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Um modelo europeu para avaliação de tecnologias de saúde :
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A Avaliação de Tecnologias de Saúde constitui um elemento fundamental para a adequada aplicação e utilização das tecnologias da saúde - medicamentos, dispositivos médicos, equipamento médico para diagnóstico e tratamento, e métodos de prevenção - com vista à obtenção dos melhores resultados em saúde para os doentes e para a sociedade em geral, promovendo um sistema de saúde equitativo, eficiente e de elevada qualidade.
Este processo, ao compreender dois tipos de análises, iniciando com uma avaliação de âmbito farmacoterapêutico e, posteriormente, de âmbito farmacoeconómico, permite às autoridades competentes a determinação da eficácia relativa das tecnologias da saúde novas ou já existentes, centrando-se essencialmente no valor acrescentado que uma tecnologia de saúde oferece, em comparação com outras alternativas existentes. É com base nesta informação que os decisores políticos de cada país, determinam quais as tecnologias de saúde a ser alvo de financiamento/reembolso.
Face ao aumento do volume tecnologias emergentes, e consequente ineficiência na condução dos processos de avaliação, surge a necessidade do desenvolvimento de redes de partilha de metodologias e informações, com vista à harmonização de processos entre os diferentes Estados Membros da União Europeia. Estes constituíram os primeiros passos para a implementação de uma rede de cooperação em matéria de Avaliação de Tecnologias de Saúde.
É neste contexto, que a presente monografia vem abordar evolução e o desenvolvimento do modelo de cooperação europeia nesta matéria, num momento tão crucial, em que se observa a transição do modelo de cooperação voluntária - através das suas primeiras iniciativas em 1994, com o projeto EUR-ASSESS, passando pelos, mais de quinze anos, de EUnetHTA - para a implementação do novo Regulamento (EU) 2021/2282 do Parlamento Europeu e do Conselho. Através desta análise pretende-se aferir se estão estabelecidos os pilares para uma plena harmonização europeia, em prol da construção de modelo europeu para a Avaliação de Tecnologias de Saúde.
Health Technology Assessment is a crucial component for the appropriate application and use of health technologies - such as medicines, medical devices, medical equipment for diagnosis and treatment, and methods of prevention - in order to achieve the best health outcomes for patients and society in general, promoting an equitable, efficient and high-quality health system. This process, comprising two types of analysis, beginning with a clinical and followed by an economic assessment, allows the competent authorities to determine the relative effectiveness of new or already existing health technologies, focusing essentially on the added value that a health technology offers compared to other existing alternatives. It is based on this information that each country's political decision-makers define which health technologies should be the subject of funding/reimbursement. Given the volume increase in new emerging technologies and the consequent inefficiency of conducting these assessment processes, there is a need to exchange information and methodologies aiming to harmonise them among the different Member States of the European Union. These constituted the first steps towards the implementation of a cooperation network on Health Technology Assessment. It is in these circumstances that the present monograph addresses the evolution and development of the European cooperation model in this subject, at such a crucial time in which we are experiencing the transition from the voluntary cooperation model, through the first initiatives in 1994, with the EUR-ASSESS project, continuing with the more than fifteen years of EUnetHTA, to the implementation of the new Regulation (EU) 2021/2282 of the European Parliament and the Council. The purpose of this analysis is to assess whether the foundations for full European harmonisation have been established, in order to develop a European model for Health Technology Assessment.
Health Technology Assessment is a crucial component for the appropriate application and use of health technologies - such as medicines, medical devices, medical equipment for diagnosis and treatment, and methods of prevention - in order to achieve the best health outcomes for patients and society in general, promoting an equitable, efficient and high-quality health system. This process, comprising two types of analysis, beginning with a clinical and followed by an economic assessment, allows the competent authorities to determine the relative effectiveness of new or already existing health technologies, focusing essentially on the added value that a health technology offers compared to other existing alternatives. It is based on this information that each country's political decision-makers define which health technologies should be the subject of funding/reimbursement. Given the volume increase in new emerging technologies and the consequent inefficiency of conducting these assessment processes, there is a need to exchange information and methodologies aiming to harmonise them among the different Member States of the European Union. These constituted the first steps towards the implementation of a cooperation network on Health Technology Assessment. It is in these circumstances that the present monograph addresses the evolution and development of the European cooperation model in this subject, at such a crucial time in which we are experiencing the transition from the voluntary cooperation model, through the first initiatives in 1994, with the EUR-ASSESS project, continuing with the more than fifteen years of EUnetHTA, to the implementation of the new Regulation (EU) 2021/2282 of the European Parliament and the Council. The purpose of this analysis is to assess whether the foundations for full European harmonisation have been established, in order to develop a European model for Health Technology Assessment.
Descrição
Trabalho Final de Mestrado Integrado, Ciências Farmacêuticas, 2022, Universidade de Lisboa, Faculdade de Farmácia.
Palavras-chave
Avaliação de tecnologias de saúde Legislação europeia EUnetHTA Stakeholders Cooperação europeia Avaliação clínica conjunta Mestrado integrado - 2022