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• W2018059451 abstract "So what is the problem about introducing clinical positron-emission tomography (PET) in the U.K.? Fluorodeoxyglucose (18FDG) uptake can be visualised in tumours and, with whole-body PET cameras, we essentially have ‘soft tissue bone scans’, which can increase the sensitivity and specificity of staging of tumours [1Jerusalem G Hustinx R Beguin Y et al.PET scan imaging in oncology.Eur J Cancer. 2003; 39: 1525-1534Abstract Full Text Full Text PDF PubMed Scopus (78) Google Scholar]. Eight-five per cent of indications for clinical PET are now in oncology. However, the comprehensive introduction of clinical PET into the NHS has not yet been established. Why? PET scanning involves the imaging of organ function rather than organ anatomy (as in computed tomography [CT] and magnetic resonance imaging), and is used, in particular, in the assessment of cancer. It involves the administration of radiopharmaceuticals to patients and the imaging of the radiation produced. As well as the PET scanners themselves, cyclotrons are also needed, within close proximity, to produce these necessary radiopharmaceuticals. PET is a type of functional imaging that enables highly sensitive and specific molecular imaging of metabolic processes in oncology. 18F-FDG is the most commonly used tracer, and its uptake is generally increased in tumours compared with normal tissues. PET scanning is expensive. Given the short half-life of the radiopharmaceuticals, cyclotrons are needed within about 2 h of transporting time of every scanner. Medical cyclotrons cost around £1.5m, including building,although one cyclotron of this type can serve several PET scanners. PET/CT scanners, which combine PET and CT imaging, cost around £1.7m. With associated radiopharmacy facilities, a complete PET facility is estimated at £4m. However, revenue consequences of PET are also high owing to the complexity of radiopharmaceutical production. At current commercial rates, the annual costs are estimated at £1.2–1.5m per annum per scanner, scanning up to 2000 patients per year. Revenue costs of introducing PET remain the major obstacle, with reluctance on the part of NHS Trusts to commit to new additional revenue demands. PET scanning is widely available in Europe. Germany has as many as 90 PET scanners, and France is about to embark on a centrally co-ordinated programme with equipment suppliers to provide an additional 25 scanners plus cyclotrons initiative as part of its National Cancer Plan [2Bradbury I, Boynton J, Cummins E, et al. Positron emission tomography (PET) imaging in cancer management. Health Technology Assessment Report 2. Glasgow: Health Technology Board for Scotland, 2002.Google Scholar]. There are about 200 PET sites in the USA, complete with reimbursable indications. In England, however, clinical PET services are currently available only in London and the SouthEast (Guy's/St Thomas’, Middlesex, Mount Vernon, Hammersmith and two private clinics in London). Research facilities are available in London, Cambridge and Manchester. A clinical machine is available in Belfast, and a research facility has been running for some time in Aberdeen: http://www-pet.umds.ac.uk/UKPET/ The controversy surrounding the introduction of clinical PET in the UK NHS is a health economic one not a diagnostic accuracy one. We may know that we can improve diagnostic staging in patients with clinical FDG PET, but the question the Department of Health want to know is does this benefit patients and at what financial cost. In any healthcare system with limited resources, clinical priorities need to be based on evidence of benefit to patients and value for money. Despite over 1800 published articles of PET applications in cancer since 1958 [3Bradbury I Facey K Laking G et al.Investing in new technology: the PET experience.Br J Cancer. 2003; 89: 224-227Crossref PubMed Scopus (8) Google Scholar], this evidence is still not available. The steps needed for the introduction of diagnostic techniques have been summarised by Thornbury and Fryback [4Thornbury JR Fryback DG Technology assessment – an American view.Eur J Radiol. 1992; 14: 147-156Abstract Full Text PDF PubMed Scopus (30) Google Scholar](Table 1). So, for FDG PET, we have worked out how to do it (step 1); we have hundreds of papers produced from radiology and nuclear medicine departments defining the sensitivity and specificity (step 2). Audit papers are now available on how FDG PET helps make a diagnosis (step 3) and how it helps clinicians direct management (step 4). However, the evidence required to quantify how PET imaging can either (1) improve the length and quality of patients’ lives at reasonable cost, or (2) reduce the overall cost of patient care without reducing effectiveness, requires step 5 and 6-type information. This is analogous to the NICE decision-making guidelines.Table 1A hierarchical model of efficacy: typical measures of analyses∗Adapted from Thornbury and Fryback [4].Step 1: Technical efficacy e.g. Grey-scale range, sharpness.Step 2: Diagnostic accuracy efficacy e.g. Diagnostic accuracy (percentage correct diagnoses in case series). Predictive value of positive or negative examination (in a case series). Sensitivity and