We developed the Criteria for the clinical use of immunoglobulin in Australia (the Criteria) using specialist working groups of expert clinicians to identify the medical conditions and circumstances for which immunoglobulin (Ig) product is supplied and funded by governments under the national blood arrangements.
The Criteria are under a continuous review cycle.
This table summarises changes made to the Criteria after we published Version 3 of the criteria in October 2018. We've listed those changes by medical condition and indication.
Changes are applied immediately to new authorisations and to existing authorisations at the next continuing treatment request, unless otherwise stated. This table will be updated when any change is made.
Solid organ transplantation – medical condition
Indications
- Immediate pre and/or post-transplant where donor specific antibody(s) prevent transplantation or threaten transplantation.
- Initial treatment of acute antibody mediated transplant rejection.
- Treatment of ongoing active antibody mediated transplant rejection.
- Ongoing desensitisation of patients to improve the likelihood of transplantation.
- Treatment or prevention of graft rejection where the use of conventional immunosuppressive therapies is contraindicated or poses a threat to the graft or patient.
Summary of the changes to the Criteria
| Change | Date changed | Version no. |
| Indication 3 – The criterion in Initial and continuing review criteria has been updated to make the biopsy evidence item non mandatory. | March 2023 | 3.1 |
| All indications – The dosing controls have been updated to allow dose frequency of between 1 to 28 days to account for variable dosing. | March 2023 | 3.1 |
| Indications 2 and 3 – The qualifying criteria have been updated to allow for inclusion of evidence for transplants other than kidney or heart transplants. | March 2023 | 3.1 |
| Indication 5 – The qualifying and review criteria have been updated to clarify that patients who have no history of immunoglobulin treatment can qualify against the Criteria. | March 2023 | 3.1 |
| Indication 4, indications 1, 2, 4 – Correction of typographical errors. | March 2023 | 3.1 |
| Indications 1 and 2 – The dose wording has been updated to clarify that the doses can be administered as divided doses. | March 2023 | 3.1 |
| Indication 3 – The dose name has been updated to be consistent with other dose names in BloodSTAR. | March 2023 | 3.1 |
| Indication 2 – Correction of data entry error to allow divided dose in BloodSTAR. | March 2023 | 3.1 |
| Indication 3 – The dose text has been updated to reflect that IVIg may be given with or without plasma exchange. | March 2023 | 3.1 |
| Indication 3 – The dose text and Max Dose have been increased from 0.5 to 1.0g/kg. | March 2023 | 3.1 |
The most up-to-date version of the Criteria is online(Opens in a new tab/window) and in BloodSTAR.
Continuous review cycle
The Criteria is under a continuous review cycle to enable appropriate access. The latest full update to the Criteria – version 3 (v.3) – was published in 2018, with full transition completed in October 2019. Following this, the Criteria moved to a continuous review cycle using one of 2 mechanisms:
- Progressive changes are made as required to address clarifications, minor corrections and administrative improvements. Changes are formally recognised through sub-numbering (version 3.1 indicates that one round of progressive changes has been implemented. It then moves to 3.2, etc).
- Programmed changes provide for formal periodic review. Once updated a ‚'transition' period applies to allow patients to move from the previous version of the Criteria to the new one.
Last updated: 01 Mar 2023