Cost-effectiveness of cardiac resynchronisation therapy for patients with moderate-to-severe heart failure: a lifetime Markov model

1-7Objective To assess the cost-effectiveness of cardiac resynchronisation therapy (CRT) both with CRT-P (biventricular pacemaker only) and with CRT-D (biventricular pacemaker with defibrillator) in patients with New York Heart Association (NYHA) functional class III/IV from a Belgian healthcare-payer perspective. Methods A lifetime Markov model was designed to calculate the cost–utility of both interventions. In the reference case, the treatment effect was based on the Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure trial. Costs were based on real-world data. Pharmacoeconomic guidelines were applied, including probabilistic modelling and sensitivity analyses. Results Compared with optimal medical treatment, on average 1.31 quality-adjusted life-years (QALY) are gained with CRT-P at an additional cost of €14 700, resulting in an incremental cost-effectiveness ratio (ICER) of about €11 200/QALY. As compared with CRT-P, CRT-D treatment adds on average an additional 0.55 QALYs at an extra cost of €30 900 resulting in an ICER of €57 000/QALY. This result was very sensitive to the incremental clinical benefit of the defibrillator function on top of CRT. Conclusions Based on efficiency arguments, CRT-P can be recommended for NYHA class III and IV patients if there is a willingness to pay more than €11 000/QALY. Even though CRT-D may offer a survival benefit over CRT-P, the incremental clinical benefit appears to be too marginal to warrant a threefold-higher device price for CRT-D. Further clinical research should focus on the added value of CRT-D over CRT-P

Rapid assessment van enkele nieuwe behandelingen voor prostaatkanker en goedaardige prostaathypertrofie

vi, 72 p.ill

Health system targets : – background material - Supplement

73 p.ill.,1 SUGGESTIONS FOR STRUCTURED HEALTH SYSTEM TARGETS 5 -- 1.1 TIME HORIZON FOR THE STRUCTURED TARGETS 5 -- 1.2 SELECTED METHOD FOR TARGET SUGGESTIONS IN THIS PROJECT 5 -- 1.3 HEALTH STATUS 7 -- 1.4 EQUITY AND INEQUALITIES 8 -- 1.5 ACCESSIBILITY 8 -- 1.6 QUALITY-OF-CARE: EFFECTIVENESS OF CARE 8 -- 1.7 QUALITY-OF-CARE: APPRO PRIATENESS OF CARE 9 -- 1.8 QUALITY-OF-CARE: SAFETY OF CARE 9 -- 1.9 QUALITY-OF-CARE: CONTINUITY OF CARE 10 -- 1.10 QUALITY-OF-CARE: PATIENT CENTEREDNESS OF CARE 10 -- 1.11 EFFICIENCY OF HEALTHCARE SYSTEM 11 -- 1.12 SUSTAINABILITY 11 -- 1.13 PREVENTIVE CARE 11 -- 1.14 MENTAL HEALTHCARE 12 -- 1.15 LONG-TERM CARE FOR THE ELDERLY 13 -- 1.16 CARE AT THE END-OF-LIFE 13 -- 1.17 HEALTH PROMOTION AND LIFESTYLES 13 -- 2 INVENTORY OF MAIN SUPRANATIONAL TARGETS, BY SOURCE 14 -- 2.1 OVERVIEW OF SUPRANATIONAL TARGETS BY SOURCE 14 -- 2.1.1 9 Global targets for NCDs – 2025 by the World Health Organization 15 -- 2.1.2 Sustainable Development Goals – 2030 by the United Nations 16 -- 2.1.3 A European policy framework and strategy for the 21st century – Health 2020 by the World Health Organization regional office for Europe 17 -- 2.1.4 The Third Health Programme (2014-2020) of the European Union 19 -- 3 INVENTORY OF QUANTIFIED TARGETS SET IN BELGIUM, BY SOURCE 20 -- 3.1 STRATEGIC FEDERAL LONG TERM VISION FOR SUSTAINABLE DEVELOPMENT 20 -- 3.2 RECENT FEDERAL MINISTERIAL ACTION PLANS AND COVENANTS 21 -- 3.2.1 Anti-tobacco plan of the federal government 21 -- 3.2.2 Covenant of Minister of Health with food industry 21 -- 3.3 RECENT INTERMINISTERIAL ACTION PLANS 22 -- 3.3.1 Protocol agreement on measles and rubella 22 -- 3.4 BABCOC (FOD VVVL) 22 -- 3.5 RIZIV – INAMI 22 -- 3.5.1 NRKP – CNPQ Feedback on prescriptions in first line (2015) 22 -- 3.5.2 Medical imaging 23 -- 3.5.3 Cheap medicines 23 -- 3.5.4 Haemodialysis 24 -- 3.5.5 Breast reconstruction 24 -- 3.5.6 Action plan e-health -- 24 -- 3.5.7 Dental care 24 -- 3.5.8 Medicomut measures with targeted budgetary impact 24 -- 3.6 WIV – ISP 25 -- 3.7 HGR-CSS 26 -- 3.8 KCE 27 -- 3.9 VLAAMS INDICATORENPROJECT VOOR PATIËNTEN EN PROFESSIONALS (VIP²) 28 -- 3.10 MINISTER OF HEALTH FLANDERS 30 -- 4 EXAMPLES ABROAD AND INLAND 30 -- 4.1 US HEALTHY PEOPLE 2020 30 -- 4.2 FRANCE 32 -- 4.2.1 “100 Objectifs de Santé” 32 -- 4.2.2 “Multiyear contracts for targets and resources” between ARS and hospitals 39 -- 4.3 GERMANY. 39 -- 4.4 AUSTRIA 42 -- 4.5 NEW ZEALAND 46 -- 4.6 FLANDERS 47 -- 4.7 THE NETHERLANDS 49 -- 4.7.1 Targets on e-health 49 -- 4.7.2 Targets on depression 49 -- 4.8 ENGLAND 50 -- 5 BREAST CANCER CARE TARGETS 61 -- 6 CANCER SCREENING RECOMMENDATIONS BY EC 6

