Delivering diabetes education through nurseled telecoaching : cost-effectiveness analysis

Background : People with diabetes have a high risk of developing micro-and macrovascular complications associated with diminished life expectancy and elevated treatment costs. Patient education programs can improve diabetes control in the short term, but their cost-effectiveness is uncertain. Our study aimed to analyze the lifelong cost-effectiveness of a nurse-led tele-coaching program compared to usual care in people with type 2 diabetes from the perspective of the Belgian healthcare system. Methods : The UKPDS Outcomes Model was populated with patient-level data from an 18-month randomized clinical trial in the Belgian primary care sector involving 574 participants; trial data were extrapolated to 40 years; Quality Adjusted Life Years (QALYs), treatment costs and Incremental Cost-Effectiveness Ratio (ICER) were calculated for the entire cohort and the subgroup with poor glycemic control at baseline ("elevated HbA1c subgroup") and the associated uncertainty was explored. Results : The cumulative mean QALY (95% CI) gain was 0.21 (0.13; 0.28) overall and 0.56 (0.43; 0.68) in elevated HbA1c subgroup; the respective incremental costs were (sic)1,147 (188; 2,107) and (sic)2,565 (654; 4,474) and the respective ICERs (sic)5,569 ((sic)677; (sic)15,679) and (sic)4,615 (1,207; 9,969) per QALY. In the scenario analysis, repeating the intervention for lifetime had the greatest impact on the cost-effectiveness and resulted in the mean ICERs of (sic) 13,034 in the entire cohort and (sic)7,858 in the elevated HbA1c subgroup. Conclusion : Taking into account reimbursement thresholds applied in West-European countries, nurseled telecoaching of people with type 2 diabetes may be considered highly cost-effective within the Belgian healthcare system

Patient and provider acceptance of telecoaching in type 2 diabetes : a mixed-method study embedded in a randomised clinical trial

Background: Despite advances in diagnosis and treatment of type 2 diabetes, suboptimal metabolic control persists. Patient education in diabetes has been proved to enhance self-efficacy and guideline-driven treatment, however many people with type 2 diabetes do not have access to or do not participate in self-management support programmes. Tele-education and telecoaching have the potential to improve accessibility and efficiency of care, but there is a slow uptake in Europe. Patient and provider acceptance in a local context is an important precondition for implementation. The aim of the study was to explore the perceptions of patients, nurses and general practitioners (GPs) regarding telecoaching in type 2 diabetes. Methods: Mixed-method study embedded in a clinical trial, in which a nurse-led target-driven telecoaching programme consisting of 5 monthly telephone sessions of +/- 30 min was offered to 287 people with type 2 diabetes in Belgian primary care. Intervention attendance and satisfaction about the programme were analysed along with qualitative data obtained during post-trial semi-structured interviews with a purposive sample of patients, general practitioners (GPs) and nurses. The perceptions of patients and care providers about the intervention were coded and the themes interpreted as barriers or facilitators for adoption. Results: Of 252 patients available for a follow-up analysis, 97.5 % reported being satisfied. Interviews were held with 16 patients, 17 general practitioners (GPs) and all nurses involved (n = 6). Themes associated with adoption facilitation were: 1) improved diabetes control; 2) need for more tailored patient education programmes offered from the moment of diagnosis; 3) comfort and flexibility; 4) evidence-based nature of the programme; 5) established cooperation between GPs and diabetes educators; and 6) efficiency gains. Most potential barriers were derived from the provider views: 1) poor patient motivation and suboptimal compliance with "faceless" advice; 2) GPs' reluctance in the area of patient referral and information sharing; 3) lack of legal, organisational and financial framework for telecare. Conclusions: Nurse-led telecoaching of people with type 2 diabetes was well-accepted by patients and providers, with providers being in general more critical in their reflections. With increasing patient demand for mobile and remote services in healthcare,the findings of this study should support professionals involved in healthcare policy and innovation

Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial

Background: Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50% of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future micro-and macro-vascular complications. Diabetes self-management education has been shown to contribute to better disease control. However, it is not known which strategies involving educational programs are cost-effective. Telehealth applications might support chronic disease management. Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality. "The COACH Program" was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions. It proved to be effective in patients with coronary heart disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed. Methods/Design: Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their medication consumption data and were recruited by their sickness fund. They were randomized to receive either usual care plus "The COACH Program" or usual care alone. The study will assess the difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses, to project effects over life-time horizon beyond the trial duration, will be undertaken from the perspective of the health care system if the intervention is effective. Discussion: The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium. Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions

Improving chronic care through patient empowerment. Clinical and health economic outcomes of nurse-led telecoaching in type 2 diabetes

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Projections de l’impact budgétaire des produits pharmaceutiques : Synthèse

