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Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2012.3.2-2 | Award Amount: 4.04M | Year: 2013

The use of HTA has increased recently in Europe and more widely (e.g. Americas) to enable evidence-based coverage decisions and improve efficiency in resource allocation. HTA has often resulted in different coverage decisions across settings despite the same evidence being used for this purpose. This may reflect in part societal preferences about value, priorities or risk perceptions, suggesting a significant need for methodological improvements and extensions. The fundamental objective of ADVANCE_HTA is to contribute to advancements in the methods for HTA in European and other settings by involving the wider stakeholder community in areas actively and heavily debated given their implications for decision-making and resource allocation, as follows: First, the issue around value for money and the different approaches surrounding current thresholds for resource allocation; Second, the concept of value assessment, and the factors that need to be considered beyond cost effectiveness, such as disease severity; Third, to improve the quality of the evidence required for and the methods associated with the assessment of rare diseases; Fourth, to advance the debate in the elicitation of preferences by deriving these in more realistic settings within the patient community in the wider EU; Fifth, to advance the debate on the suitability of current HTA tools across different categories of medical devices (e.g. diagnostics); and Sixth, to improve the implementation and capacity building of HTA including outside Europe, where HTA is considered explicitly in decision-making. ADVANCE_HTA aims to broaden the spectrum, complement and address areas of intense methodological debate in the application, use and implementation of HTA. It also aims to improve HTA methods, which can be taken further by competent authorities nationally whilst supplementing the work of supra-national bodies (e.g. EUnetHTA) towards a common understanding of choices in health care decision-making.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2010.3.1-1 | Award Amount: 3.79M | Year: 2011

Objective: To improve the dissemination of evidence-based recommendations by building on the work of the GRADE Working Group to develop and evaluate methods that address the targeted dissemination of guidelines. Background: Healthcare decision makers face challenges in understanding guidelines, including the quality of the evidence upon which recommendations are made, which often is not clear. Guidelines are also typically developed as a one-size-fits-all package. By developing and evaluating targeted dissemination strategies, DECIDE aims to increase the use of evidence-based interventions in a sustainable way and to reduce the use of interventions where benefits are uncertain. Methods: GRADE is a systematic approach towards assessing and communicating the quality of evidence and the strength of recommendations. It has been developed to address the weaknesses of other grading systems and is now widely used internationally. The DECIDE consortium, which is composed of members of the GRADE Working Group, will further develop this approach to ensure effective dissemination of evidence-based recommendations targeted at the key stakeholders (healthcare professionals; policymakers and managers; patients and the general public) who determine what happens in clinical practice. We will collect stakeholder input from advisory groups, consultations and user testing. This will be done across a wide range of health systems in Europe. The targeted dissemination strategies that are developed will be evaluated in randomized trials, refined and used and evaluated with real guidelines developed by the DECIDE partners and other guideline developers that we support. Expected results: Dissemination strategies for recommendations that have been rigorously evaluated in diverse settings, support the transfer of research into practice, and are adapted to real-world healthcare systems.


Qaseem A.,The American College | Forland F.,KIT Biomedical Research | Macbeth F.,National Institute for Health and Clinical Excellence | Ollenschlager G.,Arztliches Zentrum fur Qualitat in der Medizin | And 2 more authors.
Annals of Internal Medicine | Year: 2012

Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. Institute of Medicine and the United Kingdom's National Institute for Health and Clinical Excellence have developed recommendations to define trustworthy guidelines within their locales. Many groups charged with guideline development find the lengthy list of standards developed by such organizations to be aspirational but infeasible to follow in entirety. Founded in 2002, the Guidelines International Network (G-I-N) is a network of guideline developers that includes 93 organizations and 89 individual members representing 46 countries. The G-I-N board of trustees recognized the importance of guideline development processes that are both rigorous and feasible even for modestly funded groups to implement and initiated an effort toward consensus about minimum standards for high-quality guidelines. In contrast to other existing standards for guideline development at national or local levels, the key components proposed by G-I-N will represent the consensus of an international, multidisciplinary group of active guideline developers. This article presents G-I-N's proposed set of key components for guideline development. These key components address panel composition, decision-making process, conflicts of interest, guideline objective, development methods, evidence review, basis of recommendations, ratings of evidence and recommendations, guideline review, updating processes, and funding. It is hoped that this article promotes discussion and eventual agreement on a set of international standards for guideline development.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2013.3.1-1 | Award Amount: 2.57M | Year: 2013

