Sue Simpson

International diffusion of new health technologies: A ten-country analysis of six health technologies

OBJECTIVES The objective of this study was to examine and explain the differential international diffusion of six health innovations. METHODS A retrospective diffusion study was undertaken of sildenafil, cyclooxygenase-II (COX II) inhibitors, beta interferon, verteporfin, deep brain stimulators, and drug-eluting coronary stents in ten countries-Australia, Canada, Denmark, France, The Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom. We plotted diffusion curves of daily defined doses per quarter, vials or implants per million population, and examined the association between diffusion and five key variables. RESULTS Canada, Switzerland, and Sweden are generally high users of new technologies; Spain, Denmark, and particularly the United Kingdom are low users. Almost all countries experienced rapid adoption of sildenafil with diffusion to a similar level; there was variable adoption and diffusion of COX II inhibitors, verteporfin, and interferon beta; drug-eluting stents penetrated the market in a similar way in all but one country; and two countries had very different adoption patterns for deep brain stimulators. Above average health spending and the presence of health technology assessment (HTA) or other guidance reports are consistently associated with increased diffusion. Early warning activity and a national coverage decision being taken are more likely to be associated with a reduced diffusion. CONCLUSIONS The significant differences in diffusion between different countries are not consistent with a neat evidence-based world. The tools available to policy makers to control diffusion (early warning systems, HTA, and a fourth hurdle) play some part in influencing diffusion but need close scrutiny of how successfully they operate.

Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes What Systems Are in Development?

Background: Closed-loop artificial pancreas device (APD) systems are externally worn medical devices that are being developed to enable people with type 1 diabetes to regulate their blood glucose levels in a more automated way. The innovative concept of this emerging technology is that hands-free, continuous, glycemic control can be achieved by using digital communication technology and advanced computer algorithms. Methods: A horizon scanning review of this field was conducted using online sources of intelligence to identify systems in development. The systems were classified into subtypes according to their level of automation, the hormonal and glycemic control approaches used, and their research setting. Results: Eighteen closed-loop APD systems were identified. All were being tested in clinical trials prior to potential commercialization. Six were being studied in the home setting, 5 in outpatient settings, and 7 in inpatient settings. It is estimated that 2 systems may become commercially available in the EU by the end of 2016, 1 during 2017, and 2 more in 2018. Conclusions: There are around 18 closed-loop APD systems progressing through early stages of clinical development. Only a few of these are currently in phase 3 trials and in settings that replicate real life.

Effective early warning systems for new and emerging health technologies: Developing an evaluation framework and an assessment of current systems

OBJECTIVES The aim of this study was to define an effective early warning system, to identify and rank the characteristics of an effective early warning system for emerging health technologies, and to evaluate current early warning systems against these characteristics. METHODS An iterative Delphi-type process with the thirteen members of the International Information Network on New and Changing Health Technologies (EuroScan). We synthesized key characteristics that network members had graded. Members were then asked whether these characteristics were present or fulfilled in their system. RESULTS The definition of an effective early warning system developed was the following: a system that identifies innovations in the field of health technology likely to have a significant impact; and disseminates information relevant to the needs of the customer which is timely, so as to enable appropriate decision making (such as resource allocation), facilitate appropriate adoption, and identify further research requirements. Five primary and eleven secondary components of effective early warning systems were identified. The five primary characteristics concerned relevance, independence, resourcing, a clear pathway for the outputs to reach decision makers, and defined customers. Although the primary characteristics were present or fulfilled to some extent in the majority of evaluated early warning systems, there was considerable variability in the presence of the secondary characteristics in the evaluated systems. CONCLUSIONS Our study provides a definition for an effective early warning system and a shared understanding of the important characteristics and components of such systems. This work should provide guidance to those setting up new early warning systems as well as for those managing and reviewing current systems.

