INSTITUTIONAL ADVANCES IN HEALTH TECHNOLOGY ASSESSMENT FOR DECISION-MAKING IN THE MINISTRY OF HEALTH OF BRAZIL

1. Health Technological Assessment The MoH Experience INSTITUTIONAL ADVANCES IN HEALTH TECHNOLOGY ASSESSMENT FOR DECISION-MAKING IN THE MINISTRY OF HEALTH OF BRAZIL Reinaldo Guimarães Secretary of Science, Technology and Strategic Inputs Ministry of Health of Brazil

2. SOME INFORMATION ABOUT HEALTH FINANCIAL SUPPORT IN THE WORLD Source: http://stats.oecd.org/wbos/Index.aspx?DatasetCode=CSP2008 * The Brazilian data from 2006 refer to 2005. Source: WHO

3. GENERAL CONSIDERATIONS - 1 • Among the countries which have Universal Health Systems, the total health public expenditure in Brazil is considered relatively low. • There is a need of a health public expenditure improvement. • However, expenditure increase in health does not necessarily reflects efficiency improvement in health systems. • There is a need of qualifying the health expenditure.

4. GENERAL CONSIDERATIONS - 2 North Americans complain more than users from other developed nations about their health systems, despite of having high expenditure in health. (e.g.: United Kingdom, Canada, Australia) Source: Porter and Teisberg, 2007

5. THE HEALTH INDUSTRIAL COMPLEX IN BRAZIL MAIN MARKET FEATURES – SIZE AND PUBLIC SECTOR PARTICIPATION 10th world market on medicines ~ US$ 12 billion. SUS market share is around 30% (Direct participation: MoH Budget: ~US$ 3,0 billion + ~ US$ 0.8 billion States and Municipalities budgets) Vaccines, Diagnostics and Hemoderivatives Market ~ US$ 1.4 billion. SUS vaccine and hemoderivatives market share over 90%. Health Equipments and Medical Devices Market ~ US$ 3,0 billion.

6. THE HEALTH INDUSTRIAL COMPLEX IN BRAZIL DISBURSEMENTS WITH MEDICINES AND VACCINES – 2003 TO 2009 (R$) *1) estimado a partir dos gastos em procedimentos (entre 45% e 50% dos gastos totais) Fonte: DAF/SCTIE

7. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS POLICY ASPECTS CITEC (SCTIE,SVA,SAS,ANVISA ANS) The Minister Office (last instance) HTA OPERATIONAL ASPECTS TECHNICAL ASPECTS SAS/SVS/SCTIE (DAF) SCTIE (Decit)

8. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS - 2 POLICY ASPECTS CITEC OPERATIONAL ASPECTS TECHNICAL ASPECTS MARKET PUSH (INDUSTRY AND PRIVATE SERVICE SECTOR)

9. CITEC – SOME INFORMATION ABOUT – THE MARKET PUSH 2006 – 2009: 157 incorporation proposals – 133 presented by importers or producers

10. CITEC – SOME INFORMATION ABOUT - RESULTS 157 PROPOSALS PRESENTED. 15 PRODUCTS INCLUDED INTO THE MoH/SUS LISTS. 9 PROPOSALS REFUSED. 50 PROPOSALS ALREADY PRIORITIZED AND UNDER CURRENT SCRUTINY.

11. CITEC – SOME INFORMATION ABOUT – INCORPORATION RHYTHM INDUSTRY PRODUCT LAUNCHING RHYTHM VERSUS SAFETY, EFFECTIVENESS AND COST-EFFECTIVENESS ANALYSIS RHYTHM. INCORPORATION MEANS PRODUCT INCLUSION INTO A PROTOCOL, ENCOMPASSING STATE RESPONSIBILITY BYRISKS AND RESULTS. TWO PRODUCTS WAITING ANALYSIS HAD THEIR COMMERCIALIZATION SUSPENDED BY ANVISA (REGISTER CANCELLED). TWO OTHER GOT OUT OF MARKET BY THE PRODUCERS THEMSELVES.

