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Health Technology Assessment (HTA) evidence in the use of PET imaging which can improve the length or quality of patients' lives at reasonable cost, or it can reduce the overall expenditure without substantially reducing the effectiveness of patient care is not established.


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POSITRON EMISSION TOMOGRAPHY PET  “Ace for cancer screening”  “Precise detector of early-stage cancer”  PET Scans--- “Saving lives” or “prescribing proper care”  “Defensive Medicine" or ‘Medico- Legal cases” Doctors Choice in Clinical Practice. EMSRHS CORVINUS UNIVERSITY 2

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PET Scan-formally introduced to the medical community in 1970. 3 EMSRHS CORVINUS UNIVERSITY

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PET SCAN  Positron Emission Tomography PET scan ---nuclear medicine imaging modality use small amounts of radioactive material tracer to diagnose cancers heart disease and neurological abnormalities.  MRI or CT ---structure.  PET measures metabolism—function  Superior in differentiating tumor from benign lesions and malignant from non-malignant masses.  Alzheimers disease Parkinsons disease epilepsy and other neurological conditions.  Assess brain function after brain injury. Treatment can be specified to enhance recovery. 4 EMSRHS CORVINUS UNIVERSITY

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Benefits and Risks of Using PET Benefits:  Most Useful and Unique Information.  Precise Information than Surgery.  Detects Diseases which are not possible by CT MRI. Risks:  Radiation Exposure- equal to CT Scan.  Allergic Reactions to Radiopharmaceuticals …. Very Rare  Pregnant breastfeeding women need to be careful 6 EMSRHS CORVINUS UNIVERSITY

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Policy Perspectives in Use of PET  Many exciting and potentially valuable therapies in health care settings compete for funding – simply introducing all of them is impossible.  Health Technology Assessment HTA evidence in the use of PET imaging which can improve the length or quality of patients lives at reasonable cost or it can reduce the overall expenditure without substantially reducing the effectiveness of patient care is not established. 7 EMSRHS CORVINUS UNIVERSITY

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Policy Perspectives in Use of PET  Resources-- limited demonstrating the cost effectiveness of new technologies is an important step in their introduction.  Especially challenging for diagnostic technologies as randomized controlled trials may not be appropriate. Outcome  Most of the studies report diagnostic accuracy rather than improved patient outcomes.  Direct evidence that such improvement occurs and is sufficient to meet the criteria for cost effectiveness from well-designed trials would constitute the most immediately persuasive case for the introduction of PET imaging. 8 EMSRHS CORVINUS UNIVERSITY

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Policy Perspectives in Use of PET  No evidence to indicate PET screening reduces cancer mortality.  The problem of false-negative results cannot be ignored.  Evidence of False-Negatives - Yasuda and Ide found that 168 of 526 malignant tumor cases yielded negative PET results but were diagnosed as cancerous by other procedures such as CT MRI or ultrasonography EMSRHS CORVINUS UNIVERSITY 9

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Policy Perspectives in Use of PET  FDG accumulates physiologically in normal tissues inflammatory lesions and cancer tissues resulting in false-positives that cause anxiety for the participants and wasteful expenses of additional examinations are required to differentiate cancerous tissue from normal tissue. Ide M 2006  PET is suitable for the diagnosis of cancers of the lung breast colon pancreas head and neck as well as malignant lymphoma. However it is not suitable for the diagnosis of cancers of stomach kidney bladder prostate liver or biliary tract or leukemia. Hideo Yasunaga 2007 EMSRHS CORVINUS UNIVERSITY 10

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Policy Perspectives in Use of PET  Shortage of both medical and technical staff trained in PET and a lack of training opportunities. This is an issue that needs to be addressed urgently if PET is to expand at an appropriate rate.  PET machine cost 5 million.  PET scan cost 850–4000 depending on the type of scan.  Cancer screening for whole-body by use of FDG-PET is approximately 1000 on average.Mitsutake N et al 2007 EMSRHS CORVINUS UNIVERSITY 11

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Policy Perspectives in Use of PET  PET interpretation undertaken by nuclear medicine physicians who have little experience of CT- Deficiency of Trained Doctors.  Many Hospitals with PET facility have poor co-operation between radiologist and nuclear medicine physician in interpretation of PET results.  Radiologists specialized in cross-sectional imaging and nuclear medicine are less for expansion of PET technology. EMSRHS CORVINUS UNIVERSITY 12

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Policy Perspectives in Use of PET  Referral of a patient for a FDG-PET scan by Multi-disciplinary team MDT justified and authorized by the Administration of Radioactive Substances Advisory Committee ARSAC certificate holder or appropriate delegate as the ‘gatekeeper’.  In many Countries PET capacity is still limited to three scanners per 15 million inhabitants.  In case of PET use there should be a maximum 2-month 62-day interval from urgent GP referral for suspected cancer to first definitive treatment and a maximum 1-month 31-day interval from diagnosis i.e. the decision to treat to first definitive treatment. EMSRHS CORVINUS UNIVERSITY 13

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Few Examples In Use of PET  University of California Los Angeles who demonstrated retrospectively that PET- directed management for patients being considered for cardiac transplantation could save U.S. 34707 per patient referred Duong TH et al 1996  In an Australian decision tree model based on sensitivities and specificities for detecting mediastinal spread by use of FDG-PET scanning with selected Mediastinoscopy was judged to be able to save AU 2128 per patient and potentially reduce inappropriate surgery Yap kk et al 2005. EMSRHS CORVINUS UNIVERSITY 14

