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
- 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.
An alternative product can be requested to the one allocated in BloodSTAR however a clinical reason must be provided to support a request. Lifeblood Authorisers review these requests carefully, noting running out of stock is only a valid clinical reason in emergencies. Administering facilities are encouraged to have protocols in place for administration of both domestic and imported Ig products, in preparedness for patients who may require alternative products.
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.
Phase out of Flebogamma 5% DIF 2.5g/50mL vial size
The Flebogamma 5% DIF 2.5/50mL vial size is currently being phased out and there is now only a small amount of remaining stock for this product to order from Lifeblood. The phase out of the Flebogamma 5% DIF 2.5g/50mL size will align the remaining available Flebogamma 5% DIF vial sizes with all other imported Ig products and reduce the total number of vials potentially required for an infusion.
The changes to BloodSTAR have been made so that new authorisation requests for Flebogamma 5% DIF will receive authorised doses rounded to the nearest 5g.
Changes to Immunoglobulin Access Criteria
Updates to the Criteria took effect in April 2025. Key changes included:
- Toxic shock syndrome (TSS) – removed the qualifying criterion regarding supportive measures from indication 1
- Inborn errors of immunity (IEI) – removed the requirement for hypogammaglobulinaemia in patients with recognised inborn errors of immunity for which immunoglobulin replacement is universally indicated
- Paediatric autoimmune neuropsychiatric disorder associated with streptococcal infections (PANDAS) or paediatric acute neuropsychiatric disorders (PANS) –
- included information about age cut-off in description and diagnostic criteria
- updated qualifying and review preamble for both indications to note that they only apply to patients 18 years of age or less
- resolved an error where a qualifying criterion was missing, and 2 evidence items appeared under the incorrect qualifying criterion
Further updates to the Criteria occurred in November 2025. Key changes included:
- Antibody mediated autoimmune encephalitis (AMAE) –
- update evidence item for qualifying criteria for indication 1
- update dose text for indications 1 and 2, and dose frequency for indication 2
- update links for several references
- Cicatricial pemphigoid / mucous membrane pemphigoid (CP/MMP) –
- add qualifying preamble recommending a trial of rituximab unless contraindicated
- update links for several references
- Epidermolysis bullosa acquisita (EBA) –
- add qualifying preamble to both indications recommending a trial of rituximab unless contraindicated
- update links for several references
- Immune thrombocytopenic purpura (ITP) — adult –
- provide clarity in clinician and assessment instructions for one evidence item relating to maintenance platelet count
- add exclusion criteria for FNAIT
- reorder indications 1-3 so life-threatening indication is first in list
- update links for several references
- Immune thrombocytopenic purpura (ITP) — in children 15 years and younger –
- provide clarity in clinician and assessment instructions for one evidence item relating to maintenance platelet count
- add exclusion criteria for FNAIT
- update links for several references
- Pemphigus foliaceus (PF) –
- amend qualifying and review criteria to require a trial of rituximab unless strongly contraindicated
- update links for several references
- Pemphigus vulgaris (PV) –
- amend qualifying and review criteria to require a trial of rituximab unless strongly contraindicated
- update links for several references
- Erythromelalgia – inclusion of new ‘not supported’ condition
- Long COVID – inclusion of new ‘not supported’ condition
- Recurrent miscarriage/recurrent fetal loss (with or without antiphospholipid syndrome) – update the existing ‘not supported’ criteria entry for recurrent fetal loss (with or without antiphospholipid syndrome) to include additional information about recurrent miscarriage.
In addition to those listed above, minor changes were made to several other conditions including clarification of instructions, correction of typographical errors and updates to bibliography links. Detailed information about all changes is available on the NBA website under the Haematology, Immunology and Neurology attachments.
Improving Access to Subcutaneous Immunoglobulin (SCIg)
The NBA is implementing recommendations from a recent review to improve SCIg access. Recent actions include:
- New Ig Treatment Webpage:
- videos and treatment guides for clinicians and patients
- links to support organisations (IDFA, AusPIPS, ASCIA)
- new sharps disposal guide (details below).
- Provision of information relating to disposal of used sharps:
- development of Sharps Disposal Guide
- list of disposal locations across Australia.
- Development of a draft national statement on the benefits of SCIg:
- targeted consultation concluded in September 2025. The aim of targeted consultation is to ensure the final product meets the requirements of being a strong supportive and useful document for patients, health professionals and facilities.
- to assist with feedback, a short survey was developed in consultation with the SCIg Implementation Working Group (SCIg IWG) to accompany the draft national statement.
- SCIg Implementation Working Group:
o new group with 4 experts from NIGAC and SWGs
o 3 meetings have been held in March, May and October 2025. - Funding for SCIg Services:
o as of 1 July 2024, public hospitals can receive activity-based funding (ABF) for SCIg home therapy. Adjustments were made as of 1 July 2025.
o 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).
o 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)
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.
Support materials for changes to BloodSTAR and BloodNet are available on the NBA website:
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.
BloodSafe eLearning SCIg Course
The BloodSafe eLearning SCIg course is expected to be released in early 2026. On completion of the course the learner should be able to:
- explain the governance arrangements for the use of SCIg
- discuss the requirements for organisations to be part of the national SCIg program
- identify patient groups that are eligible for SCIg as per the Criteria
- demonstrate the training required to enable a patient to self-administer SCIg safely.
Last updated: 19 Jan 2026