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Budget impact projecties voor geneesmiddelen : Synthese
No full text39 p.ill.,Vandaag worden de toekomstige uitgaven voor geneesmiddelen vooral voorspeld op basis van uitgaven en trends uit het verleden. Dit volstaat echter niet om de impact van dure, opkomende geneesmiddelen, zoals cel- en gentherapieën, in te schatten. Om ze te identificeren en het systeem voor te bereiden op hun komst, moet de farmaceutische pijplijn systematisch worden gemonitord. Deze methode wordt ‘horizon scanning’ genoemd. Het RIZIV vroeg aan het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) om aanbevelingen te formuleren voor het beter voorspellen van de uitgaven voor geneesmiddelen, met onder andere een focus op horizon scanning.VOORWOORD 1 -- SYNTHESE . 2 -- INHOUDSTAFEL . 2 -- 1. INLEIDING 4 -- 1.1. ACHTERGROND . 4 -- 1.2. BRUTO VERSUS NETTO UITGAVEN . 4 -- 1.3. ACTUELE METHODES VOOR PROJECTIES VAN GENEESMIDDELENUITGAVEN 5 -- 1.4. HORIZON SCANNING VAN GENEESMIDDELEN - EEN ONTBREKEND ELEMENT IN PROJECTIES . 6 -- 2. ONDERZOEKSDOELSTELLINGEN . 7 -- 3. METHODE 7 -- 4. EXPLORATIEVE FASE – EVIDENCE REVIEW . 8 -- 5. CONCEPTFASE – ALGEMENE METHODE VOOR BUDGET IMPACT PROJECTIES 9 -- 6. RUWE PREDICTIES VAN GENEESMIDDELENUITGAVEN . 11 -- 6.1. METHODE . 11 -- 6.2. RESULTATEN . 11 -- 7. PROJECTIES GEBASEERD OP HORIZON SCANNING 13 -- 7.1. ACHTERGROND 13 -- 7.1.1. Internationale samenwerking voor horizon scanning 13 -- 7.1.2. Benchmarking van nationale horizon scanning systemen . 14 -- 7.2. AANBEVELINGEN VOOR NATIONALE HORIZON SCANNING IN BELGIË 17 -- 7.3. HORIZON SCANNING VOORSPELLINGEN VAN GENEESMIDDELENUITGAVEN: CASE STUDY BORSTKANKER 18 -- 7.3.1. Systemische behandeling van borstkanker 18 -- 7.3.2. Samenvatting van de methode 19 -- 7.3.3. Resultaten 19 -- 8. REFLECTIEFASE – INTERPRETATIE VAN RESULTATEN EN PRAKTISCHE IMPLICATIES 24 -- 8.1. HORIZON SCANNING VERSUS RUWE VOORSPELLINGEN, EEN VERGELIJKING 24 -- 8.2. INTERPRETATIE VAN RESULTATEN 26 -- 8.3. PRAKTISCHE IMPLICATIES 27 -- 8.3.1. Verankering van horizon scanning in het Belgische gezondheidszorgmanagement systeem . 27 -- 8.3.2. Data over geneesmiddelengebruik 28 -- 8.3.3. Verder onderzoek 28 -- AANBEVELINGEN 3
Needs Examination, Evaluation and Dissemination (NEED) : Identification of unmet health-related needs associated with malignant melanoma
No full text210 p.ill.,LIST OF FIGURES 5 -- LIST OF TABLES 6 -- LIST OF ABBREVIATIONS 8 -- SCIENTIFIC REPORT 10 -- 1 INTRODUCTION .10 -- 2 DISEASE DESCRIPTION 11 -- 2.1 EPIDEMIOLOGY .11 -- 2.2 PATHOPHYSIOLOGY 15 -- 2.3 MORTALITY 17 -- 2.4 DIAGNOSIS 18 -- 2.5 TREATMENT .19 -- 2.1.1 Targeted therapy 20 -- 2.1.2 Immune-based therapy .20 -- 2.1.3 Other therapies .21 -- 2.1.4 Follow-up 21 -- 3 METHODS 22 -- 3.1 ONLINE SURVEY 22 -- 3.1.1 Data collection tool 22 -- 3.1.2 Recruitment of participants .23 -- 3.1.3 Quantitative data collection process 24 -- 3.1.4 Quantitative data analysis 24 -- 3.2 INDIVIDUAL INTERVIEWS 25 -- 3.2.1 Selection of participants 25 -- 3.2.2 Qualitative data collection tool 26 -- 3.2.3 Qualitative data analysis 27 -- 3.3 LITERATURE REVIEW 27 -- 3.4 EXPERT OPINION .28 -- 4 RESULTS – UNMET PATIENTS NEEDS .29 -- 4.1 DESCRIPTION OF THE PARTICIPANTS .29 -- 4.1.1 Surveyed participants .29 -- 4.1.2 Interviewed participants 32 -- 4.2 UNMET HEALTH NEEDS 32 -- 4.1.1 Impact on general health-related quality of life .33 -- 4.2.2 Impact on physical health 36 -- 4.2.3 Impact on psychological health .41 -- 4.2.4 Impact on autonomy 47 -- 4.2.5 Impact on life expectancy 48 -- 4.2.6 Other unmet health needs 49 -- 4.3 UNMET HEALTHCARE NEEDS .49 -- 4.3.1 Effectiveness of treatment 49 -- 4.3.2 Burden of treatment 51 -- 4.3.3 Quality of care 59 -- 4.3.4 Accessibility of care .74 -- 4.4 UNMET SOCIAL NEEDS 76 -- 4.4.1 Impact on social life .76 -- 4.4.2 Impact on education 80 -- 4.4.3 Impact on work 80 -- 4.4.4 Financial consequences 82 -- 4.5 OTHER UNMET PATIENT NEEDS 84 -- 5 RESULTS – UNMET SOCIETAL NEEDS .85 -- 5.1 UNMET HEALTH NEEDS 85 -- 5.1.1 Frequency 85 -- 5.1.2 Transmissibility (contagiousness) 85 -- 5.1.3 Antimicrobial resistance 85 -- 5.1.4 Burden on informal caregivers 85 -- 5.2 UNMET HEALTHCARE NEEDS .85 -- 5.2.1 Value for money of standard care 85 -- 5.2.2 Preventability 86 -- 5.3 UNMET SOCIAL NEEDS 87 -- 5.3.1 Productivity losses 87 -- 5.3.2 Environmental impact of standard of care 87 -- 6 RESULTS – UNMET FUTURE NEEDS 88 -- 6.1 FUTURE HEALTH NEEDS 88 -- 6.1.1 Burden of disease 88 -- 6.2 FUTURE HEALTHCARE AND SOCIAL NEEDS 90 -- 6.2.1 Economic burden .90 -- 7 INEQUITIES 91 -- 8 DISCUSSION 92 -- 8.1 SUMMARY OF RESULTS .92 -- 8.2 LIMITATIONS 94 -- 8.2.1 Primary data collection 94 -- 8.2.2 Secondary data collection 94 -- 8.3 LESSONS LEARNED 95 -- 8.4 ADDED VALUE OF THE STUDY 97 -- 8.5 POTENTIAL SUGGESTIONS TO TACKLE UNMET NEEDS IN PATIENTS WITH MELANOMA 97 -- REFERENCES .99 -- APPENDICES 107 -- APPENDIX 1. SUMMARY TABLES 107 -- APPENDIX 2. ORIGINAL TESTIMONIALS 113 -- APPENDIX 3. SURVEYS .128 -- APPENDIX 4. INTERVIEW GUIDE .195 -- APPENDIX 5. QUALITATIVE ANALYSIS CODES 20
Recours aux tests pharmacogénétiques en Belgique : Synthèse