specificity in a defined clinical problem setting.Step 3: Diagnostic thinking efficacy e.g. Number (percentage) of cases in which image judged ‘helpful’ to making the diagnosis.Step 4: Therapeutic efficacy e.g. Number (percentage) of times image judged helpful in planning management of the patient in a case series. Number or percentage of times clinicians’ prospectively stated therapeutic choices changed after test information.Step 5: Patient outcome efficacy e.g. Percentage of patients improved with test compared without test. Morbidity (or procedures) avoided after having image information. Change in quality-adjusted life expectancy. Expected value of test information in quality-adjusted life years.Step 6: Societal efficacy e.g. Cost–benefit analysis from societal viewpoint. Cost-effectiveness analysis from societal viewpoint.∗ Adapted from Thornbury and Fryback 4Thornbury JR Fryback DG Technology assessment – an American view.Eur J Radiol. 1992; 14: 147-156Abstract Full Text PDF PubMed Scopus (30) Google Scholar. Open table in a new tab The catch is that the research to achieve step 5 just simply has not been done. There are only two randomised trials on the use of PET in outcome (number of futile thoracotomies and mediastinal staging in non-small cell lung cancer) in one disease site [5Boyer M, Viney R, Fulham MA. Randomised trial of conventional staging with or without positron emission tomography in patients with stage 1 or 2 non-small cell lung cancer. Proceedings of the American Society of Clinical Oncology 20 [abstract 1233], 2001.Google Scholar, 6van Tinteren H Hoekstra OS Smit EF et al.Effectiveness of positron emission tomography in the preoperative assessmentof patients with suspected non-small-cell lung cancer: the PLUS multicentre randomised trial.Lancet. 2002; 359: 1388-1393Abstract Full Text Full Text PDF PubMed Scopus (734) Google Scholar]. These produce conflicting results and no further trials have been published. Oncologists have not been sufficiently involved in developing trials to produce step 5 or 6 information. So, why, we could argue, didn't we need all this evidence when introducing CT and MR scanning? The purist would argue we should have. However, in reality CT scanning has replaced scanning for inferior diagnostic tests. With PET, the incremental difference in diagnostic accuracy is not as great and it is an additional test. The current clinical FDG PET costs of about £900 per scan are significant. Three main driving forces are currently behind the introduction of diagnostic PET into the NHS. First, the Intercollegiate Standing Committee on Nuclear Medicine has produced a report outlining a strategy for PET provision in the U.K. (January 2003). They recommend that a national policy should be established and that each cancer network should have access to a dedicated PET facility attached to a radiotracer production facility. The Health Technology Board for Scotland reviewed the issue (October 2003—http://www.htbs.co.uk) and made two major recommendations to NHS Scotland: to make available PET for patients with Hodgkin's disease; and to develop a comprehensive clinical PET service for Scotland. On 14 March 2003, Malcolm Chisholm, Minister for the Scottish NHS, announced £5m would be made available for PET in Scotland in 2004. Second, although there is encouragement for nuclear medicine and radiology departments to purchase PET scanners, there has been, so far, reluctance by the NHS to fund the scans. Health Technology Assessments, particularly those provided by the Scottish Health Technology Board, recognise that, although the diagnostic accuracy of PET in diagnosing cancer is established and better than conventional imaging in many cases, its value in improving outcomes of patients is not yet proven [3Bradbury I Facey K Laking G et al.Investing in new technology: the PET experience.Br J Cancer. 2003; 89: 224-227Crossref PubMed Scopus (8) Google Scholar]. Some, therefore, recommend a managed introduction in a few centres, concentrating on gathering the appropriate research and development information. Finally, many commercially managed diagnostic PET providers are bidding to establish clinical PET scanners and FDG production facilities throughout the U.K. at low or no cost, and some are even offering no obligation for a certain amount of PET activity. There is competition to be ‘first in’. This has created a desire for nuclear medicine and radiology departments to have such ‘free’ up-to-date technology, as pressures develop from service providers to establish these facilities throughout the U.K. The concern facing the NHS is the value and cost of the blanket introduction of a technique that is not yet proven in terms of increased improvement in patient outcome for oncology patients. Claxton et al. [7Claxton K Sculpher M Drummond A A rational framework for decision making by the National Institute for Clinical Excellence (NICE).Lancet. 