. p. 127-45. equation was applied to estimate mean annual income (referring to the term wages in Equation 1) by sex and age based on maximum schooling attainment, labor market experience (approximated by age and age-squared), and geographic location:

In which ln(wages) is the natural logarithm of the wages received for the individual’s principal work activity, age and age ² seek to approximate work experience, level schooling 1,... level schooling 8 represent the different levels of schooling attained, urban is the variable that indicates whether the individual lives in an urban or rural area, and ε represents the model’s error term, which assumes meeting the classical assumptions. To calculate the equation, the ordinary least squares method was applied and the data were obtained from the Brazilian National Household Sample Survey (PNAD 2015) ³⁶36. Instituto Brasileiro de Geografia e Estatística. Pesquisa Nacional por Amostra de Domicílios. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística; 2015.. The analyses were performed with Stata, version 14.1 (https://www.stata.com).

Excise tax model

This model was based on the application of percentage increases in cigarette prices. Prevalence of smoking obtained with this increase was calculated as:

In which: Prevalence_post is the prevalence of smoking after the price increase; Prevalence_pre is the prevalence of smoking before the price increase; E_d is the price elasticity of demand ⁴¹41. Iglesias R, Jha P, Pinto M, Silva V, Godinho J. Tobacco control in Brazil. Washington DC: World Bank; 2007. (HNP Discussion Paper Series).; Δ%P is the percentage variation of price; and I_p is the proportion of variation in tobacco consumption that impacts the prevalence of smokers.

We calculated the expected impact on health outcomes, drawing on the Brazilian national context to define three price increase scenarios: short-, medium-, and long-term. The basi case for comparison was estimated by the unification of the three scenarios, and the results were accumulated for 10 years. We assumed linear evolution from the short-term scenario to the medium-term scenario in a five-year period, and then to the long-term scenario, from year 6 to year 10 ¹²12. Pinto M, Bardach A, Palacios A, Biz AN, Alcaraz A, Rodríguez B, et al. Carga de doença atribuível ao uso do tabaco no Brasil e potencial impacto do aumento de preços por meio de impostos. Buenos Aires: Instituto de Efectividad Clínica y Sanitaria; 2017. (Documento Técnico IECS, 21).. Based on these estimates of change in the prevalence and redistribution involved in the proportion of smokers, former smokers, and non-smokers in the population, we focused on the estimate of the expected burden of tobacco-related diseases in the country based on these new conditions, according to the same method adopted to estimate the underlying burden of disease. The impact on health outcomes was calculated as the observed difference between the two estimates of deaths, occurrence of events, years of potential life lost, disability, and direct and indirect costs.

Impact on tax revenue

The expected variation in revenue in the different scenarios of cigarette sales price increases was estimated by ⁴²42. Santerre R, Neun SP. Health economics: theory, insights, and industry studies. 5th Ed. Boston: Cengage Learning; 2012.:

In which: Δ%R is the percentage variation in revenue; Δ% consumption is the expected percentage variation in consumption from the increase in sales price; Δ% price represents the percentage variation in the consumer sales price; and %tax is the proportion of the consumer sales price corresponding to the tax.

Impact on health outcomes and the economy

Three scenarios of price increases for cigarettes, through taxes, were proposed (25%, 50%, and 75%) over the course of 10 years. Impacts on health outcomes are expressed as the decrease in prevalence and thus in deaths, cases of tobacco-related diseases, and averted costs. Impacts on the economy are expressed as the total economic benefit calculated by the sum of the averted direct and indirect costs and the additional tax revenue due to the price increase. The results are presented in BRL for 2015.

Results

Calibration and validation

The mean event rate for each parameter was within plus-or-minus 10% of the rates found in the national statistics, which guaranteed excellent internal validation. Assessment of the correlation between the observed and expected results produced R² values between 0.700 and 0.999 (perfect fit = 1), indicating high correlation. External validation was performed by comparison of the model’s results with published epidemiological studies (that were not used as data sources in this study). A favorable correlation was observed between the model’s predicted values and those observed in the selected references (Figure 1).

