Belgische richtlijnen voor economische evaluaties en budget impact analyses : tweede editie

VIII, 76 p.ill.Het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) en het RIZIV ontwikkelden in 2008 richtlijnen waaraan de aanvragen tot terugbetaling van bepaalde geneesmiddelen (klasse 1) moeten voldoen. Het KCE heeft deze nu herzien en aangevuld met richtlijnen voor het uitvoeren van een budgetimpact analyse. Al deze richtlijnen werden bovendien uitgebreid naar alle medische interventies ( naast de geneesmiddelen ook prothesen, implantaten, evenals alle andere medische prestaties).Dit moet zorgen voor meer transparantie en consistentie van de economische analyses en het RIZIV helpen om betere en meer gemotiveerde beslissingen te nemen.SCIENTIFIC REPORT 8 -- 1 BACKGROUND 8 -- 2 OBJECTIVES 10 -- 3 METHODS10 -- 4 OVERVIEW OF THE BELGIAN GUIDELINES AND GENERAL REMARKS 12 -- 4.1 OVERVIEW OF THE BELGIAN GUIDELINES 12 -- 4.2 GENERAL REMARKS 13 -- 5 GUIDELINES FOR HEALTH ECONOMIC EVALUATIONS 15 -- 5.1 GUIDELINE 1: LITERATURE REVIEW 15 -- 5.2 GUIDELINE 2: PERSPECTIVE OF THE EVALUATION 17 -- 5.3 GUIDELINE 3: TARGET POPULATION 18 -- 5.4 GUIDELINE 4: COMPARATORS 19 -- 5.5 GUIDELINE 5: ANALYTIC TECHNIQUE 21 -- 5.5.1 Cost-effectiveness analysis 21 -- 5.5.2 Cost-utility analysis 22 -- 5.5.3 Cost-minimisation analysis 22 -- 5.5.4 Cost-benefit analysis 23 -- 5.6 GUIDELINE 6: STUDY DESIGN 23 -- 5.6.1 Trial-based economic evaluations 23 -- 5.6.2 Modelling 24 -- 5.7 GUIDELINE 7: CALCULATION OF COSTS 25 -- 5.7.1 Cost categories 25 -- 5.7.2 Measurement of resource use 26 -- 5.7.3 Valuation of resource use 26 -- 5.8 GUIDELINE 8: ESTIMATION AND VALUATION OF OUTCOMES 36 -- 5.8.1 Effectiveness evaluation in cost-effectiveness analysis 37 -- 5.8.2 Utility assessment in cost-utility analysis 37 -- 5.9 GUIDELINE 9: TIME HORIZON 39 -- 5.10 GUIDELINE 10: MODELLING 39 -- 5.10.1 Need for modelling 39 -- 5.10.2 Choice of the model design 40 -- 5.10.3 Precision of model structure and hypotheses 40 -- 5.10.4 Calibration, face validity and cross-validation of a model 41 -- 5.11 GUIDELINE 11: HANDLING UNCERTAINTY AND TESTING THE ROBUSTNESS OF THE RESULTS .. 