OBJECTIVES The aim of this study was to compare post-authorisation measures (PAMs) from the European Medicines Agency (EMA) with data requests in fixed-termed conditional appraisals of early benefit assessments from the German Federal Joint Committee (G-BA). METHODS Medicinal products with completed benefit assessments during an assessment period of 3.5 years were considered. PAMs extracted f...

Conventional models of 'evidence' for clinical practice focus on the role of randomised controlled clinical trials and systematic reviews as technologies that promote a specific model of rigour and analytic accountability. The assumption that runs through the disciplinary field of health technology assessment (HTA), for example, is that the quantification of evidence about cost and clinical eff...

An essential component of health technology assessment (HTA) is the assessment of ethical aspects. In some healthcare contexts, tasks are strictly relegated to different expert groups: the HTA-agencies are limited to assessment of the technology and other actors within the health care sector are responsible for appraisal and recommendations. Ethical aspects of health technologies are considered...

BACKGROUND Currently there is no framework for those involved in the identification, evaluation and prioritisation of new diagnostic technologies. Therefore we aimed to develop prioritisation criteria for the assessment of new diagnostic technologies, by gaining international consensus on not only which criteria should be used, but also their relative importance. METHODS A two-round Delphi pr...

OBJECTIVES Synthesizing qualitative research is an important means of ensuring the needs, preferences, and experiences of patients are taken into account by service providers and policy makers, but the range of methods available can appear confusing. This study presents the methods for synthesizing qualitative research most used in health research to-date and, specifically those with a potentia...

OBJECTIVES The European network on Health Technology Assessment (EUnetHTA) aimed to produce tangible and practical results to be used in the various phases of health technology assessment and to establish a framework and processes to support this. This article presents the background, objectives, and organization of EUnetHTA, which involved a total of sixty-four partner organizations. METHODS...

OBJECTIVES The aim of this article is to describe and analyze the stages toward recognition and implementation of health technology assessment (HTA). METHODS System analysis of structures and institutions and their use of HTA. RESULTS Austria is a latecomer in implementing evaluations/HTA as decision support. It can to a certain degree absorb the increasing international knowledge. Austria ...

BACKGROUND In 2007, Canada chose to develop a separate and distinct path for oncology drug health technology assessment (HTA). In 2013, the decision was made to transfer the pan-Canadian Oncology Drug Review (pCODR) to the Canadian Agency for Drugs and Technologies in Health (CADTH), to align the pCODR and CADTH Common Drug Review processes while building on the best practices of both. The obje...

OBJECTIVES Our objective was to gather perspectives from payers on how comparative effectiveness research (CER) in the United States and relative effectiveness (RE) research in Europe will impact evidentiary standards for access decisions of new drugs by 2020. METHODS We conducted semi-structured interviews with fourteen senior officials representing public and private payers, health technolo...

OBJECTIVES In an interrupted time series (ITS) design, data are collected at multiple instances over time before and after an intervention to detect whether the intervention has an effect significantly greater than the underlying secular trend. We critically reviewed the methodological quality of ITS designs using studies included in two systematic reviews (a review of mass media interventions ...