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v, 247 p. ill.

v, 247 p. ill.

15 p. ill., VOORWOORD 1 -- KERN BOODSCHAPPEN 2 -- SAMENVATTING 3 -- 1. DOEL VAN DE STUDIE.4 -- WAT ZIJN STATINES? 4 -- WAT HEBBEN WE ONDERZOCHT? .5 -- HOE GINGEN WE TE WERK? 5 -- 2. GEBRUIK VAN STATINES IN BELGIË 6 -- OP DE BELGISCHE MARKT SINDS DE JAREN 1990.6 -- 13% VAN DE GEHELE BELGISCHE BEVOLKING GEBRUIKT STATINE.7 -- … MAAR HOUDT DE BEHANDELING MEESTAL NIET VOL 7 -- DOELTREFFEND VOOR PRIMAIRE PREVENTI 8 -- … MAAR TOCH BIJWERKINGEN 9 -- 3. WAT IS DE KOSTENEFFECTIVITEIT VAN STATINES BIJ DE PRIMAIRE PREVENTIE? 10 -- KOSTENEFFECTIVITEIT WORDT DOOR VELE FACTOREN BEÏNVLOED.10 -- BETERE KOSTENEFFECTIVITEIT VOOR MENSEN MET EEN HOGER RISICO.11 -- 4. CONCLUSIE: AANPASSING VAN LEVENSSTIJL BLIJFT HET BELANGRIJKSTE 12 -- AANBEVELINGEN 13 -- REFERENTIES 14

219 p. ill., TABLE OF FIGURES 6 -- TABLE OF TABLES 8 -- LIST OF ABBREVIATIONS 12 -- SCIENTIFIC REPORT 16 -- 1 BACKGROUND 16 -- 2 OBJECTIVES 18 -- 3 HISTORICAL AND CURRENT STATIN USE IN BELGIUM 18 -- 3.1 INTRODUCTION 18 -- 3.2 METHODS 19 -- 3.2.1 Global data 19 -- 3.2.2 Individual data 19 -- 3.3 STATINS AVAILABLE ON THE BELGIAN MARKET 21 -- 3.3.1 Statins 21 -- 3.3.2 Combination products containing a statin 23 -- 3.4 REIMBURSEMENT RULES FOR STATINS 24 -- 3.4.1 Basic rules 24 -- 3.4.2 Indications and indicators 24 -- 3.5 NUMBER OF STATIN USERS (GLOBAL DATA) 25 -- 3.6 VOLUMES OF PRESCRIBED STATINS (GLOBAL DATA) 26 -- 3.6.1 Statins 26 -- 3.6.2 Combination products containing a statin 27 -- 3.6.3 All products containing a statin 27 -- 3.7 COST OF STATINS (GLOBAL DATA) 28 -- 3.7.1 Total cost 28 -- 3.7.2 Reimbursements 28 -- 3.7.3 Patient contribution 29 -- 3.8 SUMMARY OF THE GLOBAL DATA 30 -- 3.9 STATIN USERS (INDIVIDUAL DATA) 30 -- 3.9.1 Users and New users 30 -- 3.9.2 Characteristics of users and new users of the last years of registration 2014-2015 32 -- 3.10 PRIMARY VS. SECONDARY PREVENTION (INDIVIDUAL DATA) 36 -- 3.11 ADHERENCE (INDIVIDUAL DATA) 38 -- 3.11.1 Regular and occasional users 38 -- 3.11.2 Factors associated with poor adherence 41 -- 3.11.3 Adherence in primary prevention 44 -- 3.11.4 Probability of stopping a statin for a period longer than 365 days in new users for primary prevention 45 -- 3.11.5 Risk score assessment in regular versus occasional new users 47 -- 3.12 EXPENSES (INDIVIDUAL DATA) 48 -- 3.12.1 Brand drug or generic 48 -- 3.12.2 Evolution of mean expenditures per DDD over time 48 -- 3.13 SUMMARY OF THE INDIVIDUAL DATA 50 -- 4 CLINICAL EFFECTIVENESS AND HARMS 51 -- 4.1 INTRODUCTION 51 -- 4.2 METHODS 51 -- 4.3 RESULTS FROM THE SEARCH STRATEGY 52 -- 4.4 CHARACTERISTICS AND QUALITY APPRAISAL OF THE SELECTED SYSTEMATIC REVIEW. 52 -- 4.5 EVIDENCE ON EFFECTIVENESS OF STATINS IN PRIMARY PREVENTION 53 -- 4.5.1 Preliminary remarks 53 -- 4.5.2 Baseline risk for CVD in the included patients and follow-up time 54 -- 4.5.3 Overall results 54 -- 4.5.4 Sensitivity analyses 55 -- 4.5.5 All-cause mortality 56 -- 4.5.6 Cardiovascular mortality 56 -- 4.5.7 Fatal and non-fatal myocardial infarction 56 -- 4.5.8 Fatal and non-fatal stroke 57 -- 4.5.9 Revascularization 57 -- 4.5.10 Composite cardiovascular outcome 57 -- 4.6 EVIDENCE ON HARMS FROM RCT’S AND OBSERVATIONAL RESEARCH 57 -- 4.6.1 Evidence on harms from RCTs in the selected systematic review on primary prevention 57 -- 4.6.2 Evidence on harms from the