Immunoglobulin (Ig)

Quick view of access to Ig flowchart

 

 

 

 

This page provides an overview of immunoglobulins, immunoglobulin (Ig) product, its uses, and the National Blood Authority’s (NBA) role in managing it to ensure it is available in Australia safely, equitably and affordably. 

This page also serves as an ‘entry point’ to all NBA’s Ig content. Information is structured under seven key headings, with subheadings under each taking you to detailed information pages on the corresponding topic. A description for each page identifying key topics further assists navigation.      

Introduction and Overview

 

Immunoglobulins, also known as antibodies, are a critical part of the body’s immune defence system. Produced by a particular type of white blood cell known as a plasma cell, they recognise and bind to the toxins or other foreign substances (antigens) produced by pathogens (bacteria, viruses or other microorganism that can cause disease), thereby aiding in the pathogen’s destruction.

Immunoglobulin (Ig) products are fractionated blood products made from pooled human plasma. They are typically divided into three product types:

  • intravenous immunoglobulin (IVIg) – administered intravenously (into veins)
  • subcutaneous immunoglobulin (SCIg) – administered subcutaneously (under the skin)
  • normal human immunoglobulin (NHIg), also known as intramuscular immunoglobulin – administered intramuscularly (into a muscle).

IVIg and SCIg are generally used for:

  • replacement therapy - providing additional immunoglobulins to patients who do not make enough of their own to maintain a healthy immune system, generally because of a genetic disorder, disease, or as a side effect of disease treatment; and
  • immunomodulation therapy – supporting patients with a range of auto-immune disorders by modulating their immune system (to prevent it attacking its own body).

NHIg is generally reserved for public health disease response activities and for use in defined circumstances where IVIg and SCIg are contraindicated.

There are also hyperimmune Ig products. These contain specific formulations of Ig to target specific diseases.

Collecting, manufacturing and distributing Ig products is very expensive. The growing demand is met through a mix of domestically-produced and imported product.

As with other blood products, Ig product is available at no direct cost to eligible patients under the national blood arrangements, managed by the National Blood Authority (NBA). To ensure demand can be met safely, equitably and affordably, strict eligibility rules govern access to and use of Ig products funded under these arrangements. The rules are defined, agreed and updated by health experts from across Australia and managed nationally under the NBA’s Immunoglobulin Governance Program. Ig product is issued through Australian Red Cross Lifeblood.

Ig Policy and Governance

 

National Immunoglobulin Governance Program

Page synopsis: Eligibility for Ig funded under the national blood agreement is strictly defined under rules agreed and updated by health experts from across Australia and managed nationally by the National Blood Authority under its Immunoglobulin Governance Program. The Ig Program comprises five elements: a national policy on access to government-funded Ig in Australia, eligibility criteria, BloodSTAR, committees and interest groups and performance improvement activities.  

This page contains: an overview and brief history of the Ig governance program; information about its purpose and aims.

National Policy: Access to Government Funded Immunoglobulin Products in Australia

Page synopsis: The National Policy describes the roles, responsibilities, authority and accountability of those directly involved in prescription, use and management of Ig funded under national blood supply arrangements.

This page contains: an overview of the National Policy; a link to the full policy document.

Criteria for the Clinical Use of Immunoglobulin in Australia (the Criteria)

Page synopsis: The Criteria define eligibility for access to immunoglobulin products under the national blood supply arrangements. They define the conditions and circumstances for which the use of Ig products is considered to be clinically appropriate.

This page contains: an overview and brief history of the Criteria; a direct link to the online Criteria as they appear in BloodSTAR.

A direct link to the Criteria, as it is published in BloodSTAR, is also available here.

BloodSTAR

Page synopsis: Ig provided under the national blood supply arrangements must be applied for, approved and managed through the national online system BloodSTAR: the Blood System for Tracking Authorisations and Reviews. BloodSTAR facilitates requests for Ig in accordance with the Criteria and the National Policy. It also provides data to help inform future program arrangements.

BloodSTAR is accessed through BloodPortal. Once approved, product can be ordered through BloodNet, NBA’s online blood ordering and inventory management system.

This page contains: an overview and brief history of BloodSTAR; links to BloodSTAR support materials, registration information and privacy information.

Committees and Interest Groups

Page synopsis: A network of national immunoglobulin committees and interest groups provide recommendations, feedback and expert advice to the NBA on all aspects of the Ig Governance Program.

This page contains: information and Terms of Reference for the National Immunoglobulin Governance Advisory Committee (NIGAC) and its Immunoglobulin Specialist Working Groups (SWGs); membership lists.

Performance Improvement

See Data, Statistics, Reporting and Performance Improvement for information on this stream of work, which encompasses initiatives and strategies to strengthen Ig governance and drive improvement in the prescription, use and management of Ig.

