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A GESTÃO DE TECNOLOGIAS EMERGENTES PARA A CONDIÇÃO OSTEOPOROSE: SUBSÍDIOS PARA A ELABORAÇÃO DE UM SISTEMA DE MONITORAMENTO DO HORIZONTE TECNOLÓGICO NO BRASIL
Avaliação da Tecnologia Biomédica
Programas de Rastreamento / utilizaçäo
Osteoporose / epidemiologia
Osteoporose / diagnóstico
Avaliação da Tecnologia Biomédica
Programas de Rastreamento / utilizaçäo
Osteoporose / epidemiologia
Osteoporose / diagnóstico
Osso e Osso s/ lesöes
Osso e Ossos / metabolismo
Fujimoto, Suzana Yumi | Date Issued:
2009
Alternative title
The management of emerging technologies for the condition osteoporosis: subsidies for the development of a system for monitoring the technological horizon in BrazilAuthor
Advisor
Comittee Member
Affilliation
Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil.
Abstract in Portuguese
As atividades de rastreamento do horizonte tecnológico, uma forma de avaliação de
tecnologia em saúde realizada no início do ciclo de vida das tecnologias, vêm sendo
difundidas em países desenvolvidos desde a década de 90, visando tornar mais
eficientes os processos de tomada de decisão relativos à incorporação de novas
tecnologias. Trata-se de uma abordagem sistemática para a identificação e avaliação de
tecnologias novas/emergentes, com o objetivo de alertar os tomadores de decisão
quanto à sua existência e potenciais conseqüências de sua incorporação para o sistema
de saúde, antes da difusão do seu uso. Considerando a relevância de operacionalizar as
atividades de rastreamento do horizonte tecnológico para a atenção à saúde no Brasil, a
presente dissertação teve o objetivo de produzir subsídios para a elaboração de
diretrizes de um sistema de rastreamento do horizonte a ser criado no País. Para
auxiliar o processo de elaboração, foi realizado um exercício de rastreamento do
horizonte, no qual foi utilizado o caso das tecnologias envolvidas no manejo da
osteoporose em mulheres na pós-menopausa, um problema de saúde considerado
relevante, para o qual não existe solução razoável. Inicialmente, procedemos a uma
revisão do conceito e das experiências internacionais com sistemas de rastreamento do
horizonte tecnológico (SRH) em saúde. As fontes consultadas e os trabalhos analisados
indicam um consenso de que um SRH deve sempre basear seu trabalho na melhor
evidência preliminar disponível sobre o efeito das tecnologias, na saúde das pessoas e
sobre o sistema de saúde, e atuar de maneira transparente, explicitando ao máximo a
metodologia adotada no processo de trabalho. A revisão também permitiu a
identificação de muitos desafios e pontos críticos para o desenvolvimento e
operacionalização de tal sistema. O exercício de rastreamento realizado possibilitou a
identificação de uma nova tecnologia medicamentosa, o denosumab, para o tratamento
da osteoporose, cujos ensaios clínicos de fase II e III, recentemente publicados, foram
analisados. As limitações enfrentadas na realização do exercício permitiram reconhecer
algumas dificuldades básicas específicas da avaliação tecnológica no início do ciclo de
vida. A avaliação das experiências internacionais e o exercício acima referido indicam
que, para o desenvolvimento e operacionalização de um SRH no Brasil, o intercâmbio
e a colaboração institucional com as unidades governamentais de monitoramento do horizonte de países desenvolvidos será fundamental, tendo em vista o corpo
qualificado e a longa experiência daquelas unidades nessas atividades e, ainda, a
quantidade de trabalho e de tempo envolvidos na análise de cada tecnologia e a
urgência inerente a essas atividades. Além disso, deverá haver uma articulação entre os
atores-chave, especialmente os do âmbito governamental, com o objetivo de discutir e
estabelecer as diretrizes para a criação do sistema. Com isso, espera-se que as
informações produzidas pelo SRH brasileiro sejam adequadamente utilizadas no
processo de tomada de decisão do sistema de saúde.
