1. Health Technology Assessment Brazilian environment Denizar Vianna Universidade do Estado do Rio de Janeiro Faculdade de Ciências Médicas Departamento de Clínica Médica

2. Outline  An Overview of Health Care System  Structure of HTA in Brazil  How Brazil uses HTA to inform coverage decisions: Case Study

3. An Overview of Health Care System  Population: 192 million  Area: 8,514, 215.3 km 2, 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/

4. ParametersPublicPrivate Coverage100%25% FundingTaxes 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 An Overview of Health Care System Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13 th Annual European Congress 2010

5. ReimbursementPublicPrivate 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 An Overview of Health Care System Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13 th Annual European Congress 2010

6. Outline  An Overview of Health Care System  Structure of HTA in Brazil  How Brazil uses HTA to inform coverage decisions: Case Study

7. PRODUCERSPAYERS Supply chain of healthcare products Unified Health System (public) REGULATORSEmployers and out-of-pocket (private) MoH and Department of the treasury USERS ANVISAPatients (patients organizations) ANSEVALUATORS INMETROMoH INPIANVISA MANAGERSMedical Schools MoHPROVIDERS HMOsHealthcare providers Who is who in the Brazilian Context

9. REGISTRATION Health Technology Assessment in Brazil 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 13 th Annual European Congress 2010

10. CMED Chamber for Regulation of the Pharmaceutical Market (ANVISA) –Regulation of reference prices for drugs –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 REGISTRATION PRICING Health Technology Assessment in Brazil Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13 th Annual European Congress 2010

11. REGISTRATION PRICING REIMBURSEMENT CONITEC National Commission for Incorporation of Technologies - Evaluations based on HTA reports -Recommendations for inclusion or exclusion of technologies -Dossier submission open to the society -Final decision taken by the SCTIE Health Technology Assessment in Brazil Source: Teich V. Brazil as a Case Study of Health Technology Assessment (HTA) on Emerging Markets: How Useful are Strategies from Developed Countries? ISPOR 13 th Annual European Congress 2010

12. http://portal.saude.gov.br/portal/saude/Gestor/area.cfm?id_area=1611

17. Commission for Incorporation of Technologies (CITEC) Numbers  260 submissions to CITEC from 2003 to 2010

18. CITEC Numbers 13% 48% 10% 0%

19. CITEC Numbers 9% 26% 71% 77% 17% 14% 16% 29% 22% 33%

21. Outline  An Overview of Health Care System  Structure of HTA in Brazil  How Brazil uses HTA to inform coverage decisions: Case Study

23. Case Study: Statins for patients with high risk of cardiovascular disease

24. “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 Scenario

26. Cost-Effectiveness Analysis Results OUTCOME AVOIDEDICER*ICER** Death from any causeCost savingR$ 433.065,05 Death from cardiovascular cause Cost savingR$ 948.998,15 Myocardial infarctionCost savingR$ 157.854,22 StrokeCost savingR$ 824.860,31 CABG or PTCACost savingR$ 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.

28. Case Study: Drug Access to Rare Diseases

29. 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.

30. 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.

31. Diseases theoretically covered in the National Policy of 2009 with treatment protocol granted*

33. THANK YOU Denizar Vianna Universidade do Estado do Rio de Janeiro Faculdade de Ciências Médicas Departamento de Clínica Médica