Ig Access

 

Intravenous Immunoglobulin (IVIg)

Page synopsis: IVIg is available in Australia to eligible patients through national blood arrangements managed by the NBA. Strict eligibility criteria, access, management and review arrangements apply.

Where eligibility requirements are not met, IVIg may be available outside of the national blood arrangements (more information).

This page contains: information about accessing IVIg under national blood arrangements, including a ‘quick view’ guide to accessing IVIg and SCIg; information about checking eligibility (the Criteria) and requesting product (BloodSTAR); information on product origin; summary information about access options outside of the national blood arrangements.

Subcutaneous Immunoglobulin (SCIg)

Page synopsis: SCIg is available in Australia through national blood arrangements managed by the NBA. Hospitals must be formally approved to manage SCIg programs, and strict eligibility criteria, rules, obligations and responsibilities apply.

Where eligibility requirements are not met, IVIg may be available outside of the national blood arrangements (more information).

This page contains: information about accessing IVIg under national blood arrangements, including a ink to a ‘quick view’ guide to accessing IVIg and SCIg; information about checking eligibility (the Criteria) and requesting product (BloodSTAR); information on product origin; summary information about direct order arrangements, with links to further information.

Ig Access Outside of National Blood Arrangements

Page synopsis: Where IVIg or SCIg is not available to patients under national blood arrangements, imported product may be available through Jurisdictional Direct Order, or directly from the supplier on a private, commercial basis.

This page contains: information about Jurisdictional Direct Orders and obtaining Ig on a private, commercial basis;  a list of products available for access outside of the national blood arrangements.

Normal Human Immunoglobulin (NHIg)

Page synopsis: NHIg is only available in Australia through the national blood arrangements. It may be supplied for public health disease control activities, and for indicated uses where IVIg and SCIg are contraindicated or not otherwise suitable.

This page contains: information about accessing NHIg for post-exposure prophylaxis, or for conditions and circumstances listed in the Criteria; information on product origin.

Hyperimmune Ig Products 

Page synopsis: Hyperimmune Ig products are available through the national blood arrangements for indicated uses.

This page contains: information about plasma and recombinant products, including hyperimmune Ig.

Ig Supply

 

Procurement

Page synopsis: Approximately half of the Ig product used in Australia is produced domestically, with the remaining product imported. Domestic product is produced by CSL Behring Australia as contracted by the NBA under the National Fractionation Agreement. Human blood plasma is collected domestically from volunteers by the Australian Red Cross, Lifeblood (Lifeblood).

This page contains: information about plasma and recombinant product procurement arrangements, including, but not limited to Ig; National Fractionation Agreement.

Available Products, Prices

Page synopsis: Immunoglobulin products supplied under the National Blood Arrangements are listed in the National Product Price List.

This page contains: information about plasma and recombinant product (including Ig) prices, supplier, origin (domestic or imported); fresh blood price information.

Allocation

Page synopsis: Both domestic and imported Ig products are available under the National Blood Agreement. To ensure supply can be appropriately managed, product is allocated through BloodSTAR to domestic or imported Ig products, based on pre-determined factors.

This page contains: information about the allocation of Ig products under the National Blood Agreement. Also includes detailed information about the Criteria for the clinical use of immunoglobulin in Australia.

Ig Data, Statistics, Reporting and Performance Improvement

 

Data and Statistics

Page synopsis: Recent data and statistics on Ig use in Australia is presented in graphs and tables, providing a snapshot of Ig usage and trends in Australia.

This page contains: immunoglobulin usage data, including: Ig product issued; use by jurisdiction; use by medical condition; BloodSTAR activity; and domestic vs imported product information.

Annual Reports on the Issue and Use of Immunoglobulin

Page synopsis: Detailed reports analysing Ig product use (IVIg, SCIg and NHIg) are produced annually.

This page contains: annual reports on Ig issue and use; information about requesting data and on data governance; other (non-Ig) reports.

Performance Improvement Strategy

Page synopsis: The NBA’s strategy to improve the prescription, use and management of government-funded Ig products is outlined in the National Immunoglobulin Governance Program Performance Improvement Strategy 2019-2022 (the Strategy).

This page contains: an overview of the Ig performance improvement strategy; a link to the full strategy document.

Ig Resources

 

Ig Resources for healthcare professionals and patients

Page synopsis:  A number of resources are available to help health professionals and patients understand immunoglobulin treatment and management arrangements.  

This page contains: information and links to professional courses, BloodSTAR information, patient and healthcare professional factsheets, videos and more.

Ig Program Updates

 

Page synopsis: Immunoglobulin Governance Program Updates provides a snapshot of the current work program and priorities in the area of immunoglobulin at the NBA.

Interested parties are encouraged to subscribe to Immunoglobulin Governance Program Updates. Subscription information is available on the Ig Program Updates page.