previous KCE report 58 -- 4.6.3 Recent reviews on harms associated with statin use 59 -- 4.7 CONCLUSIONS 62 -- 4.7.1 Conclusions on effectiveness 62 -- 4.7.2 Conclusions on harms 63 -- 5 COST-EFFECTIVENESS 63 -- 5.1 INTRODUCTION 63 -- 5.2 METHODS 63 -- 5.2.1 Search strategy 63 -- 5.2.2 Selection criteria 64 -- 5.3 RESULTS OF THE ECONOMIC SEARCH STRATEGY 65 -- 5.3.1 Results of the search strategy of reviews 65 -- 5.3.2 Results of the search strategy of primary studies 65 -- 5.4 OVERVIEW OF REVIEWS OF ECONOMIC EVALUATIONS 65 -- 5.4.1 Description of the selected reviews 65 -- 5.4.2 Main results of the studies selected in these reviews of economic evaluations 66 -- 5.4.3 Main results of the models developed in these reviews of economic evaluations 68 -- 5.4.4 Recommendations from these reviews of economic evaluations 69 -- 5.4.5 Summary of results 71 -- 5.5 OVERVIEW OF SELECTED PRIMARY STUDIES 71 -- 5.5.1 Comparison of various CVD risk and age thresholds 71 -- 5.5.2 Patient with diabetes or chronic kidney disease 80 -- 5.5.3 ‘Polypills’ compared to plain statins, antihypertensive guidelines and current practice 86 -- 5.5.4 Summary of results 90 -- 5.6 CONCLUSIONS FOR THE COST-EFFECTIVENESS OF STATINS IN PRIMARY PREVENTION OF CARDIOVASCULAR EVENTS 92 -- 6 SUMMARY AND DISCUSSION 92 -- 6.1 SCOPE OF THIS HEALTH TECHNOLOGY ASSESSMENT 92 -- 6.2 HISTORICAL AND CURRENT USE OF STATINS IN BELGIUM 93 -- 6.2.1 History of the marketing of statins in Belgium 93 -- 6.2.2 Global statin use in Belgium 93 -- 6.2.3 Individual statin use in Belgium 94 -- 6.3 RISK ASSESSMENT 95 -- 6.4 EFFICACY AND HARMS OF STATIN USE IN PRIMARY PREVENTION 97 -- 6.4.1 Efficacy 97 -- 6.4.2 Harms 98 -- 6.5 COST-EFFECTIVENESS OF STATINS IN PRIMARY PREVENTION 98 -- 6.6 APPLICABILITY OF THE FINDINGS TO BELGIUM 100 -- 6.7 WHO SHOULD RECEIVE STATIN-BASED PRIMARY PREVENTION? 100 -- 6.8 LIMITATIONS OF THE CURRENT EVIDENCE 101 -- 6.9 OVERALL CONCLUSION 101 -- APPENDICES 102 -- APPENDIX 1. HISTORICAL AND CURRENT USE OF STATINS IN BELGIUM 102 -- APPENDIX 1.1. SUBGROUPS ANALYSES FOR USERS AND NEW USERS 102 -- APPENDIX 1.2. ADHERENCE 122 -- APPENDIX 1.3. CURRENT PRICES OF STATINS IN BELGIUM 124 -- APPENDIX 2. CLINICAL BENEFITS AND HARMS 126 -- APPENDIX 2.1. SEARCH STRATEGIES FOR SYSTEMATIC REVIEWS AND RCTS 126 -- APPENDIX 2.2. SEARCH STRATEGY FOR RCTS IN MEDLINE 137 -- APPENDIX 2.3. SELECTION OF STUDIES FROM SEARCH STRATEGY 139 -- APPENDIX 2.4. INCLUSION AND EXCLUSION CRITERIA 140 -- APPENDIX 2.5. QUALITY APPRAISAL 141 -- APPENDIX 2.6. CHARACTERISTICS OF INCLUDED RCTS 146 -- APPENDIX 2.7. META-ANALYSES 152 -- APPENDIX 3. COST-EFFECTIVENESS 154 -- APPENDIX 3.1. SEARCH STRATEGIES OF REVIEWS OF ECONOMIC EVALUATIONS 154 -- APPENDIX 3.2. SEARCH STRATEGIES OF PRIMARY ECONOMIC EVALUATION 163 -- APPENDIX 3.3. SELECTION PROCESS OF ECONOMIC EVALUATIONS 178 -- APPENDIX 3.4. RESULTS FROM REVIEWS OF ECONOMIC EVALUATIONS 181 -- APPENDIX 3.5. RESULTS FROM SELECTED PRIMARY STUDIES 194 -- APPENDIX 3.6. ANNUAL COST IN BELGIUM (2018) 206 -- REFERENCES 209

