Marcos B. Ferraz MD, PhD

Transcrição

1 Marcos B. Ferraz MD, PhD Associate Professor, Department of Medicine, Federal University of São Paulo Director, São Paulo Center for Health Economics, Federal University of São Paulo Director of Medical Economics, Brazilian Medical Association 3rd ISPOR Latin America September 2011 México City, México

2 Brazil and the Brazilian Health Care System in a nutshell Population: 190 million inhabitants (2010 estimates) Public Health Care System (Unified = SUS) Mandatory / Tax / 3.6% GDP / 100% Private Health Care System Optional / Premium / 4.4% GDP / 24% US$ 360/p/y US$ 1,820/p/y Brazilian 1988 Constitution states: Health is a right of the citizen and a responsibility of the Brazilian State No limits are stated or defined

3 Brazil and the Brazilian Health Care System in a nutshell Health Care System - Ministry of Health Brazil - State Secretaries of Health States (26+1 FD) - Municipal Secretaries of Health Cities (5.560) Agencies Licensing and Pricing - ANVISA National Health Surveillance Agency - ANS National Agency for Private Health Care

4 Registration and listing of drugs Registration: - ANVISA is responsible for registering drugs, devices, equipments, medical products,... - Once Registered, the drug/product can be commercialized in Brazil Listing of drugs to be available free of charge RENAME, Exceptional drug list,... MoH decision High cost medicines

5 Registration: what has been done recently ANVISA Up to 2003 all products were basically evaluated taking into consideration Safety + Effectiveness In 2003 the CMED was created to discuss the Price of new drugs (products) to be registered as well as the maximal annual price increase for drugs CMED is a governmental council that aims to economically regulate the market of drugs in Brazil

6 Listing of drugs: HTA in Brazil - what has been done in recent years July 2003 MH created the Council for Science, Technology and Innovation / Strategy Dec 2005 MH created the Institucional Committee to define HC Technology Assessment and Management Strategies and Policies (MH, ANVISA, ANS) Dec 2006 MH approved the National Policy to Evaluate and Manage HC Technologies (for the Public and Private HC Systems)

7 The National Policy to Evaluate and Manage HC Technologies (Edict Dec 27, 2006) 1. Description of Technology Required information: No Value Judgements? 2. Identification of submitter 3. Number of ANVISA registry Still Market 4. Proposed price approved by ANVISA Driven 5. Technical report presenting the scientific evidence of safety, efficacy/effectiveness comparing the proposed technology with the available and current technology 6. Economic Evaluation (CE and CU evaluation) when there is a trade-off involving effectiveness and costs 7. Budget Impact Analysis

8 Changes made to the basic requirements in the past 2 years New Law approved by the Brazilian Congress PLS 338 / 2007: 1. The revision of the list of drugs, procedures and devices listed by MoH every year 2. The establishment of the National Council for the Incorporation of Medicines and Products for Health. which includes representatives of patients and patient organizations 3. Decisions for listing products should be done within days after the submission of the dossier. If no decision is made, the drug is automatically listed. 4. Medicines and products for health should be used according to the clinical guidelines approved by the MoH

9 - 60 Technologies approved and listed by the MoH (SUS) - 29 Proposals for listing were denied (not approved) - 04 Proposals defined as out of the scope of the MoH (SUS) - 01 Proposal for delisting was not approved - 04 Technologies were delisted by the MoH (SUS) - 03 Technologies pharma company withdrew the submission

10 - 74 studies were underway - 86 clinical guidelines were under revision - 15 academic institutions (mostly universities) were somewhat working in partnership with MoH UFRGS, USP, UNIFESP, Centro Cochrane do Brasil, INC, UFBA, Inst. Mat.Inf. PE, HC de Porto Alegre, UFSC, PUC do Rio Grande do SUL, UFMG, Instituto Nacional de Traumatologia e Ortopedia (Into), Fundação Oswaldo Cruz, Universidade Federal do Paraná, Universidade Caxias do Sul

