{"id":5127,"date":"2018-01-16T11:52:18","date_gmt":"2018-01-16T13:52:18","guid":{"rendered":"http:\/\/mapesolutions.com\/?p=5127"},"modified":"2021-11-03T12:50:25","modified_gmt":"2021-11-03T15:50:25","slug":"el-proceso-de-incorporacion-de-tecnologias-sanitarias","status":"publish","type":"post","link":"https:\/\/mapesolutions.com\/es\/el-proceso-de-incorporacion-de-tecnologias-sanitarias\/","title":{"rendered":"El proceso de incorporaci\u00f3n de tecnolog\u00edas sanitarias"},"content":{"rendered":"<p>[:pb]<\/p>\n<h2><span style=\"font-weight: 400;\"> La evoluci\u00f3n del sector m\u00e9dico y la escasez de recursos<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Buscando satisfacer una demanda cada vez mayor, los sistemas de salud de todo el mundo han estado invirtiendo fuertemente en el desarrollo de procedimientos, enfoques y medicamentos con mayores capacidades de resoluci\u00f3n diagn\u00f3stica y terap\u00e9utica.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Este escenario ha incrementado los costos del sector.<\/span><span style=\"font-weight: 400;\">Incrementar el acceso a terapias m\u00e1s efectivas en un escenario de recesi\u00f3n y envejecimiento de la poblaci\u00f3n es uno de los mayores desaf\u00edos a los que se enfrentan los sistemas sanitarios. <\/span><span style=\"font-weight: 400;\">Esto ha provocado una mayor preocupaci\u00f3n entre los gerentes de \u00e1rea al evaluar los costos y beneficios de una tecnolog\u00eda antes de incorporarla.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Para hacer un mejor uso de los recursos disponibles, para ser incorporada, una nueva tecnolog\u00eda necesita <\/span><span style=\"font-weight: 400;\">presentar buenos resultados en el mundo real: eficiencia, facilidad de implementaci\u00f3n, seguridad del paciente y precio compatible, todo en comparaci\u00f3n con las tecnolog\u00edas ya presentes en el mercado.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">La Comisi\u00f3n Nacional de Incorporaci\u00f3n de Tecnolog\u00edas en el SUS<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Con el fin de institucionalizar un proceso legal para la incorporaci\u00f3n de nuevas tecnolog\u00edas de la salud en Brasil, se cre\u00f3 <\/span><span style=\"font-weight: 400;\">el CONITEC (Comisi\u00f3n Nacional para la Incorporaci\u00f3n de Tecnolog\u00edas en el SUS \u2013 Ley n\u00ba 12401\/2011), un \u00f3rgano colegiado permanente cuyo objetivo es asesorar el Ministerio de Salud en las \u00e1reas de incorporaci\u00f3n tecnol\u00f3gica y protocolo cl\u00ednico.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Este organismo es responsable de recomendar tecnolog\u00edas relevantes, seguras, efectivas y rentables para la salud brasile\u00f1a y as\u00ed garantizar el suministro de procedimientos, medicamentos y productos actualizados y calificados, acordes con lo mejor en la pr\u00e1ctica m\u00e9dica.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Para ser aprobada por CONITEC, la incorporaci\u00f3n de un nuevo procedimiento o tecnolog\u00eda pasa por una evaluaci\u00f3n basada en aspectos como eficacia, exactitud, efectividad y seguridad, adem\u00e1s de una evaluaci\u00f3n econ\u00f3mica comparativa de los beneficios y costos en relaci\u00f3n a las tecnolog\u00edas existentes.<\/span><\/p>\n<h2><span style=\"font-weight: 400;\">Etapas en el proceso de incorporaci\u00f3n de tecnolog\u00edas sanitarias<\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Para solicitar la evaluaci\u00f3n de una tecnolog\u00eda, el solicitante debe seguir los siguientes pasos:<br \/>\n<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Registro con ANVISA<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Definici\u00f3n de precio con CMED \u2013 C\u00e1mara de Regulaci\u00f3n del Mercado de Medicamentos (aqu\u00ed ya se recomienda iniciar la producci\u00f3n de dosieres de valor sobre el producto para alcanzar un precio compatible).<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Presentaci\u00f3n de documentaci\u00f3n ante la SCTIE\/MS (Ministerio de Ciencia, Tecnolog\u00eda e Insumos Estrat\u00e9gicos de la Salud<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Presentaci\u00f3n de estudios al CONITEC \u2013 que recibir\u00e1, estudiar\u00e1 (y si es necesario solicitar\u00e1 datos adicionales), someter\u00e1 a consulta p\u00fablica, evaluar\u00e1 aportes y recomendar\u00e1, o no, la incorporaci\u00f3n de la tecnolog\u00eda.<\/span><\/li>\n<li>Celebraci\u00f3n de audiencia p\u00fablica (si el Secretario de la SCTIE lo estima necesario)<\/li>\n<li><span style=\"font-weight: 400;\">Evaluaci\u00f3n del informe de la Secretar\u00eda de la SCTIE<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Publicaci\u00f3n en el Bolet\u00edn Oficial de la Federaci\u00f3n<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Lanzamiento al mercado<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">A partir de este momento, los solicitantes pueden presentar su tecnolog\u00eda a las instituciones de pago a trav\u00e9s de su equipo de  <\/span><i><span style=\"font-weight: 400;\">Market Access<\/span><\/i><span style=\"font-weight: 400;\">  (que cubriremos en el pr\u00f3ximo art\u00edculo), armados con los datos de valor recopilados por HEOR.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La solicitud de evaluaci\u00f3n tecnol\u00f3gica puede ser realizada por cualquier instituci\u00f3n o individuo, como empresa fabricante de tecnolog\u00eda, sociedad m\u00e9dica o de pacientes, \u00e1reas t\u00e9cnicas del Ministerio de Salud, Secretar\u00edas de Salud Estatales y Municipales.