HTA of Magnetic Resonance Imaging. KCE reports vol. 37C

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1 HTA of Magnetic Resonance Imaging KCE reports vol. 37C Federaal Kenniscentrum voor de gezondheidszorg Centre fédéral dêexpertise des soins de santé Belgian Health Care Knowledge Centre 2006

2 Belgian Health Care Knowledge Centre Introduction : The Belgian Health Care Knowledge Centre is a semi-public institution, founded by the program-act of December 24 th 2002 (articles 262 to 266) falls under the jurisdiction of the Ministry of Public Health and Social Affaires. The centre is responsible for the realisation of policysupporting studies within the sector of healthcare and health insurance. Board of Directors Actual members : Substitudes : Government commissioner: Gillet Pierre (President), Cuypers Dirk (Vice-President), Avontroodt Yolande, De Cock Jo (Vice-President), De Meyere Frank, De Ridder Henri, Gillet Jean-Bernard, Godin Jean-Noël, Goyens Floris, Kesteloot Katrien, Maes Jef, Mertens Pascal, Mertens Raf, Moens Marc, Perl François Smiets Pierre, Van Massenhove Frank, Vandermeeren Philippe, Verertbruggen Patrick, Vermeyen Karel Annemans Lieven, Boonen Carine, Collin Benoît, Cuypers Rita, Dercq Jean-Paul, Désir Daniel, Lemye Roland, Palsterman Paul, Ponce Annick, Pirlot Viviane, Praet Jean-Claude, Remacle Anne, Schoonjans Chris, Schrooten Renaat, Vanderstappen Anne Roger Yves Managment General Manager : Vice-General Manager : Dirk Ramaekers Jean-Pierre Closon Contact Belgian Health Care Knowledge Centre (KCE) Résidence Palace (10 th floor) Wetstraat 155 Rue de la Loi B-1040 Brussels Belgium Tel: +32 [0] Fax: +32 [0] info@kenniscentrum.fgov.be Web :

3 HTA of Magnetic Resonance Imaging KCE reports vol. 37C PHILIPPE DEMAEREL, ROBERT HERMANS, KOENRAAD VERSTRAETE, JAN BOGAERT, MIREILLE VAN GOETHEM, KAREL DEBLAERE, SAM HEYE, ERIC ACHTEN, JAN GIELEN, WOUTER HUYSSE, JOERI BARTH, THOMAS DE GROOTE, BO ARYS, PAUL PARIZEL, MARYAM SHAHABPOUR, MARTINE DUJARDIN, FREDERIK VANDENBROUCKE, LUK CANNOODT, CÉCILE CAMBERLIN, IRINA CLEEMPUT Federaal Kenniscentrum voor de gezondheidszorg Centre fédéral dêexpertise des soins de santé Belgian Health Care Knowledge Centre 2006

4 KCE reports vol. 37C Title : HTA of Magnetic Resonance Imaging Authors : Philippe Demaerel (KULeuven), Robert Hermans (KULeuven), Koenraad Verstraete (UGent), Jan Bogaert (KULeuven), Mireille Van Goethem (UA), Karel Deblaere (UGent), Sam Heye (KULeuven), Eric Achten (UGent), Jan Gielen (UA), Wouter Huysse (UGent), Joeri Barth (UGent), Thomas De Groote (UGent), Bo Arys (UGent), Paul Parizel (UA), Maryam Shahabpour (VUB), Martine Dujardin (VUB), Frederik Vandenbroucke (VUB), Luk Cannoodt (KULeuven), Cécile Camberlin (KCE), Irina Cleemput (KCE) External experts : External validators : Conflict of interest : Disclaimer : Erik Van de Kelft (A.Z. Maria Middelares), An Desutter (UGent), Daniel Knockaert (KUL), Frank Rademakers (KUL), Ronald Peeters (KUL), Paul Gemmel (UGent, Vlerick Leuven Gent Management School), Xavier Banse (UCL) Etienne Vermeire (UA), Marc Jegers (VUB), Freddy Avni (ULB) De meeste auteurs (behalve de auteurs van het KCE) werken in een ziekenhuis met een NMR The experts and validators collaborated on the scientific report, but are not responsible for the policy recommendations. These recommendations are under the full responsibility of the Belgian Health Care Knowledge Centre. Layout : Brussels, July 2006 Dimitri Bogaerts, Nadia Bonnouh Study no Domain : Health Technology Assessment (HTA) MeSH : Magnetic Resonance Imaging; Reimbursement, Incentive; Technology Assessment, Biomedical; Practice Guidelines NLM classification : WN185 Language : English Format : Adobe PDF (A4) Legal depot : D/2006/10.273/34 Any partial reproduction of this document is allowed if the source is indicated. This document is available on the website of the Belgian Health Care Knowledge Centre. How to refer to this document? Demaerel P, Hermans R, Verstraete K, Bogaert J, Van Goethem M, Deblaere K, et al. Magnetic Resonance Imaging. Health Technology Assessment (HTA). Brussels: Belgian Health Care Knowledge Centre (KCE); KCE reports 37C (D/2006/10.273/34)

