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 2020. 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.
March 2020
Acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT) – Version 3.3
- Trial of cessation criterion updated to ensure medical officers are aware this must be completed.
- Other minor typographical changes.
Acute disseminated encephalomyelitis (ADEM) – Version 3.1
- Up to two one off doses, in addition to the induction dose, are now permitted over the course of the authorisation in severely affected patients who are not responding to maintenance therapy.
- The maintenance dose can now be requested as a divided dose in all indications.
Autoimmune congenital heart block – Version 3.1
- Minor typographical changes.
Autoimmune encephalitis mediated by antibodies targeting cell-surface antigens (AMAE) – Version 3.1
- The adapted Modified Rankin Scale (MRS) replaces the MRS; allowing prescribers to accurately provide a score where their patient’s primary symptom is seizures.
- Other minor typographical changes.
Childhood epileptic encephalopathy – Version 3.2
- The age limitation has been removed in BloodSTAR to allow adult patients approved as children to access ongoing Ig at review where clinically appropriate.
- The qualifying preamble has been updated to extend the time limitation to access Ig following trial off therapy to six months.
- Other minor typographical changes.
Guillain–Barré syndrome (GBS) – Version 3.1
- Intensivist added to list of specialists that can diagnose GBS. A second dose must still be on the advice of, and after assessment by, a neurologist.
Haemolytic disease of the fetus (HDF) – Version 3.1
- Description and diagnostic criteria updated to align with Patient Blood Management Guidelines (PBM) Module 6 – Neonatal and Paediatrics.
Inflammatory Myopathies: Inclusion Body Myositis (IBM) – Version 3.2
- Minor typographical changes.
Inflammatory myopathies: polymyositis (PM), dermatomyositis (DM) and necrotising autoimmune myopathy (NAM) – Version 3.2
- Corticosteroids are now listed as one of the two immunosuppressant medications that can be trialled prior to Ig.
- Other minor typographical changes.
Neonatal haemochromatosis (NH) – Version 3.1
- Dosing controls updated to allow divisions.
Paediatric autoimmune neuropsychiatric disorder associated with streptococcal infections (PANDAS) or paediatric acute neuropsychiatric disorders (PANS) – Version 3.1
- The qualifying preamble has been updated to extend the time limitation to access Ig following trial off therapy to six months.
Primary immunodeficiency diseases (PID) with antibody deficiency – Version 3.3
- Trial of cessation criterion has been updated to ensure medical officers are aware this must be completed.
- Description and diagnostic criteria updated to provide clarity around the European Society for Immunodeficiency Diseases (ESID) diagnostic criteria.
- Other minor typographical changes.
Pyoderma gangrenosum (PG) – Version 3.1
- Removal of 6-month limitation to access Ig following trial off therapy.
Secondary hypogammaglobulinaemia unrelated to haematological malignancy or haemopoietic stem cell transplant (HSCT) – Version 3.3
- Trial of cessation criterion has been updated to ensure medical officers are aware this must be completed.
- Other minor typographical changes.
Specific antibody deficiency – Version 3.2
- Qualifying preamble updated to clarify eligibility requirements.
Susac syndrome – Version 3.1
- Minor typographical changes.
Last updated: 03 Feb 2026