16 p. ill., PRÉFACE 1 -- MESSAGES CLÉS 2 -- SYNTHÈSE 3 -- 1. OBJECTIFS DE L’ETUDE 4 -- 1.1. QUE SONT LES STATINES ? 4 -- 1.2. QU’AVONS-NOUS ETUDIE ? 5 -- 1.3. COMMENT AVONS-NOUS PROCEDE ? 5 -- 2. UTILISATION DES STATINES EN BELGIQUE 6 -- 2.1. SUR LE MARCHE BELGE DEPUIS LES ANNEES 1990 6 -- 2.2. 13 % DES BELGES PRENNENT DES STATINES… 7 -- 2.3. … MAIS ABANDONNENT GENERALEMENT LE TRAITEMENT AU BOUT D’UN MOMENT 7 -- 2.4. EFFICACES EN PREVENTION PRIMAIRE 9 -- 2.5. … MAIS PAS EXEMPTES D’EFFETS SECONDAIRES 9 -- 3. QUEL EST LE RAPPORT COÛT-EFFICACITÉ DES STATINES EN PRÉVENTION PRIMAIRE ?.10 -- 3.1. LE RAPPORT COUT-EFFICACITE EST INFLUENCE PAR DE NOMBREUX FACTEURS 10 -- 3.2. UN MEILLEUR RAPPORT COUT-EFFICACITE CHEZ LES SUJETS A PLUS HAUT RISQUE .11 -- 4. CONCLUSION : LE PLUS IMPORTANT RESTE L’ADAPTATION DU MODE DE VIE .12 -- RECOMMANDATIONS 14 -- RÉFÉRENCES 15

XI, 224 p. ill. La présente étude se concentre essentiellement sur les critères de choix entre les diverses modalités de dialyse : l’hémodialyse hospitalière, l’hémodialyse en centre collectif ou à domicile, la dialyse péritonéale. Par ailleurs, nous nous intéressons aussi à l’organisation de la dialyse chronique en Belgique, au coût des modalités de dialyse alternatives à l’hémodialyse hospitalière et au financement de ces activités. Les efforts déployés pour encourager les méthodes autres que l’hémodialyse hospitalière traditionnelle ont-ils porté leurs fruits ? Par ailleurs, dans quelle mesure le patient peut-il faire entendre sa voix ? Table of contents -- ABBREVIATIONS 4 -- 1 INTRODUCTION 7 -- 1 1 BACKGROUND 7 -- 1 2 TECHNOLOGY OVERVIEW 7 -- 1 2 1 Dialysis 7 -- 1 2 2 Haemodialysis 7 -- 1 2 3 Peritoneal dialysis 8 -- 1 3 THE ISSUE 9 -- 1 4 OBJECTIVES 10 -- 2 LITERATURE REVIEW OF CLINICAL AND ECONOMIC ASPECTS OF -- CHRONIC DIALYSIS 11 -- 2 1 INTRODUCTION 11 -- 2 2 METHODS 13 -- 2 2 1 Literature search criteria 13 -- 2 2 2 Main MeSH terms and definitions 13 -- 2 2 3 Selected literature 13 -- 2 2 4 Terminology 14 -- 2 3 MORTALITY AND MORBIDITY 14 -- 2 3 1 Hospital HD versus satellite HD versus home HD 14 -- 2 3 2 Continuous ambulatory peritoneal dialysis (CAPD) versus automated peritoneal dialysis -- (APD/CCPD) 15 -- 2 3 3 PD versus HD 15 -- 2 4 QUALITY OF LIFE 17 -- 2 4 1 Background 17 -- 2 4 2 Results 17 -- 2 5 COSTS AND COST-EFFECTIVENESS OF DIALYSIS MODALITIES 18 -- 2 5 1 Costs of dialysis modalities 18 -- 2 5 2 Cost-effectiveness of dialysis modalities 20 -- 2 6 CHOICE OF A SPECIFIC DIALYSIS MODALITY IN INDIVIDUAL PATIENTS 21 -- 2 6 1 Medical indications and contra-indications for specific dialysis modalities 21 -- 2 6 2 Patient choices 22 -- 2 7 PREDIALYSIS PATIENT EDUCATION 23 -- 2 8 CONCLUSION 24 -- 3 BELGIAN SITUATION 25 -- 3 1 EPIDEMIOLOGY 25 -- 3 1 1 The patient population 25 -- 3 1 2 Renal Transplants 28 -- 3 1 3 Use of different dialysis modalities for ESRD in Belgium 31 -- 3 2 CLINICAL CHARACTERISTICS OF DIALYSIS PATIENTS 35 -- 3 3 PLANNING, ORGANISATION AND REGULATION 35 -- 3 3 1 Legal aspects 35 -- 3 3 2 Dialysis facilities in Belgium 37 -- 3 3 3 Real-world relevance of norms and rules for hospital and satellite HD units 37 -- 3 4 FINANCING OF CHRONIC RENAL FAILURE MANAGEMENT 39 -- 3 4 1 General Principles 39 -- 3 4 2 Historical evolution of dialysis financing mechanisms 39 -- 3 4 3 Current financing of hospital haemodialysis 44 -- 3 4 4 Current financing of satellite HD, home HD and PD 46 -- 3 4 5 Summary of financing mechanisms for the different types of dialysis 47 -- 3 4 6 National expenditures for dialysis between 2002 and 2008 50 -- 3 4 7 Differences in use of alternative dialysis modalities between centres and between -- regions 52 -- 3 4 8 Income from dialysis for hospitals 54 -- 4 PATIENT CHARACTERISTICS, PUBLIC REIMBURSEMENT