5 KCE reports vol. 37 C MRI i EXECUTIVE SUMMARY THE ISSUE OBJECTIVES Magnetic resonance imaging (MRI) has been increasingly used to investigate a variety of clinical disorders since its introduction in the mid eighties. The substitution from computed tomography (CT) to MRI was less than expected. The use of CT has even risen. Although MRI is an accepted investigation for some clinical indications there is controversy and uncertainty surrounding the values of its use. The supporting evidence for appropriate use of MRI in clinical practice is weak. MRI is costly to purchase and to operate. With 40 additional MR units to be installed in the next two years, a rise in the expenses can be expected. Different financing mechanisms exist in Europe. A comparison with the Belgian system is of interest to anyone involved in health care. The use of mobile MR units merits to be studied in view of the additional MR systems that will be installed in the next two years. The objectives of this study were threefold: CLINICAL REVIEW To summarize the evidence from the literature reporting on the clinical effectiveness of MRI in clinical practice, with special attention to the possibilities of substitution of CT for MRI. To describe and analyse the advantages and disadvantages of different financing systems for MRI and CT and to compare MRI reimbursement systems in different European countries with the Belgian system. To evaluate the feasibility and desirability of the implementation of mobile MRI units in Belgium. Methods Results Published literature from January 2000 to January 2006 was identified and retrieved using a welldefined search strategy encompassing both electronic databases and grey literature. The search strategy consisted of a common approach and a more specific approach for the different subspecialties within the field of radiology. From the included references, information was extracted into evidence tables and analyzed. The diagnostic imaging efficacy was examined using the Fryback and Thornbury criteria. MRI yields high-quality images and should always be used selectively and in conjunction with history and clinical examination, because many abnormal findings occur in asymptomatic individuals and are therefore not necessarily the cause of the symptoms in the patient. An audit of MRI reveals that examinations performed at non-specialised centers are often of inferior quality. The level of experience of the radiologist and the MR unit should therefore be subjected to a quality control. In neuroradiology, MRI is considered the modality of choice in several diseases, e.g. multiple sclerosis and epilepsy. But, in general, quantitative rigorous assessments of the clinical effect of MRI in large series or well-controlled comparison trials are missing. Formal assessment of the clinical effectiveness for MRI has lagged behind its diffusion in clinical use for central nervous system problems. MRI is more sensitive than CT in assessing patients with epilepsy and patients with headache, but not all these patients should undergo MRI. The diagnostic yield largely depends on the patient