No full text43 p.ill.,Les tests pharmacogénétiques visent à déterminer comment l’ADN des patients peut influencer l’effet qu’aura, chez eux, un traitement pharmacologique donné. Grâce à cette information, il est possible d’affiner le choix du médicament ou de son dosage. À la demande de l’INAMI, le Centre Fédéral d’Expertise des Soins de Santé (KCE) s’est penché sur l’utilisation de ces tests dans notre pays. Conclusion ? Actuellement, les conditions préalables à l’utilisation efficace de la pharmacogénétique ne sont pas suffisamment réunies, et il n’existe pas toujours de consensus quant à l’utilité clinique de certains tests. Une approche plus harmonisée et scientifiquement étayée de l’utilisation de ces tests nécessite notamment un déploiement plus important de l’expertise en pharmacologie clinique, pour conseiller les médecins et leurs patients, et pour élaborer des directives nationales quant à l’utilisation des tests pharmacogénétiques.PRÉFACE 1 -- SYNTHÈSE 2 -- 1. INTRODUCTION 4 -- 1.1. QU’EST-CE QUE LA PHARMACOGÉNÉTIQUE ? 4 -- 1.2. POURQUOI CETTE ÉTUDE ? 4 -- 1.3. QUESTIONS DE RECHERCHE ET MÉTHODOLOGIE 4 -- 1.4. QUELQUES PRÉCISIONS SUR LE CHAMP D’APPLICATION DE CETTE ÉTUDE 5 -- 1.4.1. L’accent sur l’hérédité 5 -- 1.4.2. Alternative aux tests génétiques : les tests phénotypiques 6 -- 1.4.3. Du point de vue de l’assurance maladie obligatoire (INAMI) 6 -- 2. SITUATION ACTUELLE EN BELGIQUE 6 -- 2.1. UNE VINGTAINE D’INDICATIONS SUR LA LISTE DE L’INAMI 8 -- 2.2. LES TECHNOLOGIES UTILISÉES DANS LES LABORATOIRES BELGES 10 -- 2.3. LES VOLUMES D’ANALYSES PGX 12 -- 2.3.1. Dans les CGH et les laboratoires HLA 12 -- 2.3.2. Les tests PGx des panels oncologiques 14 -- 2.3.3. Que peut-on déduire des volumes de tests PGx au sujet de leur mise en application en Belgique ? 15 -- 2.4. LES DÉPENSES LIÉES AUX TESTS PGX EN BELGIQUE 15 -- 2.5. LE CONTRÔLE DE QUALITÉ DES LABORATOIRES 16 -- 3. DONNÉES PROBANTES EN MATIÈRE DE TESTS PGX 17 -- 3.1. NOTICES PHARMACEUTIQUES 17 -- 3.2. GUIDELINES 17 -- 3.3. DES NIVEAUX DE PREUVES DIFFÉRENTS 18 -- 3.4. FRÉQUENCE DES VARIANTS GÉNÉTIQUES DANS LA POPULATION ET AUTRES CRITÈRES 18 -- 3.5. DISCORDANCE ENTRE LES GUIDELINES CLINIQUES ET LES GUIDELINES PGX : L’EXEMPLE DU CLOPIDOGREL 18 -- 3.6. RÉSULTATS DE L’ÉTUDE PREPARE 19 -- 4. ASPECTS ÉCONOMIQUES 20 -- 4.1. RAPPORT COÛT-EFFICACITÉ DES TESTS PHARMACOGÉNÉTIQUES 20 -- 4.2. ANALYSES D’IMPACT BUDGÉTAIRE 20 -- 5. COMPARAISON INTERNATIONALE 22 -- 6. OPTIONS POSSIBLES POUR LA BELGIQUE 26 -- 6.1. LA PHARMACOGÉNÉTIQUE, UNE BRANCHE DE LA PHARMACOLOGIE CLINIQUE 26 -- 6.2. INTERPRÉTER LES DONNÉES SCIENTIFIQUES 26 -- 6.3. ACCÈS AUX TESTS PGX 26 -- 6.3.1. Améliorer les connaissances des prescripteurs 27 -- 6.3.2. Améliorer la logistique 28 -- 6.3.3. Remédier aux incohérences en matière de remboursement 28 -- 6.4. COLLECTER SYSTÉMATIQUEMENT DES DONNÉES 29 -- 6.5. VALIDER LES TECHNOLOGIES ET HARMONISER LE CONTRÔLE DE QUALITÉ 29 -- 6.6. CONSENTEMENT ÉCLAIRÉ DU PATIENT 30 -- 6.7. CONSERVER LES RÉSULTATS ET LES RÉUTILISER 30 -- RECOMMANDATIONS 3
Pharmacogenetic tests in Belgium
No full text232 p.ill.,LIST OF FIGURES 8 -- LIST OF TABLES 9 -- LIST OF ABBREVIATIONS 12 -- SCIENTIFIC REPORT 18 -- 1 BACKGROUND 18 -- 1.1 PHARMACOGENETIC TESTING IN THE CONTEXT OF PERSONALISED MEDICINE 18 -- 1.1.1 Which genetic information is tested? 19 -- 1.1.2 Clinical actionability of gene variants – genotype phenotype 22 -- 1.1.3 What’s in a name? 22 -- 1.2 SCOPE AND METHODOLOGY 26 -- 1.2.1 Rationale 26 -- 1.2.2 Aim and Scope 26 -- 1.2.3 Research questions and methodology 26 -- 2 BELGIAN SITUATION 28 -- 2.1 WHAT IS KNOWN AND WHAT REMAINS A MYSTERY? 28 -- 2.1.1 Is there a legal framework? 28 -- 2.1.2 The rules of financial accessibility are more stringent 29 -- 2.1.3 Scale of PGx remains unclear 30 -- 2.2 UNRAVELLING THE BELGIAN SITUATION 31 -- 2.2.1 Methodology 31 -- 2.2.2 The PGx targets on the RIZIV-INAMI limitative list 32 -- 2.2.3 Volume analysis 35 -- 2.2.4 Current RIZIV expenditure 40 -- 2.2.5 Uptake of PGx in Belgium 42 -- 3 TECHNOLOGIES FOR PHARMACOGENETIC TESTS 45 -- 3.1 METHODOLOGY 45 -- 3.2 TESTING TECHNIQUES 45 -- 3.2.1 PCR based techniques 46 -- 3.2.2 Sequencing 47 -- 3.2.3 Microarray 48 -- 3.3 TESTING APPROACHES 49 -- 3.3.1 Single gene testing 49 -- 3.3.2 Gene panel testing = multiple gene testing 50 -- 3.3.3 Whole genome/exome testing (= sequencing) 52 -- 3.4 COMPARISON TABLE OF THE AVAILABLE TECHNOLOGIES/PLATFORMS 52 -- 3.5 POINTS OF ATTENTION 57 -- 3.6 ALTERNATIVE METHODS TO GENOTYPING 57 -- 3.6.1 Assessing the enzymatic metabolic activity 58 -- 3.6.2 Therapeutic drug monitoring 59 -- 3.7 METHODS IN BELGIAN LABORATORIES 59 -- 3.8 QUALITY MONITORING OF BELGIAN LABORATORIES 61 -- 3.8.1 Legislative requirements - Certification/recognition 61 -- 3.8.2 Accreditation 61 -- 3.8.3 External quality assurance 62 -- 3.8.4 Regulation of in vitro Diagnostic: impact on quality 62 -- 4 EVIDENCE ON PHARMACOGENETIC TESTING 64 -- 4.1 SOURCES OF EVIDENCE AND THEIR METHODOLOGY 64 -- 4.1.1 Methodology 64 -- 4.1.2 Drug labels 65 -- 4.1.3 Guidelines 66 -- 4.1.4 Pharmacogenomics Knowledgebase - PharmGKB 71 -- 4.1.5 Comparison of testing recommendation in different