Subcutaneous immunoglobulin (SCIg) is a fractionated blood product containing a concentrated mix of antibodies. It's made from pooled human plasma from hundreds of donors. Clinicians use SCIg for immune replacement and immune modulation therapy.
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.
Unlike intravenous immunoglobulin (IVIg), SCIg is administered through a needle into the subcutaneous tissue. This means some patients can self-administer the product outside of a hospital setting.
In Australia, SCIg is available under the national blood arrangements for these 5 specific medical conditions, in circumstances that meet our criteria:
- inborn errors of immunity (IEI) with antibody deficiency
- specific antibody deficiency
- acquired hypogammaglobulinaemia secondary to haematological malignancies or post-haemopoietic stem cell transplantation
- secondary hypogammaglobulinaemia unrelated to haematological malignancies or post-haemopoietic stem cell transplantation
- chronic inflammatory demyelinating polyneuropathy (including IgG and IgA paraproteinaemic demyelinating neuropathies).
Patients can only access government-funded SCIg treatment through an approved hospital-based SCIg program.
Accessing SCIg
You can access SCIg in Australia as a:
- government-funded product under the national blood arrangements
- locally funded product through a Jurisdictional Direct Order or private direct order.
As with other blood products, Ig products are available at no direct cost to eligible patients under the national blood arrangements. Eligible Ig products are listed on the National Product Price List.
To ensure treatments go to those most likely to benefit, we manage access to SCIg through a governance framework. To access government-funded SCIg products, your request must meet our Criteria for the clinical use of intravenous immunoglobulin in Australia.
All requests for SCIg products are assessed against the criteria.
In addition, patients must be treated by a clinical specialist within a hospital-based SCIg program, where the hospital provides access to all resources and takes full accountability for the management and use of the SCIg product, at no additional cost to patients.
Ig provided under the national blood arrangements must be applied for, approved and managed through the national online system, BloodSTAR. BloodSTAR facilitates requests for Ig in accordance with the criteria and the national policy. It also provides data to help inform future program arrangements.
Learn more about accessing SCIg outside the national blood arrangements and how we manage Australia's immunoglobulin supply.
Hospital-based SCIg programs
A hospital must be part of the national SCIg program to access government-funded SCIg for patients. This includes both public and private hospitals.
Joining the national SCIg program in all states and territories except New South Wales
To join the national SCIg program, your chief executive or director of clinical services (or equivalent) must complete our 'Hospital acknowledgement form'.
This means the hospital has agreed to the requirements for participating in the SCIg program, which includes giving access to all necessary equipment and consumables to administer the product at no additional cost to patients.
If your hospital is in South Australia or Western Australia, you also need an endorsement from your state health department.
Joining the national SCIg program in New South Wales
In New South Wales, you don't need to complete our acknowledgement form. The NSW Ministry of Health manages this need through the local health district and specialty network chief executives. To join the national SCIg program, contact the Office of the Chief Health Officer at moh-ocho@health.nsw.gov.au.
Product allocation
When a medical officer requests access to Ig for a patient in BloodSTAR, the system allocates a product based on the patient’s specific condition, according to a pre-determined allocation matrix within BloodSTAR. The allocation matrix is updated as forecasts of demand and supply change over time. These allocations help us manage our Ig supplies.
A requesting clinician or Australian Red Cross Lifeblood authoriser can change the allocation if clinically appropriate.
SCIg support materials
These materials can help you manage your hospital-based SCIg program.
Information for patients and carers
A range of patient resources on immunoglobulin therapy is available on the immunoglobulin treatment page.
Self-administered SCIg
In some cases, your doctor might let you treat yourself at home using a needle to infuse SCIg just below the skin. You'll receive training before you start.
You'll usually get your SCIg supplies every 2 months. Your clinical team will advise where and how you can collect your products. In some cases, it may be from a different hospital to where your doctor sees you. Your treating hospital will provide you with any consumables you need.
When you get your first SCIg supply, you'll get a patient diary to record details of your doses and any reactions to the treatment. This includes keeping a record of any unused product.
You'll have regular reviews with your doctor throughout your treatment to check your progress. If you have trouble with at-home treatment, your doctor may talk to you about treating you in hospital with IVIg instead.
Storing your SCIg
Your SCIg products will come with specific storage instructions. Please read the product information sheet provided with your supply. Products can have different requirements for storage before and during use. You must know how to store your product correctly. Ask your medical team if you're not sure.
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. More information, and the report can be found here.
Get in touch
For more information about accessing government-funded SCIg products, contact us.
Phone: 1300 025 663 (13 000 BLOOD)
Email: IgGovernance@blood.gov.au
Last updated: 27 Mar 2024