Objectives: Information on the impact of computed tomography coronary angiography (CTCA) on patterns of care is scarce. In particular, it is not clear if, and to what extent, its adoption actually leads to a reduction in the use of other diagnostics tools. The aim of this study was to evaluate whether the adoption of CTCA in Emilia-Romagna (an Italian region with a population of 4.4 million) had any effect on utilization rates of myocardial perfusion scintigraphy (MPS) and coronary angiography (CA).

Methods: Interrupted time series (ITS) were applied to monthly volumes of MPS and CA tests performed from 2003 to 2010, to assess trends in usage rates for those procedures before and after CTCA was adopted by all the healthcare organizations operating in the region.

Results: After an increase in the first year of CTCA introduction, its use remained stable over the study period. After September 2006, a significant decrease in MPS volumes (31 percent; p < .0001) and a much less tangible decrease in CA volumes (5 percent; p < .0001), were detected by ITS analyses.

Conclusions: This study demonstrates that the use of CTCA had a greater impact on MPS usage rates than on CA.

Objectives: In recent years, there has been growth in the use of health technology assessment (HTA) for making decisions about the reimbursement, coverage, or guidance on the use of health technologies. Given this greater emphasis on the use of HTA, it is important to develop standards of good practice and to benchmark the various HTA organizations against these standards.

Methods: This study discusses the conceptual and methodological challenges associated with benchmarking HTA organizations and proposes a series of audit questions based on a previously published set of principles of good practice.

Results and Conclusions: It is concluded that a benchmarking exercise would be feasible and useful, although the question of who should do the benchmarking requires further discussion. Key issues for further research are the alternative methods for weighting the various principles and for generating an overall score, or summary statement of adherence to the principles. Any weighting system, if developed, would need to be explored in different jurisdictions to assess the extent to which the relative importance of the principles is perceived to vary. Finally, the development and precise wording of the audit questions requires further study, with a view to making the questions as unambiguous as possible, and the reproducibility of the assessments as high as possible.

Objectives: We compared Polish and Scottish Health Technology Assessment (HTA) process in order to elicit recommendations for future development of HTA methodological guidelines in Poland.

Methods: We studied the differences between Polish and Scottish HTA methodological guidelines. HTA recommendations issued by Polish HTA agency (AHTAPol) in the period January 1 through December 31, 2008, were benchmarked to HTA guidance published by Scottish Medical Consortium (SMC) for the same drug technology.

Results: The Scottish HTA methodological guidelines were more instructive in terms of clinical and economic evaluations than Polish guidelines. SMC evaluated forty-eight of sixty-eight drug technologies appraised by AHTAPoL. There were thirty drug technologies that received similar guidance in both countries and eighteen with contradictory HTA recommendations. In Scotland, there were more positive HTA recommendations than there were in Poland. While comments about efficacy or safety were commonplace among reasons for negative recommendations in Poland, insufficient justification of treatment's cost in relation to benefits was the most often cited reason for rejection in Scotland. SMC tended to recommend restricted use to specific sub-populations for several drug technologies negatively appraised by AHTAPoL.

Conclusions: The comparison between SMC and AHTAPoL suggests that there is potential room of improvement of the Polish HTA methodological guidelines. Comparative effectiveness and safety, subgroup analysis, and adaptation of models to local settings were identified as key areas for further development of Polish HTA methodological guidelines.

Objectives: The news media plays a central role in providing information regarding new medical technologies and exerts an influence on their social perception, understanding, and assessments. This study, therefore, analyzes how healthcare robotics are portrayed in the German print news media. It examines whether the risks and opportunities of new medical technologies are presented in a balanced manner and investigates whether or not print media coverage of these technologies is affected by science-fiction discourse, in which robots appear mostly as a threat to humans.

Methods: Ten years of German print media coverage (2000–2010) have been studied by means of systematic, standardized content analysis.

Results: Reporting focuses predominantly on beneficial advancements in medical practice and the advantages of robotics for patients, medical staff, and society. The results show that the dominant relationship between robots and humans that is transmitted in print media in medical contexts is positive, with robots mostly portrayed as assistants, colleagues, or even friends. Only a small number of articles report ethical questions and risks.

Conclusions: In contrast to science-fiction discourse, the German print media provides a positive picture of robotics to the lay public.

Objectives: Health technology assessment (HTA) was established in Austria in the 1990s and, since then, it has gained considerable importance. In this study, we aim to analyze whether the HTA reports that have been produced at the Institute for Technology Assessment (ITA) and at the Ludwig Boltzmann Institute for HTA (LBI-HTA) have had an impact on decision making within the Austrian health care system.

