Access to Intravenous Immunoglobulin (IVIg) in Australia
There are two main ways IVIg is available in Australia:
1. Supply under National Blood Supply (NBS) arrangements
If the IVIg is ordered to treat a medical condition which is funded under the Criteria for the Clinical Use of IVIg in Australia, then the product is supplied and funded under the NBS arrangements. In this case the cost of the product is shared between the Commonwealth and the relevant state or territory.
Orders for IVIg under the NBS arrangements are made to the Australian Red Cross Blood Service (Blood Service), which is contracted by the National Blood Authority (NBA) as the authoriser and distributor of all IVIg funded under these arrangements. In seeking authorisation, the requesting clinician will be asked to provide information to the Blood Service to establish that the request meets the Criteria for Use. For ongoing conditions, the Criteria for Use may specify review criteria to be applied in reviewing the patient to determine whether access to funded IVIg will continue.
In the role as authoriser of requests for IVIg, the Blood Service maintains a database of requests, and provides data to the NBA which is used as a basis for reporting on the annual use of IVIg in Australia.
2. Direct order and other supply arrangements
If the IVIg is to treat a medical condition which is not funded under the Criteria for Use, then the individual state or territory may approve the accessing of product under the direct order arrangements established by the NBA, or the product may be ordered directly from a commercial supplier of IVIg. In this case the supply of the product is not funded under the NBS arrangements, and the cost must be met in some other way.
For more information visit Access to IVIg Frequently Asked Questions.
Allocation between domestic and imported IVIg under National Blood Supply arrangements
When the Blood Service receives an order for IVIg under the NBS arrangements it first confirms that the order is for a condition funded under the Criteria and that the dosage ordered is consistent with the Criteria. If the order is not for a condition funded under the Criteria, the ordering clinician is informed of the options for availability of IVIg outside the NBS arrangements.
Orders under the NBS arrangements are then allocated by the Blood Service to be fulfilled by either the domestic IVIg product or by an imported product. This allocation is based on a plan agreed between the Blood Service and the NBA, which is developed in consultation with IVIg user groups and states and territories. The allocation plan specifies the categories of patients who will receive domestic IVIg and the categories who will receive imported IVIg. In general, the allocation plan seeks as far as possible to allocate domestic IVIg for longer term conditions and imported IVIg for shorter term conditions, and keep the allocation categories as consistent as possible between jurisdictions.
If the request is allocated to imported IVIg, then it will be for the requesting clinician (operating within any relevant jurisdictional or hospital policy that may apply) to choose which imported IVIg product available under NBA contracts will be supplied to fulfil the request. The Blood Service will provide the clinician with information about the available products including relevant precautions, but will not provide any advice or recommendation on the choice of a particular imported IVIg product.
Access to subcutaneous immunoglobulin
On 1 March 2013 the Jurisdictional Blood Committee approved the introduction of subcutaneous immunoglobulin into the nationally funded supply arrangements administered by the NBA. The NBA is presently determining management arrangements for access to this product and further details will be posted here.
Review of the Authorisation and Clinical Governance Framework for Intravenous Immunoglobulin
In 2011 and 2012 a review was conducted of the authorisation and clinical governance framework for Intravenous Immunoglobulin. Information on the review findings and the work program to implement its recommendations can be found under clinical governance review.
National Rh(D) antenatal prophylaxis program and guidelines
In June 2003 the Guidelines on the prophylactic use of Rh D immunoglobulin (anti-D) in obstetrics (817 KB) was issued by the NBA. The guidelines were approved by the National Health and Medical Research Council to update previous guidelines on the use of Rh D immunoglobulin (anti-D) released in 1999. The aim was to inform clinicians, other health professionals and policy makers about the revised recommendations for use of anti-D in Australia.
Following the release of this document, in 2004 the NBA announced (see letter to product user below) Stage 2 in a three-stage program, to extend routine antenatal prophylaxis to all Rh (D) negative women without preformed antibodies.