11 193 - Adalimumabe - Abbot / Artrite Reumatóide Adalimumabe Abbot / Espondilite anquilosante Adalimumabe Abbot / Psoríase Adalimumabe Abbot / DAF / Artrite Psoriática Abatacepte Bristol Myers Squibb / , / , / , / /2007 Artrite Reumatoíde moderada a grave Azatioprina DAF Não há processo 2010 Tratamento da Esclerose Sistêmica Esclerodermia Ciclofosfamida DAF Não há processo 2010 Tratamento da Esclerose Sistêmica Esclerod Leflumida DAF 2010 Artrite Psoriática Metotrexato DAF 2010 Artrite Psoriática Metotrexato DAF Não há processo 2010 Tratamento da Esclerose Sistêmica Esclerodermia Sulfassalazina DAF 2010 Artrite Psoriática Teriparatida injetavel Eli Lilly / , / , / , 2003 Tratamento da osteoporose severa

12 206 - Ustequinumabe Janssen-Cilag / Psoríase em placa, moderada a grave, em adultos que não responderam ou que tem uma contra-indicação, ou que são intolerantes a outras terapêuticas sistêmicas, incluindo ciclosporina, metotrexato e radiação ultravioleta A associada à administração de psoraleno (PUVA) Infliximabe Mantecorp / Espondilite Anquilosante Ativa Infliximabe Mantecorp / DAF / Artrite Psoriática Infliximabe Mantecorp Industria Química e Farmaceutica Ltda / , / /2007 Psoriase Etoricoxibe 90 mg Merck Sharp&Dohme / Espondilite Anquilosante Acido zoledrônico Novartis / , / , / , / (APENSO), / /2006 Doença de Paget Acido Zoledrônico 5 mg Novartis / , / , / / 2007 Osteoporose Pós-Menopausa Canaquinumabe Novartis Biociência S.A / Sindrome períodica associada à criopirina CAPS Tocilizumabe Roche / , / , / /2009 Tratamento da artrite reumatóide ativa moderada e grave Hidroxicloroquina SAS Não há processo 2010 Tratamento da dermatopolimiosite Infliximabe SAS Não há processo 2010 Retocolite Ulcerativa Sulfassalazina SAS Não há processo 2010 Tratamento da espondilose

13 218 - Metotrexato SAS/DAF Não há processo 2010 Tratamento da dermatopolimiosite Rituximabe SCTIE e ANAPAR / , / , (apensos / / , / )/2007 Artrite Reumatóide Efalizumabe Serono / , / , / /2004 Psoriase em placas de grau moderado a severo 221- Ranelato de Estrôncio Servier do Brasil lda / , / Tratamento da Osteoporose pósmenopausa para redução do risco defraturas vertebrais e do quadril Etanercepte (apresentação 25 mg) Wyeth Não há processo 2006 Artrite Reumatoíde 223 Etanercepte (apresentação 50 mg) Wyeth / Artrite Reumatoíde Etanercepte Wyeth / Espondilite Anquilosante Ativa Etanercepte Wyeth / Artrite Reumatóide Etanercepte Wyeth / DAF / , / Psoriase em placas e artrite psoriásica

14 Risk Sharing Negotiations / Proposals Presently, not part of the process (due to the Law) Risk sharing negotiations have rarely been discussed at Brazilian scientific meetings, pharma companies or academia.

15 Conclusion Positive aspects of the current Brazilian HTA process 1. It is a standardized and transparent process 2. It stimulates HC stakeholders to consider and value EBHC, EBPM, HE in the reasoning process 3. It contributes to the achievement of a more conscious and justifiable decision in HC 4. It contributes to identify educational and knowledge gaps in HC 5. A learning process is inherently part of the HTA process

16 Conclusion HTA in Brazil: Limitations of the current HTA process 1. Theory (ideal world) vs Practice (real world): - Knowledge and needs vs process 2. Short vs Long term decisions - Comprehensive evaluation of opportunity costs 3. Technical vs Political decisions - Perceived needs and unpopular decisions 4. Efficiency and Equity Does the current HTA process has the potential to increase any or, most importantly, both?

17 Conclusion HTA in Brazil: beyond the limitation of CEA, ICERs, to inform decisions (value to society) The Brazilian HTA process is a FUNNEL process in a still low-educated environment Transparency???? Known Objectives, Priorities???? with lots of problems and opportunities Decisions driven only by resource constraint???? Know process???? Value judgements????

18 Thank you! São Paulo Center for Health Economics