resources 73 -- 4.2 CASE STUDIES ON AVAILABLE EVIDENCE ON THE INTERVENTION OF PHARMACOGENETIC TESTING 76 -- 4.2.1 A targeted PGx test for the effectiveness and safety of clopidogrel 76 -- 4.2.2 A semi-preemptive panel approach – the PREPARE study 81 -- 4.3 ONGOING RCTS 83 -- 5 EVIDENCE ON THE COST-EFFECTIVENESS OF PHARMACOGENETICS TESTING 85 -- 5.1 METHODS 85 -- 5.1.1 Search strategies 85 -- 5.1.2 Eligibility criteria 85 -- 5.1.3 Literature screening 85 -- 5.2 OVERVIEW OF THE ECONOMIC STUDIES INCLUDED 86 -- 5.3 REVIEW OF THE LITERATURE 89 -- 5.3.1 Economic evaluations of pharmacogenetic testing in multiple therapeutic area 89 -- 5.3.9 Preemptive versus reactive testing 109 -- 6 BUDGET IMPACT ANALYSES 111 -- 6.1 RESEARCH QUESTION 111 -- 6.2 METHODOLOGY 111 -- 6.3 RESULT 113 -- 6.3.1 Conservative approach 113 -- 6.3.2 Extended approach 113 -- 7 INTERNATIONAL COMPARISON OF PGX IMPLEMENTATION 118 -- 7.2 THE NETHERLANDS 118 -- 7.2.1 Who is entitled to prescribe and perform pharmacogenetic tests? 118 -- 7.2.2 Which tests are (recommended to be) performed for which drug-gene interactions? 119 -- 7.2.3 Communication 119 -- 7.2.4 How is pharmacogenetics funded & reimbursed? 120 -- 7.2.5 What are the remaining challenges for pharmacogenetics in the Netherlands? 121 -- 7.3 FRANCE 122 -- 7.3.1 Who is entitled to prescribe and perform pharmacogenetic tests? 122 -- 7.3.2 Which tests are (recommended to be) performed for which drug-gene interactions? 123 -- 7.3.3 Communication 125 -- 7.3.4 How is pharmacogenetics funded & reimbursed? 125 -- 7.3.5 What are the remaining challenges for pharmacogenetics? 128 -- 7.4 SWITZERLAND 128 -- 7.4.1 Who is entitled to prescribe and perform pharmacogenetic tests? 128 -- 7.4.2 Which tests are (recommended to be) performed for which drug-gene interactions? 129 -- 7.4.3 Communication 129 -- 7.4.4 How is pharmacogenetics funded & reimbursed? 130 -- 7.4.5 Phenotyping 131 -- 7.4.6 What are the remaining challenges for pharmacogenetics? 131 -- 7.5 THE UNITED KINGDOM (ENGLAND) 132 -- 7.5.1 Who is entitled to prescribe and perform pharmacogenetic tests? 132 -- 7.5.2 Which tests are (recommended to be) performed for which drug-gene interactions? 132 -- 7.5.3 Communication 135 -- 7.5.4 How is pharmacogenetics funded & reimbursed? 135 -- 7.5.5 What are the remaining challenges for pharmacogenetics? 135 -- 7.6 COMPARISON OF REIMBURSEMENT LISTS 138 -- 8 FINANCIAL ACCESS TO GENETIC TESTING IN BELGIUM 140 -- 8.1 ARTICLE 33BIS 140 -- 8.2 ARTICLE 33TER – “RIZIV INTERPRETATION OF CDX” 141 -- 8.3 NGS PANEL TESTING IN PILOT PROJECTS 145 -- 9 GENERAL DISCUSSION 146 -- 9.1 NEED FOR CLEAR DEFINITIONS 147 -- 9.2 EVIDENCE ON PGX, AND TESTING IN PARTICULAR 147 -- 9.2.1 Effectiveness 148 -- 9.2.2 Other criteria relevant to consider 149 -- 9.2.3 The drug label 149 -- 9.3 FROM EVIDENCE TO CLINICAL IMPLEMENTATION 149 -- 9.3.1 Clinical practice guidelines 149 -- 9.3.2 Alternatives available 150 -- 9.3.3 Logistical challenges 150 -- 9.3.4 Knowledge gap 151 -- 9.3.5 Funding gap 151 -- 9.3.6 Communication with the patient and between health care practitioners 152 -- 9.4 PANEL TESTING 153 -- 9.5 THE BELGIAN SITUATION 154 -- 9.5.1 Access to PGx 154 -- 9.5.2 A Belgian reimbursement list – limitative list 155 -- 9.5.3 Technologies – Quality assurance 155 -- 9.5.4 Reimbursed Fees 156 -- 9.5.5 Next steps 156 -- 9.6 LIMITATIONS 156 -- APPENDICES 157 -- APPENDIX 1. BELGIAN SITUATION 157 -- APPENDIX 1.1. INFORMATION ON THE LABORATORIA 157 -- APPENDIX 1.2. SURVEY 158 -- APPENDIX 2. TECHNIQUES AND METHODS FOR PHARMACOGENETIC TESTING 165 -- APPENDIX 3. EVIDENCE 169 -- APPENDIX 4. ECONOMIC LITERATURE 174 -- APPENDIX 4.1. SEARCH STRATEGY FOR THE ECONOMIC LITERATURE 174 -- APPENDIX 4.2. ECONOMIC EVALUATIONS COVERED IN THE REVIEWS 176 -- APPENDIX 4.3. REVIEWS OF ECONOMIC EVALUATIONS OF PGX TESTING TO GUIDE WARFARIN TREATMENT IN CARDIOVASCULAR DISEASES 185 -- APPENDIX 5. INTERNATIONAL COMPARISON 186 -- APPENDIX 5.1. INTERVIEW QUESTIONS AND CONSULTED EXPERTS 186 -- APPENDIX 5.2. THE NETHERLANDS 187 -- APPENDIX 5.3. FRANCE 189 -- APPENDIX 5.4. SWITZERLAND 190 -- APPENDIX 5.5. THE UNITED KINGDOM (ENGLAND) 192 -- APPENDIX 6. BELGIUM REIMBURSEMENT 193 -- APPENDIX 7. MEDICATION USERS 194 -- APPENDIX 7.1. INCIDENCE OF USERS PER ATC5 CODE 194 -- REFERENCES 20
Assessing and monitoring waiting times in healthcare: how to proceed in Belgium? : - Supplement