AND OUT-OFPOCKET -- EXPENSES 55 -- 4 1 INTRODUCTION AND OBJECTIVES 55 -- 4 2 METHOD 55 -- 4 2 1 Financing of dialysis 55 -- 4 2 2 Inclusion criteria 55 -- 4 2 3 Working definitions 55 -- 4 2 4 Patient profiles 56 -- 4 2 5 Data analysis and presentation of results 56 -- 4 3 PATIENT CHARACTERISTICS 57 -- 4 3 1 Number of individuals receiving chronic dialysis treatment 57 -- 4 3 2 Number of patients by year of treatment and dialysis modality 57 -- 4 3 3 Age and gender 58 -- 4 3 4 Starting, continuing and stopping dialysis 61 -- 4 3 5 Mortality 62 -- 4 4 PUBLIC REIMBURSEMENTS FOR CHRONIC DIALYSIS PATIENTS: CROSS-SECTIONAL -- ANALYSIS PER YEAR 64 -- 4 4 1 NIHDI reimbursements 65 -- 4 4 2 Ambulatory dialysis 66 -- 4 4 3 Hospital stays and one-day clinic 68 -- 4 4 4 Ambulatory consultations 71 -- 4 4 5 Ambulatory medication 73 -- 4 4 6 Venofer® (intravenous iron) 74 -- 4 5 OUT-OF-POCKET EXPENSES FOR CHRONIC DIALYSIS PATIENTS: CROSS-SECTIONAL -- ANALYSIS PER YEAR 75 -- 4 5 1 Total out-of-pocket expenses for reimbursed health care items 75 -- 4 5 2 Ambulatory dialysis 77 -- 4 5 3 Hospital stays and one-day clinic 78 -- 4 5 4 Ambulatory consultations 80 -- 4 5 5 Ambulatory medication 81 -- 4 6 PUBLIC REIMBURSEMENTS FOR CHRONIC DIALYSIS PATIENTS: LONGITUDINAL -- ANALYSIS FOR INCIDENT PATIENTS 82 -- 4 6 1 Overall reimbursements 82 -- 4 6 2 Average reimbursement per patient 83 -- 4 7 OVERVIEW AND CONCLUSIONS 84 -- 4 7 1 Patients 84 -- 4 7 2 Expenses for the public payer (NIHDI) 85 -- 4 7 3 Out-of-pocket expenses for the patient 86 -- 4 7 4 Expenses before and after starting dialysis 87 -- 5 THE COSTS AND REVENUES OF DIFFERENT DIALYSIS MODALITIES IN -- BELGIUM FROM THE HOSPITAL PERSPECTIVE 88 -- 5 1 INTRODUCTION 88 -- 5 2 COSTS OF HOSPITAL HD, SATELLITE HD AND PD 88 -- 5 2 1 Methods 88 -- 5 2 2 Results 99 -- 5 3 COSTS AND REVENUES OF A DIALYSIS PROGRAMME FROM A HOSPITAL’S -- PERSPECTIVE 103 -- 5 3 1 Methods 103 -- 5 3 2 Results 106 -- 5 4 DISCUSSION 112 -- 5 4 1 Cost analysis 112 -- 5 4 2 Simulation of revenues and costs 113 -- 6 INTERNATIONAL COMPARISON 115 -- 6 1 INTRODUCTION 115 -- 6 2 ORGANISATION OF CARE FOR ESRD PATIENTS 115 -- 6 2 1 Incidence and prevalence 115 -- 6 2 2 Number of nephrologists 116 -- 6 2 3 Geographical access to dialysis facilities 117 -- 6 2 4 Distribution of patients between treatment modalities 117 -- 6 2 5 Incentives and criteria influencing the choice of the treatment 119 -- 6 3 ESRD FUNDING 120 -- 6 3 1 Introduction 120 -- 6 3 2 National budget for ESRD patients 120 -- 6 3 3 Financing of dialysis physicians 121 -- 6 3 4 Financing of dialysis units 122 -- 6 3 5 Patients’ co-payments 123 -- 6 3 6 Cost containment measures 124 -- 7 PATIENT PERSPECTIVE IN CHRONIC DIALYSIS 126 -- 7 1 INTRODUCTION 126 -- 7 2 OBJECTIVES 126 -- 7 3 METHODS 126 -- 7 4 RESULTS 128 -- 7 4 1 Methodological problems 128 -- 7 4 2 Reported issues by patients 128 -- 7 4 3 Information 128 -- 7 4 4 Choice between dialysis modalities 129 -- 7 4 5 Advantages and disadvantages of different dialysis modalities 130 -- 7 4 6 Support in case of home dialysis treatments 131 -- 7 4 7 Financial issues 131 -- 7 5 PSYCHOSOCIAL CONSIDERATIONS 132 -- 7 6 CONCLUSION 132 -- 7 6 1 Our survey 132 -- 7 6 2 Previous studies 133 -- 8 DISCUSSION AND CONCLUSIONS 136 -- 8 1 EPIDEMIOLOGY OF RENAL REPLACEMENT THERAPY IN BELGIUM 136 -- 8 2 RELATIVE EFFECTIVENESS OF DIALYSIS MODALITIES 