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Few Examples In Use of PET  The Health Technology Board of Scotland has accepted PET based on sensitivity and specificity reports than other techniques in the investigation of a number of common malignancies.  Compared with CT only CT and FDG-PET for all patients led to a relative reduction in surgery of 70 for patients with mediastinal lymph node metastasis.  PET for all with anatomical CT was shown to be cost-effective compared with CT only with life expectancy increased by 0.10 years and expected cost savings. Alzahouri l et al 2005. 15 EMSRHS CORVINUS UNIVERSITY

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Few Examples In Use of PET  For radical radiotherapy FDG-PET/CT provides the opportunity to delineate the planning target volume PTV excluding areas of collapse or consolidation seen on CT and increase in PTV may result from including sites of disease not apparent on CT. Mah K et al 2002  FDG-PET scanning can be performed for the investigation of solitary pulmonary nodules where biopsy is not possible or has failed depending on nodule size position and computed tomography CT characterization NICE 2005. 16 EMSRHS CORVINUS UNIVERSITY

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Financing PET Different Payment Methods-  Reimbursement from Health Insurance.  Copayments.  Money from Donations.  Out of Pocket  Full coverage to the Deserving people by Government Sick Fund. 17 EMSRHS CORVINUS UNIVERSITY

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Economic Evaluation Tools  Economic Evaluation of Health Care Programs  Cost Benefit Analysis CBA  Cost Effectiveness Analysis CEA  Cost Utility Analysis CUA 18 EMSRHS CORVINUS UNIVERSITY

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Factors to be considered for PET acquisition- PRIMARY ACTIVITIES SECONDARY ACTIVITIES  Appointment planning  Preparation of the patient  Injection/incorporation of 18F-FDG tracer  Data acquisition of 18F- FDG-PET procedure  Data reconstruction of the 18F-FDG-PET procedure  Reading of the 18F-FDG- PET procedure  Patient-care-related activities  Transport of 18F-FDG tracer  Dispensing the patient dose  Discharge file management  Internal quality control  External maintenance. EMSRHS CORVINUS UNIVERSITY 19

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Standard Cost for PET-Conti et al. 1994  Equipment and maintenance :1223 440/year.  Building: 1440000 20 years.  Satellite scanner equipment: 2091540 6 years  Average EAC: 954000/year  EAC/patient: very high since there were very few patients. EMSRHS CORVINUS UNIVERSITY 20

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Cost reducing options  Traditional PET imaging uses cameras specifically designed for imaging positron-emitting radioisotopes.  Gamma cameras modified for “PET-like” imaging may lower cost and offer more accessible alternatives to traditional PET. Both these PET systems have whole body scanning capability. 21 EMSRHS CORVINUS UNIVERSITY

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CONCLUSION  In any health-care system with limited resources priorities for investment must be set on the basis of clear evidence of benefit to patients and good value for the money spent.  Scarcity of health care resources necessitates appropriate selection of Diagnostic technology and its control in the diffusion of health care markets.  Commitment to high quality patient care is essential in all health care settings.  Rational resource management is needed in resource poor countries. EMSRHS CORVINUS UNIVERSITY 22

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REFERENCES-  Alzahouri K Lejeune C Woronoff-Lemsi MC Arveux P Guillemin F. Cost-effectiveness analysis of strategies introducing FDG-PET into the mediastinal staging of non-small-cell lung cancer from the French healthcare system perspective. Clin Radiol 200560:479—92.  Conti P . Keppler J.S. Halls J.M. 1994. Positron emission tomography: a financial and operational analysis. American Journal of Roentgenology 162 61279–1286. EMSRHS CORVINUS UNIVERSITY 23

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REFERENCES-  Duong TH Fonarow G Laks H et al1996. Cost effectiveness of positron emission tomography PET in the management of ischemic cardiomyopathy patients who are referred for cardiac transplantation. J Am Coll Cardiol 27:144A.  Hideo Yasunaga2007 Who wants cancer screening with PET A contingent valuation survey in Japan.  Ide M 2006. Cancer screening with FDG-PET. Q J Nucl Med Mol Imaging 50:23–7. EMSRHS CORVINUS UNIVERSITY 24

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REFERENCES-  Mah K Caldwell CB Ung YC Danjoux CE Balogh JM Ganguli SN et al 2002. The impact of 18FDG-PET on target and critical organs in CT- based treatment planning of patients with poorly defined non-small-cell lung carcinoma: a prospective study. Int J Radiat Oncol Biol Phys 52:339—50.  Mitsutake N Fujii R Oku S Furui Y Yasunaga H 2007. Business administration of PET facilities: a nationwide survey of prices for PET screening and a cost analysis of three facilities. Kaku Igaku Jpn J Nucl Med44:125–9 in Japanese EMSRHS CORVINUS UNIVERSITY 25

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REFERENCES-  Yasuda S Ide M 2005. PET and cancer screening. Ann Nucl Med. 19:167–77.  Yap KK Yap KS Byrne AJ Berlangieri SU Poon A Mitchell P et al2005. Positron emission tomography with selected mediastinoscopy compared to routine mediastinoscopy offers cost and clinical outcome benefits for pre-operative staging of non-small-cell lung cancer. Eur J Nucl Med Mol Imaging 200532:1033—40. EMSRHS CORVINUS UNIVERSITY 26

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