Objectives of the IVIg Guidelines
Although some of the new indications for IVIg are based on strong clinical evidence, a number of uses are based on relatively few data or anecdotal reports. This may be due to lack of trial data or the low prevalence of a particular disease preventing appropriate randomised controlled trials (RCTs). There is a need to provide guidance on appropriate use of immunoglobulin products and a framework for the promotion of evidence-based clinical practice to help improve consistency in patient care.
Under the aegis of the Department of Health, a review was initiated in 2006 that recommended the development of this cross-specialty national guideline. The overall objective of this guideline is therefore distinct from other disease-specific guidelines, which seek to provide recommendations on how best to manage a single disease. The goal of this guideline is to ensure best practice in the use of IVIg across all indications, based on available evidence and expert opinion.
In addition, because the supply of IVIg is limited, and demand is expected to continue to exceed supply in the medium term, there is a pressing need to introduce a process to rationalise demand as well as increasing supply, to ensure that an appropriate supply-demand balance is attained. In particular, immunoglobulin remains the only treatment option for patients with primary immune deficiencies and, in certain cases, is life-saving. Shortages must never jeopardise supply for these patients and this factor must be given primary consideration.
As a consequence, to deliver best use of IVIg requires a second factor to be considered: prioritisation of indications. To this end, this guideline has been created in synchrony with the Demand Management Plan. These two documents should be reviewed and understood in conjunction with each other.
IVIg treatment database
To complement these initiatives and support long-term planning, an immunoglobulin treatment database to record all immunoglobulin use has also been initiated. This will allow consistency in immunoglobulin use to be monitored, offer predictability in future use and will help standards of care for IVIg users to be improved.
These complementary activities are outlined in the Dear Colleague letter ‘Implementation programme to ensure security of supply of immunoglobulin’, issued through the Department of Health Gateway in March 2007 and the Dear Colleague letter ‘Programme to maintain the security of supply of immunoglobulin’, issued through the Department of Health Gateway in November 2007.