National Immunoglobulin Governance Program

The provision and supply of immunoglobulin (Ig) products under the national blood arrangements is managed and funded by the National Blood Authority (NBA) on behalf of all governments. Immunoglobulin products supplied and funded under these arrangements are listed on the National Product Price List, and include:

• Intravenous Immunoglobulin (IVIg)
• Subcutaneous Immunoglobulin (SCIg)
• Normal Human Immunoglobulin (NHIg)

Purpose of the program

Following the Review of the authorisation and clinical governance of intravenous immunoglobulin in 2012 the Jurisdictional Blood Committee (JBC) endorsed the National Blood Authority Immunoglobulin Governance Program which aims to develop and implement a number of improvement projects to address the findings and recommendations of the Review and to further strengthen the governance and authorisation for the management and use of Ig in Australia.
The program aims to improve the governance and management of publicly funded Ig to ensure that: 

• product use and management reflects appropriate clinical practice and
• represents efficient, effective and ethical expenditure of government funds
• in accordance with relevant national safety and quality standards for health care. 

Immunoglobulin treatment in Australia: governance and national policy video

Watch this video for an overview of immunoglobulin governance in Australia, including eligibility under the National Policy and how to make a request.

Outcomes of the program

Program measures include:
Development and maintenance of policies and procedures for access to Ig products – The National Policy: Access to Government-Funded Immunoglobulin Products in Australia describes the roles and responsibilities of key participants in the governance and management framework for immunoglobulin products. This includes integration of NHIg into IVIg arrangements, introduction of consent forms and centralised ordering.

Establishment and support of a national network of committees – An integrated network of National Immunoglobulin Governance Committees has been established, including the National Immunoglobulin Governance Advisory Committee and specialist working groups. The advice and recommendations of this committee network fundamentally informs the development, implementation and ongoing operation of the other governance program measures.

Evolving the criteria for access - The Criteria for the clinical use of intravenous immunoglobulin in Australia (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.  Version 3 of the Criteria was released in BloodSTAR in 2018.  More information on the transition to Version 3 of the Criteria can be found here.

Implementation of a national ordering and outcomes database – BloodSTAR has been developed to support prescribers, nurses, dispenser and health facilities, manage supply and order Ig products and assist them in meeting their obligations set out in the National Policy. BloodSTAR aims to facilitate a consistent and equitable approach to the application of the national policy and the Criteria, as well as improve transparency for governments and others to help inform supply and demand of immunoglobulin products.

Development and implementation of a performance improvement program – Under the guidance of the national committee network; and utilising the Criteria and the National Policy, and BloodSTAR, a program is being developed to monitor, assess and improve the performance of the governance system and identify improvements to systems and processes. 

Facilitate knowledge development – The knowledge development program will identify priorities for development of better knowledge to allow for better decision making. This will be at both the clinician and system level and will looking at things like value of investment in research, education and training. 
If you would like to be involved in informing the development of the Ig Governance Program, you can contact the National Blood Authority on 13 000 IGGOV (13 000 44468) or email IgGovernance@blood.gov.au.

Immunoglobulin (Ig) Program Evaluation

In 2021, the National Blood Authority engaged PricewaterhouseCoopers Consulting (PwC) to evaluate the impact of the NBA's Immunoglobulin Governance Program. The Evaluation aimed to better understand the drivers of growth in Ig use in Australia and asses the impact of the Ig Governance Program in reducing the use of Ig since the program was implemented in 2014. 

The evaluation report is available here (2.26 MB).

The evaluation was finalised in May 2021. Key highlights of the evaluation include:

• since implementation of the Ig Governance Program, the rate of growth in Ig usage had reduced from an average 10.4 per cent annually, to 7.3 per cent;
• there is a correlation between key components of the Ig Governance Program and decreasing use of Ig, most notably following the introduction of Version 3 of the Ig access Criteria and BloodSTAR;
• the reduced growth in Ig demand, has delivered estimated savings of almost $90 million in potential product expenditure since 2018-19 and is expected to grow to an estimated $2.2 billion by 2030–31;
• there have been no major changes in use observed in the ten most commonly treated medical conditions and no reduction in the doses administered. This indicates that since the Ig Governance Program was implemented, more targeted access to Ig has been achieved rather than access to Ig being ceased for those who need it. 

The evaluation made three recommendations for further improvements:

• improve the use of data to further understand the drivers of Ig use;
• consider opportunities to streamline BloodSTAR to enhance user experience; and
• improve patient education and awareness of Ig.

The NBA will incorporate these recommendations through further continuous improvement of program activities.

Keep up to date

Ig Program Updates provides a snapshot of the NBA’s current work program and priorities in the immunoglobulin space. It is updated quarterly.

To receive the latest Immunoglobulin Governance Program Updates by email, join the Ig Updates and National Immunoglobulin Interest Group (NIIG) subscription list: email Iggovernance@blood.gov.au with the words SUBSCRIBE Ig Program Updates and NIIG in the subject line.

In the body of the email, please indicate your interest (e.g. Healthcare Professional/ Patient/ Government, etc.) and include your signature block.

Subscribers receive notification of the quarterly Ig Program Updates, and may also be invited to informally discuss and comment on individual Ig-related issues as they arise (participation is optional).

For more information on NIIG, see: www.blood.gov.au/Ig-committees.

For further information

Please contact the National Blood Authority on 13 000 BLOOD (13 000 25 663)  or email IgGovernance@blood.gov.au.