109 p. ill., 1 INTRODUCTION 11 -- 1.1 CONTEXT 11 -- 1.2 AIM OF THE STUDY 13 -- 1.2.1 Research questions .13 -- 1.3 METHODS 14 -- 1.3.1 Two case studies 14 -- 1.3.2 Data sources analyzed 14 -- 1.3.3 Methods for the data analysis .15 -- 1.4 REPORT OUTLINE .17 -- 2 BACKGROUND 17 -- 2.1 THE GLOBAL AND PARTIAL BUDGETS OF THE FEDERAL RIZIV-INAMI HEALTH INSURANCE BUDGET .17 -- 2.2 THE CTIIMH – CRIDMI AND THE REIMBURSEMENT DECISION PROCEDURE FOR IMPLANTS AND INVASIVE MEDICAL DEVICES 21 -- 2.2.1 Definitions .21 -- 2.2.2 The CTIIMH – CRIDMI 22 -- 2.2.3 The list and the nominative lists .24 -- 2.2.4 The procedure .28 -- 2.3 THE HEALTH CARE RESPONSIBILITIES OF AND DATA TRANSMISSION BY THE FEDERATED INSTANCES .32 -- 3 RETROSPECTIVE ANALYSIS OF TWO CASES 33 -- 3.1 THE CASE OF MECHANICAL THROMBECTOMY 33 -- 3.1.1 Background information .33 -- 3.1.2 PICO of the reimbursement request 33 -- 3.1.3 Overview of inputs from the budget impact analyses .34 -- 3.2 THE CASE OF TAVI 41 -- 3.2.1 Background information .41 -- 3.2.2 PICO of the reimbursement request 43 -- 3.2.3 Overview of inputs from the budget impact analyses .43 -- 3.2.4 Inputs 43 -- 4 OVERVIEW OF NATIONAL DATABASES THAT CAN POTENTIALLY BE USED FOR BIA AND ACCESS POSSIBILITIES 58 -- 4.1 OVERVIEW .58 -- 4.2 LIMITATIONS OF THE NATIONAL DATABASES 72 -- 4.3 OVERVIEW OF ELEMENTS IN A BIA AND WHICH NATIONAL DATABASES CAN BE USED FOR THEM 74 -- 5 DISCUSSION .76 -- 5.1 CAUTION WHEN USING NATIONAL DATABASES FOR DEMONSTRATING EFFECTIVENESS 76 -- 5.2 (TRANSVERSAL) BUDGET IMPACT – INFORMATION NEEDED FOR DIFFERENT ELEMENTS .77 -- 5.3 (PROBLEM OF) IDENTIFYING THE RELATIVE TREATMENT EFFECT 80 -- 5.3.1 RCTs versus observational data: large-scale evidence .80 -- 5.3.2 (Lack of) comparative evidence for implants and invasive medical devices 84 -- 5.4 OPPORTUNITIES UNDER THE NEW HTA REGULATION: JOINT SCIENTIFIC CONSULTATIONS AND JOINT CLINICAL ASSESSMENTS 85 -- 5.5 LEARNING FROM MANAGED ENTRY AGREEMENTS .86 -- 5.6 FUTURE OPPORTUNITIES FOR DATA ENHANCEMENTS 86 -- 5.6.1 European UDI to replace notification code 86 -- 5.6.2 Health Data Agency .88 -- 6 CONCLUSION AND RECOMMENDATIONS 89