Tobacco smoking costs the EU an estimated 98 to 130 billion Euros each year just above 1% of the EU Gross Domestic Product in 2000. A large, robust and consistent evidence base indicates that coordinated, high impact and comprehensive approaches are the most effective way to reduce smoking initiation, prevalence and intensity. Despite this, policy makers and public health procurers often lack the data and financial justification to make the case for investment in tackling the scourge of tobacco. The CER project EQUIPT brings together expertise from multiple disciplines and aims to provide health care policy makers with bespoke information about the economic and wider returns that investing in evidence-based tobacco control including smoking cessation agendas can generate. Learning from a very recent UK experience, EQUIPT will co-create and test a return on investment (ROI) tool, designed for use by tobacco control advocates, policy makers and public health procurers. The first stage of the project will develop the existing ROI tool for use in four EU Member States Germany, Spain, Hungary and the Netherlands. Following this, it will test the transferability of the ROI methods to other EU countries (including lower-income Member States) with a view to guiding comprehensive tobacco control policies. The innovation of this project is its focus beyond simply estimating the cost-effectiveness of individual interventions: instead it will evaluate comprehensive tobacco control in an approach that mirrors real practice, where various interventions are delivered concurrently. In combination with a structured dissemination plan involving key stakeholders, this will improve investment in effective tobacco control and cessation services, in turn reducing the incidence of major chronic diseases and improving quality of life at the population level. The resulting cost-saving across the EU has the potential to be enormous.


O'Rourke N.,Gartnavel General Hospital | Macbeth F.,National Institute for Health and Clinical Excellence
Clinical Oncology | Year: 2010

In the past 15 years, the treatment of locally advanced non-small cell lung cancer (NSCLC) has shifted from radiotherapy alone. There are now schedules using induction chemotherapy, concurrent chemoradiation using either radiosensitising doses of chemotherapy or full-dose chemotherapy, consolidation chemotherapy after radiation or combinations of these options. There is no consensus on the optimal chemotherapy regimen and its scheduling and the issue of radiation dose and optimal fractionation equally remains unresolved. This overview is in two sections. First, we have evaluated a selection of international guidelines on the management of locally advanced NSCLC. We assessed the methodology by which individual guidelines were produced and the levels of evidence quoted in support of the recommendations. Second, we have updated the literature search of the 2004 Cochrane review on concurrent chemoradiation. Trials were identified that compared sequential with concurrent chemoradiation using median survival as the primary outcome measure. Two-year survival and toxicity were evaluated as secondary outcome measures. Eleven trials were identified, of which six fulfilled criteria for inclusion. The median survival for concurrent treatment was 16-17 months compared with 13-15 months with sequential treatment. Treatment-related mortality was 3% for concurrent treatment and 1.7% for sequential treatment. The rate of grade 3 or worse oesophagitis was 19% in concurrent treatment compared with 3% for sequential treatment. In conclusion, chemotherapy adds benefit to radiotherapy treatment of locally advanced NSCLC. Concurrent chemoradiation is associated with significant toxicity. The evidence to support concurrent chemoradiation as the standard of care is not robust, in spite of its recommendation within a number of guidelines. Further trials should be supported. © 2010 The Royal College of Radiologists.


Chalkidou K.,National Institute for Health and Clinical Excellence | Rawlins S.M.,National Institute for Health and Clinical Excellence
Drug Discovery Today | Year: 2011

"Tailoring medicines to patients is a key challenge for the $750 billion global pharmaceutical market." - Rt Hon David Willetts (Minister of State for Universities and Science) launching the Stratified Medicines Innovation Platform, a new £50m UK government initiative a Genetic and proteomic information can be used to identify those patient groups who are most susceptible to a disease and those who are most likely to respond to particular pharmacological treatments. In this review we discuss the impact of cost-effectiveness analysis (CEA) regarding the way pharmacogenetics are adopted by healthcare systems and also, the potential impact of pharmacogenetics on the way CEA is conducted. We conclude that, although CEA can help incentivise the development of appropriate pharmacogenetic tests, when used inappropriately by payers or when ignored by developers, it can act as an obstacle to the adoption of health and efficiency improving technologies. © 2011 Elsevier Ltd. All rights reserved.