Methods: We selected all reports that were intended for supporting (i) reimbursement/investment or (ii) disinvestment decisions. Eleven full HTA reports and fifty-eight rapid assessments fulfilled the inclusion criteria. We used interview data and administrative data on volumes, tariffs and expenditure of products/services to analyze whether and how reports were in reality used in decision making and what the consequences for health care expenditure and resource distribution have been.

Results: Five full HTA reports and fifty-six rapid technology assessments were used for reimbursement decisions. Four full HTA reports and two rapid assessments were used for disinvestment decisions and resulted in reduced volumes and expenditure. Two full HTA reports showed no impact on decision making. Impact was most evident for hospital technologies.

Conclusions: HTA has played some role in reducing volumes of over-supplied hospital technologies, resulting in reduced expenditure for several hospital providers. Additionally, it has been increasingly included in prospective planning and reimbursement decisions of late, indicating re-distribution of resources toward evidence-based technologies. However, further factors may have influenced the decisions, and the impact could be considerably increased by systematically incorporating HTA into the decision-making process in Austria.

Background: In 2008 the Danish National Board of Health launched an information campaign aimed at introducing mini-HTA as a management and decision support tool for the municipalities. Today (January 2012), mini-HTA is still not used regularly in the municipalities.

Aim: The aim of this study was to evaluate the latent attitudes toward mini-HTA among ninety-three participants in five voluntary workshops on mini-HTA held in the period of May 2008 to February 2009.

Methods: In a questionnaire including three open questions respondents were asked to state their perception of what mini-HTA could be used for in the municipality, the main barriers for using mini-HTA, and what could make it easier to implement mini-HTA. Answers were analyzed qualitatively and quantitatively using binary coding and statistical examination of patterns in form of R-factor analysis.

Results: The four significant latent attitudes were a general acceptance of HTA-principles, a derived need for a political/managerial decision to use mini-HTA in the municipality, worries about barriers in the medium run, and worries about barriers in the short run.

Conclusions: A national information campaign to support the uptake of mini-HTA in local health-care institutions was insufficient in the Danish municipalities and should have been supplemented with a strategy to secure local political/managerial willingness to use mini-HTA and the removal of short- and medium-term barriers. The implementation of local HTA should not just be seen as a question of how to increase the use of evidence in decision-making, but as a matter of reforming local decision processes.

Objectives: Cardiac resynchronization therapy (CRT) has recently been shown to reduce both mid-term and long-term mortality in patients with mild heart failure. Although proven effective, it is unclear whether CRT is cost-effective in low and middle-income countries (LMIC). Therefore, we set out to analyze the cost-effectiveness of CRT in Argentina in patients with New York Heart Association (NYHA) functional class (FC) I or II heart failure (HF). We chose to compare patients receiving optimal medical treatment (OMT) and CRT with those patients receiving only OMT.

Methods: We constructed a Markov model with a cohort simulation, and a life-time horizon to assess costs, life-years, and quality-adjusted life-year (QALY) gained as a result of treatment with both CRT and OMT from an Argentine third party payer perspective. We included patients who met the following criteria: left ventricular ejection fraction (LVEF) ≤ 40 percent, sinus rhythm with a QRS ≥ 120 msec, and NYHA FC I-II HF. The results were expressed as cost per life-year and QALY gained in international dollars (ID$) for the year 2009.

Results: For the base case analysis performed, we started at a fixed age of 65. After applying a 3 percent annual discount rate, the incremental cost-effectiveness ratio (ICER) was 38.005 ID$ per year of life gained and 34.185 ID$ per QALY gained.

Conclusions: Long-term treatment with CRT appears to be cost-effective in Argentina compared with patients treated solely with OMT. Similar analysis should be performed to determine if this treatment option is cost-effective in other LMIC.

Health technology assessment (HTA) is now 35 years old (1). During this time, the science and use of HTA has evolved enormously, adapting to changing healthcare and policy environments. Today, the HTA community has strong methods and procedures to produce HTA (5–7;10), and its results are increasingly used worldwide for decision making. It seems therefore that the time has arrived to set up best practices and to benchmark HTA processes and organizations. The work initiated by Drummond et al. is highly valued, because it opens a new area of needed work following the HTA community's previous emphasis on methodological and process development.

Objectives: The aim of this study was to evaluate the long-term cost-utility of liraglutide versus glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus (T2DM), based on the results of clinical trial conducted in Asian population.

Methods: The validated UKPDS Outcomes Model was used to project life expectancy, quality adjusted life-years (QALYs), incidence of diabetes-related complication and cost of complications in patients receiving those regimens. Baseline cohort characteristics and treatment effects were derived from an Asian study. China-specific complication costs and utility score were taken from local studies. Patients’ outcomes were modeled for 30 years and incremental cost-effectiveness ratios were calculated for liraglutide compared with glimepiride from the healthcare system perspective. Both future costs and clinical benefits were discounted at 3 percent. Sensitivity analyses were performed.

