National Immunoglobulin Governance Program update

National Immunoglobulin Governance Advisory Committee (NIGAC)

The second meeting of the NIGAC for 2022 was held via video conference on 29 July 2022. During this meeting the NIGAC reviewed and endorsed the criteria for the use of Government funded immunoglobulin for the treatment of Vaccine Associated Myocarditis and Pericarditis (VAMP) and discussed updates to the criteria changes process.

The next meeting of the NIGAC is planned for December 2022.

Immunoglobulin Specialist Working Groups (SWGs)

All four SWGs met in the second half of 2022 – Haematology and Neurology in August and Immunology and Transplant in October. The Neurology SWG also met on 5 August 2022 for a workshop to discuss strategies to reduce the misdiagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Each SWG also continued work on topics from their workplans.

All four SWGs are set to meet again in February/March 2023.

Product allocation

The NBA actively manages the national supply and allocation of Ig in conjunction with the Australian Red Cross Lifeblood (Lifeblood). This has become more important during the COVID-19 pandemic and into the COVID-19 recovery period. Amongst its many consequences, issues arising from the pandemic (such as the level of blood and plasma donations, blood inventory levels, manufacturing, logistics and other supply chain issues) have also put pressure on the global supply of plasma derived products.

To ensure the security of Australia’s overall supply of Ig, the NBA has been more actively monitoring the allocation of Ig products through BloodSTAR and has adjusted allocations as necessary to ensure that supply arrangements are properly maintained in accordance with the national blood arrangements funded by all Australian governments. This allocation process continues to take account of clinical requirements and considers the continued availability of both domestic and imported products from the various suppliers, together with any emerging pressures on product availability.

Given these pressures, the NBA relies on BloodSTAR and BloodNet to communicate supply updates and changes to allocation requirements to ensure stakeholders have the most up to date information. The NBA utilises BloodSTAR and BloodNet to:

• Request Australian Health Providers (AHPs) to hold Ig products required to have adequate coverage for patients in accordance with current product allocation.
• Provide updates on changes to product storage and temperature requirements.
• Advise of any availability issues for products and specific vial sizes.
• Advise of future product changes and/or the introduction of the new products under the National Supply Arrangements.

Australia’s domestic plasma products transition in 2023

The NBA has announced five domestically produced plasma products are undergoing a transition in 2023. Two of the products transitioning are Australia’s intravenous Ig (Intragam) and subcutaneous Ig (Evogam). Details will be provided ahead of the transition including what is changing and when and required action.

Information on the new products, communication of the changes to patients, and updating or development of relevant Australian Health Provider protocols and processes will also be provided soon.

Changes to the Criteria

The NBA has adapted the process to implement changes to the Criteria to make it more efficient while retaining the high level of clinical advice needed to support equitable access to Ig. There are a range of proposed changes being reviewed and it is anticipated that the activities being progressed by the SWG committees will generate further changes to the Criteria. Changes to the condition solid organ transplantation will be implemented in January/February 2023.

Review of the National Subcutaneous Immunoglobulin (SCIg) Program

In March 2022, the NBA commenced an evaluation of the effectiveness of the National SCIg Program. The evaluation aims to identify and present options that may be implemented to assist in overcoming current barriers to program uptake and to inform the future direction of the Program. HealthConsult was engaged to undertake the evaluation.

Consultations have been completed and the Project Working Group (made up of jurisdictions, clinical specialists and patient support groups) has provided feedback on the feasibility of options to be presented to the NBA. The final report is expected in early 2023.

NPS MedicineWise Resources

The NPS MedicineWise Value in Prescribing program resources have been developed and were published on the NPS website earlier this year. It has since been announced that NPS MedicineWise will cease operations on 31 December 2022. This follows the decision by the Federal Minister for Health and Aged Care, the Hon Mark Butler, to continue with the redesign of the Quality Use of Therapeutics, Diagnostics and Pathology (QUTDP) Program announced in the March 2022 Federal Budget.

Program materials developed as part of the Value in Prescribing Immunoglobulins program and hosted on the NPS MedicineWise website will be transitioning to the Department of Health and Aged Care. The NBA is working with the Department of Health and Aged Care to ensure resources remain available for patients and health care professionals.

SARS-Cov-2 antibodies and Immunoglobulin products

With the increasing number of COVID-19 cases and vaccination rates, more research is focussing on the levels of SARS-Cov-2 antibodies in plasma-derived Immunoglobulin (Ig) products.

The level of SARS-Cov-2 antibodies vary between different manufactured batches of Ig. It is widely understood that SARS-Cov-2 antibodies are increasingly becoming detected in Ig samples. These antibodies are derived from donors who have been exposed to COVID-19 and from vaccination.

There is some evidence of some level of neutralization of COVID-19 from Ig products. However, the clinical dose that is considered efficacious against the protection of COVID-19, is not yet established.

The NBA will continue to monitor this evolving space.

BloodSTAR Systems Release September and November 2022

BloodSTAR were implemented on 4 September 2022 (BloodSTAR version 3.8). The release included a series of enhancements for medical officers and authorisers.

A third release took effect on 27 November 2022 (BloodSTAR version 3.9). The release included a series of enhancements for medical officers, authorisers and dispensers.

Work has commenced on the analysis and development of enhancements for future releases. Enhancements are based on feedback identified by users and internally by NBA staff.

BloodSTAR and BloodNet training

The NBA provides free-of-charge training in BloodSTAR and BloodNet to new treating, administering and dispensing facilities. Additional training can also be provided to new staff members or personnel that would like to refresh their knowledge or reinforce specific procedures. Please contact the Blood Operations Centre team at 1300 025 663 or via email at support@blood.gov.au to schedule a training session.