ABSTRACT
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 (AU)
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, 20162019). 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 (AU)
Subject(s)
Humans , Drug Approval/statistics & numerical data , Drug Evaluation/methods , Drug-Related Side Effects and Adverse Reactions/epidemiology , Practice Patterns, Physicians' , Safety-Based Drug Withdrawals/statistics & numerical data , Patient Safety/statistics & numerical dataABSTRACT
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.
Subject(s)
Drug Evaluation/standards , Technology Assessment, Biomedical/standards , European Union , Guideline AdherenceABSTRACT
Taxanes offer clear benefits in adjuvant chemotherapy for early breast cancer. This review examines evidence to date on the clinical effectiveness and cost-effectiveness of their use in the adjuvant treatment of women with early breast cancer, based on three meta-analyses, one systematic review, five clinical practice guidelines and 16 randomized clinical trials. Against the background of a major increase in the use of docetaxel rather than paclitaxel in our setting over the past few years, implying a major increase in costs, we examined whether this higher use of docetaxel is supported by the available evidence. In this wide study, we found no evidence that regimens containing docetaxel yield greater benefits than those including paclitaxel. From an effectiveness standpoint, the change from paclitaxel to docetaxel in our setting is not justified.