Results: Over a period of 30 years, compared with glimepiride, liraglutide 1.8 mg was associated with improvements in life expectancy (0.1 year) and quality adjusted life-year (0.168 QALY), and a reduced incidence of diabetes-related complications leading to an incremental cost-effectiveness ratio per QALY gained versus glimepiride of CNY 25,6871 (DEC 2010, 1 USD = 6.6227 CNY).

Conclusions: Long-term projections indicated that liraglutide was associated with increased life expectancy, QALYs, and reduced complication incidences comparing with glimepiride. When the UK cost of liraglutide was discounted by 38 percent, liraglutide would be a cost-effective option in China from the healthcare system perspective using the 3X GDP/capita per QALY as the WTP threshold.

The paper by Drummond et al. in this issue of the Journal discusses how the principles that have been proposed in previous papers by these authors might be used as the basis for benchmarking health technology assessment (HTA) organizations. This raises a number of important issues, some acknowledged and discussed by the authors, and some not. The commentary by Sampietro provides an analysis of many of these. Two issues strike me as fundamental in this debate: the need for an agreed and objective approach to describing health system decision-making systems; and the need for an agreed and objective approach to the assessment of the quality of HTA reports to support specific decisions.

Objectives: High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate.

Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information.

Results: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials.

Conclusions: For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

Objectives: When a new health technology has been approved by a health system, it is difficult to guarantee that it is going to be efficiently adopted, adequately used, and that effectiveness, safety, and consumption of resources and costs are in line with what was expected in preliminary investigations. Many governmental institutions promote the idea that efficient mechanisms should be established aimed at developing and incorporating continuous evidence into health technologies management. The purpose of this article is to stimulate the discussion on systematic post-introduction observation of health technologies.

Methods: Literature review and input of HTA experts.

Results: The study addresses the key issues related to post-introduction observation and presents a summary of the guide commissioned by the Spanish Ministry of Health, Social Policy and Equality to the Galician HTA agency for the prioritization and implementation of systematic post-introduction observation in Spain. The manuscript describes the prioritization tool developed as part of this project and discusses the main aspects of protocol development, observation implementation, and assessment of results.

Conclusions: The observation of prioritized health technologies after they are introduced in standard clinical practice can provide useful information for health organizations. However, implementing the observation of health technologies can require specific policy frameworks, commitment from different stakeholders, and dedicated funding.

Objectives: The objective of this study is to review the implementation of health technology assessment (HTA) at the local and hospital levels in low- and middle-income countries (LMIC). This review will provide a starting point for identifying the conditions for HTA implementation in hospitals in LMIC through the analysis of experiments conducted in these countries.

Methods: A systematic review of the literature was conducted to document the local-/hospital-level HTA experiments performed in LMIC.

Results: This systematic review showed that few experiments of local HTA in LMIC have been published to date, with only five articles found in our survey. These documents report studies of clinical effectiveness and economic evaluation at the local level in certain Asian and Latin American countries. In addition, pharmaceuticals and medical devices were the most common topics covered by HTA at the local level in these countries.

Conclusions: Currently, HTA plays an increasingly important role in healthcare systems in supporting decision making for healthcare policies and practices. This systematic review contributes to identify priorities in the process and methodology of HTA implementation at the local/hospital level in LMIC. The paucity of HTA in LMIC is often assumed to be due to the lack of formally tasked HTA agencies, to politics and to shortage of resources.

Since the origin of technology assessment (TA) in the 1960s, including TAs of certain medical interventions, and formal recognition and institutionalization of health technology assessment (HTA) in the 1970s, the field of HTA has evolved in programs large and small in the public and private sectors. It has diffused into an increasing number of nations in a range of policy-making and decision-support contexts. Since its inception, the development and diffusion of HTA have been strongly characterized by international collaboration involving sharing of expertise and practical experience, and joint efforts to advance the state of the art. Also during that time, there have been periodic collaborations to identify or develop standard frameworks, good practices, guiding principles, checklists, and other normative, “how-to” documentation for the field. Recognizing the diversity and ongoing evolution of HTA, these efforts have generally sought to balance the appeal of standardization with that of flexibility to accommodate the ranges of HTA program remits and contexts.

Background and Objectives: Horizon scanning systems need to handle a wide range of sources to identify new or emerging health technologies. The objective of this study is to develop a validated Medline bibliographic search strategy (PubMed search engine) to systematically identify new or emerging health technologies.

