Immunoglobulin (Ig) treatment improves the quality of life for some patients with immune system disorders and immune-mediated conditions. In some cases, it can even save lives.

Manufacturers make Ig products from donated plasma (the fluid part of human blood). This means Ig products are a limited and precious resource.

The National Blood Authority (NBA) manages the supply of Australia's government-funded Ig products under the National Blood Agreement.

Government-funded Ig products are listed on the National Product Price List and include:

We carefully manage Australia's Ig products to ensure there is an adequate, secure and affordable supply for Australians who need them. However, due to the high cost and demand for Ig use in Australia, eligibility for access to government-funded IVIg, SCIg and NHIg is managed through strong governance arrangements, like many other high-cost treatments.

National Immunoglobulin Governance Program

In 2014, we established the National Ig Governance Program to improve the governance and management of government-funded Ig products.

The program aims to:

  • ensure product use and management
    • reflects appropriate clinical practice
    • represents efficient, effective and ethical expenditure of government funds and
    • is in accordance with relevant national safety and quality standards for health care.
  • ensure that access to Ig products is consistent with the criteria for access determined by Governments
  • improve the capture of information of the need for, use of, and outcomes of treatment with Ig products to inform future decisions.

Our governance program ensures we consistently direct government-funded Ig products to patients who are most likely to benefit based on:

  • reliable evidence
  • using the lowest effective dose
  • where alternative therapies are limited.

Health professionals play a key role in making our governance program a success. They must follow the national policy when prescribing and managing the use of government-funded Ig products.

We administer our governance program through a national governance framework and with the support of a national network of committees.

The governance program includes reporting, education, research, and performance improvement which drive the program toward successful outcomes.

Accessing Ig products

We administer access to Ig products through our governance program framework, which is comprised of three parts:

  • a national policy
  • criteria for the clinical use of Ig 
  • a national online system for requesting and authorising Ig access.

Each of these framework components helps us manage Australia's access to Ig products.

National policy for Ig management

The National Policy: Access to Government-Funded Ig Products in Australia (the national policy) sets out the rules and requirements for accessing Ig products in Australia.

It also explains the roles and responsibilities of people working across Australia's Ig system.

If your work involves Ig products, you should read and understand our national policy.

Criteria for clinical use of Ig products

Our 'Criteria for Clinical Use of Immunoglobulin in Australia' set out the conditions and circumstances for which the use of immunoglobulin (Ig) is clinically appropriate and can be considered under the national blood arrangements.

The criteria list the medical conditions and circumstances for patients to access Ig products under the national blood arrangements.

All requests for access to Ig products are assessed against the criteria.

The Therapeutic Goods Administration (TGA) regulates blood and blood components(Opens in a new tab/window) as prescription medicines. You can search the Australian Register of Therapeutic Goods(Opens in a new tab/window) for blood and blood products approved for supply in Australia.

There is not an exact alignment between TGA-registered indications for Ig products and the indications listed in the criteria.

The criteria do not differentiate between individual brands of Ig products in relation to funded access under the national blood arrangements. As a result, patients are able to be allocated a range of products under the criteria and the allocation model.

BloodSTAR for Ig authorisation

BloodSTAR is Australia's online system for managing requests and authorisations for government-funded Ig products. It helps us provide consistent access based on the national policy and criteria.

If you need a government-funded Ig product for your patient, you must request authorisation via BloodSTAR.

A BloodSTAR authorisation is not a prescription for Ig products or a medical record. You must follow your local legislation and processes to prescribe an Ig product.

Governance committees

A network of governance committees and interest groups plays a vital role in informing our work under the National Immunoglobulin Governance Program.

The NBA's principal Ig governance committee is the National Immunoglobulin Governance Advisory Committee (NIGAC). Four immunoglobulin specialist working groups (SWGs) provide expert advice and comment in the areas of:

  • haematology
  • immunology
  • neurology
  • transplantation.

NIGAC and the SWGs provide expert guidance to ensure our criteria reflect current scientific evidence.

They also provide advice on other Ig governance-related issues, including:

  • education
  • governance framework
  • performance improvements
  • research.

Learn more about the network of committees, including membership or how to be involved.

Performance improvement

We're making continual improvements to the governance of Australia's government-funded Ig products.

Our National Immunoglobulin Governance Program Performance Improvement Strategy 2019–20 to 2021–22 aims to improve the prescription, use and management of Ig products and support the National Ig Governance Program to continue to deliver against agreed objectives.