Deaths and events attributable to smoking

The model estimated 558,789 deaths in 2015, of which 156,337 (28%) were attributable to smoking and which corresponded to 12.6% of total deaths in the country (1,239,810). The proportion of attributable deaths was highest for COPD (74%) and lung cancer (78%). Cerebrovascular accident (stroke) and AMI corresponded to 13% and 18% of the total, respectively. Passive smoking and perinatal causes totaled 18,093 deaths per year. A total of 77,500 cases of cancer were diagnosed, of which 26,850 were lung cancer. There were 1,103,423 acute and chronic events, of which 378,594 (34%) cases of COPD, 229,071 (21%) of AMI, and 59,509 (5%) of stroke (Table 1).

Years of potential life lost

The years of life lost, expressed as YPLL, totaled 4,203,389, resulting from 71.7% of YPLL-PM for both sexes. Of this total, 64% of YPLL-PM occurred in males. Most of the YPLL-PM were attributed to ischemic cardiovascular diseases (27.1%), COPD (20%), and lung cancer (16%). Life expectancy in female smokers is 6.71 years shorter than for non-smokers, while the difference between former smokers and non-smokers is 2.45 years. Male smokers and former smokers lose 6.12 and 2.66 years of life, respectively, when compared to non-smokers.

Costs

The direct cost of healthcare for diseases not attributed to smoking was BRL 96,724,046,812. The cost (from society’s perspective) attributable to smoking totaled BRL 56,898,155,567, and the direct cost accounted for 70% (BRL 39,404,319,965). COPD (BRL 15.990.182.776), cardiac diseases (BRL 10,264.380,964), lung cancer (BRL 2,285,584,843), and stroke (BRL 2,174,230,523) accounted for 78% of this cost. The costs of passive smoking and perinatal causes totaled BRL 4,542,046,307 (Table 2). The indirect cost was BRL 19,744,770,789, of which BRL 9,751,467,172 due to premature death and BRL 9,993,303,617 due to disability (Table 3).

Expected effects of cigarette sales price increases by increasing taxes

In 10 years, the impact produced by increases in cigarette prices expressed in economic benefits would vary from BRL 55.1 billion (price increase of 25%) to BRL 128.8 billion (increase of 75%). With a 50% price increase, the number of averted deaths would vary from 68,241 to 204,723. Averted cardiac diseases and strokes would total 507,451 and 100,365 cases, respectively. For cancer, the projection would be 64,382 averted cases (Table 4).

Discussion

This study expanded the results published in 2011 ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97. by estimating indirect costs and developing a cigarette excise tax model. There were 156,337 deaths in 2015, or 6.3% more than in 2011 ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.. Factors that could explain this increase would be a difference in smoking prevalence between age groups and the 11% population growth from 2007 to 2015, the year of the first and current estimates, respectively (IBGE. http://www.ibge.gov.br, accessed on 15/Mar/2017).

Cardiac diseases, COPD, lung cancer, and stroke accounted for 65% of the deaths, maintaining the same tendency as in 2011 ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.. However, deaths from AMI and stroke were reduced by some 4% and 40%, respectively, also in comparison to 2011, which corroborates the downward trend in mortality from cardiovascular diseases in Brazil ⁴³43. Ribeiro AL, Duncan BB, Brant LC, Lotufo PA, Mill JG, Barreto SM. Cardiovascular health in Brazil: trends and perspectives. Circulation 2016; 133:422-33.. The burden of disease was concentrated in males, with 68% of all deaths and 64% of all events. However, our results showed a reduction in the burden among men when compared to 2011, with a decline of 12% and 8% in deaths and events, respectively ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.. Prevalence of smoking dropped considerably from 2008 to 2013 in both sexes, and although Brazilian men smoke more than Brazilian women ⁴⁴44. Malta DC, Vieira ML, Szwarcwald CL, Caixeta R, Brito SM, Reis AA. Smoking trends among Brazilian population - National Household Survey, 2008 and the National Health Survey, 2013. Rev Bras Epidemiol 2015;18 Suppl 2:45-56., the reduction in prevalence and thus in the burden in men indicates an important convergence of these two indicators.