Optimalisation des forfaits pour incontinence : Synthèse

34 p.ill.,Dans notre pays, les personnes souffrant d’incontinence peuvent recevoir un forfait annuel de l’INAMI si elles satisfont à certaines conditions. Le Centre fédéral d’Expertise des Soins de santé (KCE) a été chargé d’analyser les modalités d’attribution de ces forfaits afin de mieux les adapter aux besoins et d’optimaliser leur accessibilité. En 2016, environ 108 000 personnes ont bénéficié de l’un ou l’autre de ces forfaits (sur une estimation de 400 000 personnes souffrant d’incontinence à des degrés divers). Toutes les personnes souffrant d’incontinence n’y ont pas droit mais il est nécessaire de mieux préciser leurs critères d’accès. Toutefois, les professionnels interrogés dans le cadre de cette étude ont aussi souligné que les forfaits poussent certaines personnes à acheter des langes plutôt qu’à s’engager dans une démarche active de traitement. Il existe en effet diverses mesures de prévention et de traitement relativement efficaces pour la plupart des formes d’incontinence. Le KCE préconise de mieux informer les patients et les professionnels de la santé au sujet des traitements existants et d’encourager leur utilisation – dans la mesure du possible – avant de se résigner à porter des protections absorbantes.1. INTRODUCTION 5 -- 2. QU’EST-CE QUE L’INCONTINENCE ET COMMENT EST-ELLE PRISE EN CHARGE ? 6 -- 2.1. LES DIFFÉRENTES FORMES D’INCONTINENCE 6 -- 2.1.1. Incontinences urinaires non neurologiques 6 -- 2.2. PRISE EN CHARGE DE L'INCONTINENCE URINAIRE NON NEUROLOGIQUE 7 -- 2.2.1. Chez l’adulte (hors personnes âgées) 7 -- 2.2.2. Chez la personne âgée et/ou atteinte de démence 11 -- 2.2.3. Chez l’enfant 12 -- 2.3. PRISE EN CHARGE DE L’INCONTINENCE URINAIRE D’ORIGINE NEUROLOGIQUE 12 -- 2.4. PRISE EN CHARGE DE L’INCONTINENCE FÉCALE 13 -- 2.4.1. Chez l’adulte (hors personnes âgées) 13 -- 2.4.2. Chez la personne âgée et/ou atteinte de démence 13 -- 3. LA SITUATION EN BELGIQUE 13 -- 3.1. PRÉVALENCE 14 -- 3.2. QUEL MATÉRIEL D’INCONTINENCE L’INAMI REMBOURSE-T-IL ? 15 -- 3.3. FORFAITS INAMI POUR INCONTINENCE. 16 -- 3.3.1. Conditions pour bénéficier d’un forfait 18 -- 3.3.2. Caractéristiques des personnes bénéficiant de forfaits pour incontinence 19 -- 3.4. REMBOURSEMENTS ET INTERVENTIONS FINANCIÈRES POUR DES TRAITEMENTS (INAMI) 20 -- 3.4.1. Remboursement de séances de kinésithérapie de rééducation périnéale 20 -- 3.4.2. Remboursement de consultation infirmière 20 -- 3.4.3. Remboursement des prises en charge multidisciplinaires (centres de périnéologie) 20 -- 3.4.4. Remboursement des médicaments pour l’incontinence .20 -- 3.4.5. Remboursement de la chirurgie 20 -- 3.5. INTERVENTIONS DES ENTITÉS FÉDÉRÉES 21 -- 3.6. AUTRES COMPENSATIONS 21 -- 3.7. BESOINS NON RENCONTRÉS 21 -- 4. PISTES POUR L’AMÉLIORATION DU SYSTÈME DE FORFAITS21 -- 4.1. LE PRINCIPE DU FORFAIT DOIT-IL ÊTRE REMIS EN QUESTION ? 22 -- 4.2. LES FORFAITS SONT-ILS ACCESSIBLES ? 22 -- 4.2.1. Pistes d’amélioration 23 -- 4.3. LA FORMULE À DEUX FORFAITS COUVRE-T-ELLE SUFFISAMMENT LES DIFFÉRENTS FRAIS DES PATIENTS ? 23 -- 4.3.1. Pistes d’amélioration 24 -- 4.4. GRAND FORFAIT : L’ÉCHELLE DE KATZ POURRAIT-ELLE ÊTRE REMPLACÉE PAR L’INSTRUMENT BELRAI ? 25 -- 4.4.1. Piste d'amélioration 26 -- 4.5. PETIT FORFAIT : LE CONDITIONNER À L’INITIATION D’UN TRAITEMENT ?.26 -- 4.5.1. Piste d’amélioration 27 -- 4.6. LES COMPÉTENCES DES DIFFÉRENTES PROFESSIONS CONCERNÉES POURRAIENT-ELLES ÊTRE MIEUX UTILISÉES ? 27 -- 4.6.1. Pistes d’amélioration 28 -- 4.7. LES FORFAITS INCITENT-ILS SUFFISAMMENT À L’INITIATION D’UNE DÉMARCHE DE SOINS? 29 -- 4.7.1. Pistes d’amélioration 29 -- 4.8. LES PERSONNES CONCERNÉES REÇOIVENT-ELLES DES INFORMATIONS NEUTRES ET CORRECTES SUR LE MATÉRIEL D’INCONTINENCE?. 30 -- 4.8.1. Pistes d’amélioration 30 -- 4.9. AMÉLIORATIONS POSSIBLES AU NIVEAU DES CENTRES MULTIDISCIPLINAIRES 31 -- 4.9.1. Pistes d’amélioration 31 -- 4.10. AMÉLIORATIONS POSSIBLES AU NIVEAU DES RÉPARTITIONS DE COMPÉTENCE