42 -- 5.12 GUIDELINE 12: DISCOUNT RATE 43 -- 6 GUIDELINES FOR BUDGET IMPACT ANALYSES 44 -- 6.1 SIMILARITIES AND DIFFERENCES BETWEEN ECONOMIC EVALUATIONS AND BUDGET IMPACT -- ANALYSES 44 -- 6.2 GUIDELINE 13: PERSPECTIVE 45 -- 6.3 GUIDELINE 14: TARGET POPULATION 45 -- 6.4 GUIDELINE 15: COMPARATORS 46 -- 6.5 GUIDELINE 16: COSTS AND OUTCOMES 47 -- 6.6 GUIDELINE 17: TIME HORIZON 48 -- 6.7 GUIDELINE 18: MODELLING 48 -- 6.8 GUIDELINE 19: HANDLING UNCERTAINTY 49 -- 6.9 GUIDELINE 20: DISCOUNT RATE 49 -- 6.10 GUIDELINE 21: PRESENTING RESULTS 49 -- 7 DISCUSSION 50 -- 8 POLICY RECOMMENDATIONS 51 -- 9 REPORTING GUIDELINES 53 -- 9.1 EXECUTIVE SUMMARY 53 -- 9.2 INTRODUCTION 53 -- 9.3 OBJECTIVES 53 -- 9.4 LITERATURE REVIEW 53 -- 9.4.1 Clinical literature review 53 -- 9.4.2 Economic literature review 54 -- 9.5 BASIC ELEMENTS OF THE ECONOMIC EVALUATION 54 -- 9.5.1 Analytic technique 54 -- 9.5.2 Study design 54 -- 9.5.3 Methods used for valuation of costs 54 -- 9.5.4 Methods used for outcome assessment 54 -- 9.5.5 Method of analysis of the data 54 -- 9.5.6 Time horizon and discount rate54 -- 9.5.7 Sensitivity analysis 54 -- 9.6 RESEARCH METHODS 54 -- 9.6.1 Identification, measurement and valuation of costs 54 -- 9.6.2 Identification, measurement and valuation of health-related outcomes 55 -- 9.7 RESULTS 55 -- 9.7.1 Basic results 55 -- 9.7.2 Uncertainty analysis 55 -- 9.8 DISCUSSION 55 -- 9.9 CONCLUSION 55 -- 9.10 TRANSPARENCY OF FINANCIAL SUPPORT 55 -- 9.11 REFERENCES 56 -- 9.12 ADDENDA 56 -- 10 PRESENTATION OF A MODEL 56 -- 10.1 DATA 56 -- 10.2 RESULTS 56 -- 10.2.1 Reference case analysis 56 -- 10.2.2 Uncertainty analysis 56 -- 11 METHODOLOGICAL REFERENCES BY TOPIC 57 -- 11.1 COUNTRY-SPECIFIC GUIDELINES 57 -- 11.2 METHODS FOR ECONOMIC EVALUATIONS 57 -- 11.3 LITERATURE REVIEW 58 -- 11.4 STUDY DESIGN 58 -- 11.4.1 Trial-based economic evaluations 58 -- 11.4.2 Modelling 58 -- 11.5 CALCULATION OF COSTS 58 -- 11.5.1 Measurement of resource use 58 -- 11.5.2 Valuation of resource use 58 -- 11.6 HANDLING UNCERTAINTY 58 -- 11.6.1 Overview 58 -- 11.6.2 Confidence interval around the ICER 59 -- 11.7 INDIRECT COMPARISONS 59 -- 11.8 DISCOUNTING 59 -- 11.9 BUDGET IMPACT ANALYSES 59 -- APPENDICES 60 -- APPENDIX 1. CLASSIFICATION OF ECONOMIC STUDIES 60 -- APPENDIX 2. CHECKLIST FOR ASSESSING ECONOMIC EVALUATIONS 61 -- APPENDIX 3. DATA EXTRACTION SHEET FOR ECONOMIC EVALUATIONS 61 -- APPENDIX 4. TECHNICAL NOTES 62 -- APPENDIX 4.1. ASSESSMENT OF EXTERNAL VALIDITY 62 -- APPENDIX 4.2. OUTCOME VALUATION 63 -- APPENDIX 4.3. USE OF EXPERT PANELS 64 -- APPENDIX 4.4. HOSPITAL PER DIEM PRICES 64 -- APPENDIX 4.5. INDIRECT COMPARISONS 66 -- APPENDIX 5. THE COST-EFFECTIVENESS PLANE, COST-EFFECTIVENESS ACCEPTABILITY CURVE, AND EFFICIENCY FRONTIER 67 -- APPENDIX 6. LIST OF BELGIAN DATABASES FOR THE MEASUREMENT AND VALUATION OF RESOURCE USE 70 -- APPENDIX 7. FLEMISH EQ-5D INDEX VALUES 73 -- REFERENCES 7