The report is available in English with a Dutch summary - KCE

More documents

Recommendations

Info

viii Plasma KCE Reports 120A Voor een betere transparantie van de activiteiten en de rekeningen van de gesubsidieerde organismen Een subsidiërende overhead moet het gebruik van de subsidies die ze geeft direct of indirect kunnen controleren. Bijgevolg, • Bevelen we aan het verder zetten van de subsidiering van de prijs van het plasma dat aan CAF-DCF verkocht te koppelen aan een transparante communicatie o over de financiële stromen, de plasma volumes en de volumes plasmaderivaten die via het CAF-DCF en zijn buitenlandse partners passeren o over de precieze voorwaarden van het contract tussen CAF-DCF en zijn partners voor het directe en indirecte gebruik van plasma dat in België werd verzameld, om te kunnen nagaan in hoeverre deze subsidies nuttig zijn binnen een duidelijke gedefinieerde politiek van zelfvoorziening. • Bevelen we ook aan een grondige audit van de rekeningen van het RK uit te voeren om de kostenstructuur van de plasmaferese activiteiten nauwkeurig in kaart te brengen en om zo de eventueel noodzakelijke minimale subsidie vast te leggen om deze activiteit financieel in evenwicht te brengen en zo tot het gewenste niveau van plasma inzameling te komen.
KCE Reports 120 Plasma 1 Scientific summary Table of contents SCIENTIFIC SUMMARY ........................................................................................................... 1 GLOSSARY ................................................................................................................................. 3 1 INTRODUCTION ............................................................................................................ 5 1.1 CONTEXT ..................................................................................................................................................... 5 1.2 RESEARCH QUESTIONS ........................................................................................................................... 5 2 SUPPLY OF PLASMA DERIVATIVES .......................................................................... 6 2.1 COLLECTION OF PLASMA ...................................................................................................................... 6 2.1.1 Legal and ethical framework .......................................................................................................... 6 2.1.2 Plasma collection in Belgium ........................................................................................................ 12 2.1.3 Plasma collection in other countries .......................................................................................... 22 2.2 TRANSFORMATION OF PLASMA INTO PLASMA DERIVATIVES ............................................... 29 2.2.1 Quick overview of fractionation process .................................................................................. 29 2.2.2 The worldwide supply of plasma products .............................................................................. 32 2.2.3 The supply of plasma stable derivatives in Belgium ................................................................. 34 2.3 LIMITATIONS ............................................................................................................................................. 39 3 DEMAND FOR PLASMA DERIVATIVES: THE CASE OF IMMUNOGLOBULINS .......................................................................................................................................... 40 3.1 USE OF PLASMA DERIVATIVES IN BELGIUM .................................................................................... 40 3.1.1 Methods ............................................................................................................................................ 40 3.1.2 Results .............................................................................................................................................. 40 3.1.3 The case of immunoglobulins ...................................................................................................... 42 3.2 INDICATIONS FOR IMMUNOGLOBULINS ...................................................................................... 43 3.2.1 Recommendations for the use of immunoglobulins................................................................ 43 3.2.2 Evidence review on immunoglobulin effectiveness ................................................................. 49 3.3 CONSUMPTION OF IMMUNOGLOBULINS ..................................................................................... 70 3.3.1 Consumption in other countries ................................................................................................ 70 3.3.2 Consumption in Belgium ............................................................................................................... 74 3.3.3 Estimation of IG quantities to treat the main indications ...................................................... 86 3.3.4 Expected trends in consumption ................................................................................................ 97 4 SELF SUFFICIENCY OF BELGIUM ............................................................................ 98 4.1 WHAT ARE THE RISKS AT WORLDWIDE LEVEL ? ........................................................................ 98 4.1.1 Plasma collection: Key role of the North American Region ................................................. 98 4.1.2 Worldwide demand for plasma products / Focus on IVIG (2000-2008) .......................... 100 4.1.3 Potential changes in demand structure .................................................................................... 100 4.2 CONCEPT OF SELF SUFFICIENCY ..................................................................................................... 