Evaluation des certains nouveaux traitements du cancer de la prostate et de l’hypertrophie bénigne de la prostate

vi, 72 p.ill

Optimisation of RIZIV – INAMI lump sums for incontinence

231 p.ill.,LIST OF FIGURES 8 -- LIST OF TABLES 10 -- LIST OF ABBREVIATIONS 13 -- SCIENTIFIC REPORT 16 -- 1 GENERAL INTRODUCTION 16 -- 1.1 AIM OF THE STUDY 16 -- 1.2 SCOPE 17 -- 1.3 REPORT OUTLINE17 -- 2 INCONTINENCE: PATIENTS, DIAGNOSIS AND TREATMENTS 18 -- 2.1 INTRODUCTION 18 -- 2.1.1 Chapter outline 18 -- 2.1.2 Methods 18 -- 2.1.3 PICO 18 -- 2.1.4 Medline search 19 -- 2.1.5 Cochrane search 19 -- 2.1.6 Embase search .20 -- 2.1.7 Grey literature search and websites incontinence societies 20 -- 2.1.8 Results from search: retrieved reviews and guidelines 20 -- 2.2 DEFINITION INCONTINENCE.21 -- 2.2.1 Urinary incontinence in children and adolescents 21 -- 2.2.2 Urinary incontinence in women and men.22 -- 2.2.3 Faecal incontinence 22 -- 2.3 CAUSES OF INCONTINENCE 23 -- 2.3.1 Neurological causes23 -- 2.3.2 Non-Neurological causes.23 -- 2.4 MANAGEMENT OF URINARY INCONTINENCE IN HEALTHY ADULTS 25 -- 2.4.1 Conservative treatment.29 -- 2.4.2 Pharmacological treatment .32 -- 2.4.3 Surgical management 34 -- 2.4.4 Cure rates 38 -- 2.4.5 Initial evaluation and management .40 -- 2.4.6 Care pathway for the management of urine incontinence in men 41 -- 2.4.7 Care pathway for the management of urine incontinence in women 45 -- 2.5 MANAGEMENT OF URINARY INCONTINENCE IN THE FRAIL ELDERLY AND THE COGNITIVELY IMPAIRED 49 -- 2.5.1 Conservative options 49 -- 2.5.2 Pharmacological treatment .50 -- 2.5.3 Surgical treatment in the frail older person .52 -- 2.6 MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN 56 -- 2.6.1 Initial assessment.56 -- 2.6.2 Initial management 57 -- 2.6.3 Specialised management.59 -- 2.7 MANAGEMENT OF FAECAL INCONTINENCE.62 -- 2.7.1 Initial clinical assessment.62 -- 2.7.2 Specialised management (primary or secondary care) 66 -- 2.7.3 Surgery for faecal incontinence 66 -- 2.7.4 Care pathway for the management of faecal incontinence in frail older women and men.69 -- 2.8 MANAGEMENT OF NEUROLOGICAL INCONTINENCE 72 -- 2.8.1 Management of neurogenic urinary incontinence72 -- 2.8.2 Management of faecal incontinence in neurological patients 76 -- 3 REIMBURSEMENT FOR INCONTINENCE IN BELGIUM 81 -- 3.1 OVERVIEW OF RIZIV – INAMI REIMBURSEMENT/PAYMENTS FOR PATIENTS WITH INCONTINENCE .81 -- 3.1.1 Reimbursement of physiotherapy sessions for pelvic re-education 81 -- 3.1.2 Reimbursement of continence nurse consultation 82 -- 3.1.3 Reimbursement of medication for incontinence 82 -- 3.1.4 Reimbursement of technical medical interventions, implants and other invasive medical devices 85 -- 3.1.5 Reimbursement/payments for incontinence materials 85 -- 3.2 REIMBURSEMENT/PAYMENTS BY FEDERATED INSTANCES – FOR PERSONS WITH A HANDICAP.96 -- 3.2.1 VAPH – Flemish community 96 -- 3.2.2 AWIPH – AVIQ-Handicap – French Community 99 -- 3.2.3 PHARE (Personne Handicapée Autonomie Recherchée) 101 -- 3.2.4 German Community 101 -- 3.3 FINANCIAL INTERVENTIONS BY COMPLEMENTARY INSURANCE OF SICKNESS FUNDS 101 -- 3.4 OTHER COMPENSATIONS 101 -- 4 INCONTINENCE IN BELGIUM: DATA OVERVIEW.102 -- 4.1 INTRODUCTION 102 -- 4.2 METHODS 102 -- 4.2.1 MZG-RHM 2014: hospitalisations for incontinence 102 -- 4.2.2 EPS 2008-2015: sample of health insurance reimbursements and population data 104 -- 4.2.3 RIZIV – INAMI data: numbers and amounts reimbursed for incontinence (lump sums, therapeutic interventions, implants or drugs) 106 -- 4.3 DATA ON DIAGNOSIS AND TREATMENT 106 -- 4.3.1 MZG-RHM 2014: hospitalisations for incontinence 106 -- 4.3.2 EPS 2008-2015: sample of health insurance reimbursements and population data 112 -- 4.3.3 RIZIV – INAMI data: numbers and amounts reimbursed for incontinence (lump sums, therapeutic interventions, implants or drugs) 120 -- 4.4 ESTIMATING THE NUMBER OF PEOPLE WITH UNTREATED INCONTINENCE 130 -- 5 INTERNATIONAL PERSPECTIVE 131 -- 5.1 INTRODUCTION 131 -- 5.2 METHODS 131 -- 5.3 SELECTION OF COUNTRIES 131 -- 5.4 CROSS-COUNTRY ANALYSIS 132 -- 5.4.1 Absorbent