New and emerging technologies for the treatment of inherited retinal diseases: a horizon scanning review

The horizon scanning review aimed to identify new and emerging technologies in development that have the potential to slow or stop disease progression and/or reverse sight loss in people with inherited retinal diseases (IRDs). Potential treatments were identified using recognized horizon scanning methods. These included a combination of online searches using predetermined search terms, suggestions from clinical experts and patient and carer focus groups, and contact with commercial developers. Twenty-nine relevant technologies were identified. These included 9 gene therapeutic approaches, 10 medical devices, 5 pharmacological agents, and 5 regenerative and cell therapies. A further 11 technologies were identified in very early phases of development (typically phase I or pre-clinical) and were included in the final report to give a complete picture of developments ‘on the horizon’. Clinical experts and patient and carer focus groups provided helpful information and insights, such as the availability of specialised services for patients, the potential impacts of individual technologies on people with IRDs and their families, and helped to identify additional relevant technologies. This engagement ensured that important areas of innovation were not missed. Most of the health technologies identified are still at an early stage of development and it is difficult to estimate when treatments might be available. Further, well designed trials that generate data on efficacy, applicability, acceptability, and costs of the technologies, as well as the long-term impacts for various conditions are required before these can be considered for adoption into routine clinical practice.

Early identification and assessment of new and emerging health technologies : Actions, progress, and the future direction of an international collaboration-EuroScan

OBJECTIVES To report on a workshop, and subsequent discussions, that reviewed the achievements and progress of the EuroScan collaboration since its establishment in 1999 to share information on the methods and results of early identification and assessment of new and emerging health technologies; considered challenges to the collaboration; and discussed its possible future direction. METHODS A workshop was held in Stockholm in September 2006, with thirty-two participants from ten countries and representatives from EuroScan member agencies, policy makers involved in policy or decision making relating to new technologies, and invited external commentators from international HTA networks. The workshop used a mix of presentations, panel and audience discussions, and small group work to consider the achievements and challenges put forward. RESULTS EuroScan has developed as a sustainable network, and has made progress on all tasks in its initial action plan, with the EuroScan information sharing database on new and emerging technologies being one of the collaborations key achievements. Identified immediate concerns for the network included consideration of the impact of its current name and membership model; acknowledgement and publication of the full range of benefits of membership; contribution to and development of the database to encourage increased information sharing; and EuroScans ongoing interaction with the wider HTA world. CONCLUSIONS The workshop was a useful mechanism for reviewing the work of EuroScan and for creating a platform to take the collaboration forward. The workshop affirmed the benefits of the network to individual members; posed some significant challenges to the network to consider; and acted as a stimulus for an interim name change to better represent the global membership, and a major review of the EuroScan database of identified and assessed emerging health technologies.

Decline in new drug launches: myth or reality? Retrospective observational study using 30 years of data from the UK

Objective To describe trends in new drugs launched in the UK from 1982 to 2011 and test the hypothesis that the rate of new drug introductions has declined over the study period. There is wide concern that pharmaceutical innovation is declining. Reported trends suggest that fewer new drugs have been launched over recent decades, despite increasing investment into research and development. Design Retrospective observational study. Setting and data source Database of new preparations added annually to the British National Formulary (BNF). Main outcome measures The number of new drugs entered each year, including new chemical entities(NCEs) and new biological drugs, based on first appearance in the BNF. Results There was no significant linear trend in the number of new drugs introduced into the UK from 1982 to 2011. Following a dip in the mid-1980s (11–12 NCEs/new biologics introduced annually from 1985 to 1987), there was a variable increase in the numbers of new drugs introduced annually to a peak of 34 in 1997. This peak was followed by a decline to approximately 20 new drugs/year between 2003 and 2006, and another peak in 2010. Extending the timeline further back with existing published data shows an overall slight increase in new drug introductions of 0.16/year over the entire 1971 to 2011 period. Conclusions The purported ‘innovation dip’ is an artefact of the time periods previously studied. Reports of declining innovation need to be considered in the context of their timescale and perspective.