Abstract
Activities related to horizon scanning of technologies for health care, a form of health
technology assessment carried out at the beginning of the life cycle of those technologies, have been adopted in several developed countries since the 90s, with the
purpose of improving the efficiency of decision making related to the incorporation of new technologies. Horizon scanning consists of a systematic approach to identify and assess new and emerging technologies in order to warn health care decision makers about the existence and potential consequences of their incorporation to individuals and to the health system, before the diffusion stage. Given the importance of developing horizon scanning activities for health care technologies in Brazil, the present work had the objective of producing subsidies for the elaboration of guidelines to develop a horizon scanning system in Brazil. To aid that elaboration process, the case of technologies designed for the secondary prevention of osteoporotic fractures after menopause, a relevant public health problem far from being solved, was analyzed. Initially, a review of the concept of horizon scanning in health care and of the related international governmental experiences was carried out. The available sources and studies indicate a consensus on that: a) recommendations made by a horizon scanning
8 system must be supported by the best available early scientific evidence of the consequences on the health of the individuals and on the health system of the adoption of new/emerging technologies; b) the horizon scanning system must act in a transparent way, making explicit the criteria and methodology it uses. The review also
showed that there remain several challenges to be dealt with in order to further develop such monitoring system. The horizon scanning exercise related to the secondary prevention of osteoporotic fractures enabled the identification of a new drug, called denosumab; phase II and
phase III trials of that technology have been recently published and were analyzed.
Limitations faced in such exercise made it possible the identification of some specific
difficulties associated to technology assessment at the beginning of the life cycle. The review of the international experiences with horizon scanning of health care technologies, at central government level, along with the mentioned exercise, indicate that, for developing a horizon scanning system in Brazil, collaboration with developed countries’ units is essential, taking into account the qualified and experienced staff of such units as well as the amount of work and time involved in the analysis of each
technology and the inherent urgency of such activities. Finally, key actors, specially those at central government level, must be articulated for the discussion and elaboration of the guidelines towards the creation of such system.
In this way, the chances of a successful effort, with an adequate utilization of produced
information in the process of decision-making, are increased. Activities related to horizon scanning of technologies for health care, a form of health
technology assessment carried out at the beginning of the life cycle of those
technologies, have been adopted in several developed countries since the 90s, with the
purpose of improving the efficiency of decision making related to the incorporation of
new technologies. Horizon scanning consists of a systematic approach to identify and
assess new and emerging technologies in order to warn health care decision makers
about the existence and potential consequences of their incorporation to individuals
and to the health system, before the diffusion stage.
Given the importance of developing horizon scanning activities for health care
technologies in Brazil, the present work had the objective of producing subsidies for
the elaboration of guidelines to develop a horizon scanning system in Brazil. To aid
that elaboration process, the case of technologies designed for the secondary
prevention of osteoporotic fractures after menopause, a relevant public health problem
far from being solved, was analyzed.
Initially, a review of the concept of horizon scanning in health care and of the related
international governmental experiences was carried out. The available sources and
studies indicate a consensus on that: a) recommendations made by a horizon scanning system must be supported by the best available early scientific evidence of the
consequences on the health of the individuals and on the health system of the adoption
of new/emerging technologies; b) the horizon scanning system must act in a
transparent way, making explicit the criteria and methodology it uses. The review also
showed that there remain several challenges to be dealt with in order to further develop
such monitoring system.
The horizon scanning exercise related to the secondary prevention of osteoporotic
fractures enabled the identification of a new drug, called denosumab; phase II and
phase III trials of that technology have been recently published and were analyzed.
Limitations faced in such exercise made it possible the identification of some specific
difficulties associated to technology assessment at the beginning of the life cycle.
The review of the international experiences with horizon scanning of health care
technologies, at central government level, along with the mentioned exercise, indicate
that, for developing a horizon scanning system in Brazil, collaboration with developed
countries’ units is essential, taking into account the qualified and experienced staff of
such units as well as the amount of work and time involved in the analysis of each
technology and the inherent urgency of such activities.
Finally, key actors, specially those at central government level, must be articulated for
the discussion and elaboration of the guidelines towards the creation of such system.
In this way, the chances of a successful effort, with an adequate utilization of produced
information in the process of decision-making, are increased.
Keywords in Portuguese
Osteoporose / terapiaAvaliação da Tecnologia Biomédica
Programas de Rastreamento / utilizaçäo
Osteoporose / epidemiologia
Osteoporose / diagnóstico
DeCS
Osteoporose / terapiaAvaliação da Tecnologia Biomédica
Programas de Rastreamento / utilizaçäo
Osteoporose / epidemiologia
Osteoporose / diagnóstico
Osso e Osso s/ lesöes
Osso e Ossos / metabolismo
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