Health technology assessment (HTA) is a dynamic, rapidly evolving process, embracing different types of assessments that inform real-world decisions about the value (i.e., benefits, risks, and costs) of new and existing technologies. Historically, most HTA agencies have focused on producing high quality assessment reports that can be used by a range of decision makers. However, increasingly org...

The founding disciplines of HTA are clearly scientific, and have been firmly based among the natural sciences. However, common definitions of HTA indicate that HTA is something more than the "pure application of science". This article investigates whether this "something" also makes HTA an art. The question of whether HTA is a science or an art is pursued in two specific and historically rich d...

Independent regulatory agencies (IRAs) for Health Technology Assessment (HTA) are a key means by which national governments have responded to the challenge of ensuring equitable public access to a new range of medicines and treatment options within the context of limited national budgets for healthcare. In this paper, we apply a regulatory governance frame to the study of the Swedish process fo...

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...

BACKGROUND Dealing with ethical considerations is a major component of Health Technology Assessment (HTA) definitions. OBJECTIVES Present study aimed to explore and describe the manner of ethical analyses in HTA reports and the effects it had on HTA-related decision making around the world. METHODS By considering the contextual milieu of reports and searching for ethical themes and subjects...

Background: Health technology assessment (HTA) is a tool utilized for efficient dissemination of technology. For the purpose of encouraging decision-makers to utilize this tool, at first, we need to identify the obstacles in the processes of preparation, utilization, and implementation of HTAs. This study aims to define these barriers and offer solutions for effective utilization of HTA reports...

OBJECTIVES The aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies. METHODS HTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data colle...

Orphan drugs (ODs) are intended for the diagnosis, prevention, or treatment of rare diseases. Many cancer subtypes, including all childhood cancers, are defined as rare diseases, and over one-third of ODs are now intended to treat oncology indications. However, market access for oncology ODs is becoming increasingly challenging; ODs are prone to significant uncertainty around their cost-effecti...

Health technology assessment (HTA) has been discussed in Germany since the late 1990s, closely related to the advent of evidence-based medicine. The idea of technology assessment was initially discussed in Germany by the “technology assessment office of the parliament.” This was further supported by a scientific project to evaluate the use and benefit of HTA in the German health-care setting at...

OBJECTIVES Health Technology Assessment (HTA) needs to address the challenges posed by high cost, effective technologies, expedited regulatory approaches, and the opportunities provided by collaborative real-world evaluation of technologies. The Health Technology Assessment International (HTAi) Policy Forum met to consider these issues and the implications for evidence production to inform HTA....