137 -- 8 3 COSTS OF DIALYSIS MODALITIES FROM A HOSPITAL PERSPECTIVE 137 -- 8 4 COST-EFFECTIVENESS OF DIALYSIS MODALITIES 138 -- 8 5 COSTS AND REIMBURSEMENT 138 -- 8 6 LICENSING OF DIALYSIS CENTRES 140 -- 8 7 NIHDI EXPENDITURES 141 -- 8 8 INTERNATIONAL COMPARISON 141 -- 8 9 PATIENT-RELATED ISSUES 142 -- 8 10 LIMITATIONS OF THE REPORT 142 -- 8 11 FINAL CONCLUSION 142 -- 9 APPENDICES 143 -- APPENDIX TO CHAPTER 2 143 -- APPENDIX TO CHAPTER 4 187 -- APPENDIX TO CHAPTER 5 203 -- APPENDIX TO CHAPTER 7 215 -- 10 REFERENCES 221

XI, 224 p. ill. Table of contents -- ABBREVIATIONS 4 -- 1 INTRODUCTION 7 -- 1 1 BACKGROUND 7 -- 1 2 TECHNOLOGY OVERVIEW 7 -- 1 2 1 Dialysis 7 -- 1 2 2 Haemodialysis 7 -- 1 2 3 Peritoneal dialysis 8 -- 1 3 THE ISSUE 9 -- 1 4 OBJECTIVES 10 -- 2 LITERATURE REVIEW OF CLINICAL AND ECONOMIC ASPECTS OF -- CHRONIC DIALYSIS 11 -- 2 1 INTRODUCTION 11 -- 2 2 METHODS 13 -- 2 2 1 Literature search criteria 13 -- 2 2 2 Main MeSH terms and definitions 13 -- 2 2 3 Selected literature 13 -- 2 2 4 Terminology 14 -- 2 3 MORTALITY AND MORBIDITY 14 -- 2 3 1 Hospital HD versus satellite HD versus home HD 14 -- 2 3 2 Continuous ambulatory peritoneal dialysis (CAPD) versus automated peritoneal dialysis -- (APD/CCPD) 15 -- 2 3 3 PD versus HD 15 -- 2 4 QUALITY OF LIFE 17 -- 2 4 1 Background 17 -- 2 4 2 Results 17 -- 2 5 COSTS AND COST-EFFECTIVENESS OF DIALYSIS MODALITIES 18 -- 2 5 1 Costs of dialysis modalities 18 -- 2 5 2 Cost-effectiveness of dialysis modalities 20 -- 2 6 CHOICE OF A SPECIFIC DIALYSIS MODALITY IN INDIVIDUAL PATIENTS 21 -- 2 6 1 Medical indications and contra-indications for specific dialysis modalities 21 -- 2 6 2 Patient choices 22 -- 2 7 PREDIALYSIS PATIENT EDUCATION 23 -- 2 8 CONCLUSION 24 -- 3 BELGIAN SITUATION 25 -- 3 1 EPIDEMIOLOGY 25 -- 3 1 1 The patient population 25 -- 3 1 2 Renal Transplants 28 -- 3 1 3 Use of different dialysis modalities for ESRD in Belgium 31 -- 3 2 CLINICAL CHARACTERISTICS OF DIALYSIS PATIENTS 35 -- 3 3 PLANNING, ORGANISATION AND REGULATION 35 -- 3 3 1 Legal aspects 35 -- 3 3 2 Dialysis facilities in Belgium 37 -- 3 3 3 Real-world relevance of norms and rules for hospital and satellite HD units 37 -- 3 4 FINANCING OF CHRONIC RENAL FAILURE MANAGEMENT 39 -- 3 4 1 General Principles 39 -- 3 4 2 Historical evolution of dialysis financing mechanisms 39 -- 3 4 3 Current financing of hospital haemodialysis 44 -- 3 4 4 Current financing of satellite HD, home HD and PD 46 -- 3 4 5 Summary of financing mechanisms for the different types of dialysis 47 -- 3 4 6 National expenditures for dialysis between 2002 and 2008 50 -- 3 4 7 Differences in use of alternative dialysis modalities between centres and between -- regions 52 -- 3 4 8 Income from dialysis for hospitals 54 -- 4 PATIENT CHARACTERISTICS, PUBLIC REIMBURSEMENT AND OUT-OFPOCKET -- EXPENSES 55 -- 4 1 INTRODUCTION AND OBJECTIVES 55 -- 4 2 METHOD 55 -- 4 2 1 Financing of dialysis 55 -- 4 2 2 Inclusion criteria 55 -- 4 2 3 Working definitions 55 -- 4 2 4 Patient profiles 56 -- 4 2 5 Data analysis and presentation of results 56 -- 4 3 PATIENT CHARACTERISTICS 57 -- 4 3 1 Number of individuals receiving chronic dialysis treatment 57 -- 4 3 2 Number of patients by year of treatment and dialysis modality 57 -- 4 3 3 Age and gender 58 -- 4 3 4 Starting, continuing and stopping dialysis 61 -- 4 3 5 Mortality 62 -- 4 4 PUBLIC REIMBURSEMENTS FOR CHRONIC DIALYSIS