12. CITEC – SOME INFORMATION ABOUT – MARKET AND PUBLIC HEALTH PUSHES Market Push – Usually proposal of product incorporation. Mainly commercial issues involved. X Public Health System Push – Usually proposal of therapeutic protocols driven to lines of care and/or diseases Response to Health Problems Public Interests

13. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS - 3 POLICY ASPECTS PUBLIC HEALTH SYSTEM PUSH OPERATIONAL ASPECTS TECHNICAL ASPECTS MARKET PUSH (INDUSTRY AND PRIVATE SERVICE SECTOR)

14. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS - 4 POLICY ASPECTS 1 prioritizing OPERATIONAL ASPECTS TECHNICAL ASPECTS

15. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS - 5 POLICY ASPECTS 2 evidence raising 1 OPERATIONAL ASPECTS TECHNICAL ASPECTS

16. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS - 6 POLICY ASPECTS 2 1 3 evidence delivering OPERATIONAL ASPECTS TECHNICAL ASPECTS

17. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS - 7 POLICY ASPECTS MIN. OFFICE 4 APPROVAL 1 2 3 OPERATIONAL ASPECTS TECHNICAL ASPECTS

18. THE TECHNOLOGICAL INCORPORATION PROCESSA QUITE COMPLEX PROCESS - 7 POLICY ASPECTS MIN. OFFICE 4 approval 1 5 protocols and guidelines 2 3 OPERATIONAL ASPECTS TECHNICAL ASPECTS

19. HEALTH TECHNOLOGY ASSESSMENT (HTA) • Definition: • A multidisciplinary process that summarizes information about the medical, social, economic and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. • Aspects: • Safety, accuracy, efficiency, effectiveness, cost, cost-effectiveness, equity and ethical, cultural and environmental impacts. • Objectives: • To subsidize decision-making process and to support health professionals and health users concerning safety, general benefits and costs.

20. TIMELINEHISTORY OF HTA PROCESS IN THE MINISTRY OF HEALTH OF BRAZIL Brazilian HTA AGENCY and Health Research Brazilian HTA AGENCY and Health Research Brazilian HTA AGENCY and Health Research Brazilian HTA AGENCY and Health Research Brazilian HTA AGENCY and Health Research Brazilian HTA AGENCY and Health Research TIME TIME TIME TIME TIME TIME 2009 2009 2009 2009 2009 2009 Brazilian HTA Network Brazilian HTA Network Brazilian HTA Network Brazilian HTA Network Brazilian HTA Network Brazilian HTA Network 2008 2008 2008 2008 2008 2008 I International Seminar on Health Technologies Management I International Seminar on Health Technologies Management I International Seminar on Health Technologies Management I International Seminar on Health Technologies Management I International Seminar on Health Technologies Management I International Seminar on Health Technologies Management 2007 2007 2007 2007 2007 2007 2006 2006 2006 2006 2006 2006 National Policy on Health Technology Management and National Clinical Research Network National Policy on Health Technology Management and National Clinical Research Network National Policy on Health Technology Management and National Clinical Research Network National Policy on Health Technology Management and National Clinical Research Network National Policy on Health Technology Management and National Clinical Research Network National Policy on Health Technology Management and National Clinical Research Network HTA General Coordination – DECIT/SCTIE/MS HTA General Coordination – DECIT/SCTIE/MS HTA General Coordination – DECIT/SCTIE/MS HTA General Coordination – DECIT/SCTIE/MS HTA General Coordination – DECIT/SCTIE/MS HTA General Coordination – DECIT/SCTIE/MS 2005 2005 2005 2005 2005 2005 II National Conference on ST&IH II National Conference on ST&IH II National Conference on ST&IH II National Conference on ST&IH II National Conference on ST&IH II National Conference on ST&IH 2004 2004 2004 2004 2004 2004 Conselho de C, T &I do MS - GT ATS Conselho de C, T &I do MS - GT ATS Conselho de C, T &I do MS - GT ATS Conselho de C, T &I do MS - GT ATS Conselho de C, T &I do MS - GT ATS Conselho de C, T &I do MS - GT ATS 2003 2003 2003 2003 2003 2003 Clinical guidelines for high-cost medicines Clinical guidelines for high-cost medicines Clinical guidelines for high-cost medicines Clinical guidelines for high-cost medicines Clinical guidelines for high-cost medicines Clinical guidelines for high-cost medicines 2000 2000 2000 2000 2000 2000 REFORSUS Seminar REFORSUS Seminar REFORSUS Seminar REFORSUS Seminar REFORSUS Seminar REFORSUS Seminar 1997 1997 1997 1997 1997 1997 I National Conference of S&TH I National Conference of S&TH I National Conference of S&TH I National Conference of S&TH I National Conference of S&TH I National Conference of S&TH 1994 1994 1994 1994 1994 1994 International Seminar HCT International Seminar HCT International Seminar HCT International Seminar HCT International Seminar HCT International Seminar HCT 1989 1989 1989 1989 1989 1989 EVOLUTION EVOLUTION EVOLUTION EVOLUTION EVOLUTION EVOLUTION

