A new definition of health technology assessment (HTA), developed by an International Joint Task Group claims to be a “milestone,” “an historic achievement,” and “a cornerstone reference”—claims that we think to be unjustified. We too favor clear definitions, especially when confusion abounds. However, the Task Group seems to have developed a definition without the help of usual conventions regarding definitions and, in our view, through an ill-described process. A definition ought to differentiate the entity defined from other entities. This one fails to do so. It states traits that are true of HTA (e.g., that is interdisciplinary) but HTA is not alone in this. There are other concerns: examples of HTA’s use are embodied in the definition, precluding other uses; the adjectives used, although generally true of HTA, are not differentiating features; and attributing to HTA specific purposes, thereby excluding other purposes. We have sympathy for these purposes but cannot consider them HTA’s only purposes or even, its main purpose. A newcomer to HTA, on reading this definition, will have no idea of HTA’s true potential. These numerous failings, we feel, send all the wrong signals, and could ultimately weaken, rather than strengthen perceptions of HTA’s legitimacy and objectivity. The production of a good definition remains, therefore, a work in progress.

Objectives: The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system.

Methods: All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures. Decisions about selecting technologies for full assessment to produce NICE recommendations were reviewed, along with the reasons given to companies for not selecting products.

Results: Between 2009 and 2014, 186 technologies were notified (46 percent therapeutic and 54 percent diagnostic). Thirty-nine were judged ineligible (no regulatory approval), and 147 were considered by an independent committee. Of these, eighty (54 percent) were not selected for full assessment, most commonly because of insufficient evidence (86 percent): there were uncertainties specifically about benefits to the health service (54 percent), to patients (39 percent), and about cost (24 percent). The remaining 67 were selected and assessed for Medical Technology guidance (52 percent) (noninferior and/or lower cost consequences than current practice), for Diagnostics guidance (43 percent) or other NICE recommendations about adoption and use. Classifying technologies by two different systems showed no selection bias for any technology type or disease area.

Conclusions: Identifying new or under-used devices and diagnostics with potential benefits and promoting their adoption is important to health services in the United Kingdom and worldwide. This new system offers a means of fostering both uptake and further research. Lack of research data on new products is a major obstacle to evaluation.

Objectives: The objective of this study was to compare evidence requirements for health technology assessment of pharmaceuticals by national agencies across Europe responsible for reimbursement decisions focusing specifically on relative effectiveness assessment.

Methods: Evidence requirements from thirty-three European countries were requested and twenty-nine national agencies provided documents to review. Data were extracted from national documents (manufacturer's submission templates and associated guidance) into a purpose-made framework with categories covering information about the health condition, the technology, clinical effectiveness and safety.

Results: The level of detail in the required evidence varies considerably across countries. Some countries include specific questions while others request information under general headings. Some countries include all information in a single document, which may or may not include guidance on how to complete the template. Others have specific guidance documents or methods and process manuals that help with the completion of the submission templates. Despite differences in quantity and detail, the content of the evidence requirements is broadly similar. All countries ask for information on the health technology, target disease, and clinical effectiveness and safety. However, one country only requests clinical effectiveness information as part of cost-effectiveness analyses. We found twenty-six evidence requirements for which generic answers may apply across borders and nineteen in which countries requested nationally specific information.

Conclusions: This work suggests that it would be possible to put together a minimum set of evidence requirements for HTA to support reimbursement decisions across Europe which could facilitate collaboration between jurisdictions.

Objectives: The aim of this study was to determine the prevalence and methods of expert knowledge elicitation (EKE) for specifying input parameters in health economic decision models (HEDM).

Methods: We created two samples using the National Health System Economic Evaluations Database: (1) 100 randomly selected HEDM studies to determine prevalence of EKE and (2) sixty studies using a formal EKE process to determine methods used.

Results: Fifty-seven (57 percent) of the random sample included at least one EKE-derived parameter. Of these, six (10 percent) used a formal expert process. Thirty-four studies from our second sample of sixty studies (57 percent) described at least one aspect of the process (e.g., elicitation method) with reasonable clarity. In approximately two-thirds of studies the external experts estimated parameters de novo; the remainder confirmed or modified initial estimates provided by authors, or the method was unclear. The majority of elicitations obtained point estimates only, although a few studies asked experts to estimate ranges of parameter values.

Conclusions: The use of EKE for parameter estimation is common in HEDMs, although there is room for improvement in the methods used.

Objectives: This study reports on the development of a critical process for health technologies incorporation concerning an Argentinean Provincial Ministry of Health (MOH) in collaboration with the University of Lanús from 2008 to 2010.

Methods: We describe the approach developed to adapt selected international experiences to provincial scenario. Bibliographic review, regulations examination, key informants interviews and iterative adjustments after various stages of consultation and consensus building with main local players, contribution from foreign experts, and piloting of process and instruments for ultimate fine-tuning are described. We examine final proposal in the light of new updated studies.