PATIENTS: CROSS-SECTIONAL -- ANALYSIS PER YEAR 64 -- 4 4 1 NIHDI reimbursements 65 -- 4 4 2 Ambulatory dialysis 66 -- 4 4 3 Hospital stays and one-day clinic 68 -- 4 4 4 Ambulatory consultations 71 -- 4 4 5 Ambulatory medication 73 -- 4 4 6 Venofer® (intravenous iron) 74 -- 4 5 OUT-OF-POCKET EXPENSES FOR CHRONIC DIALYSIS PATIENTS: CROSS-SECTIONAL -- ANALYSIS PER YEAR 75 -- 4 5 1 Total out-of-pocket expenses for reimbursed health care items 75 -- 4 5 2 Ambulatory dialysis 77 -- 4 5 3 Hospital stays and one-day clinic 78 -- 4 5 4 Ambulatory consultations 80 -- 4 5 5 Ambulatory medication 81 -- 4 6 PUBLIC REIMBURSEMENTS FOR CHRONIC DIALYSIS PATIENTS: LONGITUDINAL -- ANALYSIS FOR INCIDENT PATIENTS 82 -- 4 6 1 Overall reimbursements 82 -- 4 6 2 Average reimbursement per patient 83 -- 4 7 OVERVIEW AND CONCLUSIONS 84 -- 4 7 1 Patients 84 -- 4 7 2 Expenses for the public payer (NIHDI) 85 -- 4 7 3 Out-of-pocket expenses for the patient 86 -- 4 7 4 Expenses before and after starting dialysis 87 -- 5 THE COSTS AND REVENUES OF DIFFERENT DIALYSIS MODALITIES IN -- BELGIUM FROM THE HOSPITAL PERSPECTIVE 88 -- 5 1 INTRODUCTION 88 -- 5 2 COSTS OF HOSPITAL HD, SATELLITE HD AND PD 88 -- 5 2 1 Methods 88 -- 5 2 2 Results 99 -- 5 3 COSTS AND REVENUES OF A DIALYSIS PROGRAMME FROM A HOSPITAL’S -- PERSPECTIVE 103 -- 5 3 1 Methods 103 -- 5 3 2 Results 106 -- 5 4 DISCUSSION 112 -- 5 4 1 Cost analysis 112 -- 5 4 2 Simulation of revenues and costs 113 -- 6 INTERNATIONAL COMPARISON 115 -- 6 1 INTRODUCTION 115 -- 6 2 ORGANISATION OF CARE FOR ESRD PATIENTS 115 -- 6 2 1 Incidence and prevalence 115 -- 6 2 2 Number of nephrologists 116 -- 6 2 3 Geographical access to dialysis facilities 117 -- 6 2 4 Distribution of patients between treatment modalities 117 -- 6 2 5 Incentives and criteria influencing the choice of the treatment 119 -- 6 3 ESRD FUNDING 120 -- 6 3 1 Introduction 120 -- 6 3 2 National budget for ESRD patients 120 -- 6 3 3 Financing of dialysis physicians 121 -- 6 3 4 Financing of dialysis units 122 -- 6 3 5 Patients’ co-payments 123 -- 6 3 6 Cost containment measures 124 -- 7 PATIENT PERSPECTIVE IN CHRONIC DIALYSIS 126 -- 7 1 INTRODUCTION 126 -- 7 2 OBJECTIVES 126 -- 7 3 METHODS 126 -- 7 4 RESULTS 128 -- 7 4 1 Methodological problems 128 -- 7 4 2 Reported issues by patients 128 -- 7 4 3 Information 128 -- 7 4 4 Choice between dialysis modalities 129 -- 7 4 5 Advantages and disadvantages of different dialysis modalities 130 -- 7 4 6 Support in case of home dialysis treatments 131 -- 7 4 7 Financial issues 131 -- 7 5 PSYCHOSOCIAL CONSIDERATIONS 132 -- 7 6 CONCLUSION 132 -- 7 6 1 Our survey 132 -- 7 6 2 Previous studies 133 -- 8 DISCUSSION AND CONCLUSIONS 136 -- 8 1 EPIDEMIOLOGY OF RENAL REPLACEMENT THERAPY IN BELGIUM 136 -- 8 2 RELATIVE EFFECTIVENESS OF DIALYSIS MODALITIES 137 -- 8 3 COSTS OF DIALYSIS MODALITIES FROM A HOSPITAL PERSPECTIVE 137 -- 8 4 COST-EFFECTIVENESS OF DIALYSIS MODALITIES 138 -- 8 5 COSTS AND REIMBURSEMENT 138 -- 8 6 LICENSING OF DIALYSIS CENTRES 140 -- 8 7 NIHDI EXPENDITURES 141 -- 8 8 INTERNATIONAL COMPARISON 141 -- 8 9 PATIENT-RELATED ISSUES 142 -- 8 10 LIMITATIONS OF THE REPORT 142 -- 8 11 FINAL CONCLUSION 142 -- 9 APPENDICES 143 -- APPENDIX TO CHAPTER 2 143 -- APPENDIX TO CHAPTER 4 187 -- APPENDIX TO CHAPTER 5 203 -- APPENDIX TO CHAPTER 7 215 -- 10 REFERENCES 221