6 ii MRI KCE reports vol. 37 C population. MRI has recently been included in the revised criteria for the diagnosis of clinically definite multiple sclerosis. There is no place for CT in the diagnostic work-up of this disease. MRI plays a crucial role in brain infection. In brain trauma the role of MRI is still not sufficiently proven although the use of diffusion-weighted images seems promising. Up until now, CT remains the method of choice in acute craniocerebral trauma. In stroke patients, the superiority in terms of diagnostic accuracy of MRI seems proven but the rapid access to the CT suite remains an important advantage of CT. For some indications, MRI has replaced more invasive examinations such as digital subtraction angiography (DSA) and myelography. In assessing aneurysms, there seems to be a role for MRA but DSA cannot be replaced in all patients. MRA is a valuable tool in screening patients at risk and in the follow-up after endovascular treatment. The role of MRI is limited in degenerative brain disorders but the increasing use of volume measurements seems promising for the future. Imaging the childês brain is considered superior in terms of diagnostic accuracy by using MRI compared to CT, but there is no firm evidence in the literature. The lack of high-quality clinical research and the widespread use of MRI are difficult problems to overcome in evidence-based clinical technology assessment. The best compromise is to present a set of suggested approaches along with information about the quality of research used to support the suggestions. It is too early to assess the clinical efficacy of newer techniques such as MR spectroscopy, perfusion MR imaging, diffusion tensor imaging and interventional MRI. MRI has a proven impact on patient outcomes in patients with low back pain and neurologic deficit. In the large majority of patients with acute low back pain, imaging studies should only be obtained when the low back pain persists longer than 6 weeks, because early use of imaging does not appear to affect treatment overall and increases costs significantly. There is currently not enough evidence to support the routine use of rapid MR imaging e.g. to replace plain radiography of the lumbar spine in low back pain, or to detect cancer as a cause of low back pain in primary care patients referred for imaging to exclude cancer as a potential cause of their pain. MRI is the modality of choice whenever there is suspicion of spinal cord compression or spinal cord involvement such as after trauma or in underlying malignancies. In head and neck radiology, clear evidence exists for MRI as modality of choice in patients with a suspicion of acustic neuroma. But, given the low disease prevalence and the high cost of MRI, auditory brainstem response should be considered as initial screening tool. Some experts recommend MRI in the pre-operative evaluation of cochlear implant patients, but CT may be sufficient in some patients. MRI is the modality of choice in symptomatic patients with suspected internal derangement of the temporomandibular joint. Overall there is no clear evidence fora n added value of MRI compared with CT in the evaluation of head and neck cancer. Only in nasopharyngeal cancer, the use of MRI, by netter showing tumour extent, has a significant impact on treatment results. In cardiac radiology, MRI has emerged as an excellent technique to study the heart, valvular and ventricular function, myocardial perfusion and myocardial viability. There is growing evidence that MRI offers substantially more valuable information than other techniques. In this area, MRI has not been compared to CT but to other established cardiac techniques, such as echocardiography, nuclear medicine and cardiac catheterization. The impact of MRI on decision-making has still to be defined, but it is increasingly being used to study therapeutic impact and patient outcome in a variety of cardiac diseases. In vascular radiology, MRA of the carotid and vertebral arteries is generally accepted, often together with ultrasound, as substitution for the invasive DSA. It is important to emphasize that the technique of contrast-enhanced MRA is the only acceptable technique nowadays. Older MR techniques, without contrast administration, performed routinely until 2000/2001 should no longer be used. MRI, MRA and CT are accurate in assessing congenital thoracic aortic disease and in the work-up of abdominal aortic aneurysm. MRA is only sensitive in case of high prevalence of significant renal artery stenosis. MRA has a higher accuracy for the detection of accessory renal arteries

7 KCE reports vol. 37 C MRI iii compared to ultrasound, but a lower accuracy compared to CTA and DSA. Both contrastenhanced MRA and CTA are accurate in the detection and grading of significant stenosis of the celiac artery, the superior mesenteric artery and the peripheral arteries. In patients with chronic critical limb ischemia, contrast-enhanced MRA can modify the choice of therapeutic strategy. Abdominal MRI is considered useful for detection of hepatic iron concentration and can be used to correct misdiagnoses from US and CT in focal steatosis. MRI provides superior characterization of liver masses. Significantly more and smaller masses are detected on MRI compared to CT and FDG-PET. Magnetic resonance cholangiopancreaticography is excellent for identifying the presence and the level of biliary obstruction in malignant invasion and as screening tool for common bile duct stones, thereby avoiding the need for an endoscopic retrograde cholangiopancreaticography or CT-cholagiopancreaticography. MRI is the modality of choice for adrenal evaluation. MRI best assesses loco-regional staging in pancreatic cancer. Wole body MRI is more sensitive in detecting metastases. MRI is considered the method of choice for preoperative staging of endometrial carcinoma. MRI is currently used as a problem solving modality in inconclusive cases of congenital malformations of the uterus. The most frequent indications of MRI in musculoskeletal radiology are traumatic, tumoural, osteoporotic and degenerative diseases of the spine, internal derangement of the knee, hip and other joints, avascular necrosis of the hip and other joints, traumatic diseases of muscles and tendons, infectious, tumoural, idiopathic (bone marrow edema syndrome, subchondral insufficiency syndrome) and traumatic bone marrow diseases, and bone and soft tissue tumours. For many indications, a higher diagnostic accuracy has been described for MR imaging in comparison with plain radiography, bone scintigraphy, ultrasound and/or CT scan, e.g. for internal derangement of the knee, acute non-traumatic hip pain in children, occult bone marrow disease, low back pain with neurologic deficit, vertebral metastasis versus osteoporosis, osteomyelitis, bone and soft tissue tumours, etc. Impact of MRI on diagnostic thinking has been described for monitoring response to therapy in bone marrow diseases. Therapeutic impact of MRI has been described for MRI of meniscal tears and soft tissue tumors. MR imaging information can affect treatment planning by helping to predict meniscal tears that are potentially reparable or will have to be resected and tears that might not need surgical intervention. In selected benign soft tissue tumours or tumour like lesions MRI is able to make an accurate diagnosis. These patients do not need biopsy and often do not need surgical therapy. Better cost-effectiveness of MRI has been described for MRI of internal derangement of the knee. The use of MRI for evaluation of the knee is associated with a positive diagnostic/therapeutic impact because MR significantly influences cliniciansê diagnoses and management plans in patients with knee problems: a significantly smaller proportion of patients undergoing MRI will undergo arthroscopy or surgery, and this reduce in cost compensates for the expenses for MR imaging. Using MRI instead of bone scanning shortens the time to diagnosis in patients with suspected hip fractures (occult fractures) in institutions performing delayed bone scintigraphy. Cost results were substantially lower if MRI is used. It is most cost effective in patients without contraindication for surgery. Due to the high sensitivity but low specificity, MRI of the breast (MR mammography) is indicated in a limited number of applications: (1) staging of tumour extent and exclusion of multicentricity, (2) assessment of scar tissue after conservative breast therapy, (3) evaluation of silicon implant, (4) problem solving early after surgery, (5) monitoring of neoadjuvant chemotherapy, (6) screening in high-risk patients and (7) nipple discharge. Currently there is no systematic review concerning interventional or intra-operative MRI. From the recent literature this technique appears promising not as a routine technique but tailored to the individual patient.

