National Immunoglobulin Governance Program Update

National Blood Authority

Key Updates

This update provides a summary of recent activities in the Immunoglobulin (Ig) Governance Program.

National Immunoglobulin Governance Advisory Committee (NIGAC)

NIGAC is the main governance committee for Ig. You can find the full list of members on the NBA website.

The second NIGAC meeting for 2025 was held on site at the National Blood Authority (NBA) in Canberra on 27 June 2025. During this meeting, members discussed updates to the criteria for clinical use of Ig in Australia (the Criteria(Opens in a new tab/window)), including the revised process for making changes to the Criteria, proposed new medical conditions for inclusion in the Criteria, and proposed changes to the Criteria for existing medical conditions.

Members endorsed the Ig Prioritisation Framework (framework), which will help guide decision-making during supply shortages. Whilst there are no concerns about Ig supply in Australia this framework is part of the NBA's long-term contingency planning.

The framework will help manage Ig supply by setting guidelines for product allocation and ethical decision-making if there is a shortage of Ig. The next step includes an implementation phase in 2026 before the framework will be made publicly available.

Members also reviewed progress on recommendations for improving access to subcutaneous immunoglobulin (SCIg) in Australia. One of the recommendations discussed was a national statement on the clinical, patient and cost-effective benefits of SCIg. The national statement was endorsed by NIGAC.

There are 4 specialist working groups (SWGs) which report to NIGAC, providing clinical advice relating to the specialties Haematology, Immunology, Neurology and Transplant Medicine. At the NIGAC meeting, members endorsed the new work plans for the 4 SWGs, which will guide their activities for 2025-28.

At the June 2025 NIGAC meeting, members approved targeted consultation for proposed changes to the following Criteria conditions:

  • haemolytic disease of the newborn (HDN)
    • desensitisation of donor specific antibodies in HLA mismatched allogeneic haemopoietic stem cell transplantation (aHSCT)
    • solid organ transplantation.

Minor changes to 3 not supported conditions - long COVID, recurrent miscarriage and erythromelalgia - were also endorsed by NIGAC.

The next NIGAC meeting is scheduled for late-2025. Outcomes from that meeting will be communicated in the first Ig Governance Program Update of 2026.

Immunoglobulin Specialist Working Groups (SWGs)

The 4 SWGs meet as required to review the Criteria, discuss future needs, and work on specific projects.

Recent meetings:

  • Immunology SWG: May and October 2025
  • Transplant Medicine SWG: January 2025
  • Haematology SWG: February and September 2025
  • Neurology SWG: June and August 2025

Immunoglobulin Use and Supply Reporting

The NBA uses data to track blood product use and ensure supply planning is accurate.

Each year, the NBA publishes the Report on the Issue and Use of Ig, which analyses national Ig supply data. The 2023-24 annual report on Ig use has now been published and is available on the NBA website at Report on the Issue and Use of Immunoglobulin | National Blood Authority(Opens in a new tab/window).

Managing Immunoglobulin Supply and Allocation

The NBA works with the Australian Red Cross Lifeblood to manage the national Ig supply. The NBA closely monitors allocations through BloodSTAR and adjusts them as needed.

BloodSTAR and BloodNet are used to:

  • Ensure health providers keep enough Ig stock for patients
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