XI, 224 p. ill. Deze studie concentreert zich voornamelijk op de criteria voor de keuze tussen de verschillende dialysemodaliteiten: hemodialyse in het ziekenhuis, hemodialyse in een satellietcentrum of thuis, peritoneale dialyse. Daarnaast wordt ook gekeken naar de organisatie van chronische dialyse in België, de kosten van de verschillende alternatieve dialysemodaliteiten en de financiering van deze activiteiten. Hebben de inspanningen om de alternatieven naast de klassieke hemodialyse in het ziekenhuis te stimuleren hun doel bereikt of niet? Tenslotte stellen we ons ook de vraag in hoeverre de patiënt hierbij mag meepraten. Table of contents -- ABBREVIATIONS 4 -- 1 INTRODUCTION 7 -- 1 1 BACKGROUND 7 -- 1 2 TECHNOLOGY OVERVIEW 7 -- 1 2 1 Dialysis 7 -- 1 2 2 Haemodialysis 7 -- 1 2 3 Peritoneal dialysis 8 -- 1 3 THE ISSUE 9 -- 1 4 OBJECTIVES 10 -- 2 LITERATURE REVIEW OF CLINICAL AND ECONOMIC ASPECTS OF -- CHRONIC DIALYSIS 11 -- 2 1 INTRODUCTION 11 -- 2 2 METHODS 13 -- 2 2 1 Literature search criteria 13 -- 2 2 2 Main MeSH terms and definitions 13 -- 2 2 3 Selected literature 13 -- 2 2 4 Terminology 14 -- 2 3 MORTALITY AND MORBIDITY 14 -- 2 3 1 Hospital HD versus satellite HD versus home HD 14 -- 2 3 2 Continuous ambulatory peritoneal dialysis (CAPD) versus automated peritoneal dialysis -- (APD/CCPD) 15 -- 2 3 3 PD versus HD 15 -- 2 4 QUALITY OF LIFE 17 -- 2 4 1 Background 17 -- 2 4 2 Results 17 -- 2 5 COSTS AND COST-EFFECTIVENESS OF DIALYSIS MODALITIES 18 -- 2 5 1 Costs of dialysis modalities 18 -- 2 5 2 Cost-effectiveness of dialysis modalities 20 -- 2 6 CHOICE OF A SPECIFIC DIALYSIS MODALITY IN INDIVIDUAL PATIENTS 21 -- 2 6 1 Medical indications and contra-indications for specific dialysis modalities 21 -- 2 6 2 Patient choices 22 -- 2 7 PREDIALYSIS PATIENT EDUCATION 23 -- 2 8 CONCLUSION 24 -- 3 BELGIAN SITUATION 25 -- 3 1 EPIDEMIOLOGY 25 -- 3 1 1 The patient population 25 -- 3 1 2 Renal Transplants 28 -- 3 1 3 Use of different dialysis modalities for ESRD in Belgium 31 -- 3 2 CLINICAL CHARACTERISTICS OF DIALYSIS PATIENTS 35 -- 3 3 PLANNING, ORGANISATION AND REGULATION 35 -- 3 3 1 Legal aspects 35 -- 3 3 2 Dialysis facilities in Belgium 37 -- 3 3 3 Real-world relevance of norms and rules for hospital and satellite HD units 37 -- 3 4 FINANCING OF CHRONIC RENAL FAILURE MANAGEMENT 39 -- 3 4 1 General Principles 39 -- 3 4 2 Historical evolution of dialysis financing mechanisms 39 -- 3 4 3 Current financing of hospital haemodialysis 44 -- 3 4 4 Current financing of satellite HD, home HD and PD 46 -- 3 4 5 Summary of financing mechanisms for the different types of dialysis 47 -- 3 4 6 National expenditures for dialysis between 2002 and 2008 50 -- 3 4 7 Differences in use of alternative dialysis modalities between centres and between -- regions 52 -- 3 4 8 Income from dialysis for hospitals 54 -- 4 PATIENT CHARACTERISTICS, PUBLIC REIMBURSEMENT AND OUT-OFPOCKET -- EXPENSES 55 -- 4 1 INTRODUCTION AND OBJECTIVES 55 -- 4 2 METHOD 55 -- 4 2 1 Financing of dialysis 55 -- 4 2 2 Inclusion criteria 55 -- 4 2 3 Working definitions 55 -- 4 2 4 Patient profiles 56 -- 4 2 5 Data analysis and presentation of results 56 -- 4 3 PATIENT CHARACTERISTICS 57 -- 4 3 1 Number of individuals receiving chronic dialysis treatment 57 -- 4 3 2 Number of patients by year of treatment and dialysis modality 57 -- 4 3 3 Age and gender 58 -- 4 3 4 Starting, continuing and stopping dialysis 61 -- 4 3 5 Mortality 62 -- 4 4 PUBLIC REIMBURSEMENTS