8 iv MRI KCE reports vol. 37 C FINANCING OF MRI MOBILE MRI Chapter 2 deals with the financing mechanisms for MRI in Belgium. In April 2006, there were officially 68 clinical MRI-units in Belgium, or 6.5 units per million people. Based on OECDstatistics, several other Western-European countries have supply rates that are considerably higher, even after the 40 announced units will be in operation. Belgium has no programming criteria for CT. The exact number of CT-units is not known, but various sources indicate that the number is very high in Belgium. This is also the case for the level of CT-activity. The ratio CT/MRI examinations is 3.2, which is amongst the highest reported. Belgium also scores high concerning the average number of CT or MRI examinations/unit. Between 2001 and 2004 the number of MRI examinations increased with 35% in Belgium, while the number of officially accredited MRI-units remained stable. Duringthat same time period, the CT-activity increased too, but to a lesser extent than MRI. However, the total volume of CT increased more than the total volume of MRI examinations and this is primarily due to the growing use of abdominal, thorax and neck CT. Contrary to most other countries analysed, the financing systems of MRI-activity versus CTactivity differ considerably in Belgium. CT-related expenses are financed via the nomenclature (majority reimbursed on a fee per activity base) while MRI-related expenses are financed in part via ear-marked amounts allocated via the hospital budget. The advantages and disadvantages of mobile MRI systems have not been studied extensively in literature. Two examples, one for Canada and one for Paris, were found. Chapter 3 discusses the examples and assesses the feasibility of mobile MRI solutions in Belgium. Technologically, the MRI scanners installed on a trailer for mobile MRI are identical to fixed MRI scanners of the same field strength. Installing a mobile MRI system near a hospital requires a certain amount of logistic capacity. Assuming these are available, the initial investment costs for mobile MRI systems are lower than the initial investment costs for fixed MRI systems. Yearly operating costs, however, are higher for mobile than for fixed systems. Advantages of mobile MRI systems from the hospital perspective are shorter installation times, lower initial investment, (potential) rapid response to acute excess demand for MRI services and cost sharing between hospitals. From the patient perspective, travel time may be shortened when mobile MRI is provided in the nearest hospital. Disadvantages of mobile MRI from the hospital perspective are potential unavailability of MRI for emergencies (when the hospital has no fixed MRI scanner), potential unavailability of qualified staff and higher operating costs. Mobile MRI scanning leads to more discomfort to the patient and the personnel. Currently, mobile MRI is only used in Belgium as a temporary solution in case a fixed MRI is being rebuilt.