2002; 360: 711-715Abstract Full Text Full Text PDF PubMed Scopus (372) Google Scholar]debate strategies for such introduction, and clinical PET would probably fall into the category of ‘probably useful’ technology but limited introduction with research. Interestingly, within all this, the oncologists have not had sufficient debate to establish a priority for such diagnostic accuracy within a financially restrained healthcare environment. It is to this end that thisJournal, Clinical Oncology, has asked us to write this editorial to initiate the debate within the U.K. Oncology community. There are clear benefits to co-ordinating an approach across the U.K. for PET, and the Department of Health are interested in engaging with a range of stakeholders. There is an impasse between an insufficient evidence base to fund clinical scans and an absence of funding to perform the scans to derive the evidence. Worryingly, no action could result in a random explosion of clinical PET centres throughout the UK, spurred on by providers competing to gain market share. This is a high-risk strategy for the speciality. A non-managed introduction has proved extremely costly in other countries. Belgium currently has 13 PET centres, and their government healthcare providers are going to undertake a review to control the expansion. The German government has decided they will no longer be able to meet the costs of the tests [8Dietlein M Schicha H Reimbursement of the PET in oncology in Europe: a questionnaire based survey [in German].Nuklearmedizin. 2003; 42: 80-85PubMed Google Scholar]. The Scottish Health Technology Board carried out an extremely detailed Health Technology Review. They established the sensitivity and specificity of PET technology, but found that there is simply insufficient research in the literature to establish the role in changing patient outcome. If a government healthcare-providing system values patient outcome over and above ‘best test’, then it is clear that there are simply no data out there to recommend an evidence-based introduction of the technology. One way forward is to provide a managed introduction with a few networked centres, who will primarily provide a national service as well as research into the technique value for the NHS. This is an approach that has been considered by Australia and is currently ongoing in Canada. The Ontario healthcare providers have accepted five research protocols in PET to establish the role in distinct sites, and Scotland are considering two areas. The U.K. could join in these protocols and develop their own so that we have a portfolio of research questions within oncology diagnostic PET that will aid the managed introduction of PET with a parallel assessment of its efficacy. However, this strategy is still not without its complications for two reasons: (1) the initiative appears to be with the commercial ‘managed’ PET service providers to establish their centres, and not necessarily with the oncology community in places where the appropriate patient base is and where the network of trials can be carried out; (2) there are no resources identified to fund these well-needed studies. One way forward is to support a limited number of clinical PET centres within a U.K. research network. The portfolio of trials can be linked with the Canadian, Scottish and U.K. initiatives. The National Translational Cancer Network may be one organisation to co-ordinate such a network (www.ntrac.org.uk). The Department of Health or the National Cancer Research Institute would need to supply funding for the research studies. Although this would mean initial financial outlay, it would save money long term compared with the random introduction of this technology that would otherwise occur. Sufficient resource and commitment to networkclinical PET studies would be needed, and adherence to agreed guidelines, training and central auditing of reporting. For research and semi-quantitative work, guidelines do exist in the form of the EORTC Functional Imaging Guidelines [9Young H Baum R Cremerius U et al.Measurement of clinical and subclinical tumour response using [18F]-fluorodeoxyglucose and positron emission tomography: review EORTC recommendations. European Organization for Research and Treatment of Cancer (EORTC) PET Study Group.Eur J Cancer. 1999; 35: 1773-1782Abstract Full Text Full Text PDF PubMed Scopus (1443) Google Scholar]. PET has a huge future. FDG PET is a 20-year old technology, and new and better tracers are being developed as you read this. The future predicts a time of personalised medicine that includes cancer and beyond, such as dementia and psychiatry. We will need a network of U.K. PET centres. If the U.K. is sensible and co-ordinates a managed introduction based on good health economic science, then the technology, we believe, will have a long-term future. If, however, we allow ourselves to be pushed by individual interest groups or commercial pressures, we will have PET by the back door and, when our paymasters see the cost-effective result from blanket introduction, there could be a backlash that will set us back years. So, as oncologists, let us seize the initiative and decide what we want. If we do not take the responsibility for decision making, someone else will. Clinical Oncology would value your thoughts. G. Laking is supported by CR U.K. (Programme Grant No. C153/A1797)." @default.
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• W2018059451 title "How Should We Introduce Clinical PET in the UK? The Oncologists Need to Have a View" @default.
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