Assessing the accuracy of forecasting: Applying standard diagnostic assessment tools to a health technology early warning system

OBJECTIVES Early warning systems are an integral part of many health technology assessment programs. Despite this finding, to date, there have been no quantitative evaluations of the accuracy of predictions made by these systems. We report a study evaluating the accuracy of predictions made by the main United Kingdom early warning system. METHODS As prediction of impact is analogous to diagnosis, a method normally applied to determine the accuracy of diagnostic tests was used. The sensitivity, specificity, and predictive values of the National Horizon Scanning Centres prediction methods were estimated with reference to an (imperfect) gold standard, that is, expert opinion of impact 3 to 5 years after prediction. RESULTS The sensitivity of predictions was 71 percent (95 percent confidence interval [CI], 0.36-0.92), and the specificity was 73 percent (95 percent CI, 0.64-0.8). The negative predictive value was 98 percent (95 percent CI, 0.92-0.99), and the positive predictive value was 14 percent (95 percent CI, 0.06-0.3). CONCLUSIONS Forecasting is difficult, but the results suggest that this early warning systems predictions have an acceptable level of accuracy. However, there are caveats. The first is that early warning systems may themselves reduce the impact of a technology, as helping to control adoption and diffusion is their main purpose. The second is that the use of an imperfect gold standard may bias the results. As early warning systems are viewed as an increasingly important component of health technology assessment and decision making, their outcomes must be evaluated. The method used here should be investigated further and the accuracy of other early warning systems explored.

The future role of genetic screening to detect newborns at risk of childhood-onset hearing loss

Abstract Objective: To explore the future potential of genetic screening to detect newborns at risk of childhood-onset hearing loss. Design: An expert led discussion of current and future developments in genetic technology and the knowledge base of genetic hearing loss to determine the viability of genetic screening and the implications for screening policy. Results and Discussion: Despite increasing pressure to adopt genetic technologies, a major barrier for genetic screening in hearing loss is the uncertain clinical significance of the identified mutations and their interactions. Only when a reliable estimate of the future risk of hearing loss can be made at a reasonable cost, will genetic screening become viable. Given the speed of technological advancement this may be within the next 10 years. Decision-makers should start to consider how genetic screening could augment current screening programmes as well as the associated data processing and storage requirements. Conclusion: In the interim, we suggest that decision makers consider the benefits of (1) genetically testing all newborns and children with hearing loss, to determine aetiology and to increase knowledge of the genetic causes of hearing loss, and (2) consider screening pregnant women for the m.1555A> G mutation to reduce the risk of aminoglycoside antibiotic-associated hearing loss.

Predicting the impact of new health technologies on average length of stay: Development of a prediction framework

OBJECTIVES The aim of this study was to develop a framework to predict the impact of new health technologies on average length of hospital stay. METHODS A literature search of EMBASE, MEDLINE, Web of Science, and the Health Management Information Consortium databases was conducted to identify papers that discuss the impact of new technology on length of stay or report the impact with a proposed mechanism of impact of specific technologies on length of stay. The mechanisms of impact were categorized into those relating to patients, the technology, or the organization of health care and clinical practice. RESULTS New health technologies have a variable impact on length of stay. Technologies that lead to an increase in the proportion of sicker patients or increase the average age of patients remaining in the hospital lead to an increase in individual and average length of stay. Technologies that do not affect or improve the inpatient case mix, or reduce adverse effects and complications, or speed up the diagnostic or treatment process should lead to a reduction in individual length of stay and, if applied to all patients with the condition, will reduce average length of stay. CONCLUSIONS The prediction framework we have developed will ensure that the characteristics of a new technology that may influence length of stay can be consistently taken into consideration by assessment agencies. It is recognized that the influence of technology on length of stay will change as a technology diffuses and that length of stay is highly sensitive to changes in admission policies and organization of care.

Emerging point of care tests for influenza: innovation or status quo

Please cite this paper as: Tayo A et al. (2012) Emerging point of care tests for influenza: innovation or status quo. Influenza and Other Respiratory Viruses 6(4), 291–298.