9 KCE reports vol. 37 C MRI v CONCLUSIONS Generally speaking MRI yields higher quality images than CT without using ionising radiation. In an ideal world, one would expect to see CT replaced by MRI for most, if not all, indications. However, the multislice CT technique is continuously improving and offering new applications in the different body areas. Therefore it will prove difficult to measure the degree of substitution between CT and MRI. The Magnetic Resonance Angiography (MRA) technique has made significant progress in the last 5 years and CT digital substraction angiography is increasingly being replaced by MRA. Although quantitative rigorous assessments of the clinical role of MRI are missing it seems justified that MRI may improve the identification of a disease. The level of evidence is often limited to the diagnostic accuracy with a few exceptions where MRI has a diagnostic or even a therapeutic impact. Very few studies have assessed cost-effectiveness of MRI and often it was not straightforward to apply the results in the Belgian health care system. It will prove difficult, or even impossible in some instances, to obtain well-controlled comparison trials in order to demonstrate the impact on patient management and ultimately patient outcome. Belgium has a very high number of CT units and the volume of CT examinations increased more than the volume of MRI examinations between 2001 and The financing systems of MRI and CT activity differ considerably in Belgium without a clear explanation. Mobile MRI solutions have a number of advantages and disadvantages, both from the patientsê point of view and from the hospitalsê point of view. Currently, mobile MRI is only used in Belgium as a temporary solution, while rebuilding a fixed MRI. RECOMMENDATIONS Revision of imaging guidelines The review of the clinical evidence of MRI in different indications reveals that the Belgian guidelines for medical imaging need revision. For some indications CT should no longer be performed. To keep the guidelines up to date they should be revised at least every two years. In order to implement the guidelines in routine clinical practice, an expert computing system would be helpful for prescribers of medical imaging procedures. Such as system could suggest the most optimal imaging strategy for a certain suspected diagnosis or recommend referral. In addition, more attention should be devoted in basic training of physicians and in continuing medical education to appropriate prescribing of medical imaging. Quality assurance of medical imaging procedures is essential to guarantee clinical effectiveness and optimal patient outcomes. Different measures for quality assurance are suggested, such as site visits by a visitation commission, training and support by experienced radiologists on-site or through teleradiology, particularly for starting MRI centres, restriction of installation of scanners with low field strength and dedicated scanners and accrediting expert centres for difficult examinations.

10 vi MRI KCE reports vol. 37 C Financing The divergence between the Belgian and other countriesê health care systems is too large to conclude to one clear solution reconciling adequate supply and appropriate use of imaging technology. The high supply (CT), and the current fee for service system, combined with lack of financial responsibility of the prescriber is unlikely to serve this goal. However, a number of options can be forwarded to address some inconsistencies in the current financing: As far as the financing of CT and MRI is concerned, some revisions of the nomenclature are to be considered, based on work load associated with the examinations. Financing mechanisms for CT and MRI should be harmonised. The limited differences in cost structure do not justify the current differences in financing. Fixed equipment costs should be financed through the hospital budget. Supply restraints are then inevitable to contain costs. Allocation of MRI scanners should be based on local needs, attractiveness of hospitals and the ratio of CT/MRI in the area. Financing of the operating costs and radiologistsê fees should give an incentive towards efficient and appropriate use of MRI and CT. Some options for financing the variable costs of MRI are proposed. A distinction is made between imaging for hospitalised patients and for ambulatory patients. o o o For hospitalised patients, including patients treated in the one-day clinic, case mix financing could be applied. For ambulatory patients, no case mix data are collected, hence alternative financing mechanisms have to be developed. One possibility is to modulate the value of the radiologistsê consultancy fee according to whether the prescription follows referral guidelines or not. This option will stimulate communication between the radiologist and the prescriber before referral. This system should be combined with the implementation of a standardised prescription form, on which the prescriber justifies his request if this falls outside the referral guidelines. Suspected and established diagnoses are coded by the radiologist, allowing peer review and auditing. Mobile MRI Elements that need to be taken into account when mobile MRI is considered in Belgium are the minimal scale (volume) required to let a mobile unit function optimally, the scope of services that can be provided with the available staff and the accessibility to MRI services in Belgium. There is insufficient evidence to conclude the advantages of mobile MRI outweigh the disadvantages or otherwise, especially in the Belgian context. Therefore, it is recommended to reserve mobile MRI as a temporary solution if a fixed MRI is out-of-service.

