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Criteria for immunoglobulin products

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  • Criteria for immunoglobulin products

We manage the 'Criteria for the clinical use of immunoglobulin in Australia'. The criteria set out the conditions and circumstances for which the use of immunoglobulin (Ig) is clinically appropriate and can be considered under the national blood arrangements.

They list the medical conditions and circumstances for patients to access Ig products under the national blood arrangements.

Patients with a medical condition or circumstances not covered in the criteria may be able to access Ig privately or through a Direct Order.

View the criteria(Opens in a new tab/window).

Read about how to use the criteria(Opens in a new tab/window).

The criteria help us direct Ig products to patients who:

  • are most likely to benefit from Ig therapy
  • have no other safe and effective alternative treatments.

Our criteria are vital to the Ig Governance Program. The program ensures we use our precious Ig resources carefully and that the use of Ig in Australia reflects:

  • appropriate clinical practice
  • current scientific evidence and expert advice
  • effective and ethical use of government money
  • relevant national safety and quality standards.

The criteria are based on published scientific evidence and the opinions of clinical experts. These include individuals, clinical colleges and clinical societies.

The criteria are not intended to be clinical practice guidelines. They identify the conditions and circumstances for which:

  • the use of Ig products is clinically appropriate
  • Ig products can be accessed under the national blood arrangements.

Medical officers and transfusion medicine professionals can use the criteria to identify patients who may be eligible to receive government-funded Ig products under the national blood arrangements. All requests for Ig products are assessed against the criteria.

Learn more about Ig products.

Updating our criteria

Since updating the Criteria in 2018, we have moved to a rolling review process.  This means we update relevant parts of medical conditions in the Criteria as necessary, following a review of evidence. When a change to the Criteria is made, we report that change under the section ‘Updates since 2018’ (Criteria for immunoglobulin products | National Blood Authority(Opens in a new tab/window)(Opens in a new tab/window)).

The Criteria is evidence based and the rolling review process allows the Criteria to be updated in response to newly published evidence. Anyone can request the NBA consider changes to the Criteria to allow access for additional medical conditions or changes to current medical conditions on the Criteria at any time. Submissions should be supported by evidence and can be emailed to IgGovernance@blood.gov.au.

When new evidence is identified, or a submission is received, it is reviewed and evaluated by clinical experts on one of the NBA’s 4 Specialist Working Groups spanning neurology, haematology, immunology and transplant medicine (National immunoglobulin governance committees | National Blood Authority(Opens in a new tab/window)(Opens in a new tab/window)) to determine if a change to the Criteria is necessary. Proposed changes to the Criteria are then considered by the National Ig Governance Advisory Committee and the Jurisdictional Blood Committee. If necessary, consultation with relevant stakeholders such as the peak associations for medical specialists and patient representative groups may also be undertaken. The final decision is made by the NBA Chief Executive.

Updates since 2018

Since 2018, we've made changes to the criteria. Search for changes made by medical condition under the relevant specialty:

  • haematology
  • immunology
  • neurology
  • transplant medicine
  • not supported conditions

Get in touch

For more information about the criteria, contact us.

Phone: 1300 025 663 (13 000 BLOOD)

Email: IgGovernance@blood.gov.au

Last updated: 27 Mar 2024

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