41 p.ill.,À l’heure actuelle, les prévisions quant aux dépenses futures en médicaments sont formulées principalement sur la base des dépenses et tendances du passé. Cette approche n’est toutefois pas suffisante pour évaluer l’impact de médicaments émergents très coûteux, comme les thérapies cellulaires et géniques. Pour les identifier et préparer le système à leur arrivée sur le marché, le pipeline pharmaceutique doit faire l’objet d’un suivi systématique, connu sous le nom d’horizon scanning. L’INAMI a chargé le Centre Fédéral d’Expertise des Soins de Santé (KCE) de formuler des recommandations pour mieux prédire les dépenses futures en médicaments, en mettant notamment l’accent sur l’horizon scanning.AVANT-PROPOS 1 -- SYNTHÈSE 3 -- 1. INTRODUCTION 5 -- 1.1. CONTEXTE 5 -- 1.2. DÉPENSES BRUTES ET DÉPENSES NETTES 5 -- 1.3. MÉTHODES ACTUELLEMENT UTILISÉES POUR LES PROJECTIONS CONCERNANT LES DÉPENSES EN MÉDICAMENTS 6 -- 1.4. L’HORIZON SCANNING DES PRODUITS PHARMACEUTIQUES – UNE PIÈCE MANQUANTE DANS LE PUZZLE DES PROJECTIONS 7 -- 2. OBJECTIFS DE CETTE ÉTUDE 8 -- 3. MÉTHODE 8 -- 4. PHASE EXPLORATOIRE – REVUE DES DONNÉES PROBANTES 9 -- 5. PHASE CONCEPTUELLE – MÉTHODOLOGIE GÉNÉRALE POUR LES PROJECTIONS D’IMPACT BUDGÉTAIRE 10 -- 6. PRÉVISIONS DE BASE DES DÉPENSES EN MÉDICAMENTS 12 -- 6.1. MÉTHODOLOGIE 12 -- 6.2. RÉSULTATS 12 -- 7. PROJECTIONS BASÉES SUR L’HORIZON SCANNING 14 -- 7.1. CONTEXTE 14 -- 7.1.1. Coopération internationale pour l’horizon scanning 14 -- 7.1.2. Benchmarking de différents systèmes nationaux d’horizon scanning 15 -- 7.2. RECOMMANDATIONS POUR UN HORIZON SCANNING NATIONAL EN BELGIQUE 18 -- 7.3. PRÉVISIONS DES DÉPENSES EN MÉDICAMENTS BASÉES SUR L’HORIZON SCANNING : ÉTUDE DE CAS SUR LE CANCER DU SEIN 19 -- 7.3.1. Traitement systémique du cancer du sein 19 -- 7.3.2. Présentation succincte de la méthodologie 20 -- 7.3.3. Résultats 20 -- 8. PHASE DE RÉFLEXION – INTERPRÉTATION DES RÉSULTATS ET IMPLICATIONS PRATIQUES 25 -- 8.1. COMPARAISON ENTRE L’HORIZON SCANNING ET LES PRÉVISIONS DE BASE 25 -- 8.2. INTERPRÉTATION DES RÉSULTATS 27 -- 8.3. IMPLICATIONS PRATIQUES 28 -- 8.3.1. Intégrer l’horizon scanning dans le système belge de gestion des soins de santé 28 -- 8.3.2. Données sur l’utilisation des médicaments 29 -- 8.3.3. Recherches ultérieures 30 -- RECOMMANDATIONS 3

Budget impact projecties voor geneesmiddelen : Synthese

39 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

Budget impact projections for pharmaceuticals

220 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

Impact of Nurse-Led Telecoaching on the Annual Healthcare Utilization and Costs in People with Type 2 Diabetes in Belgium. Within-Trial Analysis of Health Insurance Data

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Delivering Diabetes Education through NurseLed Telecoaching. Cost-Effectiveness Analysis

BACKGROUND: People with diabetes have a high risk of developing micro- and macrovascular complications associated with diminished life expectancy and elevated treatment costs. Patient education programs can improve diabetes control in the short term, but their cost-effectiveness is uncertain. Our study aimed to analyze the lifelong cost-effectiveness of a nurse-led telecoaching program compared to usual care in people with type 2 diabetes from the perspective of the Belgian healthcare system. METHODS: The UKPDS Outcomes Model was populated with patient-level data from an 18-month randomized clinical trial in the Belgian primary care sector involving 574 participants; trial data were extrapolated to 40 years; Quality Adjusted Life Years (QALYs), treatment costs and Incremental Cost-Effectiveness Ratio (ICER) were calculated for the entire cohort and the subgroup with poor glycemic control at baseline ("elevated HbA1c subgroup") and the associated uncertainty was explored. RESULTS: The cumulative mean QALY (95% CI) gain was 0.21 (0.13; 0.28) overall and 0.56 (0.43; 0.68) in elevated HbA1c subgroup; the respective incremental costs were €1,147 (188; 2,107) and €2,565 (654; 4,474) and the respective ICERs €5,569 (€677; €15,679) and €4,615 (1,207; 9,969) per QALY. In the scenario analysis, repeating the intervention for lifetime had the greatest impact on the cost-effectiveness and resulted in the mean ICERs of €13,034 in the entire cohort and €7,858 in the elevated HbA1c subgroup. CONCLUSION: Taking into account reimbursement thresholds applied in West-European countries, nurse-led telecoaching of people with type 2 diabetes may be considered highly cost-effective within the Belgian healthcare system. TRIAL REGISTRATION: NCT01612520.status: publishe