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

112 Plasma KCE Reports 120
A difficulty with this system is that the rationale behind the choice of classification is not
always stated or made clear, the categories need to be regulary updated, and the
application of this priorization is not always described: in the absence of shortage,
should a patient from a last priority group receive IG or not?
Establishing guidelines and criteria for use
The Canada, Australia and the UK have invested important resources and time to
produce guidelines, based on evidence and consensus sessions among experts:
• The Canadian Blood Services and the National Advisory Committee on
Blood and Blood Products began in 2004 to develop detailed and evidence
based guidelines for the use of IVIG in hematological and neurological
conditions. The results of this work are published in a supplement of the
journal Transfusion Medicine Reviews in 2007. 18-21
• In Australia, the “Criteria for the Clinical Use of Intravenous
Immunoglobulin” was developed in 2004-2007, based on evidence
identified through systematic reviews of the literature and the opinions of
clinical experts. The clinical criteria are contained within condition proforma
and have been set out to cover four major issues: list of indications
for IG use; qualifying criteria, exclusion criteria and review criteria. 22
• In the UK, as part of the “Demand Management Programme”, National
Clinical Guidelines for the appropriate use of IVIG have been produced
based on available evidence and expert opinion in the period 2006-2008.
After literature review and expert review, interested bodies registered as
“Stakeholders” provided comments on the document. Regular updates
are ensured, at least yearly.
• In France, the CEDIT has issued recommendations that are widely used.
National guidelines are also expected at national level, based on the
CEDIT work. l
• In Australia, the concept of ‘criteria for use’ constitutes a more directive
framework for decisions about the use of a particular treatment, as
opposed to the concept of “guidelines” that usually refer to the
management of conditions rather than to the use of specific therapeutic
products such as IVIG. 22 The latter term has been selected to describe the
circumstances, based on evidence and clinical experience, under which the
clinical use of IVIG is considered appropriate in Australia.
It should be noted that in each country, the production of guidelines has cost a
considerable amount of time (around 3 years), in literature review and negotiations with
experts and stakeholders. Guidelines also need to be regularly updated.
Only one study assessed the impact of guidelines on IG use. In the Atlantic region of
Canada, a study compared IVIG use between a baseline phase (2003-2004) before
guideline use, and after implementation of “optimization tools” (2005). In the second
period, they found a 7% decrease in IG use, contrasting with the previous annual rises
(7% in 2002-03 to 2003-04 and 10% from 2003-04 to 2004-05). 146
Limiting prescription of IG to specific groups
In the UK under the “Commissioning Policy”, all immunoglobulin must be prescribed by
a consultant with specialist knowledge of its use; no GP may prescribe. Prescribers must
monitor future communications on any risks to supply and understand the mechanism
for handling any shortages.