Methodological guideline for REA of pharmaceuticals: Safety
This guideline aims at providing a framework for the evaluation of relative safety performed by HTA assessors in the context of Relative Effectiveness Assessment (REA) of pharmaceuticals. When performing relative safety assessment the safety profile of the pharmaceutical is assessed in comparison to the comparator(s) of the same or different therapeutic class and to the […]
Methodological guideline for REA of pharmaceuticals: Surrogate endpoints
This guideline provides a set of recommendations for the selection and assessment of surrogate endpoints when completing a Relative Effectiveness Assessment (REA) of pharmaceuticals. Surrogate endpoints act as substitutes for clinical endpoints and are expected to predict the effect of therapy (benefit and/or harm). An improvement in surrogate endpoint may be or may not be […]
Methodological guideline for REA of pharmaceuticals: Clinical endpoints
This guideline provides a set of recommendations for the selection and assessment of clinical endpoints when completing a Relative Effectiveness Assessment (REA) of pharmaceuticals. Clinical endpoints are regarded as a means to measure the impact of a treatment on how a patient feels, functions and survives. That impact is usually in the form of improved […]
A new application of the HTA Core Model – the HTA Core Model for Rapid Relative Effectiveness Assessment of pharmaceuticals
The HTA Core Model defines the content elements to be considered in a health technology assessment (HTA) and facilitates standardised reporting. The aim is to share information, to avoid duplication of work, and to facilitate the adaptation of information in national HTA reports and the co-production of HTA reports (by multiple HTA agencies). Detailed information […]
Public consultation on HTA Core Model® for Rapid Relative Effectiveness Assessment of Pharmaceuticals
This document presents the public consultation of WP5 HTA Core Model® for Rapid Relative Effectiveness Assessment of Pharmaceuticals. The draft HTA Core Model® for Rapid Relative Effectiveness Assessment of Pharmaceutical under production by Work Package 5 Joint Action 1 was open for public consultation from 1 October 2012 to 30 November 2012. Objectice of the […]
A new application of the HTA Core Model – the HTA Core Model for Rapid Relative Effectiveness Assessment of pharmaceuticals
The HTA Core Model defines the content elements to be considered in a health technology assessment (HTA) and facilitates standardised reporting. The aim is to share information, to avoid duplication of work, and to facilitate the adaptation of information in national HTA reports and the co-production of HTA reports (by multiple HTA agencies). Detailed information […]
National report based on pilot assessment of a vaccine using the HTA Core Model® published
LBI, (Ludwig Boltzmann Institute for Health Technology Assessment) Austria, has published a national report based on a EUnetHTA pilot rapid assessment of the herpes zoster vaccine, Zostavax®. Since 2006, a vaccine against Herpes Zoster (Zostavax®) has been licensed for people over 50 years of age. A systematic pilot rapid relative effectiveness assessment of the vaccine […]
EUnetHTA Joint Position to EMA Public consultation on draft policy on the publication and access to clinical trial data
This document is the completed consultation form submitted 30 September, 2013 as the EUnetHTA Joint Position response to the public consultation on the EMA draft policy on the publication and access to clinical trial data. EUnetHTA Consultation Forum_final_20130919.pdf
WP7 SG1 Concept paper on Osteoarthritis
This document is WP7’s concept paper on osteoarthritis titled the “EunetHTA guideline on data requirements for the assessment of health technologies used for the treatment of osteoarthritis of the hip and knee”. EUnetHTA disease-specific guidelines aim to give recommendations about type of data to be produced during the development of technologies (initial evidence generation) to support […]
HTA Core Model Terms of Use Version 1.1
This new version of the terms of use contains key principles relevant to HTA Core Model users. Version 1.1 replaces the first version produced in 2008. The new version contains two licenses, one for non-commercial use and another for commercial use. It is the first ToU to allow also commercial use. As of July 2013, […]