21. HTA Some Products

22. HTA More products Apoio em comissões: CITEC; COMARE; GT_HPV...

23. BRAZILIAN NETWORK FOR HTA - REBRATS • REBRATS aims to produce and to disseminate priority research and studies in HTA, to standardize methodologies, to validate the studies quality and to train human resources. • It also includes horizon scanning and a new educational vision toward HTA. • All of those factors facilitate the incorporation or removal of technologies or the decision to maintain the existing ones in SUS. The network is composed by government, educational and research institutions as well as actors from different society sectors.

24. HTAREBRATS PRODUCTS • Systematic Reviews • Economic Assessment • Technical Reports • Strategic research • Structured texts for broader dissemination • - Standardized methodologies • Human resources • Monitoring of emerging technologies Virtual Environment

25. HTA Studies and Clinical Research, Brazil, 2006 to 2008 US$

26. HTA – SOME INFORMATION ABOUT – PARTNERS 43 STUDIES SUPPORTED BY THE MoH INCLUDE RESEARCH TEAMS IN THE FOLLOWING INSTITUTIONS. Federal University of Rio Grande Do Sul (UFRGS) São Paulo University (USP) São Paulo Federal University (UNIFESP) Cochrane Center Brazil (UNIFESP) National Institute of Cardiology (INC) Federal University of Bahia (UFBa) Pernambuco Institute for Mother and Child Health (IMIP) Porto Alegre Teaching Hospital (HCPA) Federal University of Santa Catarina (UFSC) Catholic University of Rio Grande do Sul (PUC-RS) Federal University of Minas Gerais (UFMG) National Institute of Trauma and Orthopedy (InTO) Oswaldo Cruz Foundation (FIOCRUZ) Federal University of Parana (UFPr) Caxias do Sul University (UCS) +19 Clinical Research Network Teams

27. CHALLENGES To disseminate HTA culture by: • Applying HTA in hospitals; • Easier access to HTA database; • Producing relevant and reliable information in a simple communication way to all audiences; • To develop continuous training and knowledge process. • To reduce the gap between development of HTA studies and the decision making process.

28. INTERNATIONAL COOPERATION “HTA work is no longer done in national isolation. The national HTA concept should include an international network strategy right from the beginning.” Handbook on HTA Capacity Building from EUnetHTA

29. HTAi 2011RIO DE JANEIRO - BRAZIL - JUNE 2011 Copacabana

30. REINALDO GUIMARÃES Secretariat of Science, Technology and Strategic Inputs Ministry of Health of Brazil reinaldo.guimaraes@saude.gov.br www.saude.gov.br