materials: included or excluded from the health benefit basket 132 -- 5.4.2 Absorbent materials: eligible indications and age groups 134 -- 5.4.3 Reimbursement method 140 -- 5.4.4 Strengths and weaknesses of different reimbursement methods 144 -- 5.4.5 Patient classification and reimbursement amounts 145 -- 5.4.6 Involved professionals for assessing incontinence 151 -- 6 COST OF ABSORBENT MATERIALS 154 -- 6.1 INTRODUCTION 154 -- 6.2 UROBEL COST ESTIMATES 154 -- 6.3 VAPH DATA 155 -- 6.4 DATA ESTIMATES FROM DUTCH COLLEGE VOOR ZORGVERZEKERINGEN 159 -- 7 BELRAI 159 -- 7.1 INTRODUCTION 159 -- 7.2 BELRAI ITEMS ON (IN)CONTINENCE 160 -- 7.3 CLINICAL ASSESSMENT PROTOCOLS (CAPS) 161 -- 7.3.1 CAP for urinary incontinence 161 -- 7.3.2 CAP for bowel conditions 163 -- 7.4 ASSESSMENT OF THE POSSIBLE USE OF BELRAI FOR THE INCONTINENCE LUMP SUMS 164 -- 7.4.1 Sensitivity of the BelRAI scale for incontinence 164 -- 7.4.2 For which patients can the BelRAI be filled out? 165 -- 7.4.3 Who fills out the BelRAI? 165 -- 8 POLICY ANALYSIS: ASSESSMENT OF THE CURRENT SITUATION AND PROPOSALS FOR IMPROVEMENT 166 -- 8.1 INTRODUCTION 166 -- 8.2 METHODS 166 -- 8.3 REIMBURSEMENT METHOD: LUMP SUM VERSUS REIMBURSEMENT PER ITEM 167 -- 8.3.1 Assessment of the current situation 167 -- 8.4 ACCESS TO THE INCONTINENCE LUMP SUMS 167 -- 8.4.1 Evaluation of the current situation 167 -- 8.4.2 Proposals for improvement 168 -- 8.5 ELIGIBLE INDICATIONS 168 -- 8.5.1 Assessment of the current situation 168 -- 8.5.2 Proposals for improvement 171 -- 8.6 PATIENT CATEGORISATION 172 -- 8.6.1 Assessment of the current situation 172 -- 8.6.2 Possible typologies of patients 175 -- 8.6.3 Proposals for improvement 177 -- 8.7 THE VALIDITY PERIOD OF THE LUMP SUMS 178 -- 8.7.1 Assessment of the current situation 178 -- 8.7.2 Proposals for improvement 178 -- 8.8 ACCESS TO DIAGNOSIS, TREATMENT AND TOILETING AIDS 178 -- 8.8.1 Assessment of the current situation 178 -- 8.8.2 Proposals for improvement 180 -- 8.9 OPTIMISING THE PATHWAYS TO THE LUMP SUMS 182 -- 8.9.1 Assessment of the current situation 182 -- 8.9.2 Proposals for improvement 182 -- 8.10 FINANCIAL ACCESSIBILITY OF TREATMENTS AND SUPPORT AIDS 183 -- 8.10.1 Assessment of the current situation 183 -- 8.10.2 Proposals for improvement 184 -- 8.11 PATIENT INFORMATION ON SUPPORT AIDS 184 -- 8.11.1 Assessment of the current situation 184 -- 8.11.2 Proposals for improvement 184 -- 8.12 PATIENT AWARENESS AND HEALTH LITERACY 185 -- 8.12.1 Appraisal of the current situation 185 -- 8.12.2 Proposals for improvement 185 -- 8.13 FOCUS ON THE SETTING: NURSES 185 -- 8.13.1 Appraisal of the current situation 185 -- 8.13.2 Proposals for improvement 185 -- 8.14 FOCUS ON THE SETTING: PHYSIOTHERAPISTS 186 -- 8.14.1 Appraisal of the current situation 186 -- 8.14.2 Proposals for improvement 186 -- 8.15 FOCUS ON THE SETTING: CONTINENCE CLINICS 187 -- 8.15.1 Appraisal of the current situation 187 -- 8.15.2 Proposals for improvement 188 -- 8.16 INTERVENTION BY THE FEDERAL AND FEDERATED LEVELS 188 -- 8.16.1 Appraisal of the current situation 188 -- 8.16.2 Proposals for improvement 188 --  APPENDIX TO CHAPTER 2 189 -- APPENDIX 1. SELECTION OF REFERENCES 189 -- APPENDIX 1.1. MEDLINE AND COCHRANE.189 -- APPENDIX 1.2. EMBASE 191 -- APPENDIX 2. SELECTION GUIDELINE – AGREE ICS 2017 194 -- APPENDIX 3. INCONTINENCE IMPACT QUESTIONNAIRES: IIQ7 AND IIQ LONG VERSION 196 --  APPENDIX TO CHAPTER 3 199 -- APPENDIX 1. HOME NURSE FORM WITH KATZ SCALE 199 -- APPENDIX 2. REQUEST FORM FOR “SMALL LUMP SUM” FOR INCONTINENCE 200 --  APPENDIX TO CHAPTER 4 201 -- APPENDIX 1. NUMBER AND TYPE OF ADMISSIONS, AGE AND SEX PER APR-DRG (2014) 201 -- APPENDIX 2. TEN MOST FREQUENT PROCEDURE PERFORMED PER MDC (2014)202 -- APPENDIX 3. SELECTION CRITERIA TO EXTRACT EPS DATA 2008-2015 .204 -- APPENDIX 4. VARIABLES DERIVED FROM EPS VARIABLES (2015) 214 -- APPENDIX 5. VOLUME (DDD), REIMBURSEMENTS (€) AND NUMBER OF PATIENTS FOR URINARY FREQUENCY AND INCONTINENCE DRUGS (RIZIV – INAMI 2008-2017) 223 -- APPENDIX 6. – NUMBER OF IMPLANTS AND REIMBURSEMENTS FOR INCONTINENCE (DOC N 2016) 225 -- REFERENCES 22

