<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0213-9111</journal-id>
<journal-title><![CDATA[Gaceta Sanitaria]]></journal-title>
<abbrev-journal-title><![CDATA[Gac Sanit]]></abbrev-journal-title>
<issn>0213-9111</issn>
<publisher>
<publisher-name><![CDATA[Sociedad Española de Salud Pública y Administración Sanitaria (SESPAS)]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0213-91112017000400336</article-id>
<article-id pub-id-type="doi">10.1016/j.gaceta.2016.10.005</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Guía metodológica para la evaluación de la eficacia y la seguridad de nuevos fármacos: implementación de las recomendaciones de EUnetHTA]]></article-title>
<article-title xml:lang="en"><![CDATA[Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ubago Pérez]]></surname>
<given-names><![CDATA[Ruth]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Castillo Muñoz]]></surname>
<given-names><![CDATA[María Auxiliadora]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Galván Banqueri]]></surname>
<given-names><![CDATA[Mercedes]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[García Estepa]]></surname>
<given-names><![CDATA[Raúl]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Alfaro Lara]]></surname>
<given-names><![CDATA[Eva Rocío]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Vega Coca]]></surname>
<given-names><![CDATA[María Dolores]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Beltrán Calvo]]></surname>
<given-names><![CDATA[Carmen]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Molina López]]></surname>
<given-names><![CDATA[Teresa]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Agencia de Evaluación de Tecnologías Sanitarias de Andalucía (AETSA) Servicio de Evaluación de Tecnologías Sanitarias ]]></institution>
<addr-line><![CDATA[Sevilla ]]></addr-line>
<country>España</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>08</month>
<year>2017</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>08</month>
<year>2017</year>
</pub-date>
<volume>31</volume>
<numero>4</numero>
<fpage>336</fpage>
<lpage>341</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_arttext&amp;pid=S0213-91112017000400336&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_abstract&amp;pid=S0213-91112017000400336&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://scielo.isciii.es/scielo.php?script=sci_pdf&amp;pid=S0213-91112017000400336&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen La colaboración European Network for Health Technology Assessment (EUnetHTA) es la red colaborativa de agencias y organismos públicos de evaluación de tecnologías sanitarias de la Unión Europea. En este marco se han elaborado guías metodológicas y procedimientos comunes que han dado lugar al denominado HTA Core Model®. La Agencia de Evaluación de Tecnologías Sanitarias de Andalucía (AETSA), miembro de la Red Española de Agencias de Evaluación de Tecnologías Sanitarias y Prestaciones del Sistema Nacional de Salud, y de la colaboración EUnetHTA, participa en la recién iniciada Tercera Acción Conjunta (Joint Action 3) de EUnetHTA (2016-2019). Adicionalmente, la AETSA cuenta con una línea de evaluación de medicamentos. Parte del trabajo se integra en la elaboración de informes de posicionamiento terapéutico (IPT) sobre fármacos que han recibido recientemente la autorización de comercialización, que coordina la Agencia Española de Medicamentos y Productos Sanitarios. Como apoyo a este trabajo, la AETSA elabora «Informes de síntesis de evidencia: medicamentos», en los que se realiza una evaluación comparada de la eficacia y la seguridad de los fármacos de los que va a elaborarse un IPT. La AETSA ha diseñado un proceso para la elaboración de dichos informes, basado en el HTA Core Model® y en las guías metodológicas de EUnetHTA. En este trabajo se describe la metodología empleada en la elaboración de la guía realizada por la AETSA para la elaboración de estos informes y se presentan los distintos apartados en los que esta se estructura.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract The European network for Health Technology Assessment (EUnetHTA) is the network of public health technology assessment (HTA) agencies and entities from across the EU. In this context, the HTA Core Model®, has been developed. The Andalusian Agency for Health Technology Assessment (AETSA) is a member of the Spanish HTA Network and EUnetHTA collaboration In addition, AETSA participates in the new EUnetHTA Joint Action 3 (JA, 2016-2019). Furthermore, AETSA works on pharmaceutical assessments. Part of this work involves drafting therapeutic positioning reports (TPRs) on drugs that have recently been granted marketing authorisation, which is overseen by the Spanish Agency of Medicines and Medical Devices (AEMPS). AETSA contributes by drafting &#8220;Evidence synthesis reports: pharmaceuticals&#8221; in which a rapid comparative efficacy and safety assessment is performed for drugs for which a TPR will be created. To create this type of report, AETSA follows its own methodological guideline based on EUnetHTA guidelines and the HTA Core Model®. In this paper, the methodology that AETSA has developed to create the guideline for &#8220;Evidence synthesis reports: pharmaceuticals&#8221; is described. The structure of the report itself is also presented.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Evaluación comparada]]></kwd>
<kwd lng="es"><![CDATA[Eficacia y seguridad]]></kwd>
<kwd lng="es"><![CDATA[Fármacos]]></kwd>
<kwd lng="es"><![CDATA[Metodología]]></kwd>
<kwd lng="es"><![CDATA[Guía]]></kwd>
<kwd lng="en"><![CDATA[Comparative assessment]]></kwd>
<kwd lng="en"><![CDATA[Efficacy and safety]]></kwd>
<kwd lng="en"><![CDATA[Pharmaceuticals]]></kwd>
<kwd lng="en"><![CDATA[Methodology]]></kwd>
<kwd lng="en"><![CDATA[Guideline]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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