Measures to reduce exposure to second-hand smoke are a reality in Brazil (Law n. 12,546 of 2011), but before 2011 there was an increase in deaths and in the direct cost related to passive smoking and perinatal diseases (7% and 69%, respectively) ¹⁰10. Pinto MT, Pichon-Riviere A, Bardach A. Estimativa da carga do tabagismo no Brasil: mortalidade, morbidade e custos. Cad Saúde Pública 2015; 31:1283-97.. In newborns, the consequences of second-hand smoke include reduction in weight, stature, and head circumference ⁴⁵45. Zhang L, Gonzalez-Chica DA, Cesar JA, Mendoza-Sassi RA, Beskow B, Larentis N, et al.Tabagismo materno durante a gestação e medidas antropométricas do recém-nascido: um estudo de base populacional no extremo sul do Brasil. Cad Saúde Pública 2011; 27:1768-76.. Thus, protective measures for non-smokers must be enforced routinely in all environments.

In recent years, Brazil has adopted a policy of increasing excise taxes on cigarettes. In 2011, an ad valorem tax rate entered into force for cigarettes, currently set at 66.7%, besides a policy of minimum prices per pack ⁴⁶46. Secretaria da Receita Federal, Ministério da Fazenda. Estudos tributários e aduaneiros. https://idg.receita.fazenda.gov.br/dados/receitadata/estudos-e-tributarios-e-aduaneiros/estudos-e-eestatisticas/carga-tributaria-no-brasil/ctb-2015 (acessado em 03/Mar/2017).
https://idg.receita.fazenda.gov.br/dados... ^,4747. Iglesias RM. Increasing excise taxes in the presence of an illegal cigarette market: the 2011 Brazil tobacco tax reform. Rev Panam Salud Pública 2016; 40:243-9.. Our results demonstrate the benefits generated for tax revenue (an increase of up to BRL 50 billion in 10 years). It is an effective measure, as demonstrated in Brazilian and international studies ⁴¹41. Iglesias R, Jha P, Pinto M, Silva V, Godinho J. Tobacco control in Brazil. Washington DC: World Bank; 2007. (HNP Discussion Paper Series).^,4848. Kostova D, Chaloupka FJ, Shang C. A duration analysis of the role of cigarette prices on smoking initiation and cessation in developing countries. Eur J Health Econ 2015; 16:279-88., contributing to the expansion of fiscal space and favoring public investments. The success with the price and excise tax policy in avoiding costs, mortality, and morbidity also assumes the joint involvement of government areas in health, the economy, and law enforcement due to the volume of the illegal cigarette market in Brazil.

The cost of disease not attributed to smoking was significant, reaching BRL 96.7 billion per year. The estimates of burden and costs of chronic diseases at the national level in adults are scarce, and the current study is intended to support policymakers and researchers in chronic diseases by providing data on the problem’s magnitude in Brazil. The direct cost attributable to smoking increased by 70% from 2011 to 2015, which could be explained by the incorporation of new technologies both in the SUS (CONITEC. http://conitec.gov.br/decisões-sobre-incorporacoes, accessed on 11/Sep/2016) and in the private supplementary health system (ANS. http://ans.gov.br, accessed on 11/Sep/2016). The indirect cost accounted for 30% of the total cost. Since this was the first such estimate in Brazil, we suggest that indirect costs should be incorporated into future studies, given their magnitude, as already observed in other countries ²³23. Centers for Disease Control and Prevention. Smoking-attributable mortality, years of potential life lost, and productivity losses - United States, 2000-2004. MMWR Morb Mortal Wkly Rep 2008; 57:1226-8.^,4949. Yang L, Sung HY, Mao Z, Hu TW, Rao K. Economic costs attributable to smoking in China: update and an 8-year comparison, 2000-2008. Tob Control 2011; 20:266-72.^,5050. Ruff LK, Volmer T, Nowak D, Meyer A. The economic impact of smoking in Germany. Eur Respir J 2000; 16:385-90.^,5151. McGhee SM, Ho LM, Lapsley HM, Chau J, Cheung WL, Ho SY, et al. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control 2006; 15:125-30..

