Immunoglobulin Governance Program Updates

This page is updated 3-4 times a year to provide medical specialists, nurses, dispensers, consumers and other stakeholders a snapshot of the NBA’s current work program and priorities in the Immunoglobulin (Ig) space. Links to further information are provided as applicable.

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July 2022 Update

 

A snapshot of recent activity in the Immunoglobulin Governance program is provided below. 

Key Issue Summary

National Immunoglobulin Governance Advisory Committee (NIGAC)

The third meeting for 2021 of the NIGAC was held by videoconference on 7 December 2021. During this meeting the NIGAC reviewed and endorsed the workplans for each of the four Specialist Working Groups (SWG) and the SWG Chairs provided updates on the work of each group.

Representatives from NPS MedicineWise also attended the meeting and provided an update on their work on the Value in Prescribing project.

The meeting also included updates on the Health Technology Assessment (HTA) reviews by Medical Services Advisory Committee (MASC), Horizon scanning and monitoring regarding Intravenous immunoglobulin (IVIg) and COVID-19, data and reporting on the use of Ig as well as a discussion about the Ig Governance Program Impact Evaluation report.

The NIGAC was also called for an ad hoc meeting on 11 March 2022 to discuss the availability of Privigen and the need for the NBA to move some existing patients off Privigen and on to an alternative product. NIGAC provided clinical advice and patient perspectives to assist the NBA in deciding how best to change some patient’s treatment.

The next meeting of the NIGAC is being planned for July 2022.

Product Allocation

The NBA actively manages the national supply and allocation of immunoglobulin in conjunction with the Australian Red Cross Lifeblood (Lifeblood). This has become more important during the COVID-19 pandemic. 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 caused global challenges to the 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 maintained in accordance with the national blood arrangements funded by all Australian governments. The allocation process takes into account clinical requirements primarily 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 has temporarily set allocations in BloodSTAR such that no new patients are being allocated some Ig products. Although there is no current overall shortage of Ig in Australia, this is intended to ensure that all Ig products can be maintained to meet the demand from existing patients already being prescribed these products and minimise the risk of patients needing to change products during their treatment. It also aims to ensure an equivalent range of products are available for new patients. As part of this process, Australian Health Providers (AHPs) have been requested to hold the required Ig products to have in place adequate coverage for patients in accordance with the current product allocation.

Additional information to support patients through this process is in the linked pamphlet – Switching Immunoglobulin Products – What Should I know? What Can I Do?

Australia’s Domestic Plasma Products Will Transition in 2023

The NBA has announced five domestically produced plasma products are undergoing a transition in 2023 -AUSTRALIA’S DOMESTIC PLASMA PRODUCTS WILL TRANSITION IN 2023 | National Blood Authority. Two of the products transitioning are Australia’s intravenous Ig (Intragam) and subcutaneous Ig (Evogam).

Details on the product changes will be provided ahead of the transition including what is changing and when; what action is required; and information on the transitioned products to assist with their use, the communication of the changes to patients, and the updating or development of relevant Australian Health Provider protocols and processes.

Vaccine-Induced Thrombotic Thrombocytopenia (VITT)

In April 2021, the NBA temporarily added vaccine-induced immune thrombotic thrombocytopenia (VITT) - also known as thrombosis with thrombocytopenia syndrome (TTS) or vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) - as a condition to Version 3 of the Criteria for the Clinical Use of Immunoglobulin in Australia (Criteria).

The number of cases has plateaued over the last three months and as very few cases are expected going forward, the Criteria will not be updated at this time.

Evaluation of the Impact of the National Ig Governance Program

In the last update, the NBA reported on an evaluation of the impact of the NBA’s Ig governance program by PricewaterhouseCoopers Consulting (PwC). The evaluation has now been published on the NBA website and is publicly available. at https://www.blood.gov.au/Ig-program.

The evaluation reported that the flagship and award-winning NBA program has moderated the growth in Ig demand from 10-12 per cent to 7.3 per cent annually. Importantly, the evaluation concluded that 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 program was implemented, more targeted access to Ig has been achieved rather than access to Ig being ceased for those who need it. Further information including key highlights and recommendations are also available at the link above.

Review of the National Subcutaneous Immunoglobulin (SCIg) Program

The NBA has commenced an evaluation of the effectiveness of the National SCIg Program which aims to identify options that can overcome current barriers to program uptake and inform the future direction of the Program. The NBA has engaged HealthConsult to undertake the review.

Consultations have commenced, with outcomes expected by the end of 2022.

Education and Training Resources

The NBA continues to work with the Department of Health and NPS MedicineWise to deliver the Value in Prescribing (ViP) Program, which aims to develop improvement in the prescription and use of Ig through education and training initiatives for patients and clinicians. The NIGAC functions as a steering committee for the program. Finalised resources are available at Value in Prescribing - Immunoglobulin products (nps.org.au) 

AusPIPS Patient Ig Brochure

AusPIPS has recently released a patient information brochure explaining the uses of Ig replacement therapy and providing tips for new and existing patients receiving treatment. The brochure is also available in Mandarin, Italian, Greek, Hindi, Samoan, Vietnamese and Auslan and is available at AusPIPS | Primary Immune Deficiency Support.

Previous Ig Program Updates

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.