<\/span><\/p>\n<p>&#8212;<\/p>\n<p>Conoce m\u00e1s detalles sobre nuestras soluciones y estudios t\u00e9cnico-cient\u00edficos para el desarrollo e incorporaci\u00f3n de tecnolog\u00edas con el mejor costo-efectividad en los sistemas de salud p\u00fablicos y privados. Descargue ahora nuestro contenido <strong><a href=\"https:\/\/conteudo.mapesolutions.com\/cases-ciencias-da-vida-e-acesso-ao-mercado-de-saude\">MAPES Cases &#038; Soluciones.<\/a>.<\/strong><\/p>\n<p><a href=\"https:\/\/conteudo.mapesolutions.com\/cases-ciencias-da-vida-e-acesso-ao-mercado-de-saude\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-5178\" src=\"https:\/\/espanol.mapesolutions.com\/wp-content\/uploads\/2018\/01\/728x90-300x37.jpg\" alt=\"\" width=\"916\" height=\"113\" \/><\/a>[:en]<\/p>\n<h2>The medical section evolution and the scarcity of resources<\/h2>\n<p>Seeking to meet an increasingly demand, the health systems all over the world have heavily invested in the development of procedures, approaches and drugs with bigger capacity of diagnostic and therapeutic resolution.<\/p>\n<p>This scenario has been increasing the cost of the sector. Increasing the access to more efficient therapies in a scenario of recession and of ageing population is a big challenge of health systems. This has been aggravated a bigger concern of the managers of the area when evaluating the costs and benefits of a technology before incorporating it.<\/p>\n<p>Having the goal of making a better use of the available resources, to be incorporated, a new technology needs to present good results in the real world: efficiency, ease of implementation, security to the patients and compatible price, everything comparing to the technologies in the market.<\/p>\n<h2>The National Commission for the Incorporation of Technologies in SUS<\/h2>\n<p>In order to institutionalize a legal process to incorporate new health technologies in Brazil, CONITEC (Comiss\u00e3o Nacional de Incorpora\u00e7\u00e3o de Tecnologias no SUS &#8211; National Commission for the Incorporation of Technologies in SUS \u2013 Law number 12401\/2011) was created. It\u2019s a permanent collegiate agency that has the goal of advice the Brazilian Health Ministry in the subject of incorporating new technology and clinical protocol.<\/p>\n<p>This agency is responsible for recommending relevant, safe, efficient and cost-effective technologies to the Brazilian health and then be sure that the proceeding offer, medicines and updated and qualified products, are consistent with the best of medical practice.<\/p>\n<p>To be aproved by the CONITEC, the incorporation of a new proceedment or technology goes through an assessment based on aspects such as efficiency, accuracy, effectiveness and security, besides the economic assessment comparing the benefits and costs related to technologies that already exist.<\/p>\n<h2>Stages of the incorporation process<\/h2>\n<p>To request the assessment of a technology, the applicant must go through the following stages:<\/p>\n<ul>\n<li>Record in ANVISA<\/li>\n<li>Defining the price with the CMED (C\u00e2mara de Regula\u00e7\u00e3o do Mercado de Medicamentos) &#8211; Market of Regulation of the Market of Medicines (in this point it\u2019s recommended to start the production of value dossiers about the product to get to a compatible price).<\/li>\n<li>Documentation protocol with SCTIE\/MS (Science Secretary, Technology and Strategic Inputs of the Health Ministry &#8211; Secretaria de Ci\u00eancia, Tecnologia e Insumos Estrat\u00e9gicos do Minist\u00e9rio da Sa\u00fade)<\/li>\n<li>Presenting the studies to CONITEC \u2013 which will receive, study (and, if it\u2019s necessary it will ask for complementary data), submit to public consultation, evaluate the contribution and recommend, or not, the incorporation of the technology.<\/li>\n<li>Holding a public hearing (if the SCTIE secretary thinks it\u2019s necessary).<\/li>\n<li>Evaluation of the report by the Secretary of the SCTIE.<\/li>\n<li>Publication in Di\u00e1rio Oficial da Uni\u00e3o<\/li>\n<li>Market Launch<\/li>\n<\/ul>\n<p>After this the applicant can already present his technology to the payer institution through his <em>Market Access<\/em> team (which we will\u00a0 be the subject of our next article), provided with value data collected by HEOR.<\/p>\n<p>The technology assessment request can be made by any institution or person, for example, by a company that makes technology, a medical or patient society, technical areas of the Health Ministry, State secretaries and Town Health areas.<\/p>\n<p>&nbsp;[:]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>[:pb] La evoluci\u00f3n del sector m\u00e9dico y la escasez de recursos Buscando satisfacer una demanda cada vez mayor, los sistemas de salud de todo el mundo han estado invirtiendo fuertemente en el desarrollo de procedimientos, enfoques y medicamentos con mayores capacidades de resoluci\u00f3n diagn\u00f3stica y terap\u00e9utica. Este escenario ha incrementado los costos del sector.Incrementar el [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":5184,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-5127","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sem-categoria"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>[:pb]O processo de incorpora\u00e7\u00e3o de tecnologias de sa\u00fade[:]<\/title>\n<meta name=\"description\" content=\"{:pb}Os sistemas de sa\u00fade do mundo todo v\u00eam investindo pesado no desenvolvimento de tecnologias de sa\u00fade procedimentos e em nosso falaremos sobre isso.{:}\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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