Kakkar A.K.,Queen Mary, University of London | MacBeth F.,National Institute for Health and Clinical Excellence
British Journal of Cancer | Year: 2010

A broad range of studies suggest a two-way relationship between cancer and venous thromboembolism (VTE). Patients with cancer have consistently been shown to be at elevated risk for VTE; this risk is partly driven by an intrinsic hypercoagulable state elicited by the tumour itself. Conversely, thromboembolic events in patients without obvious risk factors are often the first clinical manifestation of an undiagnosed malignancy. The relationship between VTE and cancer is further supported by a number of trials and meta-analyses which, when taken together, strongly suggest that antithrombotic therapy can extend survival in patients with cancer by a mechanism that extends beyond its effect in preventing VTE. Moreover, accumulating evidence from in vitro and in vivo studies has shown that tumour growth, invasion, and metastasis are governed, in part, by elements of the coagulation system. On 22 May 2009, a group of health-care providers based in the United Kingdom met in London, England, to examine recent advances in cancer-associated thrombosis and its implications for UK clinical practice. As part of the discussion, attendees evaluated evidence for and against an effect of antithrombotic therapy on survival in cancer. This paper includes a summary of the data presented at the meeting and explores potential mechanisms by which antithrombotic agents might exert antitumour effects. The summary is followed by a consensus statement developed by the group. © 2010 Cancer Research UK. All rights reserved.


Rawlins M.D.,National Institute for Health and Clinical Excellence
British Journal of Clinical Pharmacology | Year: 2012

The fourth hurdle, the requirement that pharmaceutical manufacturers can demonstrate that their new products represent good value for money as well as being of good quality, effective and safe, is increasingly being required by healthcare systems. In crossing this 'fourth' hurdle, companies will usually need to demonstrate that their products are more effective than relevant comparators and that the increased cost is offset by the enhanced benefits. Decision makers, however, must draw their conclusions not only on the basis of the underpinning science but also on the social values of the people they serve. © 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.


Rawlins M.D.,National Institute for Health and Clinical Excellence
Clinical medicine (London, England) | Year: 2013

From 1 April 2013, the National Institute for Health and Clinical Excellence (NICE) will be re-established under the provisions of the Health and Social Care Act 2012. Although its name will change to the National Institute for Health and Care Excellence, its acronym--NICE--has been written into the face of the Act. The new NICE will continue to provide the full range of guidance and other products with which the Institute has become associated. It will, though, have enhanced responsibilities in the development of quality standards and in the introduction of value-based pricing. In addition, it will be responsible for producing guidance for social care (hence the change in its name) and associated quality standards. The changes to the structure of NICE will not change its relationship with the professions and we are confident that it will continue to be relevant to all those working in the National Health Service.


Van Loon J.,Maastricht University | Van Loon J.,National Institute for Health and Clinical Excellence | Grutters J.,Maastricht University | Macbeth F.,National Institute for Health and Clinical Excellence
The Lancet Oncology | Year: 2012

Technical innovations in radiation oncology-eg, intensity-modulated radiotherapy, stereotactic radiotherapy, and particle therapy-can be developed rapidly and introduced into the clinic even when costs associated with their use are much higher than those for conventional radiotherapy. Although clinical benefit is expected on the basis of superior biological and physical characteristics, data for clinical effectiveness of new radiotherapy techniques are scarce. Evidence from randomised clinical trials would be ideal but such studies focus mostly on new drugs. High investment costs and modifications over time make evaluation of novel radiotherapy technologies in clinical trials more complex. Here, we propose an algorithm for evaluation of the clinical and cost effectiveness of novel radiotherapy technologies. We suggest situations when randomised trials might be feasible and the type of trial that should be undertaken when they are not. Furthermore, we discuss the usefulness of dose-distribution models for estimation of expected clinical benefit and for selection of the patients' population with the highest expected benefit. Economic modelling, including the approach of real options analysis, can inform whether implementation of a technology should begin (based on available evidence) or be delayed (until further data are available), and it can indicate the best trial design and required sample size. © 2012 Elsevier Ltd.

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