Remboursement des appareils et implants auditifs : Synthèse

26 p.ill.,Notre assurance maladie (INAMI) veille à ce que chaque personne atteinte de perte auditive puisse avoir accès au remboursement (parfois partiel) d’un appareil auditif. Mais la question qui se pose aujourd’hui est de savoir si les appareils de plus en plus sophistiqués qui apparaissent sur le marché présentent une réelle valeur ajoutée par rapport aux appareils de base déjà remboursés. L’INAMI a donc demandé au Centre fédéral d'Expertise des Soins de santé (KCE) de mener une recherche sur l’efficacité de certains implants auditifs et sur l’éventuelle nécessité d’élargir leur remboursement. Son constat est que l’on ne dispose pas de suffisamment de preuves scientifiques solides pour soutenir un élargissement des critères de remboursement actuels.1. INTRODUCTION 4 -- 1.1. CONTEXTE DE CETTE ÉTUDE 4 -- 1.2. MÉTHODOLOGIE ET QUESTIONS DE RECHERCHE 4 -- 2. QUELQUES NOTIONS SUR LES PERTES AUDITIVES ET LEURS TRAITEMENTS 5 -- 2.1. LE CHEMIN DU SON 5 -- 2.2. LES DIFFÉRENTS TYPES DE PERTES AUDITIVES 6 -- 2.2.1. En fonction des seuils d’audition 6 -- 2.2.2. En fonction des parties de l’oreille qui sont déficientes 6 -- 2.2.3. En fonction du stade d’acquisition du langage parlé 6 -- 2.2.4. En fonction des causes 7 -- 3. LES DISPOSITIFS À CONDUCTION OSSEUSE 7 -- 3.1. DESCRIPTION 7 -- 3.2. CRITÈRES ACTUELS DE REMBOURSEMENT EN BELGIQUE 8 -- 3.3. PROBLÈMES IDENTIFIÉS 9 -- 3.3.1. Remboursement de la partie non implantable 9 -- 3.3.2. Remboursement des BCD transcutanés actifs (tBCD actifs) 10 -- 3.3.3. Adaptation des tests d’audition pour le remboursement des BCD en cas de perte auditive unilatérale 11 -- 3.3.4. Période d’essai obligatoire 11 -- 4. LES IMPLANTS COCHLÉAIRES 11 -- 4.1. DESCRIPTION 11 -- 4.2. QUI EST HABILITÉ À PLACER DES IMPLANTS COCHLÉAIRES ? 12 -- 4.3. REMBOURSEMENT DES IMPLANTS COCHLÉAIRES 12 -- 4.4. PROBLÈMES IDENTIFIÉS 14 -- 4.4.1. Implants cochléaires bilatéraux chez les adultes et les enfants de plus de 12 ans avec perte d’audition bilatérale 14 -- 4.4.2. Implants unilatéraux en cas de surdité unilatérale (SSD) 16 -- 4.4.3. Autres suggestions d’adaptations mineures des critères de remboursement 18 -- 4.4.4. Réglages des implants et rééducation après implantation 19 -- 5. VERS UNE APPROCHE ET UN REMBOURSEMENT COHÉRENTS ET FONDÉS SUR DES DONNÉES PROBANTES 20 -- RECOMMANDATIONS 2

De terugbetaling van hoorapparaten en implantaten bij gehoorverlies : Synthese

28 p.ill.,Onze ziekteverzekering (RIZIV) voorziet dat elke persoon met gehoorverlies recht heeft op een (soms gedeeltelijke) terugbetaling van een hoorapparaat. De vraag die zich echter nu stelt is of deze steeds meer gesofisticeerde systemen een echte meerwaarde bieden tegenover de reeds bestaande en terugbetaalde apparaten. Het RIZIV vroeg daarom aan het Federaal Kenniscentrum voor de Gezondheidszorg (KCE) om na te gaan of bepaalde gehoorimplantaten doeltreffend zijn, en of de terugbetaling ervan moet worden uitgebreid. Het KCE vond echter onvoldoende wetenschappelijk bewijs van hoge kwaliteit om een uitbreiding van de huidige terugbetalingscriteria te ondersteunen.1. INLEIDING 4 -- 1.1. CONTEXT VAN DE STUDIE 4 -- 1.2. METHODOLOGIE EN ONDERZOEKSVRAGEN 4 -- 2. KORT OVERZICHT VAN GEHOORSTOORNISSEN EN HUN AANPAK 5 -- 2.1. DE WEG VAN HET GELUID 5 -- 2.2. DE VERSCHILLENDE SOORTEN GEHOORVERLIES 6 -- 2.2.1. Op basis van de gehoordrempel 6 -- 2.2.2. Op basis van de disfunctie van delen van het oor 6 -- 2.2.3. Op basis van het moment van spraak- en taalontwikkeling 6 -- 2.2.4. Op basis van de oorzaken 7 -- 3. APPARATEN MET BEENGELEIDING 7 -- 3.1. BESCHRIJVING 7 -- 3.2. HUIDIGE TERUGBETALINGSCRITERIA IN BELGIË 8 -- 3.3. GEÏDENTIFICEERDE PROBLEMEN 9 -- 3.3.1. Terugbetaling van het niet-implanteerbare deel 9 -- 3.3.2. Terugbetaling van de actieve transcutane BCD’s (actieve tBCD’s) 10 -- 3.3.3. Aanpassing van de gehoortesten voor de terugbetaling van BCD’s bij eenzijdig gehoorverlies 10 -- 3.3.4. Verplichte proefperiode 11 -- 4. COCHLEAIRE IMPLANTATEN 11 -- 4.1. BESCHRIJVING 11 -- 4.2. WAAR WORDEN COCHLEAIRE IMPLANTATEN GEPLAATST? 12 -- 4.3. TERUGBETALING VAN DE COCHLEAIRE IMPLANTATEN 12 -- 4.4. GEÏDENTIFICEERDE PROBLEMEN 14 -- 4.4.1. Dubbelzijdige implantaten bij volwassenen en kinderen ouder dan 12 jaar met dubbelzijdig ernstig gehoorverlies 14 -- 4.4.2. Eenzijdige implantaten bij eenzijdige doofheid (SSD) 16 -- 4.4.3. Andere suggesties voor aanpassingen van de terugbetalingscriteria 18 -- 4.4.4. Afstelling van de implantaten en revalidatie na implantatie 20 -- 5. NAAR EEN CONSISTENTE, WETENSCHAPPELIJK ONDERBOUWDE AANPAK EN TERUGBETALING 2

