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48 Plasma KCE Reports 120 Myasthenia gravis Not mentioned Yes, selected (2) Yes, selected Not mentioned Yes (3) Yes, selected Dermatomyositis Not mentioned Yes, selected (2) Yes, selected Not mentioned Yes (3) Yes, selected Inclusion body myositis Not mentioned No No Not mentioned Yes, selected (3) Yes, selected Stiff person syndrome Other indications Not mentioned Yes, selected (2) Yes, selected Not mentioned Yes (3) Yes, selected Kawasaki disease Yes (1) Yes (1) Yes Yes (1) Yes, selected (1) Yes Treating septic shock and/or Yes, streptococcus NA Yes, selected Not mentioned Yes, streptococcus Yes, streptococcus necrotizing fasciitis (1) (3) staphylococcus Viral myocarditis in children Not mentioned NA Not mentionned Not mentioned Not mentioned Yes but (3) Yes: Immunoglobulin use is recommended No: recommendations state that IG is not indicated for that disease Selected: Immunoglobulin use is recommended or reimbursed for this indication in selected cases; criteria have been established for recommendation or reimbursement. NA: non available, meaning that recommendations on this indication have not been published yet Not mentionned: this indication is not mentionned in exhaustive guidelines or list of indications RRMS: relapsing remitting multiple sclerosis a: reimbursed indications b: from national guidelines c: from labelled indications, according to the Medicine Evaluation Board d: from the “Commission de la Transparence », “Haute Autorité de Santé” (HAS), Avis 19 juillet 2006 and from AFSSAPS « Proposition de hiérarchisation des indications des immunoglobulines humaines intraveineuses (IgIV) en situation de tension forte sur les approvisionnements pour le marché français, 06/05/2008 ». (1): Labelled use (or registered use or use included in the marketing authorization) (2): Off-label use (i.e. not included in the registered indications) but IG use is recommended for this disease in the guidelines (3): Use of IG is only recommended for this disease in specific cases: after failure of other therapies or in vital emergencies (France); considered on a case by case basis in the UK, prioritised against other competing demands (grey indications); or in exceptional circumstances - urgent or life-threatening circumstances, or in circumstances in which significant morbidity would be expected and other clinically appropriate standard therapies have been exhausted or are contraindicated (Australia).
KCE Reports 120 Plasma 49 3.2.2 Evidence review on immunoglobulin effectiveness 3.2.2.1 Background 3.2.2.2 Methods The mechanisms of action of polyvalent immunoglobulins (IG) are complex and not totally elucidated today, aside of their use in correcting immunodeficiencies. In immunodeficiency diseases, polyvalent IG is given to restore normal humoral immune function by increasing antibody levels. In autoimmune disorders and some inflammatory diseases, it is assumed to have a rapid immunomodulatory action, by neutralizing circulating auto-antibodies, modulating the production of inflammatory cytokines, interfering in complement activation, and a few other mechanisms. In the long term, it also regulates the production of antibodies and cytokines. This evidence review does not cover the IG mechanisms of action but it reviews the effectiveness of IG in treating a number of diseases. Scope As more than 100 indications have been considered for IG use, this literature review focuses on the indications that contribute to address the research question. We selected indications for which IG are reimbursed or recommended by national authorities and/or likely to consume significant amounts of IG and/or have been covered in systematic reviews. We included the following diseases (see Table 21): • indications reimbursed in Belgium • diseases for which IG is recommended in five comparable industrialized countries (France, Netherlands, UK, Canada and Australia) • other diseases covered by Cochrane systematic reviews including IG effectiveness • diseases under investigation that may consume high amounts of IG Twenty-nine indications have thus been selected for this literature review: Haematological diseases 1. Primary immune deficiency conditions 2. Secondary immune deficiencies: • Multiple myeloma and chronic lymphocytic leukaemia • Allogenic bone marrow or stem cell transplant • Prophylaxis in solid organ transplant • Suspected or proven infections in neonates • Preterm and/or low birth weight infants • Paediatric HIV/AIDS 3. Idiopathic thrombocytopenic purpura 4. Isoimmune haemolytic jaundice in neonates 5. Fetal allo-immune thrombocytopenia Neurological and neuro-muscular diseases 1. Guillain-Barré syndrome (and variants) 2. Chronic inflammatory demyelinating polyradiculoneuropathy 3. Multifocal motor neuropathy 4. Paraprotein-associated peripheral neuropathies 5. Multiple sclerosis 6. Lambert-Eaton myasthenic syndrome (LEMS)
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KCE Reports 120B Plasma i PRÉFACE
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KCE Reports 120B Plasma iii MÉTHOD
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KCE Reports 120 Plasma 117 4.4 CONC
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KCE Reports 120 Plasma 119 FAVOURIN
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KCE Reports 120 Plasma 121 APPENDIX
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KCE Reports 120 Plasma 123 For othe
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KCE Reports 120 Plasma 125 Table 48
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KCE Reports 120 Plasma 131 Distribu
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KCE Reports 120 Plasma 137 6 REFERE
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KCE Reports 120 Plasma 145 165. Cua
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73. Financement du programme de soi
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