This article examines the current status and most important changes over time to the legislative framework on the health technology assessment-informed decision-making process on diagnostic and therapeutic 'methods' in Germany. The relevant information was obtained through documentary analysis covering the period 1990 to 2017. The findings show that, even if the outpatient care sector appears t...

In light of growing demands for public accountability, the broadening scope of health technology assessment organizations (HTAOs) activities and their increasing role in decision-making underscore the importance for them to demonstrate their performance. Based on Parson's social action theory, we propose a conceptual model that includes four functions an organization needs to balance to perform...

OBJECTIVES The aim of this study was to facilitate effective internal and external communication of an international network and to explore how to support communication and work processes in health technology assessment (HTA). STRUCTURE AND METHODS: European network for Health Technology Assessment (EUnetHTA) connected sixty-four HTA Partner organizations from thirty-three countries. User needs...

BACKGROUND New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. METHODS Our 5-year qualitative research program examined the proces...

European patients may benefit from innovative medicines only at the end of a complex process with a sequence of positive decisions on different levels by different stakeholders. The decision of the industry to invest in a usually global clinical development must be followed by a European marketing authorization decision and a mostly national decision on price and reimbursement until finally pat...

OBJECTIVES The aim of this study was to review the history of health technology assessment (HTA) in Italy. METHODS Founded in 1978, the Italian National Health Service (NHS) has been strongly regionalized mainly after a constitutional reform, which started a devolution process. HTA started in the 1980s at the National Institute of Health and in a few University Hospitals, with a focus on big ...

BACKGROUND Authors from the Canadian Agency for Drugs and Technologies in Health (CADTH) presented an analysis of submissions to the Common Drug Review (CDR) between 2004 and February 3, 2016 for drugs for rare disorders (disorders with a prevalence of <50 per 100,000). OBJECTIVE The aim of this analysis was to examine the same CDR submissions to evaluate whether the negative reimbursement re...

The validity of mixed treatment comparisons (MTCs), also called network meta-analysis, relies on whether it is reasonable to accept the underlying assumptions on similarity, homogeneity, and consistency. The aim of this paper is to propose a practicable approach to addressing the underlying assumptions of MTCs. Using data from clinical studies of antidepressants included in a health technology ...

A workshop was organized by the Agenzia Italiana del Farmaco (AIFA) to discuss unmet needs and ways forward in the development of medicines in heart failure, their rationale, and cost-effective use. An integrated, multidisciplinary approach, including patients' needs and perspectives, was advocated by all the participants as the way to the most effective treatment regimens. More work is needed ...

OBJECTIVES The aim of this study was to get insight in what criteria as presented in Health technology assessment (HTA) studies are important for decision makers in healthcare priority setting. METHODS We performed a discrete choice experiment among Dutch healthcare professionals (policy makers, HTA experts, advanced HTA students). In twenty-seven choice sets, we asked respondents to elect re...