No full text229 p.ill.,1. APPENDIX I - SEARCH STRATEGIES (PROVISIONAL VERSION) 9 -- 1.1. COCHRANE 9 -- 1.2. EMBASE 10 -- 1.3. EMBASE 14 -- 1.4. MEDLINE 15 -- 2. APPENDIX II – OVERVIEW OF THE LITERATURE 17 -- 2.1. WAITING TIME ASSESSMENT TECHNICS 17 -- 2.2. IMPACT OF WAITING TIME ON HEALTH OUTCOMES 30 -- 2.2.1. Systematic reviews 30 -- 2.2.2. Primary studies 41 -- 2.3. IMPACT OF WAITING ON COSTS 89 -- 2.3.1. Systematic reviews 89 -- 2.3.2. Primary studies 91 -- 2.4. STRATEGIES TO REDUCE WAITING TIMES 95 -- 3. APPENDIX III – EXPERIENCES FROM CANADA (CA) 111 -- 3.1. HEALTH SYSTEM AT A GLANCE 111 -- 3.1.1. Health care organisation 111 -- 3.1.2. Healthcare resources in 2020 111 -- 3.1.3. Health status 112 -- 3.2. WAITING TIMES 112 -- 3.2.1. Organisational framework 112 -- 3.2.2. Purpose of waiting times data collection 113 -- 3.2.3. Application areas of waiting times assessment 113 -- 3.2.4. Definition of waiting times 114 -- 3.2.5. Waiting times data collection methods 114 -- 3.2.6. Waiting times data analysis 115 -- 3.2.7. Waiting times data publication 116 -- 3.2.8. Strategic commitments for waiting times 116 -- 3.2.9. Points of evaluation 116 -- 4. APPENDIX IV – EXPERIENCES FROM SPAIN (ES) 123 -- 4.1. HEALTH SYSTEM AT A GLANCE 123 -- 4.1.1. Healthcare organisation 123 -- 4.1.2. Healthcare resources 123 -- 4.1.3. Health status 123 -- 4.2. WAITING TIMES 124 -- 4.2.1. Legal framework 124 -- 4.2.2. Purpose of waiting times data collection 124 -- 4.2.3. Application areas of waiting times assessment 125 -- 4.2.4. Definition of waiting times 125 -- 4.2.5. Waiting times data collection methods 126 -- 4.2.6. Waiting times data analysis 127 -- 4.2.7. Waiting times data publication 129 -- 4.2.8. Targets for waiting times 131 -- 4.2.9. Points of evaluation 133 -- 5. APPENDIX V – EXPERIENCES FROM FINLAND (FI) 140 -- 5.1. HEALTH SYSTEM AT A GLANCE 140 -- 5.1.1. Healthcare organisation 140 -- 5.1.2. Healthcare resources 141 -- 5.1.3. Health status 141 -- 5.2. WAITING TIMES 142 -- 5.2.1. Legal framework 142 -- 5.2.2. Purpose of waiting times data collection 142 -- 5.2.3. Application areas of waiting times assessment 143 -- 5.2.4. Definition of waiting times 143 -- 5.2.5. Waiting times data collection methods 145 -- 5.2.6. Waiting times data analysis 145 -- 5.2.7. Waiting times data publication 146 -- 5.2.8. Targets for waiting times 147 -- 5.2.9. Points of evaluation 148 -- 6. APPENDIX VI – EXPERIENCES FROM THE NETHERLANDS (NL) 150 -- 6.1. HEALTH SYSTEM AT A GLANCE 150 -- 6.1.1. Healthcare organisation 150 -- 6.1.2. Healthcare resources 151 -- 6.1.3. Health status 151 -- 6.2. WAITING TIMES 151 -- 6.2.1. Legal framework 151 -- 6.2.2. Purpose of waiting times data collection 152 -- 6.2.3. Application areas of waiting times assessment 152 -- 6.2.4. Definition of waiting times 153 -- 6.2.5. Waiting times data collection methods 153 -- 6.2.6. Waiting times data analysis 153 -- 6.2.7. Waiting times data publication 153 -- 6.2.8. Targets for waiting times 154 -- 6.2.9. Points of evaluation 154 -- 6.2.10. Tables for the application areas of WT assessment 157 -- 7. APPENDIX VII – EXPERIENCES FROM SWEDEN (SE) 163 -- 7.1. HEALTH SYSTEM AT A GLANCE 163 -- 7.1.1. Healthcare organisation 163 -- 7.1.2. Healthcare resources 164 -- 7.1.3. Health status 164 -- 7.2. WAITING TIMES 164 -- 7.2.1. Legal framework 164 -- 7.2.2. Purpose of waiting times data collection 165 -- 7.2.3. Application areas of waiting times assessment 165 -- 7.2.4. Definition of waiting times 165 -- 7.2.5. Waiting times data collection methods 166 -- 7.2.6. Waiting times data analysis 167 -- 7.2.7. Waiting times data publication 168 -- 7.2.8. Targets for waiting times 169 -- 7.2.9. Points of evaluation 171 -- 8. APPENDIX VIII – EXPERIENCES FROM THE UNITED KINGDOM (UK) 173 -- 8.1. HEALTH SYSTEM AT A GLANCE 173 -- 8.1.1. Healthcare organisation 173 -- 8.1.2. Healthcare 174 -- 8.1.3. Health status 174 -- 8.2. WAITING TIMES IN THE NHS ENGLAND 175 -- 8.2.1. Legal framework 175 -- 8.2.2. Purpose of waiting times data collection 175 -- 8.2.3. Application areas of waiting times assessment 175 -- 8.2.4. Definition of waiting times 176 -- 8.2.5. Waiting times data collection methods 177 -- 8.2.6. Waiting times data analysis 178 -- 8.2.7. Waiting times data publication 178 -- 8.2.8. Waiting times standards 179 -- 8.3. WAITING TIMES IN THE NHS SCOTLAND 181 -- 8.3.1. Legal framework 181 -- 8.3.2. Purpose of waiting times data collection 181 -- 8.3.3. Application areas of waiting times assessment 181 -- 8.3.4. Definition of waiting times 182 -- 8.3.5. Waiting times data collection methods 183 -- 8.3.6. Waiting times data analysis 184 -- 8.3.7. Waiting times data publication 184 -- 8.3.8. Targets for waiting times 185 -- 8.4. WAITING TIMES IN THE NHS WALES 186 -- 8.4.1. Legal framework 186 -- 8.4.2. Purpose of waiting times data collection 186 -- 8.4.3. Application areas of waiting times assessment 186 -- 8.4.4. Definition of waiting times 187 -- 8.4.5. Waiting times data collection methods 187 -- 8.4.6. Waiting times analysis 188 -- 8.4.7. Waiting times data publication 188 -- 8.4.8. Targets for waiting times 188 -- 8.5. WAITING TIMES IN NORTHERN IRELAND 189 -- 8.5.1. Legal framework 189 -- 8.5.2. Purpose of waiting times data collection 189 -- 8.5.3. Application areas of waiting times assessment 189 -- 8.5.4. Definition of waiting times 190 -- 8.5.5. Waiting times data collection methods 191 -- 8.5.6. Waiting times data analysis191 -- 8.5.7. Waiting times data publication 191 -- 8.5.8. Targets for waiting times 192 -- 8.6. POINTS OF EVALUATION 193 -- 8.6.1. UK countries comparability 193 -- 8.6.2. Evolution over time 193 -- 8.6.3. Variation between regions within each UK country 196 -- 8.6.4. Data quality 196 -- 8.6.5. Limitations in the interpretation of waiting times 197 -- 8.6.6. Equity or not 19
Needs Examination, Evaluation and Dissemination (NEED) : assessment framework