Methods: The proposed Medline search strategy combines free text terms commonly used in article titles to denote innovation within index terms that make reference to the specific fields of interest. Efficacy was assessed by running the search over a period of 1 year (2009) and analyzing its retrieval performance (number and characteristics). For comparison purposes, all article abstracts published during 2009 in six preselected key research journals and eight high impact surgery journals were scanned. Sensitivity was defined as the proportion of relevant new or emerging technologies published in key journals that would be identified in the search strategy within the first 2 years of publication.

Results: The search yielded 6,228 abstracts of potentially new or emerging technologies. Of these, 459 were classified as new or emerging (383 truly new or emerging and 76 new indications). The scanning of 12,061 journal abstracts identified 35 relevant new or emerging technologies. Of these, twenty-nine were located within the Medline search strategy during the first 2 years of publication (sensitivity = 83 percent).

Conclusions: The current search strategy, validated against key journals, has demonstrated to be effective for horizon scanning. Even though it can require adaptations depending on the scope of the horizon scanning system, it could serve to simplify and standardize scanning processes.

Objectives: A new decision-making process was set up by the Austrian Ministry of Health to regulate coverage of new proposed Extra Medical Services (EMS; German: Medizinische Einzel-Leistung [MEL]) in 2008. As part of the annual decision-making process an independent academic institution (LBI-HTA) is evaluating relevant evidence on these new technologies and provides HTAs, including evidence-based recommendations for decision makers.

Methods: About ten EMS assessments are performed annually by the LBI-HTA simultaneously between January and March. Each peer-reviewed report consists of a systematic literature review and critical appraisal of evidence using the GRADE methodology. The generation of numerous reports of good quality standards within the short timeframe is achieved by a standardized workflow with predefined assignment of tasks for all participants.

Results: In total, the LBI-HTA performed twenty-five EMS assessments on thirty-three different interventions in the last three years. Coverage was recommended with limitation for eleven (33%) interventions, and not recommended for twenty-two (66%) interventions. The federal health commission decided on acceptance or preliminary acceptance of coverage in seven (22%) cases, rejection in eighteen (55%) cases and changed the status to “subject to approval” in seven (24%) cases.

Conclusions: Pre-coverage assessment of new hospital interventions was implemented successfully in Austria. It has proved to be a useful tool to support decision makers with objective evidence when deciding whether or not to reimburse medical services.

Background: Mental illness constitutes a large proportion of the burden of disease in Zambia. Yet mental health services at the primary care level are either provided in a fragmented manner or are lacking altogether.

Methods: A literature review focused on terms including mental health and primary care and strategic options were analyzed.

Results: From the analysis, two options were considered for integrating mental health into primary health care. An incremental option would start with a pilot project introducing mental health services into primary care with a well-designed evaluation before scaling up. One key advantage of this option is that it is possible to make improvements in the plan, if needed, before scaling up. A comprehensive option would entail introducing mental health services into primary care in all nine provinces of Zambia. In this option, scaling up could occur more rapidly than an incremental approach.

Conclusions: Strategies to implement either option must address several barriers, including insufficient funding for mental health services, inadequate mental health indicators, lack of general public awareness of and social stigma attached to mental illnesses and mental health care not being perceived as cost-effective or affordable.

Introduction: HTA agencies, especially in developing countries, are under resourced and unable to conduct the desired amount of assessments. Adapting HTA reports (HTAs) from other jurisdictions is an alternative for saving resources.

Objectives: To explore HTA transferability experiences in Latin-America and Caribbean (LAC): are decision makers (DMs) using HTAs from other jurisdictions? Are researchers adapting HTAs when developing local reports? How useful is the information found in HTAs from other jurisdictions?

Methods: Web-based survey sent to 13031 HTA researchers and DMs.

Results: We received 671 responses from 19 countries. DMs reported using HTAs from other jurisdictions to guide decisions in the majority of the situations: 52.6 percent HTAs from outside LAC (e.g., Europe), 23.1 percent from other LAC countries, and only 24.3 percent HTAs from their own countries. 63 percent of researchers reported using HTAs from other jurisdictions. Usefulness scored significantly higher for HTAs from other jurisdictions as compared to local HTAs (7.1 versus 6.0 in a 1–10 scale; p < .01). Both DMs and researchers considered the information regarding safety and effectiveness more applicable than the information on social aspects, or economic evaluation. Barriers that limit transferability had significantly different scores for HTAs from other LAC countries as compared to those from regions outside LAC (i.e., poor methodological quality 6.7 versus 5.3, different epidemiological context 6.0 versus 7.4; all p < .01).

Conclusions: HTAs from outside the region are commonly used. However, DMs and researchers agreed that HTAs from LAC had the greatest potential for transferability, provided that barriers such as poor methodological quality could be overcome.