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
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%
Brazilian 1988 Constitution states: Health is a right of the citizen and a responsibility of the Brazilian State
No limits are stated or defined
US$ 360/p/y
US$ 1,820/p/y
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
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
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
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)
The National Policy to Evaluate and Manage HC Technologies (Edict 3.233 – Dec 27, 2006) Required information: 1. Description of Technology
No Value Judgements ?
2. Identification of submitter Still Market 3. Number of ANVISA registry Driven 4. Proposed price approved by ANVISA 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
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 180 + 60 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
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60 Technologies approved and listed by the MoH (SUS)
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29 Proposals for listing were denied (not approved)
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04 Proposals defined as out of the scope of the MoH (SUS)
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01 Proposal for delisting was not approved
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04 Technologies were delisted by the MoH (SUS)
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03 Technologies – pharma company withdrew the submission
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74 studies were underway
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86 clinical guidelines were under revision
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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
193 - Adalimumabe - Abbot 169522/2007-31 2007 - Artrite Reumatóide 194 - Adalimumabe Abbot 609537/2009-15 2009 Espondilite anquilosante 195 - Adalimumabe Abbot 609499/2009-92 2009 Psoríase
196 - Adalimumabe Abbot / DAF 609502/2009-78 2009 Artrite Psoriática 197 - Abatacepte Bristol Myers Squibb 168965/2007-12, 026038/2008-07 , 551859/2009-50, 593277/2009-41/2007 Artrite Reumatoíde moderada a grave 198 - Azatioprina DAF Não há processo 2010 Tratamento da Esclerose Sistêmica – Esclerodermia 199 - Ciclofosfamida DAF Não há processo 2010 Tratamento da Esclerose Sistêmica – Esclerod. 200 - Leflumida DAF 2010 Artrite Psoriática 201 - Metotrexato DAF 2010 Artrite Psoriática 202 - Metotrexato DAF Não há processo 2010 Tratamento da Esclerose Sistêmica – Esclerodermia
203 - Sulfassalazina DAF 2010 Artrite Psoriática 205 - Teriparatida injetavel Eli Lilly 146795/2003-83, 049508/2007-11, 125890/2008-58, 2003 Tratamento da osteoporose severa
206 - Ustequinumabe Janssen-Cilag 032308/2010-25 2010 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) 207 - Infliximabe Mantecorp 170583/2007-41 2007 Espondilite Anquilosante Ativa 208 - Infliximabe Mantecorp / DAF 170588/2007-73 2008 Artrite Psoriática 209 - Infliximabe Mantecorp Industria Química e Farmaceutica Ltda 170596/2007-10, 080654/2006-33 /2007 Psoriase 210 - Etoricoxibe 90 mg Merck Sharp&Dohme 050669/2007-58 2007 Espondilite Anquilosante 211 - Acido zoledrônico Novartis 048433/2006-71, 076035/2006-44, 181999/2006-11, 050108/2007-59 (APENSO), 114154/2006-11/2006 Doença de Paget 212 - Acido Zoledrônico 5 mg Novartis 170734/2007-61, 537367/2009-51, 608714/2009-38/ 2007 Osteoporose Pós-Menopausa 213 - Canaquinumabe Novartis Biociência S.A 136527/2010-82 2010 Sindrome períodica associada à criopirina – CAPS 214 - Tocilizumabe Roche 045192/2009-51, 539923/2009-24, 662142/2009-32/2009 Tratamento da artrite reumatóide ativa moderada e grave 215 - Hidroxicloroquina SAS Não há processo 2010 Tratamento da dermatopolimiosite 216 - Infliximabe SAS Não há processo 2010 Retocolite Ulcerativa 217 - Sulfassalazina SAS Não há processo 2010 Tratamento da espondilose
218 - Metotrexato SAS/DAF Não há processo 2010 Tratamento da dermatopolimiosite 219 - Rituximabe SCTIE e ANAPAR 134543/2007-35, 151054/2007-48, (apensos 135690/2008-11 182656/2008-28, 032642/2010-89)/2007 Artrite Reumatóide 220 - Efalizumabe Serono 170365/2007-14, 202428/2008-81, 214946/2008-48/2004 Psoriase em placas de grau moderado a severo 221- Ranelato de Estrôncio Servier do Brasil lda 138171/2008-05, 172131/2008-84 2008 Tratamento da Osteoporose pósmenopausa para redução do risco defraturas vertebrais e do quadril
222 - Etanercepte (apresentação 25 mg) Wyeth Não há processo 2006 Artrite Reumatoíde 223 – Etanercepte (apresentação 50 mg) Wyeth 198348/2006-52 2004 Artrite Reumatoíde 224 - Etanercepte Wyeth 166061/2007-44 2007 Espondilite Anquilosante Ativa
225 - Etanercepte Wyeth 609521/2009-02 2009 Artrite Reumatóide 226 - Etanercepte Wyeth / DAF 166081/2007-15, 074124/2008-18 2007 Psoriase em placas e artrite psoriásica
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.
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
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?
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 ? ? ? ?
with lots of problems and opportunities
Known Objectives, Priorities ? ? ? ?
Decisions driven only by resource constraint ? ? ? ?
Know process ? ? ? ?
Value judgements ? ? ? ?
Thank you! São Paulo Center for Health Economics
www.cpes.org.br
[email protected]