No full text117 p.ill.,1 INTRODUCTION 9 -- 1.1 CHALLENGES IN THE CURRENT HEALTH INNOVATION ECOSYSTEM 10 -- 1.1.1 Consequences of a supply-driven health innovation ecosystem 11 -- 1.1.2 Are improvements in narrow outcome measures a good indicator for unmet needs? 12 -- 1.2 THE DESIRED HEALTH INNOVATION ECOSYSTEM: NEEDS-DRIVEN AND PROACTIVE 13 -- 1.2.1 National initiatives for moving towards a needs-driven early access to medicinal products 15 -- 1.2.2 International initiatives for moving towards a needs-driven system 16 -- 1.3 HOW WILL THE NEED PROJECT CONTRIBUTE TO A MORE NEEDS-DRIVEN HEALTHCARE POLICY AND INNOVATION SYSTEM? 18 -- 2 AIM AND RESEARCH QUESTIONS 20 -- 3 DEFINITION OF THE CONCEPTS 20 -- 3.1 DEFINITION OF NEEDS 20 -- 3.2 THE USE OF “UNMET MEDICAL NEEDS” (UMN) IN MEDICINAL PRODUCT DEVELOPMENT 21 -- 3.3 DEFINITION OF HEALTH-RELATED NEEDS IN THE CONTEXT OF THIS STUDY 21 -- 3.3.1 Terminology 21 -- 3.3.2 Perceived, unperceived, and clinically-validated needs 23 -- 3.4 UNMET NEEDS 23 -- 3.4.1 Intersection between need, demand and supply in health(care) 23 -- 3.4.2 Unmet needs from a burden of disease perspective 24 -- 4 DEVELOPMENT OF THE NEED ASSESSMENT FRAMEWORK 27 -- 4.1 BACKGROUND: FROM UNMET NEEDS IN THE CONTEXT OF DRUG REIMBURSEMENT TO UNMET NEEDS IN A WIDER CONTEXT 27 -- 4.1.1 Recommendations to policy makers about drug reimbursement criteria (KCE report 147) 27 -- 4.1.2 Development of a multi-criteria appraisal methodology to rank therapeutic and societal unmet needs for early temporary reimbursement decisions (KCE report 272) 27 -- 4.1.3 Development of a method to identify patient unmet needs (KCE report 348) 28 -- 4.2 METHODS TO DEVELOP THE NEED ASSESSMENT FRAMEWORK 30 -- 4.2.1 Identification of tools to measure health-related patient needs: update 30 -- 4.2.2 Identification of criteria to measure health-related societal needs 31 -- 4.2.3 Discussion of the NEED framework with the Minister of Health and Social Affairs, advisors from the Minister’s Cabinet, federal health agencies, and an academic expert 34 -- 4.3 RESULTS OF RESEARCH TO PREPARE THE DEVELOPMENT OF THE NEED ASSESSMENT FRAMEWORK 34 -- 4.3.1 Results from the literature review on tools to identify health-related patient needs 34 -- 4.3.2 Results from the systematic literature review on societal health-related needs criteria 36 -- 4.3.3 Results from the stakeholder consultations 38 -- 4.3.4 Results from the meetings with the Minister of Health and Social Affairs, advisors from the Minister’s Cabinet, federal health agencies and an academic expert 39 -- 5 THE NEED ASSESSMENT FRAMEWORK 39 -- 5.1 STRUCTURE OF THE NEED ASSESSMENT FRAMEWORK 39 -- 5.2 CRITERIA AND INDICATORS TO IDENTIFY HEALTH-RELATED NEEDS 40 -- 5.2.1 Primary data collection methods 53 -- 5.2.2 Secondary data collection methods 55 -- 5.3 APPLICATION OF THE NEED ASSESSMENT FRAMEWORK 61 -- 5.3.1 Testing the feasibility of the NEED framework: two case studies 61 -- 5.3.2 Moving from the NEED framework to an unmet needs database 61 -- 5.3.3 Usability of the NEED framework and database 61 -- 6 DISCUSSION 64 -- 6.1 SUMMARY OF THE RESULTS 65 -- 6.2 STRENGTHS AND LIMITATIONS OF THE STUDY 66 -- 6.3 FUTURE RESEARCH AND NEXT STEPS 69 -- 7 CONCLUSION 71 -- APPENDIX 1. SEARCH STRATEGY TO IDENTIFY TOOLS TO MEASURE PATIENT HEALTH-RELATED NEEDS 81 -- APPENDIX 1.1. SEARCH STRATEGY IN COCHRANE TO IDENTIFY TOOLS TO MEASURE PATIENT HEALTH-RELATED NEEDS 81 -- APPENDIX 1.2. SEARCH STRATEGY IN EMBASE® TO IDENTIFY TOOLS TO MEASURE PATIENT HEALTH-RELATED NEEDS 82 -- APPENDIX 1.3. SEARCH STRATEGY IN MEDLINE® TO IDENTIFY TOOLS TO MEASURE PATIENT HEALTH-RELATED NEEDS 83 -- APPENDIX 2. SEARCH STRATEGY TO IDENTIFY CRITERIA TO MEASURE SOCIETAL HEALTH-RELATED NEEDS 84 -- APPENDIX 2.1. SEARCH STRATEGY IN OVID MEDLINE® TO IDENTIFY CRITERIA TO MEASURE SOCIETAL HEALTH-RELATED NEEDS 84 -- APPENDIX 2.2. SEARCH STRATEGY IN EMBASE® TO IDENTIFY CRITERIA TO MEASURE SOCIETAL HEALTH-RELATED NEEDS 85 -- APPENDIX 3. MIXED METHODS APPRAISAL TOOL (MMAT) 86 -- APPENDIX 4. STAKEHOLDER GROUPS INVOLVED IN THE STAKEHOLDER CONSULTATIONS ON THE NEED ASSESSMENT FRAMEWORK 88 -- APPENDIX 5. DATA EXTRACTED FROM THE LITERATURE REVIEW UPDATE TO IDENTIFY TOOLS TO MEASURE PATIENT HEALTH-RELATED NEEDS 89 -- APPENDIX 6. LONG LIST OF CRITERIA EXTRACTED FROM THE 43 INCLUDED STUDIES 93 -- APPENDIX 7. RESULTS OF THE QUALITY APPRAISAL OF STUDIES INCLUDED IN THE LITERATURE REVIEW TO IDENTIFY CRITERIA TO MEASURE SOCIETAL HEALTH-RELATED NEEDS 104 -- APPENDIX 8. SOCIETAL NEEDS CRITERIA RETAINED FROM THE LONG LIST 107 -- APPENDIX 9. STAKEHOLDER GROUPS INVOLVED IN THE STAKEHOLDER CONSULTATION ON SOCIETAL NEEDS CRITERIA 108 -- APPENDIX 10. RESULTS OF STAKEHOLDERS’ FEEDBACK ON THE RELEVANCE AND ESSENTIALITY OF THE SELECTED SOCIETAL NEEDS CRITERIA 110 -- APPENDIX 11. MEASUREMENT METHODS AND DATA SOURCES FOR INDICATORS OF THE FRAMEWORK 112 -- APPENDIX 11.1. MEASUREMENT METHODS, DATA COLLECTION METHODS AND DATA SOURCES FOR INDICATORS ON PATIENT HEALTH-RELATED NEEDS 112 -- APPENDIX 11.2. MEASUREMENT METHODS AND DATA SOURCES FOR INDICATORS ON SOCIETAL AND FUTURE HEALTH-RELATED NEEDS 11
How can we improve endometriosis care in Belgium?
