Made available in DSpace on 2011-05-04T12:36:28Z (GMT). No. of bitstreams: 0 Previous issue date: 2009 / 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 sistemade 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, apresente 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 tratamentoda 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 devida. 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. / 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.

No description available.

Health technology assessment (HTA) is a process that evaluates the value and effects of health technology during its life cycle and provides scientific information to decision makers. However, the chasm between healthcare and innovation has been highlighted in several research areas. HTA as a bridge connecting the research and decision-making demands, achieving more transparent processes and high quality of evidence to enable more effective and safer MedTech innovations to reach and benefit healthcare and patients. This thesis aims to examine the current status of HTA across different countries compared to Sweden to identify the major hurdles and enablers in this process and any opportunities for learning across systems. Germany, the United Kingdom, and Finland are three countries being compared to Sweden in the thesis. A literature review combined with interviews were the main methodologies used for this project. Peer-reviewed literature, government documents, and official websites gave an overview of the HTA systems in selected countries and laid a solid foundation for the more in-depth interviews. Eight interviews (nine interviewees) with HTA agencies and companies were performed via Zoom, along with an email communication(one interviewee) with Fimea. The interviews were used as a support tool to gain a better understanding of the whole HTA system. Some personal opinions were also helpful to gain a view of the system from an alternative, more practical perspective. The results show the different HTA processes and the evidence generation paths in four countries. Views from MedTech companies are also given. The HTA in Sweden has two main pathways: SBU and TLV. These two agencies have particular traits that work differently with distinct purposes. In terms of the evidence generation and assessment methods, they also share different points of view. It is difficult to simply compare these systems in parallel due to the system's complexity and different healthcare conditions in every country. But all countries, including Sweden, should realize the challenges ofthe existing HTA systems, and try to reduce the evidence generation gap between expectation and reality. This would create more opportunities for small MedTech companies to be involved in the process, and actively participate in international HTA cooperation. / Hälsoteknikutvärdering (HTA) är en process som utvärderar värdet och effekterna avhälsoteknik i dess livscykel och ger vetenskaplig information till beslutsfattare. Klyftanmellan hälso- och sjukvård och innovation har dock lyfts fram inom fleraforskningsområden. HTA länkar forskning och beslutsfattande genom att möjliggöramer transparenta processer och hög kvalitet på bevis för effektivare och säkrareMedTech-innovationer att nå och gynna sjukvård och patienter. Denna uppsats syftartill att undersöka HTA:s nuvarande status i olika länder jämfört med Sverige för attidentifiera de största hindren och möjliggörare i denna process och eventuellamöjligheter till lärande i olika system. Tyskland, Storbritannien och Finland är treländer som jämförs med Sverige i avhandlingen. Litteraturöversikt och intervjuer är de huvudsakliga metoderna som används för dettaprojekt. Forskargransakad litteratur, regeringsdokument och officiella webbplatser gaven översikt över HTA-systemen i utvalda länder och lade en solid grund för följandeintervjuer. Åtta intervjuer (nio intervjuade) med HTA-byråer och MedTech-företaggenomfördes via Zoom, tillsammans med en e-postkommunikation med Fimea.Intervjuerna användes som ett stödverktyg för att ge en bättre förståelse för hela HTAsystemet.Vissa personliga åsikter gav tillfälle att förstå HTA från ett alternativtperspektiv jämfört med dess beskrivning i litteraturen. Resultaten visar olika HTA-processer och bevisgenereringsvägar i fyra länder, samtsynpunkter från MedTech-företag. HTA i Sverige har två huvudvägar: SBU (viaregionala HTA centra) och TLV. Dessa två vägar har speciella egenskaper som fungerarannorlunda och med olika syften. När det gäller bevisgenerering ochbedömningsmetoder skiljs de även åt. Det är utmanande att jämföra dessa systemparallellt på grund av systemets komplexitet och olika sjukvårdsförhållanden i varjeland. Men alla länder, inklusive Sverige, bör inse brister i befintlig HTA och försökaminska bevisgenereringsgapet mellan förväntan och verkligheten. Under tiden skapasfler möjligheter för små MedTech-företag att delta i processen och delta aktivt iinternationella HTA-samarbeten.