11 KCE reports vol. 37 MRI 1 Table of contents Scientific summary PART 1: EVALUATION OF THE CLINICAL EFFECTIVENESS OF MRI IN DIFFERENT INDICATIONS INTRODUCTION OBJECTIVES METHODS NEURORADIOLOGY BRAIN Epilepsy Multiple Sclerosis Infection Trauma Stroke Aneurysm Tumour Degenerative diseases Headache Cranial Nerves Pediatric neuroimaging Foetal SPINE AND SPINAL CORD Degenerative disorders of the cervical spine Degenerative disorders of the lumbar spine Trauma Malignancy: spinal cord compression Malignancy: spinal metastasis Infection Congenital spinal abnormality CARDIAC RADIOLOGY ISCHEMIC HEART DISEASE Myocardial ischemia Cardiac Masses and Tumors Myocarditis, Cardiomyopathies, Myocardial Hypertrophy, Heart Transplantation Pericardial Diseases Valvular Heart Disease Congenital Heart Disease VASCULAR RADIOLOGY CAROTID AND VERTEBRAL ARTERIES THORACIC AND ABDOMINAL AORTA, VISCERAL ARTERIES AND PERIPHERAL ARTERIES HEAD AND NECK SENSORINEURAL HEARING LOSS Screening for acustic neuroma Congenital hearing loss and preoperative imaging in cochlear implant patients PHARYNGEAL NEOPLASMS...45

12 2 MRI KCE reports vol LARYNGEAL NEOPLASMS NECK LYMPH NODES SINONASAL NEOPLASMS SALIVARY GLAND NEOPLASMS PARATHYROID DISEASE TEMPOROMANDIBULAR JOINT DISORDERS MUSCULOSKELETAL RADIOLOGY LOWER LIMB Ankle: Osteochondral lesion and osteochondritis dissecans of the talus Knee Hip UPPER LIMB Shoulder Elbow Wrist BONE MARROW BONE TUMOUR SOFT TISSUE NEOPLASM Introduction, Diagnosis, Grading and Staging HTA reports Reviews Clinical Studies Conclusion Soft Tissue Neoplasms SOFT TISSUE INJURY Systematic Review Clinical Studies SOFT TISSUE INFECTIONS/INFLAMMATIONS HTA reports Systematic Reviews Clinical Studies Conclusion Soft Tissue Infections ABDOMEN UPPER ABDOMEN Liver Spleen Biliary ducts Gallbladder THE RETROPERITONEUM Adrenals Pancreas KIDNEY Renal masses Acute pyelonephritis Chronic medical nephropathies Living Renal Donors All-in-one approach RETROPERITONEUM Neoplasms WHOLE BODY MRI...97

13 KCE reports vol. 37 MRI PELVIS Intestinal CrohnÊs disease Colorectal cancer Pelvic floor Anal fistulas PROSTATE Cancer CERVIX Cancer UTERUS Leiomyoma Adenomyosis Congenital anomalies Endometrial cancer OVARY Benign conditions Cancer PEDIATRIC ONCOLOGY Neuroblastoma and WilmsÊ tumour Non-palpable testis MR urography MR enterography MAGNETIC IMAGING RESONANCE OF THE BREAST GENERAL INDICATIONS Recommendations of the Institute for Clinical Systems Improvement (ICSI) in Diagnosis of breast disease 721 (86 references) EORTC guidelines STAGING OF TUMOR EXTENT WITHIN THE BREAST AND EXCLUSION OF MULTIFOCALITY, MULTICENTRICITY IN THE SAME OR CONTRA LATERAL BREAST DISTINGUISHING POSTOPERATIVE SCAR VS. TUMOR (RECURRENCE) PROBLEM SOLVING EARLY AFTER SURGERY AFTER SILICONE IMPLANT MONITORING OF NEOADJUVANT CHEMOTHERAPY SEARCH FOR PRIMARY UNKNOWN TUMOR WHEN BREAST CANCER IS SUSPECTED SCREENING OF HIGH RISK WOMEN OTHER Nipple discharge Diagnosis of breast lesions PART 2: FINANCING MECHANISMS FOR MRI IN BELGIUM INTRODUCTION CURRENT FINANCING MECHANISMS OF MRI AND CT IN BELGIUM + RELATION WITH COST-STRUCTURE FINANCING MRIÊS IN BELGIUM Part A3 of the hospital budget Part B3/B7 of the hospital budget Physician reimbursement: the fixed part...117