No full text271 p.ill.,LIST OF FIGURES 5 -- LIST OF TABLES 6 -- LIST OF ABBREVIATIONS 9 -- SCIENTIFIC REPORT 12 -- 1 INTRODUCTION .12 -- 1.1 ENDOMETRIOSIS, AN ENIGMATIC DISEASE .12 -- 1.2 ENDOMETRIOSIS, ON THE BELGIAN POLICY AGENDA AT LAST .13 -- 1.3 RESEARCH QUESTIONS AND OBJECTIVES 13 -- 1.4 TARGET AUDIENCE 14 -- 1.5 DISCLAIMER .14 -- 1.6 METHODOLOGY 14 -- 1.7 STRUCTURE OF THE REPORT 14 -- 2 BACKGROUND 15 -- 2.1 ENDOMETRIOSIS .15 -- 2.1.1 Introduction .15 -- 2.1.2 Origin, location and classification .17 -- 2.1.3 Symptoms 17 -- 2.1.4 Diagnosis .18 -- 2.1.5 Treatment .18 -- 2.1.6 Prevalence and incidence 19 -- 2.1.7 Burden of disease 20 -- 2.2 THE BELGIAN CONTEXT .21 -- 2.2.1 Introduction .21 -- 2.2.2 Rehabilitation conventions 23 -- 2.2.3 Care programmes 23 -- 2.2.4 Pain policy in Belgian hospitals .25 -- 2.2.5 Measures for citizens with a chronic condition .26 -- 2.2.6 Multidisciplinary team meetings (MDT) .27 -- 2.2.7 Registries .28 -- 2.2.8 Initiatives taken by patients’ associations and others on endometriosis .29 -- 3 PATIENT PERSPECTIVES ON ENDOMETRIOSIS .31 -- 3.1 INTRODUCTION .31 -- 3.2 METHODOLOGY 31 -- 3.2.1 Literature review 31 -- 3.2.2 The development of a conceptual framework 31 -- 3.2.3 The analysis of women’s testimonials 31 -- 3.3 FINDINGS 32 -- 3.3.1 Patients’ medical trajectory .32 -- 3.3.2 Biographical disruption of all life domains 37 -- 3.3.3 Quality of life 39 -- 3.3.4 Potential support resources 41 -- 3.4 FEEDBACK FROM PATIENTS’ ASSOCIATIONS .43 -- 4 ENDOMETRIOSIS CARE IN BELGIUM .44 -- 4.1 ENDOMETRIOSIS-RELATED HOSPITAL ADMISSIONS IN BELGIUM (2016-2020) 44 -- 4.1.1 Introduction .44 -- 4.1.2 Results at the national level 46 -- 4.1.3 Results at the hospital level 55 -- 4.2 HOW IS CARE FOR INDIVIDUALS WITH ENDOMETRIOSIS CURRENTLY ORGANISED IN THE BELGIAN HOSPITALS? 58 -- 4.2.1 Methods 58 -- 4.2.2 General information .59 -- 4.2.3 Hospitals with a self-reported endometriosis clinic .59 -- 4.2.4 Hospitals without an endometriosis clinic 63 -- 5 WHAT CAN WE LEARN FROM OTHER COUNTRIES? 67 -- 5.1 INTRODUCTION .67 -- 5.2 METHODOLOGY 67 -- 5.3 KEY ELEMENTS IN ENDOMETRIOSIS CARE 68 -- 5.4 ORGANISATION OF ENDOMETRIOSIS CARE 70 -- 5.4.1 Initiatives at the primary care level 70 -- 5.4.2 Initiatives at the specialty care level 71 -- 5.5 ENDOMETRIOSIS REGISTRY 78 -- 5.6 RECOGNITION OF ENDOMETRIOSIS AS A CHRONIC CONDITION .81 -- 5.7 OTHER ACQUIRED RIGHTS FOR PATIENTS WITH ENDOMETRIOSIS 82 -- 5.8 NATIONAL ACTION PLAN FOR ENDOMETRIOSIS 82 -- 5.9 TRAINING ON ENDOMETRIOSIS FOR HEALTH CARE PROFESSIONALS 82 -- 5.9.1 Initiatives for health care professionals of the primary care level 82 -- 5.9.2 Initiatives for health care professionals of the specialty care level .83 -- 5.10 INFORMATION FOR PATIENTS & THE GENERAL PUBLIC .83 -- 6 GUIDELINES & QUALITY INDICATORS ON ENDOMETRIOSIS 84 -- 6.1 GUIDELINES ON ENDOMETRIOSIS 84 -- 6.2 FROM QUALITY GOALS TO QUALITY MEASUREMENTS 85 -- 6.2.1 Introduction .85 -- 6.2.2 Data for quality measurement 86 -- 6.3 QUALITY INDICATORS ON ENDOMETRIOSIS 88 -- 6.3.1 Assessment of processes of care 88 -- 6.3.2 Assessment of the patient-centredness of care 89 -- 6.3.3 Assessment of outcomes of care .90 -- 7 DISCUSSION 92 -- REFERENCE LIST .95 -- APPENDICES 120 -- APPENDIX 1. BACKGROUND .120 -- APPENDIX 2. PATIENT PERSPECTIVES ON ENDOMETRIOSIS .130 -- APPENDIX 3. ENDOMETRIOSIS-RELATED HOSPITAL ADMISSIONS IN BELGIUM - ADDITIONAL RESULTS .135 -- APPENDIX 4. SURVEY IN THE BELGIAN HOSPITALS 151 -- APPENDIX 5. ORGANISATION OF ENDOMETRIOSIS CARE ABROAD 189 -- APPENDIX 6. GUIDELINES & QUALITY INDICATORS ON ENDOMETRIOSIS .26
Versnelde wetenschappelijke studies en publicatie (ESRO) door het KCE : Synthese
No full text28 p.ill.,1. ACHTERGROND 6 -- 1.1. EEN COMPLEXE PROCEDURE OM NAUWKEURIGHEID EN KWALITEIT TE GARANDEREN 6 -- 1.2. DE BEHOEFTE AAN EEN ‘FAST TRACK’ 6 -- 1.3. EEN GEBREK AAN SPECIFIEKE RICHTLIJNEN 6 -- 2. ALGEMEEN ESRO-KADER BIJ HET KCE 8 -- 2.1. ESRO 8 -- 2.2. BEOORDELEN VAN DRINGENDE ONDERZOEKSAANVRAGEN 8 -- 2.2.1. Beoordeling van de relevantie van de onderzoeksaanvraag 9 -- 2.2.2. Beoordeling van de urgentie van de aanvraag 10 -- 2.2.3. Totaalscore 11 -- 2.3. OPNEMEN VAN ESRO-METHODEN IN HET ONDERZOEKSPROTOCOL 11 -- 2.3.1. De scopingfase 12 -- 2.3.2. Protocol challenge fase 15 -- 2.4. MENSELIJKE MIDDELEN ONMIDDELLIJK BESCHIKBAAR HEBBEN VOOR AD-HOC AANVRAGEN 15 -- 2.5. WANNEER IS HET GEPAST OM HET RAADPLEGEN VAN EXPERTS EN STAKEHOLDERS IN TE KORTEN OF NIET TE HOUDEN? 16 -- 2.6. WANNEER IS HET GEPAST OM GEEN KLINISCHE OF BELEIDSAANBEVELINGEN TE FORMULEREN? 16 -- 2.7. VERSNELLEN VAN DE PEER REVIEW VAN DE WETENSCHAPPELIJKE RAPPORTEN 17 -- 2.8. VERSNELLEN VAN DE PEER REVIEW VAN DE SYNTHESES 18 -- 2.9. PUBLICATIE 18 -- 2.9.1. Synthese en vertaling 18 -- 2.9.2. Labelling van ESRO-rapporten 18 -- 2.10. GOEDKEURING DOOR DE RAAD VAN BESTUUR 19 -- 3. ESRO-CHECKLIST 19 -- 3.1. IS DE REIKWIJDTE VAN MIJN ONDERZOEKSPROJECT GOED GEDEFINIEERD? 