How to improve the Belgian process for Managed Entry Agreements? : An analysis of the Belgian and international experience

69 p. ill., LIST OF FIGURES 3 -- LIST OF TABLES .3 -- LIST OF ABBREVIATIONS 4 -- SCIENTIFIC REPORT .6 -- 1 INTRODUCTION 6 -- 1.1 BACKGROUND 6 -- 1.2 STUDY OBJECTIVES AND RESEARCH QUESTIONS 7 -- 1.3 A DIFFICULT PROCESS DUE TO DATA CONFIDENTIALITY AND THREAT OF LEGAL PROCEEDINGS .7 -- 1.4 A RAPID LOOK AT THE EXISTING TAXONOMY 8 -- 2 A REVIEW OF THE LITERATURE ON MANAGED ENTRY AGREEMENTS: WHAT CAN BE LEARNED FROM THE CURRENT EUROPEAN EXPERIENCE? 11 -- 2.1 INTRODUCTION .11 -- 2.2 METHODS 11 -- 2.3 RESULTS 16 -- 2.3.1 Strengths of MEAs 16 -- 2.3.2 Weaknesses/Challenges of MEAs 18 -- 2.3.3 What products should be the target of MEAs 24 -- 2.3.4 Evaluation process for MEAs .24 -- 2.3.5 Checklists for evaluating the need for a MEA or the impact of an already established MEA 30 -- 2.4 LIMITATIONS 33 -- 3 DESCRIPTION OF THE LEGISLATION 34 -- 3.1 INTRODUCTION .34 -- 3.2 METHOD .34 -- 3.3 MARKET AUTHORIZATION, PRICING AND REIMBURSEMENT IN BELGIUM (FOR BOTH OUTPATIENTS AND INPATIENTS PHARMACEUTICALS) 34 -- 3.3.1 Market authorization 34 -- 3.3.2 Price setting 34 -- 3.3.3 The reimbursement procedure 35 -- 3.3.4 Specificities of orphan drugs 39 -- 3.4 EVOLUTION OF THE LEGISLATION ON MEA IN BELGIUM .40 -- 3.4.1 Situation from January 2010 until July 2014 41 -- 3.4.2 Situation from July 2014 41 -- 3.4.3 The negotiation process 42 -- 3.4.4 The convention 43 -- 3.4.5 Process at the end of the convention .43 -- 3.5 NO REGULATION OF MEAS IN A EUROPEAN CONTEXT 44 -- 4 ANALYSIS OF THE BELGIAN PROCESS FOR MEA: WHAT LESSONS CAN BE LEARNED FROM THE BELGIAN EXPERIENCE? 45 -- 4.1 INTRODUCTION .45 -- 4.2 METHOD .45 -- 4.3 RESULTS 47 -- 4.3.1 Description of the convention procedure .47 -- 4.3.2 The evaluation by the CTG-CRM .51 -- 4.3.3 Analysis of approved conventions 53 -- 4.3.4 Analysis of expired conventions 58 -- 4.3.5 Impact on the health care budget for pharmaceuticals .60 -- 5 STAKEHOLDER CONSULTATION .61 -- APPENDIX .62 -- REFERENCES .64