14 4 MRI KCE reports vol Physician reimbursement: the variable part FINANCING CTÊS IN BELGIUM SYSTEMS OF REIMBURSING HEALTH CARE ACTIVITY: A GENERAL OVERVIEW INTRODUCTION RETROSPECTIVE VERSUS PROSPECTIVE REIMBURSEMENT SCHEMES THE DEGREE TO WHICH THE REIMBURSEMENT SCHEME IS EARMARKED TO REIMBURSE SPECIFIC MEDICAL ACTIVITIES BUILT-IN INCENTIVES FOR EFFICIENT USE OF THE DIAGNOSTIC TECHNOLOGY BUILT-IN INCENTIVES TO ASSURE QUALITY OF CARE OF DIAGNOSTIC SERVICES THE DEGREE TO WHICH COST STRUCTURE CHARACTERISTICS ARE INCORPORATED THE ADMINISTRATIVE WORKLOAD THE DEGREE TO WHICH INNOVATION IS ENCOURAGED MRI AND CT-SCANS IN BELGIUM SUPPLY OF MRI- AND CT-UNITS IN BELGIUM ACTIVITY LEVELS OF MRI AND CT IN BELGIUM Total activity MRI + CT MRI and CT-activity per type of activity MRI and CT-activity : inpatient versus outpatient MRI and CT-activity: Regional variation MRI and CT-activity : types of prescribers INTERNATIONAL COMPARISON SUPPLY OF MRI- AND CT-UNITS OECD-statistics INAHTA-survey Data from the industry E.A.R./U.E.M.S.-data Location of MRI - and CT- units VOLUME OF MRI- AND CT- ACTIVITY IN OTHER COUNTRIES NUMBER OF RADIOLOGISTS IN OTHER COUNTRIES FINANCING SYSTEMS IN OTHER COUNTRIES INTERNATIONAL COMPARISON: SITE VISITS DENMARK THE NETHERLANDS FRANCE IMPROVING THE FINANCING SYSTEM: SOME REFLECTIONS REFLECTIONS ABOUT SUPPLY AND UTILISATION FINANCING SYSTEM AND COST STRUCTURE RESPONSIBILITY OF THE PRESCRIBER AND THE RADIOLOGIST REFLECTIONS CONCERNING QUALITY ASSURANCE...151

15 KCE reports vol. 37 MRI 5 PART 3: SHORT HEALTH TECHNOLOGY ASSESSMENT: MOBILE MAGNETIC RESONANCE IMAGING INTRODUCTION TECHNOLOGY DESCRIPTION METHODS RESULTS IMPLEMENTATION MODELS AND COST STRUCTURE OF MOBILE AND FIXED MRI SYSTEMS COSTS OF MOBILE VERSUS FIXED MRI IN PARIS COST OF FIXED VERSUS MOBILE MRI IN CANADA THE BELGIAN CONTEXT ADVANTAGES AND DISADVANTAGES OF MOBILE MRI Advantages of mobile MRI Disadvantages of mobile MRI FINANCING PART 4: GENERAL CONCLUSIONS AND RECOMMENDATIONS GENERAL CONCLUSIONS CLINICAL EFFECTIVENESS FINANCING OF MRI IN BELGIUM MOBILE MRI POLICY RECOMMENDATIONS ADAPTATION OF EXISTING IMAGING GUIDELINES IMPLEMENTATION OF REFERRAL GUIDELINES QUALITY ASSURANCE FINANCING OF MRI IN BELGIUM Recalibration of the nomenclature Planning of MRI supply Structural changes in the financing system RESPONSIBILITY OF THE PRESCRIBER MOBILE MRI Economies of scale Economies of scope Accessibility APPENDICES: HEALTH TECHNOLOGY ASSESSMENT OF MAGNETIC RESONANCE IMAGING...177

16 6 MRI KCE reports vol. 37 GLOSSARY ABR: Auditory Brainstem Response CDMS: clinically definite MS CI: confidence interval CIS: clinically isolated syndrome CSF: cerebro-spinal fluid CT: computed tomography CTA: computed tomography angiography DSA: digital subtraction angiography MRI: magnetic resonance imaging MRA: magnetic resonance angiography MS: multiple sclerosis PPMS: primary progressive MS RRMR: relapsing-remitting MS SEP: sensory evoked potentials US: ultrasound USPIO: Ultrasmall Superparamagnetic Iron Oxide VEP: visually evoked potentials