101 4.2.1 In Belgium ....................................................................................................................................... 101 4.2.2 In other countries ........................................................................................................................ 103 4.3 HOW TO STAY OR BECOME SELF SUFFICIENT .......................................................................... 111 4.3.1 Strategies to decrease IG use: lessons learned ...................................................................... 111 4.3.2 Strategies to decrease IG use: what could be applied in Belgium ...................................... 115 4.3.3 Increasing the capacities of collecting plasma ......................................................................... 115 4.3.4 Transparency and better control of the supply of derivatives ........................................... 116 4.4 CONCLUSIONS ....................................................................................................................................... 117 5 APPENDICES ............................................................................................................... 118 APPENDIX 1: ETHICAL DIMENSION OF DONATION: QUICK OVERVIEW .................................... 118 APPENDIX 2 : SEARCH TERMS ........................................................................................................................ 120 APPENDIX 3: GRADE CRITERIA FOR ASSIGNING GRADE OF EVIDENCE ...................................... 121 APPENDIX 4: IMMUNO-HAEMATOLOGICAL SURVEY ........................................................................... 122 APPENDIX 5: POTENTIAL CHANGES IN DEMAND VOLUME: FOCUS ON TWO EMERGING COUNTRIES .............................................................................................................................................. 124
Page 1 and 2: Hoe zelfvoorziening in stabiele pla
Page 3 and 4: Hoe zelfvoorziening in stabiele pla
Page 5 and 6: KCE Reports 120A Plasma i VOORWOORD
Page 7 and 8: KCE Reports 120A Plasma iii METHODO
Page 9 and 10: KCE Reports 120A Plasma v Elke lite
Page 11: KCE Reports 120A Plasma vii AANBEVE
Page 15 and 16: KCE Reports 120 Plasma 3 GLOSSARY A
Page 17 and 18: KCE Reports 120 Plasma 5 1 INTRODUC
Page 19 and 20: KCE Reports 120 Plasma 7 Focus: sta
Page 21 and 22: KCE Reports 120 Plasma 9 Two techni
Page 23 and 24: KCE Reports 120 Plasma 11 Therefore
Page 25 and 26: KCE Reports 120 Plasma 13 FRENCH-SP
Page 27 and 28: KCE Reports 120 Plasma 15 Number of
Page 29 and 30: KCE Reports 120 Plasma 17 Table 4:
Page 35 and 36: KCE Reports 120 Plasma 23 Role of t
Page 37 and 38: KCE Reports 120 Plasma 25 2.1.3.2 P
Page 39 and 40: KCE Reports 120 Plasma 27 • 73% o
Page 41 and 42: KCE Reports 120 Plasma 29 2.2 TRANS
Page 43 and 44: KCE Reports 120 Plasma 31 Figure 6:
Page 45 and 46: KCE Reports 120 Plasma 33 GEOGRAPHI
Page 47 and 48: KCE Reports 120 Plasma 35 It is sur
Page 49 and 50: KCE Reports 120 Plasma 37 Plasma fr
Page 51 and 52: KCE Reports 120 Plasma 39 2.3 LIMIT
Page 55 and 56: KCE Reports 120 Plasma 43 3.2 INDIC
Page 57 and 58: KCE Reports 120 Plasma 45 Subcutane
Page 61 and 62: KCE Reports 120 Plasma 49 3.2.2 Evi
Page 63 and 64:
KCE Reports 120 Plasma 51 Search re
Page 65 and 66:
KCE Reports 120 Plasma 53 CIDP IG i
Page 67 and 68:
KCE Reports 120 Plasma 55 • IG re
Page 69 and 70:
KCE Reports 120 Plasma 57 Solid org
Page 71 and 72:
KCE Reports 120 Plasma 59 A Cochran
Page 73 and 74:
KCE Reports 120 Plasma 61 • In ch
Page 75 and 76:
KCE Reports 120 Plasma 63 Two small
Page 77 and 78:
KCE Reports 120 Plasma 65 was lower
Page 79 and 80:
KCE Reports 120 Plasma 67 Three RCT
Page 81 and 82:
KCE Reports 120 Plasma 69 Severe se
Page 83 and 84:
KCE Reports 120 Plasma 71 The analy
Page 85 and 86:
KCE Reports 120 Plasma 73 3.3.1.2 T
Page 87 and 88:
KCE Reports 120 Plasma 75 Figure 7:
Page 89 and 90:
KCE Reports 120 Plasma 77 Figure 10
Page 91 and 92:
KCE Reports 120 Plasma 79 Table 30:
Page 93 and 94:
KCE Reports 120 Plasma 81 Table 36:
Page 95 and 96:
KCE Reports 120 Plasma 83 • For b
Page 97 and 98:
KCE Reports 120 Plasma 85 3.3.2.6 L
Page 99 and 100:
KCE Reports 120 Plasma 87 • The p
Page 101 and 102:
KCE Reports 120 Plasma 89 In Belgiu
Page 103 and 104:
KCE Reports 120 Plasma 91 Multifoca
Page 105 and 106:
KCE Reports 120 Plasma 93 Based on
Page 107 and 108:
KCE Reports 120 Plasma 95 Disease /
Page 109 and 110:
KCE Reports 120 Plasma 97 3.3.4 Exp
Page 111 and 112:
KCE Reports 120 Plasma 99 Figure 12
Page 113 and 114:
KCE Reports 120 Plasma 101 Key poin
Page 115 and 116:
KCE Reports 120 Plasma 103 Key poin
Page 117 and 118:
KCE Reports 120 Plasma 105 • Conf
Page 119 and 120:
KCE Reports 120 Plasma 107 As far a
Page 121 and 122:
KCE Reports 120 Plasma 109 Followin
Page 123 and 124:
KCE Reports 120 Plasma 111 4.3 HOW
Page 125 and 126:
KCE Reports 120 Plasma 113 Improvin
Page 127 and 128:
KCE Reports 120 Plasma 115 4.3.2 St
Page 129 and 130:
KCE Reports 120 Plasma 117 4.4 CONC
Page 131 and 132:
KCE Reports 120 Plasma 119 FAVOURIN
Page 133 and 134:
KCE Reports 120 Plasma 121 APPENDIX
Page 135 and 136:
KCE Reports 120 Plasma 123 For othe
Page 137 and 138:
KCE Reports 120 Plasma 125 Table 48
Page 139 and 140:
Page 141 and 142:
Page 143 and 144:
KCE Reports 120 Plasma 131 Distribu
Page 145 and 146:
KCE Reports 120 Plasma 133 • Conv
Page 147 and 148:
Page 149 and 150:
KCE Reports 120 Plasma 137 6 REFERE
Page 151 and 152:
KCE Reports 120 Plasma 139 41. Pruz
Page 153 and 154:
KCE Reports 120 Plasma 141 82. Comi
Page 155 and 156:
KCE Reports 120 Plasma 143 123. Cre
Page 157 and 158:
KCE Reports 120 Plasma 145 165. Cua
Page 159 and 160:
This page is left intentionally bla
Page 161 and 162:
KCE reports 1. Effectiviteit en kos
Page 163 and 164:
73. Financiering van het zorgprogra
show all

The report is available in English with a Dutch summary - KCE

Create successful ePaper yourself

Delete template?

Save as template?