Results: Analysis of regulations revealed that rules governing the provincial system were historically linked to administrative resolutions in relation to procurement with poor consideration to clinical, epidemiological, organizational, and health policy aspects. Key informants from hospitals, MOH, and other governmental agencies agreed on the lack of a process capable of guaranteeing a decision about health technology incorporation based on a transparent use of the best available information, ready to deal with competitive pressures. This adaptation provided a structured and explicit process (introduction, implementation, and development) as well as essential and supporting tools.

Conclusions: MOH adopted the proposal for its progressive implementation while institutional evaluation capacity develops. Further studies are needed on the value placed on health technology assessment–based processes and recommendations by clinicians, managers, policy makers, and patients.

Objectives: Obsolescence is a natural phase of the lifecycle of health technologies. Given increasing cost of health expenditures worldwide, health organizations have little choice but to engage in health technology reassessment (HTR); a structured, evidence-based assessment of the medical, social, ethical, and economic effects of a technology, currently used within the healthcare system, to inform optimal use of that technology in comparison to its alternatives. This research was completed to identify and summarize international HTR initiatives for non-drug technologies.

Methods: A systematic review was performed using the terms disinvestment, obsolescence, obsolete technology, ineffective, reassessment, reinvestment, reallocation, program budgeting, and marginal analysis to search PubMED, MEDLINE, EMBASE, and CINAHL until November 2011. Websites of organizations listed as members of INAHTA and HTAi were hand-searched for gray literature. Documents were excluded if they were unavailable in English, if the title/abstract was irrelevant to HTR, and/or if the document made no mention of current practices. All citations were screened in duplicate with disagreements resolved by consensus.

Results: Sixty full-text documents were reviewed and forty were included. One model for reassessment was identified; however, it has never been put into practice. Eight countries have some evidence of past or current work related to reassessment; seven have shown evidence of continued work in HTR. There is negligible focus on monitoring and implementation.

Conclusions: HTR is in its infancy. Although health technology reassessments are being conducted, there is no standardized approach. Future work should focus on developing and piloting a comprehensive methodology for completing HTR.

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: Establishing an effective and sustainable structure for a transnational network involved many managerial, policy, and methodological tools, according to the objective of each task or Work Package. Transparency in organization, financial transactions, and decision making was a key principle in the management of the Project as was the commitment to appropriately involve stakeholders.

Results: EUnetHTA activities resulted in a clear management and governance structure, efficient partnership, and transnational cooperation. The Project developed a model for sustainable continuation of the EUnetHTA Collaboration.

Conclusions: The EUnetHTA Project achieved its goals by producing a suite of practical tools, a strong network, and plans for continuing the work in a sustainable EUnetHTA Collaboration that facilitates and promotes the use of HTA at national and regional levels. Responsiveness to political developments in Europe should be balanced with maintaining a high level of ambition to promote independent, evidence-based information and well-tested tools for best practice based on a strong network of HTA institutions.

Objectives: This article presents an overview of the practical methods and tools to support transnational Health Technology Assessment (HTA) that were developed and pilot tested by the European network for HTA (EUnetHTA), which involved a total of sixty-four Partner organizations.

Methods: The methods differ according to scope and purpose of each of the tools developed. They included, for example, literature reviews, surveys, Delphi and consensus methods, workshops, pilot tests, and internal/public consultation.

Results: Practical results include an HTA Core Model and a Handbook on the use of the model, two pilot examples of HTA core information, an HTA Adaptation Toolkit for taking existing reports into new settings, a book about HTA and health policy making in Europe, a newsletter providing structured information about emerging/new technologies, an interactive Web-based tool to share information about monitoring activities for emerging/new technologies, and a Handbook on HTA capacity building for Member States with limited institutionalization of HTA.

Conclusions: The tools provide high-quality information and methodological frameworks for HTA that facilitate preparation of HTA documentation, and sharing of information in and across national or regional systems. The tools will be used and further tested by partners in the EUnetHTA Collaboration aiming to (i) help reduce unnecessary duplication of HTA activities, (ii) develop and promote good practice in HTA methods and processes, (iii) share what can be shared, (iv) facilitate local adaptation of HTA information, (v) improve the links between health policy and HTA.

The purpose of this study was to determine how horizon-scanning organizations can encourage the implementation of recommendations contained in their early warning messages about emerging health technologies. We reviewed the conclusions of the EUR-ASSESS Project Subgroup report on dissemination and impact, an overview of systematic reviews of interventions to promote implementation of research findings by health care professionals, and various Cochrane Effective Practice and Organisation of Care Group protocols and reviews. The evidence on the effectiveness of different implementation strategies aimed at distinct target groups is of variable quality. There is some evidence from rigorous study designs on the effectiveness of strategies designed to influence the behavior of health care professionals; the quality of the evidence relating to policy makers and the general public is more limited. Horizon-scanning organizations can improve the likelihood of their recommendations being acted upon by developing active implementation strategies based on the best available evidence, establishing links with key groups, and directing early warning messages at specific target audiences. Given the relative lack of good quality evidence, it is important that implementation strategies be rigorously evaluated to determine their effectiveness.