Ig Governance Criteria and Progress Updates (page under review)

July 2019

Version 3 of the Criteria

Version 3 of the Criteria for access to Ig under the national blood arrangements was implemented nationally on 22 October through BloodSTAR. Further information on Version 3 Criteria is available at https://www.blood.gov.au/igcriteria-version3.

The Ig Governance Program has received and responded to feedback relating to the new Criteria, which can inform further changes or future system requirements. A number of changes to the Criteria have been identified for consideration, and will follow a process for evolving the Criteria.

The Criteria for each medical condition can be printed from BloodSTAR or from www.criteria.blood.gov.au if required, but any printed version must regularly be checked for currency.


BloodSTAR was fully implemented as a national system on 22 October 2018 and is now the sole channel for clinicians to seek authorisation for access to Ig products under the national blood arrangements, in accordance with the Criteria.

The NBA has continued to enhance BloodSTAR so that functionality supports the Criteria and the Ig Governance Program objectives in general, as well as improving usability for end users.

A new release of BloodSTAR (version 3.1) has been implemented which provides a number of useability improvements and functionality to support Version 3 of the Criteria. The new release covers enhancements to support:

  • transitioning authorisations to the latest minor version of the Criteria;
  • product allocation; and
  • general system improvements and bug fixes.

BloodSTAR Statistics

There are currently over 13,700 patients in BloodSTAR with active authorisations and over 14,000 users as Authorisers, Medical Officers, Nurses or Facility Administrators.

There were 1004 initial authorisation requests and 17,359 dispense episodes of Ig in BloodSTAR nationally during June 2019.

Dose Rounding in BloodSTAR

When an Ig dose is requested in BloodSTAR the system automatically rounds the dose to fit the most appropriate Ig vial sizes. Generally the rounding is by a very small margin and improves the ease of dispensing and administration to patients. The requested dose is displayed to the prescriber, along with a message stating the rounded dose.

Once the request has been approved, only the rounded dose is visible on the treatment plan. The Medical Officer must continue to follow local requirements for prescription, dispensing and administration; this may be either the rounded dose, or the original requested dose if more appropriate.

As BloodSTAR authorisation is not a prescription for treatment, prescribers must consider which dose is most appropriate when completing a prescription following authorisation approval.

Health Technology Assessment of Ig use (Ig Reviews)

All Australian Governments, through the Jurisdictional Blood Committee (JBC), have agreed to conduct pilot Health Technology Assessments of Ig use for three conditions funded under the Criteria, to ensure government-funded use within Australia is based on evidence of clinical safety, effectiveness and cost-effectiveness.

The process for conducting the assessments has been based on the framework for conducting Post Market Reviews of medicines subsidised under the Pharmaceutical Benefits Scheme, with modification to allow evaluation of the evidence for each Ig indication by the Medical Services Advisory Committee (MSAC). The assessments will consider Ig use in the context of both intravenous and subcutaneous infusion where relevant.

Assessment has commenced on the following three medical conditions:

  • Chronic inflammatory demyelinating polyneuropathy (CIDP);
  • Acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation; and
  • Myasthenia gravis

Outcomes of the assessments are expected in late November 2019 and will be provided to the JBC for consideration.  Further information can be found at https://www.blood.gov.au/health-technology-assessment-reviews-immunoglobulin.

National Policy: Access to Government Funded Ig Products in Australia

An update to the National Policy: Access to Government-Funded Ig Products in Australia is being prepared to ensure it is up to date, and to provide clarification around roles and responsibilities, and access arrangements. The update to the policy will take account of the full implementation of BloodSTAR and the release of Version 3 of the Criteria, and will improve clarity, without any change of policy intent.  NBA intends to publish the updated policy on the NBA website once finalised.   

Performance Improvement and Knowledge Development

The NBA has developed a National Immunoglobulin Governance Performance Improvement Strategy (the Strategy) to monitor performance and promote continuous improvement across the Ig Governance arrangements.

The NBA has consulted with stakeholders and developed a list of activities for inclusion in the Strategy, which include:

  • educational material – a range of education activities and resources that could support clinicians and others to undertake their roles and responsibilities under the National Policy;
  • horizon scanning – options to ensure the NBA is well informed about upcoming issues, trends, advancements, policy changes, ideas, and events in relation to the use, management and governance of Ig products both domestically and internationally;
  • addressing variation in Ig use – to better understand the reasons underpinning the variation and whether it represents appropriate clinical practice or requires more active management by the NBA; and
  • auditing, reporting and identifying jurisdictional issues – a number of reporting activities are planned.

The NBA is working with BloodSafe eLearning Australia (BEA) to progress the development of an e-learning module on accessing Ig through national governance arrangements.

The NBA is also working with the Department of Health under the Value in Prescribing Program. Through this program, an external provider will be funded to deliver education tools and resources to support specialists to use Ig appropriately and in accordance with the National Policy and Criteria. 

Data and Reporting

Having availability and access to quality data is crucial in analysing current usage pattern of Ig products and identifying areas of opportunity to make targeted improvements in an efficient and effective manner.

Sharing certain data is a useful tool for communicating with stakeholders about various aspects of performance. A number of data and reporting activities have been identified as priorities and will be a focus for NBA over the next six months. These activities will facilitate ongoing work within the Performance Improvement Strategy and include:

  • establishing regular reporting (including extracts) to support Ig Governance Program activities;
  • presenting a selection of high-level snapshot data regarding Ig use; and
  • determining current user issues with governance arrangements and system via better internal reporting.

National Immunoglobulin Interest Group

The National Immunoglobulin Interest Group (NIIG) is still receiving nominations for representatives. The NBA intends to seek input from members into various Ig Governance matters as necessary. When the NBA has a specific need, NIIG members will be contacted via email with issues being discussed via teleconference if necessary.

If you would like to participate please let us know by providing your full name, facility name, position, contact phone number and email address to support@blood.gov.au. The NIIG is open to all those involved in the use and management of Ig and the NBA welcomes newcomers as well as experienced participants.

Keep Up to Date

Keep up to date with the latest Immunoglobulin Governance updates - create a BloodPortal account and from the home page click on ‘My Subscriptions’ and ‘Subscribe’ to Immunoglobulin. The latest update is available at Ig Governance Criteria and Progress Updates.

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