Latest updates to Ig Criteria: April 2025

The Criteria for the clinical use of immunoglobulin in Australia (the Criteria) undergoes periodic review to reflect the latest scientific evidence and expert advice from our National Immunoglobulin Governance Advisory Committee and its Specialist Working Groups.

This page summarises the changes to the Criteria which were implemented in April 2025. Changes are applied immediately to new authorisations and to existing authorisations at the next continuing treatment request, unless otherwise stated. For more information about any of these changes, please contact the Ig Governance team at IgGovernance@blood.gov.au. 

Acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT) – Version 3.5

• Minor typographical changes.

Autoimmune congenital heart block – Version 3.2

• Added information to indication 3 to clarify that this indication only applies to patients up to 6 months of age.
• Other minor typographical changes.

Fetal and neonatal alloimmune thrombocytopenia (FNAIT) – Version 3.2

• Added information to indication 3 to clarify that this indication only applies to patients up to 3 months of age.
• Other minor typographical changes.

Inborn errors of immunity (IEI) with antibody deficiency – Version 3.6

• Updated descriptive text to include more information about IEIs.
• Amended the criteria for indication 4 to remove the requirement of hypogammaglobulinaemia in patients with recognised IEIs for which Ig replacement is universally indicated.
• Other minor typographical changes.

Neonatal haemochromatosis (NH) – Version 3.2

• Added information to indication 2 to clarify that this indication only applies to patients up to 6 months of age.
• Other minor typographical changes.

Paediatric autoimmune neuropsychiatric disorder associated with streptococcal infections (PANDAS) or paediatric acute neuropsychiatric disorders (PANS) – Version 3.3

• Updated the description and diagnostic criteria, as well as qualifying and review preamble for both indications to clarify that this medical condition only applies to patients 18 years of age or less.
• Other minor typographical changes.

Secondary hypogammaglobulinaemia unrelated to haematological malignancy or haemopoietic stem cell transplant (HSCT) – Version 3.6

• Minor typographical changes.

Toxic shock syndrome (TSS) – Version 3.1

• Removed qualifying criterion regarding supportive measures from indication 1.
• Other minor typographical changes.