Methodological guideline for REA of pharmaceuticals: Direct and indirect comparison

To make the best use of available evidence on the efficacy of a treatment, it is common to combine results from several randomised controlled trials (RCTs) in a meta-analysis. This guideline focuses on the methods available for treatment comparisons. Their strengths and limitations are discussed and recommendations are provided in order to support Relative Effectiveness […]

Methodological guideline for REA of pharmaceuticals: Criteria for the choice of the most appropriate comparator(s)

This document provides a summary of current national policies and best practice recommendations for HTA assessors for selecting the most appropriate comparator for relative effectiveness assessments. The comparator in a relative effectiveness assessment (REA) is a health care intervention or other technology with which a pharmaceutical is compared in order to establish if it has […]

Methodological guideline for REA of pharmaceuticals: Health-related quality of life

This guideline provides a set of recommendations for the selection and assessment of Health-related quality of life (HRQoL) when completing a Relative Effectiveness Assessment (REA) of pharmaceuticals. Health-related quality of life (HRQoL) is often considered to be an important endpoint of health care interventions. Because improvement in HRQoL is highly subjective, it does not necessarily […]

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 […]

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 […]