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. The committee recently welcomed 8 new members. You can find the full list of members on the NBA website.

The first NIGAC meeting for 2025 was held via video conference on 30 January. During this meeting, members discussed updates to the criteria(Opens in a new tab/window) for Ig access. They also reviewed progress on recommendations for improving access to subcutaneous immunoglobulin (SCIg) in Australia. 

Members considered a draft of the Ig Prioritisation 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. It will be reviewed by key stakeholders before it us finalised.

The next NIGAC meeting is scheduled for mid-2025.

Immunoglobulin Specialist Working Groups (SWGs)

Four specialist groups support NIGAC: Immunology, Haematology, Neurology, and Transplant. These groups meet several times a year to review criteria, discuss future needs, and work on specific projects.

Recent meetings:

  • Immunology SWG: November 2024
  • Transplant SWG: January 2025
  • Haematology SWG: February 2025
  • Neurology SWG: Meeting planned in the next few months

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 2022-23 report is available on the NBA website.

The 2023-24 report will be released soon.

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
  • Share updates on changes to product storage and temperature requirements
  • Notify users of availability issues for specific products or vial sizes
  • Announce new product introductions and changes under the National Supply Arrangements

A reminder that an alternative product can be requested to the one allocated in BloodSTAR. A clinical reason must be provided to support the request. Lifeblood Authorisers review these requests carefully. Running out of stock is only a valid clinical reason in emergencies.

Immunoglobulin Product Supply Update

Plasma collection in 2023-24 improved after a decline in growth in 2022-23. The NBA continues to monitor supply and demand to prevent shortages.

Recent Ig product changes:

  • Xembify 20% introduced into supply arrangements: The addition of this SCIg product supplied by Grifols Australia Pty Ltd commenced 1 February 2024. It strengthens Australia’s diverse supply of SCIg products.
  • New vial size for Gamunex 10% (IVIg): A 40g/400ml vial was introduced in April 2024, improving infusion efficiency.
  • Transition to new IVIg and SCIg products: Patients have moved from Intragam 10 and Evogam to Privigen AU and Hizentra AU following CSL Behring’s manufacturing upgrades.

Changes to Immunoglobulin Access Criteria 

Updates to the Criteria for the Clinical Use of Immunoglobulin in Australia took effect in December 2024. Key changes include:

  • Specific antibody deficiency (SAD): Clarified the maximum dosage per period.
  • Secondary hypogammaglobulinaemia (SHG): Clinicians must provide the patient’s current IgG level when requesting an additional dose.
  • Vaccine-associated myocarditis and pericarditis (VAMP): Updated criteria to specify the vaccine must have been given within the past 20 days.
  • Toxic epidermal necrolysis (TEN) / Stevens-Johnson syndrome (SJS): Clarified dosage text.
  • Inborn errors of immunity (formerly primary immunodeficiency diseases - PID): 
    1. Changed terminology from ‘primary immunodeficiency diseases’ to ‘inborn errors of immunity’.
    2. Clinicians must provide the patient’s current IgG level when requesting an additional dose.
    3. Removed an incorrect IgA level requirement.
    4. Fixed an error in BloodSTAR requiring patients to be older than 4 years instead of 2 years.
  • Acquired hypogammaglobulinaemia (AHG) due to haematological conditions or stem cell transplant: Clinicians must provide the patient’s IgG level when requesting an additional dose.

Minor typographical corrections were also made. Full details are available on the NBA website.

Improving Access to Subcutaneous Immunoglobulin (SCIg)

The NBA is implementing recommendations from a recent review to improve SCIg access. The review identified 5 key barriers and suggested 11 solutions. Recent actions include:

  • New Ig Treatment Webpage:
    1. Videos and treatment guides for clinicians and patients
    2. Links to support organizations (IDFA, AusPIPS, ASCIA)
    3. New Sharps Disposal Guide (details below).
  • Provision of information relating to disposal of used sharp:
    1.  Development of Sharps Disposal Guide
    2. A list of disposal locations across Australia 
  • SCIg Implementation Working Group:
  1. New group with four experts from NIGAC and SWGs.
  2. First meeting in early 2025.
  • Funding for SCIg Services:
  1. As of July 1, 2024, public hospitals can receive activity-based funding (ABF) for SCIg home therapy.
  2. Funding details are outlined in the Pricing Framework for Australian Public Hospital Services 2024-25(Opens in a new tab/window) (see Item 10.22 - SCIg infusion therapy - home delivered).
  3. Additional guidance on the counting and classification rules is provided in the Tier-2 Non-Admitted Services Compendium 2024-25(Opens in a new tab/window) (see pages 23-24)
     

Updates to Blood Sector Systems (BSS)

Recent updates to BloodNet and BloodSTAR include:

  • September 2024:
    1. Multi-Factor Authentication (MFA): Added for extra security
    2. BloodSTAR v3.13 Updates: Includes AHPRA field updates and auto-suspension of users with credential changes.
  • December 2024:
    1. Not supported conditions: Medical officers can no longer create a request for unsupported conditions.
    2. Automated approval for emergency Ig requests: Certain conditions now qualify for automatic approval if they meet all criteria and the medical officer selects the status ‘emergency’.

Support materials for these changes are available on the NBA website:

The NBA is committed to delivering systems that support a dynamic blood sector. We have commenced planning to improve our digital systems and ensure they are fit for purpose into the future. Enhancement of current systems continues to support critical needs of the sector, and to maintain the integrity and security of our services.  

BloodSTAR and BloodNet Training

The NBA provides free training for new treating, administering, and dispensing facilities. Refresher training is also available.

To schedule a session, contact the Blood Operations Centre at 1300 025 663 or email support@blood.gov.au.

Last updated: 11 Mar 2025

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