19 -- 3.1.1. Wat zijn de werkelijke informatiebehoeften van de indieners? Wat zijn de belangrijkste aanbevelingen die nuttig zijn voor de besluitvorming (Sectie 3.2.2.1)? 19 -- 3.1.2. Wat is de mate van urgentie van de onderzoeksaanvraag? (Sectie 3.2.2.2) 19 -- 3.1.3. Welke gegevens en analyses zijn er minstens nodig om de verwachte aanbevelingen te ondersteunen of te ontkrachten (Sectie 3.3, Sectie 5.2, Sectie 6.3)? 19 -- 3.2. KAN IK MIJN LITERATUURSTUDIE VERSNELLEN DOOR: 20 -- 3.2.1. Het aantal databanken (Sectie 4.1) of tijdschriften (Sectie 4.2) te verminderen? 20 -- 3.2.2. De nauwkeurigheid van de zoekstrategie te optimaliseren (Sectie 4.3)? 20 -- 3.2.3. Niet te zoeken naar grijze literatuur (Sectie 4.4)? 20 -- 3.2.4. Eén enkele reviewer in te zetten voor gegevensextractie (Sectie 4.5), kwaliteitsbeoordeling van studies (Sectie 4.9) of beoordeling van de kwaliteit van bewijs (Sectie 4.10)? 20 -- 3.2.5. Te vertrouwen op surrogaat- of modelstudies (Sectie 4.6)? 20 -- 3.2.6. Te vertrouwen op tussentijdse resultaten (Sectie 4.7)? 21 -- 3.2.7. Zich te baseren op een gepubliceerde systematische review, met of zonder update (Sectie 4.8)? 21 -- 3.2.8. De kwaliteitsbeoordeling van studies in te korten of over te slaan (Sectie 4.9)? 21 -- 3.2.9. De kwaliteitsbeoordeling van wetenschappelijk bewijs in te korten of over te slaan (Sectie 4.10)? 22 -- 3.3. KAN IK MIJN INTERNATIONALE VERGELIJKING VERSNELLEN DOOR: 22 -- 3.3.1. De reikwijdte te beperken (Sectie 5.2)? 22 -- 3.3.2. Het aantal landen te beperken (Sectie 5.3)? 22 -- 3.3.3. De gegevensverzameling te optimaliseren (Sectie 5.4)? 22 -- 3.3.4. De gegevensextractie en -publicatie te optimaliseren (Sectie 5.5)? 22 -- 3.4. KAN IK MIJN KWALITATIEF ONDERZOEK VERSNELLEN DOOR: 22 -- 3.4.1. Secundaire analyses van bestaande literatuur en gegevens te gebruiken (Sectie 6.4)? 22 -- 3.4.2. Het verzamelen van primaire gegevens te vergemakkelijken (Secties 6.5.1 tot 6.5.10)? 22 -- 3.4.3. Het analyseproces te versnellen (Secties 6.6.1 tot en met 6.6.6)? 23 -- 3.5. KAN EEN DEEL VAN MIJN WERK WORDEN VERLICHT DOOR AUTOMATISERING? 2
Het recht om vergeten te worden: voorstellen voor diabetes type 1 : Synthese
No full text43 p.ill.,Weigeringen, premieverhogingen... een schuldsaldoverzekering afsluiten is niet altijd gemakkelijk als je een gezondheidsprobleem hebt. In 2019 voerde België het ‘recht om vergeten te worden’ in. Het maakt het gemakkelijker voor personen met bepaalde chronische aandoeningen of die genezen zijn van bepaalde kankers om dit soort verzekering af te sluiten, onder een aantal voorwaarden en na een bepaalde tijdsduur. Het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) kreeg de opdracht om de lijst van de betrokken ziekten regelmatig te herzien, in het licht van nieuwe kennis en de medische vooruitgang. Na een eerste studie over borstkanker, die tot gunstigere voorwaarden leidde voor bepaalde groepen patiënten in 2023, hebben de KCE-onderzoekers nu onderzocht of diabetes type 1 kan worden opgenomen in de lijst van aandoeningen.VOORWOORD 1 -- SYNTHESE 2 -- 1. DE OPDRACHT VAN HET KCE INZAKE HET 'RECHT OM VERGETEN TE WORDEN' 5 -- 1.1. CONTEXT 5 -- 1.2. KCE-OPDRACHT 6 -- 2. DOELSTELLINGEN VAN DE STUDIE 7 -- 2.1. WAAROM DIABETES TYPE 1? 7 -- 2.2. ONDERZOEKSVRAGEN 7 -- 2.3. METHODOLOGIE 9 -- 2.3.1. Deel 1 - Vraag 1 9 -- 2.3.2. Deel 2 - Vraag 2 9 -- 2.3.3. Gegevensbescherming 9 -- 3. DIABETES TYPE 1 10 -- 3.1. EEN ZIEKTE WAARVAN DE OORZAKEN NOG STEEDS NIET GOED WORDEN BEGREPEN 10 -- 3.2. EPIDEMIOLOGIE 11 -- 3.2.1. Prevalentie en incidentie 11 -- 3.2.2. Sterfte 11 -- 3.3. RISICO VOORAL DOOR COMPLICATIES 11 -- 3.4. PRINCIPES EN VOORUITZICHTEN VAN DE BEHANDELING 12 -- 3.5. KWALITEIT VAN DE DIABETESZORG IN BELGIË 13 -- 4. STUDIE VAN DE BELGISCHE BEVOLKING 14 -- 4.1. SELECTIE VAN DE PATIËNTEN 14 -- 4.2. AANPAK MET PERIODIEKE STERFTETABELLEN 16 -- 4.2.1. Relatieve en absolute risico's op oversterfte bij diabetes type 1 16 -- 4.2.2. Resterende levensverwachting en verloren levensjaren als gevolg van diabetes type 1 20 -- 4.3. PROSPECTIEVE STERFTETABELBENADERING 21 -- 4.4. WAT KUNNEN WE LEREN VAN DE GECOMBINEERDE ANALYSE VAN STERFTETABELLEN? 21 -- 5. LITERATUURSTUDIE EN META-ANALYSE 22 -- 5.1. SAMENVATTING VAN HET LITERATUURONDERZOEK EN DE META-ANALYSE 23 -- 5.2. VERGELIJKING VAN BELGISCHE RESULTATEN MET GEGEVENS UIT ANDERE LANDEN 24 -- 6. ACTUARIËLE ANALYSE 24 -- 6.1. ENQUETE ONDER VERZEKERAARS EN HERVERZEKERAARS 24 -- 6.2. PREMIEBEREKENING 25 -- 7. VOORSTELLEN VOOR HET REFERENTIEROOSTER 28 -- 7.1. MAATSCHAPPELIJKE CONTEXT VAN DIT VOORSTEL 32 --  AANBEVELINGEN 3
Budget impact projections for pharmaceuticals