There are 5 key performance management objectives for this strategy.

  • Provision of Ig reflects appropriate clinical practice
  • Uniform compliance with the national policy
  • Local Ig governance arrangements are robust and align with relevant standards, guidelines and legislative requirements
  • Efficient and effective service delivery that supports appropriate management and use of Ig
  • Collection of data to support future work

We've developed improvement pathways to achieve our objectives. Each pathway includes relevant projects and deliverables.

Our pathways are:

  • education and support
  • communications and relationships
  • program assurance and policy compliance
  • knowledge development
  • enhancement of policy and access arrangements.

Our performance improvement strategy is dynamic and can adapt to reflect our progress as we work to achieve our objectives.

For more information, read our National Immunoglobulin Governance Program Performance Improvement Strategy 2019–20 to 2021–22.

Report on improving access to SCIg

In 2022 we reviewed the access arrangements for subcutaneous immunoglobulin (SCIg) in Australia. Advice was sought from Australian patients to better understand current barriers to accessing SCIg in Australia. A range of stakeholders were consulted with to identify options to improve access for patients. The main barriers identified were:

  • Funding and resourcing: limitations in funding and resourcing were identified as the main impediment to SCIg uptake in both the public and private healthcare sectors
  • Clinician and hospital preference: preference of clinicians for SCIg was identified as a key driver of SCIg uptake
  • Low awareness of SCIg and its benefits: hospitals and clinicians with a strong clinical awareness of the benefits of SCIg usage have a higher uptake of SCIg
  • Dispensing and supply arrangements: work associated with dispensing and supply of SCIg is not funded, therefore, some hospitals are unwilling to provide SCIg
  • Access: patients from rural, regional, and remote communities often need to travel to metropolitan hospitals to collect SCIg
  • Patient preference for intravenous immunoglobulin (IVIg): some patients prefer to use IVIg for a variety of reasons.

To address these barriers, 11 options were recommended for implementation. These recommendations aim to increase the funding and resourcing of SCIg programs, improve awareness of SCIg and its benefits, improve guidelines, documents, and access to data, and aid patients to properly dispose of sharps containers. The barriers and recommendations are described in more detail in the report, available here.

The NBA is working on implementation of the recommendations as part of its commitment to continuous improvement activities to support the prescription, management, and use of immunoglobulin products.

Ig access outside the national blood arrangements

Sometimes, medical officers prescribe Ig products for patients whose clinical circumstances don't meet eligibility requirements. For example, a patient may have a condition that isn't listed in the criteria.

In these cases, you may be able to access Ig products through:

  • local Direct Orders
  • purchasing from suppliers at private cost.

We can't help you access Ig products outside the scope of the national blood arrangements.

Direct Orders

Direct Orders are a way for Australian Health Providers (AHPs) to buy imported Ig products at the same price the NBA has negotiated under the national blood arrangements.

You can only request a Direct Orders for imported IVIg or SCIg products.

Each Australian state and territory has local arrangements for managing access to Ig products using Direct Orders.

The application and approval process can vary between jurisdictions and facilities. You might need to apply for a Direct Orders via your local hospital's therapeutics committee.

Speak to your hospital or health department to find out your local process for accessing Ig products through a Direct Orders.

Usually, the local health service, insurer or patient will pay for Ig products ordered through a Direct Orders. It depends on your local arrangements.

Private expense orders

If you can't access your Ig product under the national blood arrangements or through a Direct Orders, you may be able to place an order directly with the supplier at private expense.

Private expense orders may be for products available under Direct Orders arrangements or other imported Ig products.

National Immunoglobulin Governance Program updates

We provide updates on our work and priorities around Ig products and governance.

Our Ig updates are useful for medical specialists, nurses, dispensers, patients and other people interested in our Ig work.

To get update notifications, email us at IgGovernance@blood.gov.au.

Include the following in your email:

  • in the subject line, put 'SUBSCRIBE Ig Program Updates and NIIG'
  • in the body of the email, let us know whether you're a healthcare professional, patient or other Ig stakeholder
  • include your signature block or contact details in the email.

We may invite subscribers to discuss or comment on Ig-related issues. Participation is optional.

See the National Immunoglobulin Governance Program's latest updates.

Get in touch

For more information about the governance of Ig products, contact us.

Phone: 1300 025 663 (13 000 BLOOD)

Email: IgGovernance@blood.gov.au

Last updated: 27 Mar 2024

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