RT Journal Article
T1 [Methodological guideline for the efficacy and safety assessment of new pharmaceuticals: implementation of EUnetHTA's recommendations].
T2 Guía metodológica para la evaluación de la eficacia y la seguridad de nuevos fármacos: implementación de las recomendaciones de EUnetHTA.
A1 Ubago Pérez, Ruth
A1 Castillo Muñoz, María Auxiliadora
A1 Banqueri, Mercedes Galván
A1 García Estepa, Raúl
A1 Alfaro Lara, Eva Rocío
A1 Vega Coca, María Dolores
A1 Beltrán Calvo, Carmen
A1 Molina López, Teresa
K1 Comparative assessment
K1 Efficacy and safety
K1 Eficacia y seguridad
K1 Evaluación comparada
K1 Fármacos
K1 Guideline
K1 Guía
K1 Methodology
K1 Metodología
K1 Pharmaceuticals
AB 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 "Evidence synthesis reports: pharmaceuticals" 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 "Evidence synthesis reports: pharmaceuticals" is described. The structure of the report itself is also presented.
YR 2017
FD 2017-01-03
LK http://hdl.handle.net/10668/10748
UL http://hdl.handle.net/10668/10748
LA es
DS RISalud
RD Apr 11, 2025