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46 Plasma KCE Reports 120 has been classified in 5 groups and published by the AFSSAPS, based on the expert recommendations. g In total, 8 groups of diseases are defined, and how to apply these priority levels is not clearly described. 5. In Australia, the “Criteria for the clinical use of intravenous immunoglobulin in Australia” has been issued by the Australian health Ministers’ conference in December 2007. 22 It is intended to be regularly updated, and revisions are periodically issued on http://www.nba.gov.au/ivig/pdf/criteria-revisions.pdf (last update February 2009). It also set up several groups of diseases for priority setting: 1. Conditions for which IVIg has an established therapeutic role; 2. conditions for which IVIg has an emerging therapeutic role: 3. conditions for which IVIg is used in exceptional circumstances; 4. conditions for which IVIg use is not indicated. As previously said, the legal status of these recommendations differs per country, due to the difference between sources describing them. Based on the comparison of national recommendations (Table 20), the following conclusions on indication for IG can be drawn: • IG is recommended in all countries for a number of diseases, in a consistent way: primary immune deficiencies, multiple myeloma and chronic lymphocytic leukaemia for selected situations, idiopathic thrombocytopenic purpura, Kawasaki disease and selected neurological diseases such as Guillain Barré syndrome. It should be noted that the recommendations published in the Netherlands include only a limited number of indications because only reimbursed indications are listed; this does not precludes that IG use is accepted for other diseases. • In many indications, IG is only recommended in “selected” cases of a given disease, according to specific criteria described by each country. Criteria include clinical variables, severity or level of disability, age, biological criteria (e.g. serum Ig levels) or therapeutic response to other treatments. For instance, IG is only recommended for multiple sclerosis and dermatomyositis cases showing failure or contra-indications to standard treatment. • However for many other diseases, recommendations for the use of IG are not consistent across countries. In most of these diseases, the available evidence on IG effectiveness is either not available, of low level, inconsistent across studies, or only show a marginal benefit. Key points • In these six industrialized countries, IG is recommended for a defined number of diseases in a consistent way. • In many indications, IG is only recommended in “selected” cases and the criteria for IG treatment vary per country. • In a number of diseases, IG is not recommended on a consistent way across countries. This mostly concern diseases with an auto-immune component, for which the available evidence is either of low level or only shows marginal benefit. g Comité d’Evaluation et de Diffusion des Innovations Techniques” (CEDIT) of the “Assistance Publique des Hôpitaux de Paris. Proposition de Hiérarchisation des indications hors AMM des IgIV réalisée par le Comité d'experts IgIV du Cedit de l'AP-HP, dans l'attente de la publication par l'Afssaps prévue d'ici fin Juin 2008 des référentiels de bon usage sur les IgIV, qui définiront les situations temporairement acceptables justifiant la mise en place d'un protocole thérapeutique temporaire. Available on http://www.afssaps.fr/Infos-de-securite/Autres-mesures-de-securite/Proposition-de-hierarchisation-desindications-des-immunoglobulines-humaines-intraveineuses-IgIV-en-situation-de-tension-forte-sur-lesapprovisionnements-pour-le-marche-francais2
KCE Reports 120 Plasma 47 Table 20: Recommendations for intravenous immunoglobulins use in six selected countries Indications Belgium a Canada b The UK b Netherlands c France d Australia b Immuno-haematological indications Idiopathic thrombocytopenic purpura Yes, selected (1) Yes (1) Yes, selected Yes (1) Yes, selected (1) Yes, selected Primary immune deficiency conditions Secondary immune deficiencies: Yes, selected (1) Yes (1) Yes, long term Yes, selected (1) Yes (1) Yes, selected - in general Not mentioned Yes (1) Yes (3) Not mentioned Yes (1) Yes in general, for selected conditions Yes, selected (1) Yes, selected (2) Yes, selected Yes, in CLL (1) Yes, selected (1) Yes, selected - multiple myeloma, chronic lymphocytic leukaemia - Allogenous bone marrow transplant - paediatric HIV/AIDS - in solid organ transplant - septicaemia in neonates - infections in preterm and/or low birth weight Isoimmune haemolytic jaundice in neonates Alloimmune thrombocytopenia, foetal and neonatal Yes (1) No but labelled Yes if low IgG Yes (1) Yes (1) Yes, selected Yes (1) Yes, selected (2) No Yes (1) Yes, selected (1) Yes, selected Not mentioned NA For CMV pneumonitis For rejection (3) Yes, kidney (1) Yes (kidney) (3) Yes, selected Yes treatment (1) NA No Not mentioned Yes (3) Yes but (3) Preterm, to treat NA NA Yes (
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KCE Reports 120B Plasma i PRÉFACE
Page 7 and 8: 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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73. Financement du programme de soi
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