The Criteria for clinical use of immunoglobulin in Australia (Criteria) is under a continuous review cycle.
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 now moves to a continuous review cycle using one of two 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.).
A summary of all progressive changes made in each speciality, listed by medical condition and indication, is also provided in the attachments below. These documents will be updated when any change is made and the file name shows the date of the most recent update.
- Immunology March 2020 (652.15 KB)
- Haematology March 2020 (628.52 KB)
- Neurology March 2020 (644.33 KB)
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.
The Criteria were first published in 2007 and updated in 2012, and have been successful in defining the eligibility for access to product funded under the national blood arrangements. A further review of the Criteria commenced in 2014 and followed a comprehensive process to result in Version 3 of the Criteria, released nationally and into BloodSTAR in 2018.
The review addressed recommendations that arose from the Review of the clinical governance and authorisation process for intravenous IG commissioned by the NBA and undertaken by Ernst and Young in 2012. The review recommended the next development of the Criteria apply more consistent qualifying and review criteria across the conditions.
Version 3 of the Criteria more clearly articulates and standardises the diagnostic, qualifying and review criteria, initial and continuing authorisation periods, dosing controls and supporting evidence for access to Ig under the National Blood Agreement. These changes enhance consistency in access and further support the use of Ig products for clinically appropriate purposes, and for the treatment of patients whose health is most likely to be improved with Ig therapy.