Due to methodological issues, comparison of the findings with other studies is limited. Still, the results in other countries are similar to ours, presenting a heavy burden for the economy. In Europe, smoking compromises 2.5% of the annual GDP, reaching 0.55% in China ⁵²52. World Health Organization Regional Office for the Western Pacific. The bill China cannot afford: health, economic and social costs of China's tobacco epidemic. Manila: World Health Organization Regional Office for the Western Pacific; 2017.. In the USA and Canada, smoking accounts for losses of 3% in the GDP, compared to 1% in the other countries of the Americas ²2. U.S. National Cancer Institute; World Health Organization. The economics of tobacco and tobacco control. Bethesda: U.S. Department of Health and Services, National Institutes of Health, National Cancer Institute/Geneva: World Health Organization; 2016. (National Cancer Institute Tobacco Control Monograph, 21). (NIH Publication, 16-CA-8029A).. In Brazil, the loss was 0.7% of the GDP, and tax revenue from the tobacco industry reached BRL 13 billion in 2015 ⁴⁶46. Secretaria da Receita Federal, Ministério da Fazenda. Estudos tributários e aduaneiros. https://idg.receita.fazenda.gov.br/dados/receitadata/estudos-e-tributarios-e-aduaneiros/estudos-e-eestatisticas/carga-tributaria-no-brasil/ctb-2015 (acessado em 03/Mar/2017).
https://idg.receita.fazenda.gov.br/dados... , that is, 23% of the total cost of BRL 56.89 billion. On this point, article 19 of the WHO-FCTC which deals with criminal and civil liability, raises the possibility of compensation for damages, which has already been enforced through court action in the United States ⁵³53. Jones WJ, Silvestri GA. The master settlement agreement and its impact on tobacco use 10 years later: lessons for physicians about health policy making. Chest 2010; 137:692-700..

The results proved robust, based on the process of calibration and validation, guaranteeing the reproducibility of the model’s results. But some limitations should be addressed. The literature points to friction cost ⁵⁴54. Koopmanschap MA, Rutten FF, van Ineveld BM, van Roijen L. The friction cost method for measuring indirect costs of disease. J Health Econ 1995; 14:171-89., the Washington panel approach ³³33. Nyan JA. Productivity costs revisited: towards a new US policy. Health Econ 2012; 21:1387-401., and the theory of human capital ³⁵35. Krol M, Brouwer W, Rutten F. Productivity costs in economic evaluations: past, present, future. Pharmacoeconomics 2013; 31:537-49.^,3636. Instituto Brasileiro de Geografia e Estatística. Pesquisa Nacional por Amostra de Domicílios. Rio de Janeiro: Instituto Brasileiro de Geografia e Estatística; 2015. as the principal methods for calculating indirect cost. The theory of human capital may overestimate costs, especially when compared to friction costs, whose calculation is more complex ³⁴34. Zhang W, Bansback N, Anis AH. Measuring and valuing productivity loss due to poor health: a critical review. Soc Sci Med 2011; 72:185-92.. However, this approach was applied due to the availability of local data, the concepts’ simplicity and that of the associated calculations, and because it is also the preferred method in the guidelines for economic evaluation in Brazil ³⁰30. Departamento de Tecnologia e Insumos Estratégicos, Secretaria de Ciência, Tecnologia e Insumos Estratégicos, Ministério da Saúde. Diretrizes metodológicas: estudos de avaliação econômica de tecnologias em saúde. Brasília: Ministério da Saúde; 2014.. Another limitation was the correction of hospitalizations for the supplementary health system (private) based on a single adjustment factor ²⁸28. Azambuja MI, Foppa M, Maranhão MF, Achutti AC. Economic burden of severe cardiovascular diseases in Brazil: an estimate based on secondary data. Arq Bras Cardiol 2008; 91:148-55., which was necessary given the insufficiency of data based on the ICD-10. This was the solution adopted in order for calculations of case-fatality and direct cost to be performed comprehensively. Finally, the results may be underestimated, since an association with smoking has been established for a broader set of diseases than those included in the current burden-of-disease model ⁴4. Carter BD, Abnet CC, Feskanich D, Freedman ND, Hartge P, Lewis CE, et al. Smoking and mortality-beyond established causes. N Engl J Med 2015; 372:631-40..

Cost-effective measures should be intensified in order to avoid deaths and illness from smoking, and in consequence, generating benefits for Brazilian society. The costs for society reflect an important opportunity cost, and compensation for damages is a timely topic for the debate on the tobacco control agenda. The resulting resources can be invested in the full implementation of the Framework Convention on Tobacco Control, but they should not be limited only to this purpose, since other public policies can also benefit from this compensation.

Acknowledgments

The authors wish to thank the Brazilian National Cancer Institute José Alencar Gomes da Silva and the International Development Research Centre.

References

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