Objective: To develop and test a decision-support tool for prioritizing new competing Health Technologies (HTs) after their assessment using the mini-HTA approach.

Methods: A two layer value/risk tool was developed based on the mini-HTA. The first layer included 12 mini-HTA variables classified in two dimensions, namely value (safety, clinical benefit, patient impact, cost-effectiveness, quality of the evidence, innovativeness) and risk (staff, space and process of care impacts, incremental costs, net cost, investment effort). Weights given to these variables were obtained from a survey among decision-makers (at National/Regional level and hospital settings). A second layer included results from mini-HTA (scored as higher, equal or lower), which compares the performance of the new HT (in terms of the abovementioned 12 variables) with the available comparator. An algorithm combining the first (weights) and second (scores) layers was developed to obtain an overall score for each HT, which was then plotted in a value/risk matrix. The tool was tested using results from the mini-HTAs for three new HTs (Surgical Robot, Platelet Rich Plasma, Deep Brain Stimulation).

Results: No significant differences among decision-makers were observed as regards the weights given to the 12 variables, therefore, the median aggregate weights from decision-makers were introduced in the first layer. The dot plot resulting from the mini-HTA presented good power to visually discriminate between the assessed HTs.

Conclusion: The decision-support tool developed here makes possible a robust and straightforward comparison of different competing HTs. This facilitates hospital decision-makers deliberations on the prioritization of competing investments under fixed budgets.

Objectives: Early awareness and alert (EAA) activities are increasingly recognized to be an important component of the health technology assessment (HTA) process. Sharing information on methods used in this discipline is vital to ensure the development of sustainable systems. The objectives of this study is to outline the approach taken to share the different methods that members of the EuroScan International Network use by producing a methods toolkit; and to provide an overview of the similarities and differences in methods adopted by EAA systems.

Methods: A Delphi technique was used to develop the methods toolkit. Structured questionnaires were used to identify the sources used in the identification of emerging technologies and to determine the methods used by agencies to carry out EAA activities.

Results: A methods toolkit incorporating guidance on all of the stages described by EuroScan members was produced. The toolkit and an accompanying checklist presents users with different methods that can be adopted to suit their needs. The comparative analysis demonstrates that different methods are being used by EAA systems dependent on resources available and customer requirements. Differences in identification, filtration, prioritization, and assessment are apparent along with the role of collaborators in these processes.

Conclusions: The methods used by EAA systems are not homogeneous resulting in a toolkit constructed on the basis of “one size doesn't fit all.” Methods in this discipline are developing continually to accommodate changes in health systems and the HTA world. Differences between agencies and the sharing of ideas and experiences enable EAA agencies to adapt to these developments.

Objectives: Pharmaceutical reimbursement agencies’ processes and methods of appraisal vary across countries. The objective of this study was to examine the contribution of formal health economic analysis in a process using such analysis in Scotland in comparison to a process not routinely using such analysis in France.

Methods: A framework for classifying reimbursement systems was used to analyze the two systems. A typology of recommendation was defined and a qualitative analysis of decisions on a sample of medicines appraised by both reimbursement agencies was conducted. Reasons for differences in recommendations were analyzed and case studies selected to illustrate the common reasons.

Results: Thirty-nine common medicines appraised by both agencies were identified between 2005 and 2010, treating a variety of diseases for which the Scottish Medicines Consortium tended to provide more restrictive, or did not recommend, listing. Similarities in clinical evidence submitted to the respective reimbursement committees were observed. Differences in recommendation can be explained by a combination of the manufacturer's freedom to set price and the incentives provided by the consideration of health economic analysis and quality of life, alongside differences in relevant comparators, relevant outcomes, treatment guidelines, and the propensity to use network meta-analysis, in decision making.

Conclusions: This study provides some explanations and hypotheses for the differences observed in recommendations for a selected sample of medicines with regards to differences in appraisal processes and methods adopted. Further research using larger datasets may allow stakeholders to assess the impact of such differences on the efficient use of health resources.

Objectives: The aim of this study was to assess the accuracy of the English National Horizon Scanning Centre (NHSC) in identifying and filtering pharmaceutical developments using end user and international collaborator databases of emerging technologies as proxies for new drugs of likely significance to health services and/or patients.

