Access to subcutaneous immunoglobulin in Australia
On 1 March 2013, the Jurisdictional Blood Committee (JBC) approved the introduction of subcutaneous immunoglobulin (SCIg) under the national blood arrangements through an assurance framework for the appropriate use of the product.
Participation in the SCIg program requires hospitals to establish their capability and capacity to manage a hospital based SCIg program within the governing requirements described below, and requires endorsement by state health departments in some states. A list of participating hospitals and their contact details is available on this web page.
SCIg is only approved for patients with a medical condition:
1. where there is support for use cited in the Criteria for the clinical use of intravenous immunoglobulin in Australia, namely:
- primary immunodeficiency diseases with antibody deficiency
- specific antibody deficiency
- acquired hypogammaglobulinaemia secondary to haematological malignancies (chronic lymphocytic leukaemia, multiple myeloma, non-Hodgkin lymphoma and other relevant malignancies, and post-haemopoietic stem cell transplantation)
- secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency)
2. being treated by a clinical specialist within a hospital based SCIg program (see below), where the hospital provides access to all resources and takes full accountability for the management and use of the SCIg product, at no additional cost to patients, and
3. following a patient-specific SCIg request submitted to, and authorised by, the Australian Red Cross Blood Service (Blood Service).
The NBA has arrangements in place for the supply of SCIg products. There are both domestic and imported SCIg products available. All SCIg products must be ordered from the Blood Service.
Outcomes of RFT for supply of imported immunoglobulin products (NBA RFT 02/2014)
The NBA has successfully concluded the tender process for the supply of imported intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg), to replace the contracts for these products which expire on 31 December 2015.
Further information on the outcomes of the tender and the transition arrangements is available at http://www.blood.gov.au/Ig-tender-outcomes.
Hospitals participating in the national SCIg programs are required to provide an acknowledgement of the governing requirements by the Chief Executive or Director of Clinical Services (or equivalent) prior to ordering and providing SCIg products to their patients, using the following form.
New South Wales (NSW) requirements
In NSW these requirements are being managed by the NSW Ministry of Health through communication with Local Health District and Specialty Health Network Chief Executives, and this form is not required. For information on NSW arrangements contact Dr Jan Fizzell, Medical Adviser, Office of the Chief Health Officer via email at jan.fizzell [at] doh.health.nsw.gov.au.
South Australia (SA) and Western Australia (WA) requirements
In South Australia and Western Australia, hospitals participating in the program are still required to complete the National SCIg program - hospital acknowledgement form. On receipt of this form the Blood Service will liaise with the relevant state health department to confirm hospital participation.
Hospitals participating in the National SCIg program
A number of hospitals across most states and territories are participating in the National SCIg Program. To view the current list, please click on the image below.
The following materials are provided to assist hospital based SCIg programs.
- Generic training checklist for SCIg Program (pdf) (78.88 KB)
- Generic training checklist for SCIg Program (docx) (26.51 KB)
- Patient Information: Subcutaneous Immunoglobulin Treatment (pdf) (636.33 KB)
- Patient Information: Subcutaneous Immunoglobulin Treatment (docx) (2.62 MB)
- Patient Receipt and Use Diary - Subcutaneous Immunoglobulin Treatment Record (pdf)(36.33 KB)
- Patient Receipt and Use Diary - Subcutaneous Immunoglobulin Treatment Record (xlsx)(12.15 KB)
- Frequently Asked Questions: Subcutaneous Immunoglobulin (pdf) (177.82 KB) (176.34 KB)
- Frequently Asked Questions: Subcutaneous Immunoglobulin (docx) (148.92 KB) (148.2 KB)
For further information please contact the National Blood Authority on 13 000 IG GOV (13 000 44 468) or email IgGovernance [at] blood.gov.au.