Immunoglobulin Governance Program Updates

Updates on the National Immunoglobulin (Ig) Governance Program provide medical specialists, nurses, dispensers, consumers and other stakeholders a snapshot of the NBA’s Ig related work program and priorities. Links to further information are provided as applicable.

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February 2024 Update 

A snapshot of recent activities in the Immunoglobulin Governance Program is provided below.


Key Issue Summary

National Immunoglobulin Governance Advisory Committee (NIGAC)

Members reviewed proposed changes to the Criteria for the condition Guillain-Barré Syndrome (GBS) following new evidence regarding effectiveness of a second dose of Ig.

Members discussed findings and recommendations of the report on improving access to Subcutaneous Immunoglobulin (SCIg). The report can be found at Final Report (blood.gov.au).

The next meeting of the NIGAC is planned for May/June 2024.
 

Immunoglobulin Specialist Working Groups (SWGs)

All 4 SWGs (Immunology Haematology, Transplant and Neurology) met in the first half of 2023. Each SWG discussed criteria changes, horizon scanning and continued work on topics from their workplans.

The Immunology and Haematology SWG also met in September 2023, and the Neurology SWG met on 18 October 2023 for a workshop to discuss the current issues regarding the condition inflammatory myopathies.

All SWGs are planned to be scheduled in late March/April 2024.


Product Allocation

The NBA actively manages the national supply and allocation of Ig in conjunction with the Australian Red Cross Lifeblood (Lifeblood). 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. 
     

Immunoglobulin product supply

The reduced level of domestic plasma collections in 2022-23 has most significantly affected the availability of domestic Ig products. Although domestic plasma collections are strengthening following the decrease in 2022-23, this is expected to result in a 46.2% / 53.8% split between domestic and imported Ig in 2023-24 compared with a ratio of 59.8% / 40.2% when original forecasting was done in early 2022-23. This follows a split of 46.6% / 53.3 % domestic to imported split (actuals) in 2022-23. The NBA continues to actively monitor supply and demand across all Ig products to ensure there is no overall shortage.

A number of planned Ig product changes have either been implemented or are planned to be implemented in 2023 and 2024. These product changes include:

  • Kiovig, an imported 10% concentration Intravenous immunoglobulin (IVIg) product, was introduced on 1 May 2023. The rate of uptake of Kiovig has been significant, and it has now been established as routine within most centres. The introduction of Kiovig will assist the NBA to strengthen and diversify the supply of Ig products in Australia.

  • The NBA is progressing the agreed arrangements with Grifols Australia Pty Ltd to introduce Xembify 20% (SCIg) to the national blood arrangements. Supply to the Australian market is planned to commence on 1 February 2024. The NBA website has been updated and communications have been sent out to stakeholders to help them prepare for the launch of the new product.

  • The transition of Australia’s IVIg (Intragam 10) and SCIg (Evogam) is nearing completion with the majority of patients now on the replacement products (Privigen AU and Hizentra AU). This transition is the result of CSL Behring’s expansion of its manufacturing facility to support the processing of Australia’s growing plasma collections which has included a change to the way CSL Behring manufactures Australia’s Ig products to align with its global manufacturing processes.

Engagement of various stakeholder groups to ensure appropriate communication is vital. The NBA is working with various committees, clinical groups, patient groups and individuals, as well as with Lifeblood and CSL Behring, to ensure clear and timely communication on transition issues.

 

Changes to the Criteria

Changes to the Criteria were implemented on 30 November 2023. The changes were:

  • Primary immunodeficiency diseases - Common variable immune deficiency (PID-CVID): The change reduced the age to 2 years (from 4 years) for indication 1 (replacement therapy in CVID). The change applies to new authorisation requests.
  • Secondary hypogammaglobinaemia (SHG) - The changes allow clinicians to order a higher maintenance dose of Ig (up to 2g/kg/4 weeks) for patients with chronic disseminated enterovirus infection.

In addition, minor typographical errors have been corrected for several medical conditions.

Detailed information about the changes is available on the NBA's website at https://blood.gov.au/summary-version-3-criteria-changes under the Haematology, Immunology and Neurology attachments.

Review to develop options to improve access to SCIg

In March 2022, the NBA engaged HealthConsult Pty Ltd to advise on options to improve access to SCIg funded under the national blood arrangements. HealthConsult undertook a range of exploration activities to identify barriers to the optimal uptake of SCIg due to the current service model. Informed by this, HealthConsult undertook consultations with key stakeholders including jurisdictions, health services, SCIg consumer groups, clinical professional groups, suppliers, and dispensers (pharmacies and pathology laboratories), and stakeholders to inform the development of options to improve access. 

Key issues identified during the project include limitations in funding and resourcing of SCIg, the need to consider access, (noting that as a current schedule 4 medicine SCIg cannot be home delivered), and the varying levels of awareness of SCIg availability, indications and benefits by some clinicians, hospitals, and consumers.

The final report was published on the NBA website on 23 November 2023, which can be found at National Immunoglobulin Governance Program | National Blood Authority. The report describes the key issues and provides recommended options to address these issues, including funding and resourcing options in the private and public sectors; options to improve awareness of SCIg and its benefits; and options to improve guidelines, documents, and data.

 

OPTIC Trial: Intravenous immunoglobulin and intravenous methylprednisolone (IVMP) as optical induction treatment in chronic inflammatory demyelinating polyneuropathy (CIDP)

The OPTIC trial has now been formally terminated through the National Blood Sector - Research and Development Program after receiving funding in Round 5, 2021. The project aimed to include Australia in an international randomised double-blind placebo-controlled trial to determine whether the addition of IVMP to initial IVIg treatment of CIDP for 18 weeks would result in substantially more CIDP patients being in remission at one year than if they were using IVIg alone. A secondary aim was to assess whether IVIg and IVMP lead to more frequent and faster functional improvement compared to IVIg alone.

The international arm of the project had achieved an 80% inclusion rate, but due to a series of adverse events, the latest in March 2023, a meeting with the data safety monitoring board (DSMB) was held and it was decided to follow the DSBM’s advice and stop recruitment due to the probable risk of thrombosis. The Australian arm of this project was halted before a site was activated or recruitment began, so no Australian patients were impacted.

The NBA look forward to receiving the results and publications from the data collected prior to the termination of the trial.

 

Blood Sector Systems Release

The following changes to BloodSTAR and BloodNet have been implemented:

  • BloodSTAR version 3.10 (4 June 2023) - enhancements to warning messages when requesting continuing treatment to reduce the risk of unintentional treatment gaps and streamlining the approach for dose change requests.
  • BloodNet version 5.11 (24 September 2023) - enhancements to blood ordering to improve support for staff and reduce clarification phone calls between the Lifeblood and AHPs. 
  • BloodNet version 5.12 (3 December 2023) - enhancements to the BloodNet order process to reduce calls and manual clarification of blood orders from AHPs when the order is processed by Lifeblood. Changes complement enhancements made in October 2023 to support Lifeblood processing orders.

The NBA develops tip sheets for enhancements to BloodSTAR and BloodNet. Tip sheets and a range of support materials are available from the NBA website:

Work continues 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 who 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 (link sends e-mail) to schedule a training session.

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.