17 KCE reports vol. 37 MRI 7 Part 1: Evaluation of the clinical effectiveness of MRI in different indications PHILIPPE DEMAEREL, ROBERT HERMANS, KOENRAAD VERSTRAETE, JAN BOGAERT, MIREILLE VAN GOETHEM, KAREL DEBLAERE, SAM HEYE, ERIC ACHTEN, JAN GIELEN, WOUTER HUYSSE, JOERI BARTH, THOMAS DE GROOTE, BO ARYS, PAUL PARIZEL, MARYAM SHAHABPOUR, MARTINE DUJARDIN, FREDERIK VANDENBROUCKE, LUK CANNOODT, CÉCILE CAMBERLIN, IRINA CLEEMPUT

18 8 MRI KCE reports vol INTRODUCTION This report summarizes the evidence in the literature regarding the clinical efficacy of magnetic resonance imaging (MRI) in clinical practice. Financing mechanisms for MRI in a selection of European countries are presented and compared to our current system. Different options for financing MRI in Belgium are explored. Finally, a short Health Technology Assessment of mobile MRI is performed and presented in the third part of this report. MRI is a relatively expensive but non-invasive radiological examination. The most important advantage compared to other techniques such as computed tomography (CT) and digital subtraction angiography (DSA) is the absence of ionising radiation. In addition the superior resolution, multiplanar imaging capability and safer contrast agents are the major advantages of MRI. Patients with ferro-magnetic implants cannot be examined by MRI and more co-operation from the patient is generally required, which renders the examination of intensive care patients more difficult. The frequent detection of incidental findings that can be misinterpreted as causing the patientês symptoms is another disadvantage of MRI that is often underestimated. Since the introduction of MRI, more than 25 years ago, remarkable technological advances have been achieved providing better resolution, increased speed of imaging and new applications. In the first decade, the excellent diagnostic performance of MRI has been demonstrated for many neurological and musculoskeletal applications. The imaging of the brain stem, the spinal cord and the cartilage bone are only a few examples. Later abdominal, breast, cardiac and vascular imaging developed rapidly taking advantage of the advances in MR technology. Functional MRI and interventional MRI are now the most important emerging MR applications. At this stage, there are no systematic reviews on interventional MRI but the application seems to be promising when tailored to the individual patient and in combination with advanced functional imaging techniques. In the early days, there was hope that MRI might replace not only CT but also more invasive imaging techniques such as DSA, CT-myelography, endoscopic retrograde cholangiopancreaticography and even surgical procedures such as arthroscopy. Due to the limited access, the long examination time and the lack of confidence that is often associated with a new technique, the substitution was far less than expected. While the more invasive examinations and procedures were more easily replaced by MRI, the substitution of CT lagged behind. MRI was often being used as an additional examination rather than as a substitute. With the introduction of helical CT and multi-slice CT scanners that led to very short examination times, 3D-imaging applications and a renewed interest in some older applications, it has even become more difficult to assess the degree of substitution from CT to MRI. It is not excluded that, for an indication where MRI has replaced CT or DSA, CT may become the examination of choice again in the future. The appropriate use of MRI is the key issue. Unfortunately, there is a clear lack of high quality evidence regarding the efficacy of MRI. Only few randomized-controlled trials have compared MRI with other diagnostic alternatives and there is almost no proof that the use of MRI in the diagnostic process is significantly associated with improvement in patient quality of life and survival. For many of the more established applications of MRI, randomization is not feasible anymore, on ethical grounds and the judgment of appropriateness of the applications will often be based on observational data. Costeffectiveness studies regarding MRI are rare and often difficult to apply in the Belgian health care system. It will be very important to define guidelines for adequate use of MRI, taking into consideration the ongoing technological progress both in CT and in MRI. These guidelines should avoid the simultaneous recommendation of two or more radiological techniques in as many conditions as possible. In 2006 the Minister of Public Health decided to grant approval to 40 additional MR scanners in Belgium in the next two years. This will have financial implications. A review

19 KCE reports vol. 37 MRI 9 of possible financing mechanisms for MRI in Belgium is therefore provided as well as a description of financing mechanisms in a number of European countries. Finally, in Belgium there is currently no mobile MRI provision. The main question is whether mobile MRI is feasible in a Belgian context and under which conditions mobile MRI can be considered. The advantages and disadvantages of mobile MRI in a Belgian context were assessed.

20 10 MRI KCE reports vol OBJECTIVES The objectives of this Health Technology Assessment are threefold: Examine the substitution possibilities between CT and MRI in different indications; Examine possible financing systems for MRI in Belgium; Perform a short HTA on mobile MRI systems.