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Universidade do Estado do Rio de Janeiro Faculdade de Ciências Médicas Departamento de Clínica Médica Health Technology Assessment Brazilian environment Denizar Vianna Outline An Overview of Health Care System Structure of HTA in Brazil How Brazil uses HTA to inform coverage decisions: Case Study An Overview of Health Care System Population: 192 million Area: 8,514, 215.3 km2, 27 states GDP: US$ 2.201 trillion, with a GDP per capita of US$ 11,600. Public Health Care System Coverage: Universal Access Private Coverage: 25% of the population (≈ 48 million) Source: http://www.ipeadata.gov.br/ An Overview of Health Care System Parameters Public Private 100% 25% Taxes Employers and employees contributions Individuals out-of-pocket Provision 64,000 primary care units 5,900 hospitals in the federal, state, and municipal level Dedicated private hospitals and outpatient clinics Purchasing Diagnostic Related Groups Salaries for physicians Fee for service Coverage Funding Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010 An Overview of Health Care System Reimbursement Public Private Drugs Basic health care Basic Component of Pharmaceutical Assistance Not reimbursed Out of pocket Drugs Endemics, HIV, Blood products Component of Strategic Pharmaceutical Assistance Not reimbursed Public programme Drugs Specialized health care Component of Specialized Pharmaceutical Assistance Registered drugs taken in ambulatory or inhospital care (ICD-10) Exclusion of oral drugs Procedures Medium and High Complexity of Ambulatory and Inpatient Care List of covered procedures updated every 2-years Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010 Outline An Overview of Health Care System Structure of HTA in Brazil How Brazil uses HTA to inform coverage decisions: Case Study Who is who in the Brazilian Context PRODUCERS Supply chain of healthcare products REGULATORS MoH and Department of the treasury ANVISA ANS INMETRO INPI MANAGERS MoH HMOs PAYERS Unified Health System (public) Employers and out-of-pocket (private) USERS Patients (patients organizations) EVALUATORS MoH ANVISA Medical Schools PROVIDERS Healthcare providers Health Technology Assessment in Brazil REGISTRATION ANVISA National Agency of Sanitary Vigilance –Efficacy and safety of new technologies –Production quality –Approved label Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010 Health Technology Assessment in Brazil REGISTRATION CMED Chamber for Regulation of the Pharmaceutical Market (ANVISA) –Regulation of reference prices for drugs PRICING – International price – 9 reference countries – Price of other drugs with similar efficacy in the market –Yearly price updates –Coefficient of Price Adaptation (21.87%) for sales to public bodies Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010 Health Technology Assessment in Brazil REGISTRATION CONITEC National Commission for Incorporation of Technologies -Evaluations based on HTA reports PRICING -Recommendations for inclusion or exclusion of technologies -Dossier submission open to the society REIMBURSEMENT -Final decision taken by the SCTIE Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13th Annual European Congress 2010 http://portal.saude.gov.br/portal/saude/Gestor/area.cfm?id_area=1611 Commission for Incorporation of Technologies (CITEC) Numbers 260 submissions to CITEC from 2003 to 2010 80 73 70 56 60 50 43 49 40 30 24 20 10 2 4 2003 2004 9 0 Industry 2005 2006 Public Bodies 2007 2008 Medical Societies 2009 Others 2010 CITEC Numbers 0 20 40 60 80 100 120 140 48% Public Bodies Others 180 13% Industry Medical Societies 160 10% 0% Submissions Recommendations Incorporations CITEC Numbers 0 5 10 15 20 25 30 35 Rheumatology 9% 26% Oncology 17% Endocrine and Metabolic Disorders 14% Mental Health and Neurology 16% Cardiovascular System 29% Genetic Disorders 71% AIDS and Viral Hepatitis 77% Hematology 22% Respiratory Disorders Infectious Diseases Submissions 33% Recommendations Incorporations 40 Outline An Overview of Health Care System Structure of HTA in Brazil How Brazil uses HTA to inform coverage decisions: Case Study Case Study: Statins for patients with high risk of cardiovascular disease Scenario “In Brazil, the expense of the public sector with statins in the last 12 months was approximately R$ 92 million, and of this amount, 96% spending represented only with atorvastatin. Regarding the quantity purchased, atorvastatin also has higher percentage (approximately 52%), followed by simvastatin (46%), which consumed only 3% of public expenditures with this class of drugs.” Source: Boletim Brasileiro de Avaliação de Tecnologias em Saúde, Ano IV, nº 9, 2009 Results Cost-Effectiveness Analysis OUTCOME AVOIDED ICER* ICER** Death from any cause Cost saving R$ 433.065,05 Death from cardiovascular cause Cost saving R$ 948.998,15 Myocardial infarction Cost saving R$ 157.854,22 Stroke Cost saving R$ 824.860,31 CABG or PTCA Cost saving R$ 517.761,59 *simvastatin versus placebo **atorvastatin versus placebo Source: Araujo DV et al. Análise de Custo-Efetividade da Sinvastatina versus Atorvastatina na Prevenção Secundária de Eventos Cardiovasculares no Sistema Único de Saúde Brasileiro. Value in Health 2011;14:S29-S32. Case Study: Drug Access to Rare Diseases Drug Access to Rare Diseases The fact that Brazil does not have an official policy specifically for rare diseases does not mean, however, that patients do not receive care and treatment. They eventually secure medication, mostly through the courts. And the SUS, one way or another, meets the needs of these people - but in a piecemeal fashion, without planning, with great waste of public resources. Drug Access to Rare Diseases Through these protocols – the official entryway to care for rare diseases in the public system – 45 drugs and surgical and clinical treatments were offered, 70,000 office visits and more than 560 laboratory procedures for treatment and diagnosis were carried out, with investment of more than than R$ 4 million per year. Diseases theoretically covered in the National Policy of 2009 with treatment protocol granted* Universidade do Estado do Rio de Janeiro Faculdade de Ciências Médicas Departamento de Clínica Médica THANK YOU Denizar Vianna