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.

Approved access conditions for SCIg

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 immunoglobulin in Australia, namely:

• primary immunodeficiency diseases with antibody deficiency
• specific antibody deficiency
• acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT)
• secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT)
• Chronic inflammatory demyelinating polyneuropathy (CIDP), (including IgG and IgA paraproteinaemic demyelinating neuropathies)*

* SCIg is approved for use for the treatment of CIDP under the national blood arrangements pending the outcome of a current Health Technology Assessment (HTA) review evaluating the use of immunoglobulin in the treatment of CIDP. For more information please visit here [2].

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 in BloodSTAR.

SCIg Products

The NBA has arrangements in place for the supply of SCIg products. There are both domestic and imported SCIg products available. Orders for SCIg are made through BloodNet [3]. In seeking authorisation, the requesting medical officer will be asked to provide information to the Blood Service through BloodSTAR [4] to establish that the request meets the Criteria. 

Access to BloodSTAR is only available through the BloodPortal [5]. To register an individual account follow the process outlined in the instructions and tip sheets available here [6].

BloodSTAR has been designed to implement best practice privacy controls and is fully compliant with the Privacy Act 1988 (Cwlth) [7]. For more information about the privacy controls in BloodSTAR, visit the BloodSTAR Privacy Controls [8] page.

Requirements for hospitals participating in national SCIg programs

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.

[9]   (pdf)  [10]   (docx)

In all states (except NSW)

In all states except NSW, hospitals participating in the program are required to provide an acknowledgement of the governing requirements by the Chief Executive or Director of Clinical Services (or equivalent) and forward this form to the National Blood Authority via fax or email (please see contact details below). In South Australia and Western Australia, hospitals participating in the program also require endorsement from their State Health Department.

Please forward the completed form to the National Blood Authority at
Fax: (02) 6151 5235  (Attention: Ig Governance)
Email: iggovernance@blood.gov.au [11] 

[12]

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 Marianne Gale, Medical Adviser, Office of the Chief Health Officer via email at MGALE@doh.health.nsw.gov.au [13].

Hospitals participating in the National SCIg program

A number of hospitals across all states and territories are participating in the National SCIg Program.  To view the current list, please click on the image below.

[14]   (pdf)  [15]    (xlsx)

SCIg support materials

The following materials are provided to assist hospital based SCIg programs.

• Generic training checklist for SCIg Program (pdf) [16] (78.88 KB)
• Generic training checklist for SCIg Program (docx) [17] (26.51 KB)
• Patient Information: Subcutaneous Immunoglobulin Treatment (pdf) [18] (636.33 KB)
• Patient Information: Subcutaneous Immunoglobulin Treatment (docx) [19] (2.62 MB)
• Patient Receipt and Use Diary - Subcutaneous Immunoglobulin Treatment Record (pdf) [20](36.33 KB)
• Patient Receipt and Use Diary - Subcutaneous Immunoglobulin Treatment Record (xlsx) [21](12.15 KB)
• Frequently Asked Questions: Subcutaneous Immunoglobulin (pdf) [22] (177.67 KB) (176.34 KB)
• Frequently Asked Questions: Subcutaneous Immunoglobulin (docx) [23] (148.9 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@blood.gov.au [24].