Exploratory steps for the formulation of Belgian health system targets

46 p.ill.,INTRODUCTION 8 -- 1.1 CONTEXT .8 -- 1.2 AIM OF THE PROJECT 9 -- 1.3 SCOPE OF THE PROJECT: OVER ARCHING OBJECTIVES 9 -- 1.4 PRIMARY VIEWPOINT OF THIS STUDY IS ON FEDERAL COMPETENCIES 11 -- 2 METHODS 12 -- 2.1 GUIDING OF THE PROJECT 12 -- 2.2 INVENTORY OF EXISTING TARGETS 12 -- 2.2.1 Definition of “target” .12 -- 2.2.2 Identification and sifting of targets 12 -- 2.2.3 Validation of national targets by the steering group 12 -- 2.2.4 Validation and completion of the target inventory in expert meetings 13 -- 2.2.5 Categorisation of targets 13 -- 2.3 FORMULATION OF SUGGESTIONS FOR HEALTH SYSTEM TARGETS BASED ON THE INDICATORS OF THE HSPA 13 -- 2.4 HEALTH TARGET SYSTEMS IN OTHER COUNTRIES 13 -- 3 RESULTS: INVENTORY OF TARGETS (ORDERED BY HSPA DOMAIN) 14 -- 3.1 HEALTH STATUS 15 -- 3.2 EQUITY AND INEQUALITIES 16 -- 3.3 ACCESSIBILITY 16 -- 3.4 QUALITY-OF-CARE: EFFECTIVENESS OF CARE .17 -- 3.5 QUALITY-OF-CARE: APPROPRIATENESS OF CARE .17 -- 3.6 QUALITY-OF-CARE: SAFETY OF CARE 19 -- 3.7 QUALITY-OF-CARE: CONTINUITY OF CARE19 -- 3.8 QUALITY-OF-CARE: PATIENT CENTEREDNESS OF CARE 19 -- 3.9 EFFICIENCY OF THE HEALTHCARE SYSTEM 20 -- 3.10 SUSTAINABILITY 20 -- 3.11 HEALTH PROMOTION AND LIFESTYLES 21 -- 3.12 MENTAL HEALTHCARE .23 -- 3.13 LONG-TERM CARE FOR THE ELDERLY .23 -- 3.14 CARE AT THE END-OF-LIFE 23 -- 3.15 PREVENTIVE CARE .24 -- 4 GETTING INSPIRATION FROM OTHER COUNTRIES AND REGIONS .25 -- 4.1 INTRODUCTION .25 -- 4.2 COUNTRY AND PROGRAMME SELECTION.25 -- 4.3 OVERVIEW 26 -- 4.3.1 Structured target-setting programmes versus ad hoc approaches .26 -- 4.3.2 Type of targets (outcomes – processes – structures) and level to which targets are imposed (macro – meso – micro) 27 -- 4.3.3 Stated aims of the target-setting programmes 28 -- 4.3.4 Descriptive target formulation versus quantified targets 29 -- 4.3.5 Scope of the target-setting programmes: comprehensiveness versus focus 30 -- 4.3.6 Time horizon 31 -- 4.3.7 Additions to target formulation 31 -- 4.3.8 Monitoring and publication of results .33 -- 4.3.9 Communication of target-setting programmes 33 -- 5 DISCUSSION 33 -- 5.1 THE LIST OF TARGETS PRESENTED IS A GROSS INVENTORY 33 -- 5.1.1 This is an inventory of quantified targets only 33 -- 5.1.2 The inventory of targets includes a mixture of target layers 33 -- 5.2 WHAT THE INVENTORY OF FEDERAL TARGETS CONFIRMS , 36 -- 5.2.1 Many targets have already been formulated by the federal actors in Belgium 36 -- 5.2.2 but the initiatives are not coordinated 37 -- 5.3 WHAT THE INVENTORY OF SUPRANATIONAL TARGETS SHOWS .37 -- 5.4 HEALTH INTELLIGENCE ELEMENTS FOR SETTING AND MONITORING HEALTH TARGETS IN BELGIUM ARE ABUNDANTLY AVAILABLE .38 -- 5.5 CRITICAL SUCCESS FACTORS FOR TARGETS .38 -- 5.6, POSSIBLE NEXT STEPS 39 -- 5.6.1 Prioritise topics for target-setting .39 -- 5.6.2 Involve stakeholders 39 -- 5.6.3 Work on a coherent set of targets at different layers .40 -- 5.6.4 Link targets to action plans to foster implementation .40 -- 5.6.5 Develop a more diversified palette of target-setting modalities 40 -- 5.6.6 Evolve towards “Health in all policies”

