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KCE Reports 120 Plasma 45
Subcutaneous immunoglobulins
Sub-cutaneous immunoglobulins, Subcuvia® and Vivaglobin®, are reimbursed for the
following indications:
• Primary immune deficiency conditions: agammaglobulinemia,
hypogammaglobulinemia with specific criteria, congenital deficiency in antipolysaccharidic
antibodies with specific criteria
• Multiple myeloma and chronic lymphocytic leukaemia.
3.2.1.2 Recommendations in other countries
The recommendations for IG use in terms of which clinical indications can be treated
with IG are presented for five other industrialized countries and compared to Belgium
in Table 20.
In Canada, the UK and Australia, guidelines are clearly stating that “IG therapy is not
indicated” for specific conditions, described as “No” in the table, when applicable.
The sources of these recommendations on IG use are described below:
1. In Canada, detailed national guidelines covering the haematological and
neurological indications have been published in four articles in the journal
Transfusion Medicine Reviews in 2007. 18-21 They have been elaborated by a
special committee, based on scientific evidence and using expert panels.
2. In the United Kingdom, evidence-based guidelines from the Department of
Health have been elaborated and the most updated version is dated May
2008. 17 Besides a list of recommendations on IG use, a list of “grey
indications” has been established: grey indications are those “for which the
evidence base is weak, in many cases because the disease is rare, and for
which IVIG treatment should be considered on a case by case basis,
prioritised against other competing demands”. This comprehensive list of
grey indications is not included in the table unless the disease was listed in
other country recommendations, and grey indications are indicated with a
“(3)”, see Table 3 legend. This guideline also includes a short list of
indications for which IVIG is not recommended (indicated as “No” in the
table).
3. In the Netherlands, labelled indications are described in a document for
prescribers from the Medicines Evaluation Board (2003). e
4. In France, full recommendations have not been yet established at national
level. Each IG specialty has a limited list of authorized indications; in addition,
a wider list of diseases for which IG is recommended has been published by
the “Commission de la Transparence”, “Haute Autorité de Santé” (HAS) for
specific products, and from the Drug Agency (AFSSAPS) for IG in general in
its document «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 ».f
Clinical indications have been categorized per level of priority in several
groups, to identify patients that should receive IG in a context of shortage.
On one hand, the indications included in the marketing authorizations
(Autorisation de Mise sur le Marché or AMM) have been classified in priority
groups: priority indications; indications to keep for vital emergencies or after
failure of alternative treatment; and non-priority indications (that can wait till
shortage end). On the other hand, a list of diseases non included in the AMM
e Medicines Evaluation Board. http://db.cbg-meb.nl/IB-teksten/h16942.pdf
f AFSSAPS. Proposition de Hiérarchisation des indications des IgIV reconnues dans l'AMM, disponible dans
la circulaire DGS/PP/DHOS/E2/AFSSaPS/2008/92 du 14/03/2008 relative à la surveillance des
approvisionnements en immunoglobulines humaines normales et à la gestion des situations de tension. 6
June 2008. Available on http://www.afssaps.fr/Infos-de-securite/Autres-mesures-de-securite/Propositionde-hierarchisation-des-indications-des-immunoglobulines-humaines-intraveineuses-IgIV-en-situation-detension-forte-sur-les-approvisionnements-pour-le-marche-francais2
Accessed January 2009.