Methods: We used the NHSC information system and the list of National Institute for Health and Clinical Excellence (NICE) technology appraisals to estimate the false positive rate for NHSC identification, filtration, and reporting. We assessed the sensitivity of NHSC identification and filtration of pharmaceuticals for NICE technology appraisals from 1999 to the end of December 2010, and for pharmaceuticals entered into the EuroScan International Network database.

Results: We estimate that overall NHSC identification, filtration and reporting had a positive predictive value of 0.39 (95 percent CI, 0.36 to 0.43) and a false positive rate of 60 percent. Using NICE appraisals and EuroScan's database as proxies for pharmaceuticals of significance, we estimate the NHSC sensitivity over the 10-year period at 0.92 (95 percent CI, 0.89 to 0.95) and 0.89 (95 percent CI, 0.82 to 0.96) respectively.

Conclusions: Our results suggest that the NHSC has performed well in terms of sensitivity over the past decade, but that the false positive rate of 60 percent may indicate that the filtration criteria for pharmaceuticals could be tightened for increased efficiency. Future evaluations of EAA systems should include an element of external review and explore the level of accuracy acceptable to funders and customers of such systems.

Objectives: The aim of this study was to briefly describe the current state of early awareness and alert (EAA) activities and systems in four Latin-American countries (Argentina, Brazil, Colombia, and Mexico).

Methods: Key informants were selected and completed an open questionnaire that included the following domains: current state of EAA activities and systems in each country, potential role for EAA systems in the health system, and future EAA projects that are currently being considered.

Results: In all four countries, health technology assessment (HTA) processes are used to prioritize the use of health resources, albeit at varying degrees and with different mechanisms and methodologies. EAA activities are still limited and there are virtually no institutions or units with specific functions explicitly devoted to EAA activity. However, most countries have developed some initial forms of EAA systems. Being in its initial stages there is no clear differentiation between these early awareness activities and other HTA functions, and no specific methodologies or processes are used to anticipate the emergence of new technologies. Consequently, early evaluation of technologies generally occurs in a reactive manner, after they have been introduced in the market and under the pressure of different stakeholders.

Conclusions: There is growing awareness that the early identification and assessment of emerging technologies should be an integral part of HTA and the decision-making process. Many initiatives are currently focusing on building partnerships between the various regulatory bodies involved in the incorporation of technologies at national levels. It is reasonable to foresee that EAA activities will continue to develop and expand in the region.

In their article “Different methods for ethical analysis in health technology assessment: An empirical study” published in International Journal of Technology Assessment in Health Care, Volume 27 Number 4, Samuli I. Saarni, Annette Braunack-Mayer, Bjørn Hofmann, and Gert Jan van der Wilt present an empirical study about different methods for ethical analysis in health technology assessment (HTA). They claim that ethical analysis is an important issue which can highlight values inherent in a technology and value-decisions underlying a HTA process (4). Although their study is rich in detail; gives an interesting overview of casuistry, principlism, and axiological ethic frameworks; and make ethical evaluations within HTA more transparent, we suppose, one important point needs further serious discussion: the clarification of what is meant by “value.”

Objectives: The aim of this study was to establish a national Early Awareness and Alert (EAA) system for the identification and assessment of new and emerging health technologies in Italy.

Methods: In 2008, Agenas, a public body supporting Regions and the Ministry of Health (MoH) in health services research, started a project named COTE (Observatory of New and Emerging Health Technologies) with the ultimate aim of implementing a national EAA system. The COTE project involved all stakeholders (MoH, Regions, Industry, Universities, technical government bodies, and Scientific Societies), in defining the key characteristics and methods of the EAA system. Agreement with stakeholders was reached using three separate workshops.

Results: During the workshops, participants shared and agreed methods for identification of new and emerging health technologies, prioritization, and assessment. The structure of the Horizon Scanning (HS) reports was discussed and defined. The main channels for dissemination of outputs were identified as the EuroScan database, and the stakeholders’ Web portals. During the final workshop, Agenas presented the first three HS reports produced at national level and proposed the establishment of a permanent national EAA system.

Conclusions: The COTE Project created the basis for a permanent national EAA system in Italy. An infrastructure to enable the stakeholders network to grow was created, methods to submit new and emerging health technologies for possible evaluation were established, methods for assessment of the technologies selected were defined, and the stakeholders involvement was delineated (in the identification, assessment, and dissemination stages).