Evaluation of the reimbursement for hearing aids and implants in hearing loss

265 p.ill.,1 INTRODUCTION .19 -- 1.1 CONTEXT, AIM AND RESEARCH QUESTIONS 19 -- 1.2 METHODS AND REPORT OUTLINE 20 -- 2 CLINICAL BACKGROUND 23 -- 2.1 PATHOLOGY AND CAUSES OF HEARING LOSS .23 -- 2.2 TYPES OF HEARING LOSS .23 -- 2.2.1 Sensorineural, conductive and mixed hearing loss 24 -- 2.2.2 Bilateral and unilateral hearing loss 24 -- 2.2.3 Prelingual and postlingual deafness 24 -- 2.2.4 The special case of auditory neuropathy .25 -- 2.3 CATEGORISATION OF HEARING DEVICES: HEARING AIDS AND IMPLANTS 28 -- 2.3.1 Conventional hearing aid (CHA) 28 -- 2.3.2 Bone conduction hearing device (BCD) 28 -- 2.3.3 Middle ear implant (MEI) 31 -- 2.3.4 Cochlear implant (CI) .32 -- 2.3.5 Auditory Brainstem Implant .32 -- 2.4 INDICATIONS AND TREATMENT OPTIONS BY PATHOLOGY 32 -- 2.4.1 Sensorineural hearing loss (SNHL) 32 -- 2.4.2 Conductive hearing loss (CHL) .33 -- 2.4.3 Mixed hearing loss (MHL) 33 -- 2.4.4 Single sided deafness (SSD) and asymmetrical hearing loss (AHL) .34 -- 3 REIMBURSEMENT OF HEARING AIDS AND IMPLANTS IN BELGIUM 34 -- 3.1 DECISION-MAKING AT RIZIV-INAMI 34 -- 3.2 REIMBURSED DEVICES 35 -- 3.3 REIMBURSED INDICATIONS .37 -- 3.3.1 Conventional hearing aids 37 -- 3.3.2 Implantable part of the bone conduction devices 39 -- 3.3.3 Middle Ear Implants 39 -- 3.3.4 Cochlear Implants 42 -- 3.3.5 Exceptional reimbursement by Special Solidarity Fund 46 -- 3.4 REIMBURSEMENT FEES AND OUT-OF-POCKET EXPENDITURES 46 -- 3.4.1 Conventional hearing aids and the sound processor of bone conduction devices .46 -- 3.4.2 Implantable part of bone conduction devices 47 -- 3.4.3 Middle Ear Implants 47 -- 3.4.4 Cochlear Implants 47 -- 3.5 CONDITIONS IMPOSED TO THE IMPLANTING UNITS 48 -- 3.5.1 Middle Ear Implants 48 -- 3.5.2 Cochlear Implants 48 -- 3.6 CONDITIONS FOR THE IMPLANTS 48 -- 3.6.1 Middle Ear Implants 48 -- 3.6.2 Cochlear Implants 49 -- 4 CLINICAL EVIDENCE .49 -- 4.1 RESEARCH QUESTIONS .49 -- 4.2 METHODOLOGY 50 -- 4.2.1 Search strategy .50 -- 4.2.2 Data to retrieve 52 -- 4.3 RESULTS OF THE SYSTEMATIC SEARCH 52 -- 4.4 ANSWERING THE RESEARCH QUESTIONS: RESULTS OF THE LITERATURE SEARCH 53 -- 4.4.1 Clinical effectiveness of active transcutaneous bone conduction implants. 53 -- 4.4.2 Clinical effectiveness of bilateral CI (compared to unilateral CI) in bilateral hearing loss in adults. .55 -- 4.4.3 Clinical effectiveness of cochlear implant and other hearing solutions in single sided deafness with or without tinnitus 56 -- 4.4.4 Clinical effectiveness of fully implanted middle ear implants and traditional semi-implanted MEIs .65 -- 4.4.5 Complications, safety and adverse events of hearing implants. 66 -- 5 ECONOMIC REVIEW AND COST-CONSEQUENCES ANALYSIS IN BELGIAN SETTING .69 -- 5.1 LITERATURE SEARCH 69 -- 5.1.1 Research questions 69 -- 5.1.2 Selection criteria 70 -- 5.1.3 Search strategy .70 -- 5.2 RESULTS OF THE LITERATURE SEARCH 73 -- 5.2.2 General characteristics of included economic studies 74 -- 5.3 DESCRIPTION AND DISCUSSION OF THE ECONOMIC STUDIES .77 -- 5.3.1 Cost-effectiveness results and thresholds applied .77 -- 5.3.2 Utility results and instruments used 82 -- 5.3.3 Costs 91 -- 5.4 COST-CONSEQUENCE ANALYSIS IN A BELGIAN SETTING .93 -- 5.4.1 Long-term incremental costs for (sequential or simultaneous) BCI compared to UCI or bimodal treatment 93 -- 5.4.2 Long-term incremental costs for CI in SSD compared to unaided or treatment with CROS or BCD 94 -- 5.4.3 Incremental long-term costs for active tBCD in SSD / mixed and conductive hearing loss 94 -- 5.5 CONCLUSIONS 95 -- 6 DATA ANALYSIS 98 -- 6.1 INTRODUCTION .98 -- 6.2 DATA SOURCES 98 -- 6.2.1 Document N data .98 -- 6.2.2 Minimal Hospital data: 98 -- 6.2.3 Administrative data from the Intermutualistic Agency 99 -- 6.3 RIZIV-INAMI BUDGET FOR HEARING AIDS AND HEARING IMPLANTS .99 -- 6.4 AMOUNT OF REIMBURSED HEARING