FOR CHRONIC DIALYSIS PATIENTS: CROSS-SECTIONAL -- ANALYSIS PER YEAR 64 -- 4 4 1 NIHDI reimbursements 65 -- 4 4 2 Ambulatory dialysis 66 -- 4 4 3 Hospital stays and one-day clinic 68 -- 4 4 4 Ambulatory consultations 71 -- 4 4 5 Ambulatory medication 73 -- 4 4 6 Venofer® (intravenous iron) 74 -- 4 5 OUT-OF-POCKET EXPENSES FOR CHRONIC DIALYSIS PATIENTS: CROSS-SECTIONAL -- ANALYSIS PER YEAR 75 -- 4 5 1 Total out-of-pocket expenses for reimbursed health care items 75 -- 4 5 2 Ambulatory dialysis 77 -- 4 5 3 Hospital stays and one-day clinic 78 -- 4 5 4 Ambulatory consultations 80 -- 4 5 5 Ambulatory medication 81 -- 4 6 PUBLIC REIMBURSEMENTS FOR CHRONIC DIALYSIS PATIENTS: LONGITUDINAL -- ANALYSIS FOR INCIDENT PATIENTS 82 -- 4 6 1 Overall reimbursements 82 -- 4 6 2 Average reimbursement per patient 83 -- 4 7 OVERVIEW AND CONCLUSIONS 84 -- 4 7 1 Patients 84 -- 4 7 2 Expenses for the public payer (NIHDI) 85 -- 4 7 3 Out-of-pocket expenses for the patient 86 -- 4 7 4 Expenses before and after starting dialysis 87 -- 5 THE COSTS AND REVENUES OF DIFFERENT DIALYSIS MODALITIES IN -- BELGIUM FROM THE HOSPITAL PERSPECTIVE 88 -- 5 1 INTRODUCTION 88 -- 5 2 COSTS OF HOSPITAL HD, SATELLITE HD AND PD 88 -- 5 2 1 Methods 88 -- 5 2 2 Results 99 -- 5 3 COSTS AND REVENUES OF A DIALYSIS PROGRAMME FROM A HOSPITAL’S -- PERSPECTIVE 103 -- 5 3 1 Methods 103 -- 5 3 2 Results 106 -- 5 4 DISCUSSION 112 -- 5 4 1 Cost analysis 112 -- 5 4 2 Simulation of revenues and costs 113 -- 6 INTERNATIONAL COMPARISON 115 -- 6 1 INTRODUCTION 115 -- 6 2 ORGANISATION OF CARE FOR ESRD PATIENTS 115 -- 6 2 1 Incidence and prevalence 115 -- 6 2 2 Number of nephrologists 116 -- 6 2 3 Geographical access to dialysis facilities 117 -- 6 2 4 Distribution of patients between treatment modalities 117 -- 6 2 5 Incentives and criteria influencing the choice of the treatment 119 -- 6 3 ESRD FUNDING 120 -- 6 3 1 Introduction 120 -- 6 3 2 National budget for ESRD patients 120 -- 6 3 3 Financing of dialysis physicians 121 -- 6 3 4 Financing of dialysis units 122 -- 6 3 5 Patients’ co-payments 123 -- 6 3 6 Cost containment measures 124 -- 7 PATIENT PERSPECTIVE IN CHRONIC DIALYSIS 126 -- 7 1 INTRODUCTION 126 -- 7 2 OBJECTIVES 126 -- 7 3 METHODS 126 -- 7 4 RESULTS 128 -- 7 4 1 Methodological problems 128 -- 7 4 2 Reported issues by patients 128 -- 7 4 3 Information 128 -- 7 4 4 Choice between dialysis modalities 129 -- 7 4 5 Advantages and disadvantages of different dialysis modalities 130 -- 7 4 6 Support in case of home dialysis treatments 131 -- 7 4 7 Financial issues 131 -- 7 5 PSYCHOSOCIAL CONSIDERATIONS 132 -- 7 6 CONCLUSION 132 -- 7 6 1 Our survey 132 -- 7 6 2 Previous studies 133 -- 8 DISCUSSION AND CONCLUSIONS 136 -- 8 1 EPIDEMIOLOGY OF RENAL REPLACEMENT THERAPY IN BELGIUM 136 -- 8 2 RELATIVE EFFECTIVENESS OF DIALYSIS MODALITIES 137 -- 8 3 COSTS OF DIALYSIS MODALITIES FROM A HOSPITAL PERSPECTIVE 137 -- 8 4 COST-EFFECTIVENESS OF DIALYSIS MODALITIES 138 -- 8 5 COSTS AND REIMBURSEMENT 138 -- 8 6 LICENSING OF DIALYSIS CENTRES 140 -- 8 7 NIHDI EXPENDITURES 141 -- 8 8 INTERNATIONAL COMPARISON 141 -- 8 9 PATIENT-RELATED ISSUES 142 -- 8 10 LIMITATIONS OF THE REPORT 142 -- 8 11 FINAL CONCLUSION 142 -- 9 APPENDICES 143 -- APPENDIX TO CHAPTER 2 143 -- APPENDIX TO CHAPTER 4 187 -- APPENDIX TO CHAPTER 5 203 -- APPENDIX TO CHAPTER 7 215 -- 10 REFERENCES 221

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