Optimalisatie van de werkingsprocessen van het Bijzonder ... - KCE

2 Special Solidarity Fund KCE Reports 133
6.1.3 Familiarity of the SSF ..................................................................................................................... 56
6.1.4 Procedure ........................................................................................................................................ 56
6.1.5 The criteria for decision-making ................................................................................................. 57
6.2 THE SOCIAL SERVICES ............................................................................................................................ 57
6.2.1 Brief presentation of the interviewed social services ............................................................. 57
6.2.2 Positive elements regarding the existence and functioning of the SSF ............................... 58
6.2.3 Negative elements on the functioning of the SSF/suggestions for improvement ............. 58
6.3 PATIENT ORGANISATIONS .................................................................................................................. 59
6.3.1 Overview of the interviewed patient organisations ................................................................ 59
6.3.2 Positive elements regarding the existence and functioning of the SSF ............................... 59
6.3.3 Negative elements on the functioning of the SSF / suggestions for improvement ........... 59
6.4 THE MEDICAL SPECIALISTS ................................................................................................................... 60
6.4.1 Brief presentation of the interviewed physicians ..................................................................... 60
6.4.2 Positive elements regarding the existence and functioning of the SSF ............................... 61
6.4.3 Negative elements on the functioning of the SSF / suggestions for improvement ........... 61
6.5 THE PHARMACEUTICAL INDUSTRY ................................................................................................. 62
6.5.1 Positive elements on the functioning of the SSF ...................................................................... 62
6.5.2 Negative elements on the functioning of the SSF / suggestions for improvement ........... 62
7 EXPLORATION OF (COMPARABLE) SAFETY NETS IN A SELECTION OF
FOREIGN COUNTRIES ................................................................................................ 64
7.1 FRANCE ....................................................................................................................................................... 64
7.1.1 The reimbursements of medicines ............................................................................................. 64
7.1.2 Rare and chronic diseases in France .......................................................................................... 68
7.1.3 Recent Health French System Reforms ..................................................................................... 69
7.2 THE NETHERLANDS ................................................................................................................................ 71
7.2.1 Reimbursement of medicines ...................................................................................................... 71
7.3 SPAIN ............................................................................................................................................................ 77
7.3.1 Rare diseases in Spain – coverage of costs of treatment and medication .......................... 77
7.3.2 Access to medication in special situations ................................................................................ 78
7.3.3 Overall situation for drugs and medical devices used in the specialized care ................... 79
7.4 OVERVIEW OF THE CASES .................................................................................................................... 81
7.5 CONCLUSIONS OF THE CHAPTER ON THE INTERNATIONAL APPROACH .................... 83
7.5.1 Costs of drugs at secondary care level (hospital care) .......................................................... 83
7.5.2 Costs of drugs at primary care level .......................................................................................... 83
7.5.3 Reference centers for rare diseases ........................................................................................... 83
7.5.4 Early access to new drugs ............................................................................................................ 84
8 DISCUSSION AND CONCLUSIONS ......................................................................... 85
8.1 ELIGIBILITY CRITERIA FOR SSF INTERVENTION ........................................................................... 86
8.1.1 Expensive ......................................................................................................................................... 86
8.1.2 Proven scientific value and prescription by a recognised specialist in the respective
domain ........................................................................................................................................................... 86
8.1.3 Threatening the vital functions of the patient .......................................................................... 87
8.1.4 Rare indication/disease .................................................................................................................. 87
8.2 INFORMATION CHANNELS ON THE EXISTENCE OF THE SSF ............................................... 87
8.3 APPRAISAL BY STAKEHOLDERS OF THE APPLICATION PROCEDURE AND DECISION-
MAKING PROCESS ................................................................................................................................... 87
8.3.1 Clarity of the eligibility criteria .................................................................................................... 87
8.3.2 Duration ........................................................................................................................................... 87
8.3.3 Administrative burden ................................................................................................................... 88
8.3.4 Reporting and transparency ......................................................................................................... 88
8.3.5 Stakeholder involvement .............................................................................................................. 88
8.3.6 Sufficient expertise at SSF level ................................................................................................... 89
8.3.7 Appeal ............................................................................................................................................... 89
8.4 EXPLORATION OF (COMPARABLE) SAFETY NETS IN A SELECTION OF FOREIGN
COUNTRIES ................................................................................................................................................ 89
8.4.1 Early access system to new drugs ............................................................................................... 89