Kathrin Dengler and Uta Bittner demand a full-fledged philosophy of values in our empirical study of various methods for ethical analysis in health technology assessment (HTA). This may be like putting the classification of disease on hold until the concept of disease is clarified, or postponing the development of health care until the term “health” is clarified. As Dengler and Bittner rightly point out, the term value has many meanings, and as they properly recognize: “[P]hilosophically, the definition of what is meant by ‘a good life’ or ‘well-being’ is a very challenging project.” Hence, it may be a bit over the top to crave that we solve eternal issues in an empirical article on methodology.

Canada has a highly decentralized health care system with 13 provinces and territories delivering health care within their own respective jurisdictions. Decisions regarding which innovative health technologies to adopt are often driven by the unique health care priorities of each jurisdiction's population. To understand these needs, the Canadian Agency for Drugs and Technologies in Health's (CADTH's) Early Awareness Service has expanded its activities. In addition to proactively scanning the horizon for new and emerging health technologies, the Early Awareness Service also scans the horizon for national and jurisdictional health policy issues. This paper looks at CADTH's process for identifying and monitoring policy issues at a national and jurisdictional level.

CADTH's Early Awareness Service delivers timely information on emerging health care concerns and technologies that may affect health care finances, facilities, operations, and patient care. The identification of important policy issues can help determine which new and emerging technologies will have the most significant impact on the health care system. The information that CADTH scans can also be used to help decision-makers prepare for potential developments and events that may have an impact on health care systems.

By improving its capability to identify and share policy issues across and within jurisdictions, CADTH is better situated to provide information that can be used by policy-makers to help them plan and anticipate for the introduction of new technologies and future developments affecting the unique health care needs of their jurisdictions.

Background: Throughout the world, decision makers face the need to plan on the basis of uncertainty. Prospective updates on future trends of medical technology usage are tools to improve national health status. In Israel, this challenge is met by several steps taken to promote insight into the realm of emerging technologies. Israel's unique horizon strategy refers to three time spans: the immediate to short-term (for the coming year) updating the National List of Health Services (NLHS) and quarterly scanning; the medium-term (3 years to a decade) revitalizing hospital devices and infrastructure; and long-term planning (over a decade), such as the “Health Israel 2020 Project”.

Methods: A description of the Israeli setup of different time spans and tiers.

Results: The matrix of players, loci, interests, population groups, and incentives creates a complex situation and the Ministry of Health has to regulate the different suppliers and tiers of insurance (obligatory, supplementary, and private), balancing need, equity, and cost containment in preparing for future health care. However, preparedness is not a sterile laboratory and is pervaded by numerous dilemmas and the search for adequate evidence for new less mature technologies is an on-going challenge.

Conclusion: Bridging the forecasting chasm for the future requires analyzing needs, reinforcing evidence and seeing “around the corner” when synergizing between all the “actors” in the national arena. Expert consultation and international cooperation with similar horizon organizations can assist in paving the way for more successful planning efforts for future medical technology implementation.

Objectives: There is a growing need for efficient procedures for identification of emerging technologies by horizon scanning systems. We demonstrate the value of best-worst scaling (BWS) in exploring clinicians’ views on emerging technologies that will impact outcomes in hepatocellular carcinoma (HCC) in the next 5 to 10 years.

Methods: Clinicians in Asia, Europe, and the United States were surveyed and their views about eleven emerging technologies relevant to HCC were explored using BWS (case 1). This involved systematically presenting respondents with subsets of five technologies and asking them to identify those that will have the most and least impact on HCC within 5 to 10 years. Statistical analysis was based on sequential best-worst and analyzed using conditional logistic regression.

Results: A total of 120 clinicians uniformly distributed across ten countries completed the survey (37 percent response rate). Respondents were predominately hepatologist (41 percent) who focused on HCC (65 percent) and had national influence in this field (39 percent). Respondents viewed molecular targeted therapy (p < .001) and early detection of HCC (p < .001) as having most potential, while improved surgical techniques (p < .001) and biopsy free HCC diagnostics (p < .001) were viewed upon negatively.

Conclusions: We demonstrate that BWS could be an important research tool to facilitate horizon scanning and HTA more broadly. Our research demonstrates the value of including clinicians’ preferences as a source of data in horizon scanning, but such methods could be used to incorporate the opinions of a broad array of stakeholders, including those in advocacy and public policy.