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.

These tables summarise 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.

Acute disseminated encephalomyelitis (ADEM)

Indications

  • Monophasic ADEM unresponsive to corticosteroid therapy or where corticosteroids are contraindicated.
  • Recurrent or multiphasic ADEM unresponsive to steroid therapy or where corticosteroid therapy has become intolerable or is contraindicated.
  • Relapse of patients with recurrent or multiphasic ADEM within 6 months of commencement of trial off immunoglobulin therapy.
Summary of the changesDate changedVersion no.
  • Up to 2 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.
March 20203.1

Autoimmune encephalitis mediated by antibodies targeting cell-surface antigens (AMAE)

Indications

  • Confirmed antibody mediated autoimmune encephalitis (AMAE) or limbic encephalitis – cell surface antibody positive.
  • Suspected antibody mediated autoimmune encephalitis (AMAE) – antibody results not available or sero-negative AMAE or seronegative limbic encephalitis.
Summary of the changesDate changedVersion no.
  • The adapted Modified Rankin Scale (MRS) replaces the MRS; allowing prescribers to accurately provide a score where their patient’s primary symptom is seizures.
  • The Qualifying Criteria post-script has been updated in suspected AMAE to clarify the appropriate indication for patients with antiGAD, thyroid and the classical intracellular antineuronal antibodies.
March 20203.1

Childhood epileptic encephalopathy

Indications

  • Children with epileptic encephalopathy resistant to anti-epileptic medications and steroid therapy or steroid responsive but dependent.
  • Relapse of epileptic encephalopathy following a trial of weaning from Ig therapy in a patient previously demonstrating response.
Summary of the changesDate changedVersion no. 
  • The age limitation has been removed in BloodSTAR to allow adult patients approved as children to access ongoing Ig at review where clinically appropriate.
  • Exclusion Criteria links have been updated.
  • Correction of typographical errors in the qualifying postscript and review preamble.
  • The Qualifying Preamble has been updated to extend the time limitation to access Ig following trial off therapy to 6 months.
March 20203.2 

Chronic inflammatory demyelinating polyneuropathy (CIDP), (including IgG and IgA paraproteinaemic demyelinating neuropathies)

Indications

  • Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) for patients in whom walking is compromised or there is significant disability.
  • Relapse of chronic inflammatory demyelinating polyneuropathy (CIDP) patients within 6 months of commencement of trial off Ig therapy.
Summary of the changesDate changedVersion no.
  • An additional one-off dose is now available during the course of the authorisation in the form of intravenous immunoglobulin or subcutaneous immunoglobulin.
  • Separate doses are now available for intravenous and subcutaneous immunoglobulin administration.
October 20193.2
  • Bibliography links have been corrected.
  • Data entry error has been corrected in the Qualifying Criteria for indication Relapse of chronic inflammatory demyelinating polyneuropathy (CIDP) patients within 6 months of commencement of trial off immunoglobulin therapy.
  • Subcutaneous administration of Ig can be considered as an alternative to intravenous Ig (IVIg) following stabilisation with IVIg.
August 20193.1

Guillain–Barr√© syndrome (GBS)

Indications

  • Initial therapy for GBS with significant disability and progression
  • Relapse in GBS treatment-related fluctuation with initial improvement and subsequent deterioration post IVIg treatment
Summary of the changesDate changedVersion no.
  • Intensivist added to list of specialists that can diagnose GBS, in addition to a Neurologist, Paediatrician or a General Medicine Physician. A second dose must still be on the advice of, and after assessment by, a neurologist.
March 20203.1

Inflammatory myopathies: inclusion body myositis (IBM)

Indications

  • Patients with inclusion body myositis (IBM) who have dysphagia limiting dietary intake.
Summary of the changesDate changedVersion no.
  • Maintenance dose text has been clarified.
March 20203.1

Inflammatory myopathies: polymyositis (PM), dermatomyositis (DM) and necrotising autoimmune myopathy (NAM)

Indications

  • Treatment of significant muscle weakness or dysphagia unresponsive to corticosteroids and other immunosuppressant agents in adults with biopsy-proven PM or DM or NAM or children with clinical, biochemical and imaging abnormalities consistent with definite PM or DM or NAM.
Summary of the changesDate changedVersion no.
  • Corticosteroids are now listed as one of the 2 immunosuppressant medications that can be trialled prior to Ig.
  • List order changed to most common order of trial.
March 20203.2

Opsoclonus-myoclonus ataxia (OMA)

Indications

  • Treatment of OMA initially diagnosed in a child.
Summary of the changesDate changedVersion no.
  • Data entry error corrected to remove age limitation in BloodSTAR.
May 20193.1

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

Indications

  • Relapse of paediatric autoimmune neuropsychiatric disorder associated with streptococcal infections (PANDAS) or paediatric acute neuropsychiatric disorders (PANS) symptoms within 3 months of commencement of trial off Ig therapy.
Summary of the changesDate changedVersion no.
  • The Qualifying Preamble has been updated to extend the time limitation to access Ig following trial off therapy to 6 months.
March 20203.1

Susac syndrome

Indications

  • Probable or definite Susac syndrome in concurrence with high dose corticosteroids.
Summary of the changesDate changedVersion no.
  • Data entry error corrected in the Modified Rankin Scale controls for Review Criteria.
March 20203.1

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 ‚Äòtransition’ period applies to allow patients to move from the previous version of the Criteria to the new one.

Learn more about the Criteria.

Get in touch

Phone: 13 000 25 663 (13 000 BLOOD)

Email: IgGovernance@blood.gov.au

Last updated: 01 Mar 2020

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