ISPOR 2nd BRAZILIAN
CHAPTER CONGRESS
Dr José Roberto Tebet
Médico Oncologista
Titular da SBC
Especialista em Auditoria
Membro da Câmara Técnica de Perícia e Auditoria do CRMPr
Membro das Câmaras Técnicas de Oncologia da Unimed do
Brasil e da Unimed Mercosul
Médico Auditor em Oncologia da Unimed Federação doParaná
Médico Auditor da Unimed Curitiba
Médico Auditor em Oncologia do Setor de Alto Custo da
Secretaria Municipal de Saúde de Curitiba
Presidente da ABAM
CT brain scanner, 1970-1. Patients describe feelings of trust and fear towards high-tech
medical devices such as scanners, ventilators and dialysis machines.
© Science Museum/Science & Society Picture Library
Science News
Nano-sized Technology Has Super-sized Effect On Tumors
ScienceDaily (Apr. 4, 2008) — Anyone facing chemotherapy would welcome an
advance promising to dramatically reduce their dose of these often harsh drugs.
Using nanotechnology, researchers at Washington University School of Medicine
in St. Louis have taken a step closer to that goal.
Cost of Cancer Care: Issues and Implications
Neal J. Meropol and Kevin A. Schulman
J Clin Oncol 25:180-186. 2007
Ciência & Saúde Coletiva, 13(Sup):589-601, 2008
Public and private expenditure on health
US dollars per capita, calculated using PPPs, 2004 or latest
year available
www.oecd.org
Cost of Cancer Care: Issues and Implications
Neal J. Meropol and Kevin A. Schulman
J Clin Oncol 25:180-186. 2007
BRASIL
2002
7,8% PIB
gasto per capita US$206,00
2003
gasto per capita R$303,17
Fonte Ministério da Saúde
Avaliação Econômica em Saúde
Cost of Cancer Care: Issues and Implications
Neal J. Meropol and Kevin A. Schulman
J Clin Oncol 25:180-186. 2007
Cost of Cancer Care: Issues and Implications
Neal J. Meropol and Kevin A. Schulman
J Clin Oncol 25:180-186. 2007
Cost of Cancer Care: Issues and Implications
Neal J. Meropol and Kevin A. Schulman
J Clin Oncol 25:180-186. 2007
BRASIL
Gastos com quimioterapia
1999= R$306,0 milhões
2004=R$735,6 milhões
ONCOLOGIA
Muitas prescrições baseadas em estudos
fase II
Indicações não aprovadas (``off label``)
Analysis of Phase II Studies on Target Agents and
Subsequent Phase III Trials: What are de Predictors for
Success?
John K. Chan, Stefanie M. Ueda, Valerie E. Sugiyama, Christopher D. Stave, Jacob Y. Shin
Bradley J. Monk, Branimir I. Sikic, Kathryn Osann, Daniel S. Kapp
JCO26:1511-1518;2008
Estudos fase II de 1985-2005 em tumores
avançados
Terapias alvo somente = 203(57,8%)
combinação com quimioterapia=148(42.2%)
Analysis of Phase II Studies on Target Agents and
Subsequent Phase III Trials: What are de Predictors for
Success?
John K. Chan, Stefanie M. Ueda, Valerie E. Sugiyama, Christopher D. Stave, Jacob Y. Shin
Bradley J. Monk, Branimir I. Sikic, Kathryn Osann, Daniel S. Kapp
JCO26:1511-1518;2008
Estudo fase III positivo
desfecho primário proposto foi alcançado, ou
quando a droga estudada foi superior ao
regime ``standard``ou melhor que o tratamento
de suporte
Estudo fase II positivo= quando seu autor o
considerou positivo
Analysis of Phase II Studies on Target Agents and
Subsequent Phase III Trials: What are de Predictors for
Success?
John K. Chan, Stefanie M. Ueda, Valerie E. Sugiyama, Christopher D. Stave, Jacob Y. Shin
Bradley J. Monk, Branimir I. Sikic, Kathryn Osann, Daniel S. Kapp
JCO26:1511-1518;2008
351 estudos fase II
167 (47.6%) fase III foram positivos
184(52,4%) fase III foram negativos
Analysis of Phase II Studies on Target Agents and
Subsequent Phase III Trials: What are de Predictors for
Success?
John K. Chan, Stefanie M. Ueda, Valerie E. Sugiyama, Christopher D. Stave, Jacob Y. Shin
Bradley J. Monk, Branimir I. Sikic, Kathryn Osann, Daniel S. Kapp
JCO26:1511-1518;2008
Análise Multivariada= fatôres preditivos positivos
estudos multicentricos x uni-institucionais
resultado do estudo fase II
estudos financiados pela indústria farmacêutica
curto intervalo de tempo entre a publicação do
estudo fase II e o III (menos de 1 ano)
Characteristics of phase II studyand percentage of phase III trials with
positive results (n 351). Institutions and locations
Predictors for Success in Phase II Studies and Subsequent Phase III Trials
J Clin Oncol 26:1511-1518. © 2008
John K. Chan, Stefanie M. Ueda, Valerie E. Sugiyama, Christopher D. Stave, Jacob Y. Shin
Bradley J. Monk, Branimir I. Sikic, Kathryn Osann, Daniel S. Kapp
Characteristics of phase II study and percentage of phase III trials with
positive results (n 351). Year of phase II trial and time interval between publications.
Predictors for Success in Phase II Studies and Subsequent Phase III Trials
J Clin Oncol 26:1511-1518. © 2008
John K. Chan, Stefanie M. Ueda, Valerie E. Sugiyama,
Christopher D. Stave, Jacob Y. Shin, Bradley J. Monk,
Branimir I. Sikic, Kathryn Osann, Daniel S. Kapp
Characteristics of phase II study and percentage of
phase III trials with positive results (n 351).
(C) number of patients, results, and end points.
J Clin Oncol 26:1511-1518.
© 2008
John K. Chan, Stefanie M. Ueda, Valerie E. Sugiyama, Christopher D. Stave, Jacob Y.
hin, Bradley J. Monk, Branimir I. Sikic, Kathryn Osann, Daniel S. Kapp
Inclusion of cost effectiveness in licensing
requirements of new drugs: the fourth hurdle
R S Taylor, M F Drummond, G Salkeld, S D Sullivan
Summary points
Licensing of drugs has traditionally been based
on quality, safety, and efficacy
Faced with increasing healthcare costs, many
countries are now also requiring evidence of cost
effectiveness—the fourth hurdle
The limited evidence available suggests fourth
hurdle policies have contributed to more cost
effective use of drugs
Increasing international harmonisation and
greater openness could improve the operation of
fourth hurdle systems
Australia has required data on cost effectiveness of drugs
since 1993.
BMJ VOLUME 329 23 OCTOBER 2004 bmj.com
Nanotherapeutics: new challenges for
safety and cost-effectiveness regulation in Australia
Thomas A Faunce
NANOTECHNOLOGY
The Medical Journal of Australia ISSN: 0025729X 19 February 2007 186 4 189-191
©The Medical Journal of Australia 2007
www.mja.com.au
MODELO DE ANÁLISE ECONÔMICA
Tipos de Análises
Tipos de Custos
Perspectivas
Custo-efetividade
Médicos diretos
Pagador
Custo-benefício
Não médicos
indiretos
Provedor
Custo-utilidade
Produtividade
Paciente
Custo-minimização Intangíveis
Sociedade
Seven alternatives to evidence based
medicine
David Isaacs, Dominic Fitzgerald
Obrigado!
[email protected]
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