No full text220 p.ill.,LIST OF FIGURES 5 -- LIST OF TABLES 8 -- LIST OF ABBREVIATIONS 9 -- SCIENTIFIC REPORT 13 -- 1 BACKGROUND 13 -- 1.1 PHARMACEUTICAL EXPENDITURE FORECAST: THE CHALLENGE 13 -- 1.2 GROSS VERSUS NET EXPENDITURE .14 -- 1.3 WHAT ARE THE CURRENT METHODS FOR THE PHARMACEUTICAL EXPENDITURE PROJECTIONS? .14 -- 1.4 HORIZON SCANNING OF MEDICINES – A MISSING ELEMENT IN PROJECTIONS 15 -- 2 PURPOSE AND SCOPE 16 -- 3 GENERAL METHOD 16 -- 4 EXPLORATIVE PHASE: EVIDENCE REVIEW 17 -- 4.1 OBJECTIVE AND RESEARCH QUESTIONS .17 -- 4.2 METHOD .17 -- 4.2.1 Inclusion criteria 17 -- 4.2.2 Search strategy .17 -- 4.2.3 Data extraction and synthesis method 18 -- 4.3 RESULTS 18 -- 4.3.1 Search and study selection .18 -- 4.3.2 Key characteristics of included studies .20 -- 4.3.3 Individual model description 25 -- 4.4 DISCUSSION 37 -- 5 CONCEPTUAL PHASE: DRAFT METHOD .39 -- 5.1 PHARMACEUTICAL EXPENDITURE PROJECTIONS – GENERAL APPROACH .39 -- 5.2 METHODS FOR THE PHARMACEUTICAL EXPENDITURE PROJECTIONS BASED ON HISTORICAL TREND ANALYSIS .42 -- 5.2.1 Scope .42 -- 5.2.2 Data sources 42 -- 5.2.3 Forecast targets 43 -- 5.2.4 Which statistical model(s) provide the best forecasts for the next year(s)? 44 -- 5.2.5 Which product aggregation level(s) provide the best forecasts for the next year(s)? 55 -- 5.2.6 Which time aggregation level(s) provide the best forecasts for the next year(s)? 57 -- 5.2.7 Which historical data window length provides the best forecasts for the next year(s)? 57 -- 5.2.8 Comparing models for crude predictions 58 -- 5.2.9 Conclusion 65 -- 5.3 METHODS FOR PHARMACEUTICAL EXPENDITURE PROJECTIONS BASED ON HORIZON SCANNING OF MEDICINES 65 -- 5.3.1 International collaboration on Horizon Scanning 65 -- 5.3.2 Benchmarking national horizon scanning systems 68 -- 5.3.3 Recommendations for national horizon scanning in Belgium 74 -- 5.3.4 Inclusion of drugs in the tracking list and prioritization for early budget impact estimation 77 -- 5.3.5 Estimation of the incremental budget impact of medicines based on horizon scanning 78 -- 5.3.6 Expert consultations 90 -- 5.3.7 Conclusion 91 -- 5.4 FORECAST UNCERTAINTIES AND VALIDATION METHODS 91 -- 5.4.1 Ex-post validation of Crude Predictions 91 -- 5.4.2 Ex-post validation of horizon scanning forecasts 95 -- 6 PILOTING PHASE: TESTING THE DRAFT METHODOLOGIES 95 -- 6.1 RESULTS OF THE CRUDE PREDICTIONS OF PHARMACEUTICAL EXPENDITURES 95 -- 6.1.1 Data available for predictions 95 -- 6.1.2 Expenditure forecast for drugs dispensed by public pharmacies 98 -- 6.1.3 Expenditures for drugs dispensed by hospital pharmacies 102 -- 6.1.4 Conclusions 105 -- 6.2 RESULTS OF THE HORIZON SCANNING PREDICTIONS OF PHARMACEUTICAL EXPENDITURES: BREAST CANCER CASE STUDY 107 -- 6.2.1 Method summary 107 -- 6.2.2 Systemic treatment of breast cancer 109 -- 6.2.3 Historical expenditure of medicines used in breast cancer 115 -- 6.2.4 New options for systemic treatment of breast cancer 120 -- 6.2.5 Breast cancer therapies in late-stage clinical development 121 -- 6.2.6 Impact analysis of new therapies for the treatment of breast cancer 124 -- 6.3 HORIZON SCANNING FORECAST VERSUS CRUDE PREDICTIONS: A COMPARISON 130 -- 6.3.1 Bringing the crude predictions and the horizon scanning forecasts at the same aggregation level 130 -- 6.3.2 Expenditure projections: case studies 131 -- 6.3.3 Discussion 141 -- 7 REFLECTION PHASE: DISCUSSION AND LESSONS LEARNT 142 -- 7.1 THE DISTINCT NATURE OF CRUDE PREDICTIONS AND THE HORIZON SCANNING FORECAST 142 -- 7.2 PHARMACEUTICAL EXPENDITURE PROJECTIONS – RECOMMENDATIONS AND RESOURCE ESTIMATION 143 -- 7.2.1 Crude predictions 143 -- 7.2.2 Horizon scanning 146 -- 7.3 FURTHER RESEARCH 153 -- APPENDICES 154 -- APPENDIX 1. SYSTEMATIC LITERATURE REVIEW 154 -- APPENDIX 1.1. SEARCH STRATEGY 154 -- APPENDIX 1.2. ARTICLES EXCLUDED AT FULL TEXT APPRAISAL WITH REASONS 159 -- APPENDIX 1.3. DATA EXTRACTION TOOL 161 -- APPENDIX 2. INTERNATIONAL HORIZON SCANNING INITIATIVE 166 -- APPENDIX 2.1. IHSI DATABASE 166 -- APPENDIX 2.2. IHSI - HIGH IMPACT REPORTS 169 -- APPENDIX 2.3. IHSI PROCESS 170 -- APPENDIX 3. BENCHMARKING NATIONAL HORIZON SCANNING SYSTEMS 171 -- APPENDIX 3.1. GENERAL DESCRIPTION OF THE SELECTED HORIZON SCANNING SYSTEMS 171 -- APPENDIX 3.2. DATA COLLECTION APPLIED BY SELECTED HORIZON SCANNING SYSTEMS 176 -- APPENDIX 3.3. METHODS TO BUDGET IMPACT CALCULATION APPLIED BY THE SELECTED HORIZON SCANNING SYSTEMS 180 -- APPENDIX 3.5. METHODS TO EXTERNAL EXPERT INVOLVEMENT APPLIED BY THE SELECTED HORIZON SCANNING SYSTEMS 185 -- APPENDIX 3.6. THE DUTCH “HORIZONSCAN” METHOD OF PATENT TRACKING 188 -- APPENDIX 4. HORIZON SCANNING: INDIVIDUAL DRUG PROFILE TEMPLATE 191 -- APPENDIX 5. DATA USED FOR CRUDE PREDICTIONS 194 -- APPENDIX 6. HORIZON SCANNING OF BREAST CANCER MEDICINES 196 -- APPENDIX 6.1. ESMO RECOMMENDATIONS FOR THE TREATMENT OF BREAST CANCER 196 -- APPENDIX 6.2. ANNUAL GROSS NIHDI COSTS OF TARGETED THERAPIES USED IN BREAST CANCER TREATMENT (2013-2020)* 201 -- APPENDIX 6.3. PIVOTAL PHASE 3 TRIALS OF BREAST CANCER MEDICINES WITH ESTIMATED COMPLETION IN 2023-2024 20