DEVICES DURING THE YEARS 2014 UP TO 2018 IN BELGIUM .100 -- 6.4.1 Conventional hearing aids 100 -- 6.4.2 Bone conduction devices 101 -- 6.4.3 Cochlear implants .102 -- 6.4.4 Middle Ear Implants .103 -- 6.5 AMOUNT OF PATIENTS WITH HEARING AIDS OR IMPLANTS .103 -- 6.5.1 Conventional hearing aids 103 -- 6.5.2 Hearing implants 103 -- 6.6 REIMBURSED COSTS OF THE DIFFERENT IMPLANTATION PHASES 106 -- 6.6.1 Procedural phase 106 -- 6.6.2 Pre- and postprocedural phase 109 -- 6.7 DISTRIBUTION OF THE DELIVERED HEARING AIDS AND IMPLANTS IN BELGIUM AND THE PLACE OF IMPLANTATION 113 -- 6.7.1 Accessibility 113 -- 6.7.2 Place of implantation 113 -- 7 INTERNATIONAL COMPARISON .115 -- 7.1 INTRODUCTION 115 -- 7.2 METHODS 115 -- 7.3 SELECTION OF COUNTRIES 115 -- 7.4 NETHERLANDS 116 -- 7.4.1 Cochlear Implants .116 -- 7.4.2 Middle Ear Implants .121 -- 7.4.3 Bone Conduction Devices .121 -- 7.5 FRANCE 122 -- 7.5.1 Cochlear Implants .122 -- 7.5.2 Middle Ear Implants .126 -- 7.5.3 Bone Conduction Devices .126 -- 7.6 GERMANY 127 -- 7.6.1 Cochlear Implants .127 -- 7.6.2 Bone Conduction Devices and Middle Ear Implants 129 -- 7.7 SWITZERLAND .130 -- 7.7.1 Cochlear Implants .130 -- 7.7.2 Middle Ear Implants .132 -- 7.7.3 Bone Conduction Devices .132 -- 7.8 SPAIN .132 -- 7.8.1 Cochlear Implants .132 -- 7.8.2 Middle Ear Implants .137 -- 7.8.3 Bone Conduction Devices .137 -- 7.9 NHS ENGLAND .138 -- 7.9.1 Cochlear Implants .138 -- 7.9.2 Bone Conduction Devices .140 -- 7.9.3 Middle Ear Implants .141 -- 7.10 CANADA – ONTARIO 141 -- 7.10.1 Cochlear Implants .141 -- 7.10.2 Bone conduction devices and middle ear implants 143 -- 7.11 CANADA – QUEBEC .143 -- 7.11.1 Cochlear Implants .143 -- 7.12 CROSS-COUNTRY COMPARISON AND KEY POINTS FOR CI 144 -- 7.12.1 Approaches in the reimbursement of CI 144 -- 7.12.2 Reimbursed/Guideline indications for CI 146 -- 7.12.3 Volume of CI per newborn and inhabitant 154 -- 7.12.4 Pricing of CI 156 -- 7.12.5 Registration of CI patients .156 -- 7.12.6 Upgrade term for sound processor 157 -- 7.13 CROSS-COUNTRY COMPARISON AND KEY POINTS FOR BCD .157 -- 7.14 CROSS-COUNTRY COMPARISON AND KEY POINTS FOR MEI 158 -- 8 LIST OF OPTIONS AND EVALUATION OF EACH OPTION 158 -- 8.1 REIMBURSEMENT OF CONVENTIONAL HEARING AIDS .159 -- 8.2 REIMBURSEMENT OF BONE CONDUCTION DEVICES .159 -- 8.2.1 Increased reimbursement for the non-implantable bone conduction devices 160 -- 8.2.2 Reimbursement of the implantable part of passive transcutaneous and percutaneous bone conduction devices 161 -- 8.2.3 Reimbursement of active transcutaneous bone conduction devices 161 -- 8.2.4 Adaptation of hearing gain test for bone conduction devices in children 165 -- 8.2.5 Ensure that the mandatory trial period for BCD is complied to 165 -- 8.3 REIMBURSEMENT OF MEI 166 -- 8.4 REIMBURSEMENT OF CI 167 -- 8.4.1 Expansion of reimbursement to bilateral CI in patients above 12 years: according to selected criteria 167 -- 8.4.2 Expansion of reimbursement for CI in SSD: according to selected criteria .170 -- 8.4.3 Minor adaptation of the criteria for CI implantation 175 -- 8.4.4 Modification or elaboration of tests for CI .177 -- 8.4.5 Facilitation and quality-assurance of fitting and rehabilitation for CI 177 -- 8.5 CONDITIONS IMPOSED TO CENTRES .180 -- 8.5.1 Towards networking for quality assurance 180 -- 8.5.2 A Belgian or international registry for hearing implants? 185 -- 8.5.3 Precise rules versus more flexibility in criteria? (a topic linked to organisation of care) 185 -- 8.6 EXPANSION OF REIMBURSEMENT – VARIOUS OPTIONS RAISED BY THE EXPERTS 186 -- 8.6.1 Expansion of reimbursement for frequency modulation (FM) systems for unilateral hearing loss? 186 -- 8.6.2 Creation of nomenclature for facialis monitoring? 187 -- 8.6.3 Public availability of Bluetooth protocols 187 -- 8.6.4 Harmonization of payment for simultaneous as well as sequential cochlear implantation 187 -- APPENDICES 18