Immunoglobulin therapy

Immunoglobulins are protein molecules (antibodies) found in plasma and they perform a critical role within immune response in the body. Antibodies recognise and bind to particular antigens (such as bacteria or viruses) and assist in their destruction. Thus immunoglobulin (Ig) plays a vital role in fighting infection and disease. Immunoglobulins are fractionated blood products made from human plasma. There is a range of Ig therapies which are summarised below.

Intravenous immunoglobulin

Intravenous immunoglobulin (IVIg) is registered for use in Australia for the treatment of a number of diseases where Ig replacement or immune modulation therapy is indicated, such as primary immunodeficiency and chronic inflammatory demyelinating polyneuropathy. IVIg is also used to treat a growing number of unregistered indications where there is some clinical evidence for its utility. The significant cost and continuing substantial increase in demand for IVIg makes its supply and management a high priority. Under the national blood arrangements IVIg is provided through clinical governance and management framework which is described under National Framework for Immunoglobulin Products and facilitated through BloodStar (external site).

Subcutaneous immunoglobulin

Subcutaneous immunoglobulin (SCIg) is similar to IVIg and provides an alternative method of infusion into the subcutaneous tissue. Hospitals participating in the national SCIg programs are required to provide an acknowledgement of the governing requirements by the Chief Executive or Director of Clinical Services (or equivalent) prior to ordering and providing SCIg products to their patients. There are a range of resources and materials which have been produced to support hospital based SCIg programmes (external site). The quick links are regularly updated.

Normal immunoglobulin

Normal human immunoglobulin (NHIg) may be supplied for two purposes: the treatment of susceptible contacts of measles, hepatitis A, poliomyelitis and rubella, as directed by public health officials; and the treatment of immunodeficiency conditions for which the product is indicated (where IVIg and SCIg are both contraindicated).

Hyperimmune immunoglobulin products

Hyperimmune immunoglobulin products are similar to IVIg but are prepared from the plasma of donors with high titres of antibody against a specific organism or antigen.

Cytomegalovirus (CMV) immunoglobulin - is used to prevent CMV infection in bone marrow, renal, cardiac and liver transplant recipients, who are CMV antibody negative, where the donor is CMV antibody positive. It is also used for the treatment of established CMV infection in association with virucidal treatment.

Hepatitis B immunoglobulin - is administered intramuscularly and indicated for the prevention of an infection developing in a person who has been exposed to the hepatitis B virus, who has not received prior vaccination, or whose vaccination program is incomplete. It is also indicated for those whose antibody levels are inadequate.  In addition, Hepatitis B immunoglobulin helps prevent hepatitis B infection in infants born to mothers with hepatitis B.

Rh(D) immunoglobulin - is given intramuscularly as prophylaxis to Rh(D)-negative women during pregnancy and following birth of an Rh(D)-positive baby to help prevent Haemolytic Disease of the Newborn. An intravenous product is also available for use in large fetomaternal haemorrhage where administration of intramuscular Rh(D) Ig is either contraindicated or not practical, or for inadvertent or emergency transfusion of Rh(D) positive blood to an Rh(D) negative female of childbearing potential.

Tetanus immunoglobulin - is used intramuscularly for passive protection of individuals who have sustained a tetanus-prone wound and who have either not been actively immunised against tetanus or whose immunisation history is doubtful. It is also given to fully immunised individuals with a tetanus prone wound if more than 10 years have elapsed since the last dose of toxoid or vaccine. Tetanus Ig is also issued intravenously for management of tetanus infection.

Zoster immunoglobulin - is indicated for prophylaxis against varicella in patients who meet the following criteria: neoplastic disease (leukaemia or lymphoma), congenital or acquired immunodeficiency, undergoing immunosuppressive therapy with steroids or antimetabolites, and a negative or unknown prior history of chickenpox.

Further information regarding public health, infectious diseases and vaccination within WA.

Governance arrangements for immunoglobulin therapy

The provision and supply of immunoglobulin (Ig) products under the national blood arrangements is managed and funded by the National Blood Authority (NBA) on behalf of all governments. If the product is ordered to treat a medical condition which is funded under the Criteria for the clinical use of immunoglobulin in Australia (external site), the product is supplied and funded under the national blood supply arrangements. The National Blood Authority Australia has further guidance on  Access to Government Funded Immunoglobulin Products in Australia (external site).

The NBA does not manage individual requests to access Ig products outside of the conditions funded under the national blood arrangements as described in the Criteria for the clinical use of immunoglobulin in Australia (external site).  For conditions not funded under the criteria an approved health provider (AHP) may seek access to Ig products through a jurisdictional direct order (JDO, which allow the AHP’s to purchase the product directly from the supplier at the same price negotiated by the NBA.

The cost of Ig products raised through a JDO is borne solely and directly by the AHP following local approval by the Drugs and Therapeutics Committee . Only imported Ig products are available under a JDO.

Process for JDO Ig requests

For conditions not funded under the criteria (external site).  Approved health providers (AHP’s) may seek access to immunoglobulin (Ig) products through a jurisdictional direct order (JDO), which allow the AHP to purchase the product directly from the supplier at the same price negotiated by the NBA. The Office of the Chief Medical Officer (OCMO) is responsible for receiving and assessing JDO under a strict process which allows the AHP to receive the Ig.

The cost of Ig products raised through a JDO is borne solely and directly by the AHP. Only imported Ig products are available under a JDO.

JDO requests are made and submitted electronically through a secure web-based program REDCap™. REDCap is hosted by the Department of Health, Western Australia.

Users of this form are not required to open a REDCap account or install a specific computer program. Access to REDCap is free and can be accessed through the internet. The request form is intuitive and easy to complete, and REDCap itself contains “How to” instructions. (Requestors will receive a confirmatory email confirming the request which includes a copy of the completed form in PDF format for their own records).

Approved Health Provider instructions for submitting JDO Ig requests via REDCap

If the condition is not funded under the criteria the AHP must undertake the following processes:

  1. AHP obtains approval for use locally through the form of the Drugs and Therapeutics Committee (to approve the medical treatment and ensure appropriate clinical use).
  2. AHP places order with supplier (usually via Pharmacy or locally approved supply contact).
  3. AHP completes and submits the JDO Ig request form (external site) via REDCap™. The electronic request is a simple electronic form based on previous paper versions.
  4. A confirmation email will be forwarded to the email account of the individual completing the request.

Office of the Chief Medical Officer procedure for JDO Ig requests

  1. OCMO receives notification through REDCap and assesses the JDO request .
  2. OCMO approves or denies the request and notifies the supplier.
  3. OCMO will contact the requestor identified on the form if any additional information is required or if the JDO request is not approved.
  4. OCMO enters the request information into the REDCap database with all relevant supporting documentation

Suppliers responsibilities

  1. Ig supplier sends an approval request to OCMO.
  2. Ig supplier dispatches Ig to AHP.

Other important notes

In circumstances where Ig cannot be accessed under the Criteria or JDO arrangements, it may be possible to access imported Ig directly from the relevant suppliers on a commercial basis and at private expense.

More information

Blood Unit
GPO Building, Level 3
3 Forrest Place
 Perth 6000

Phone: 08 6373 2321

Further information

Members of the Blood Unit are available from Monday to Friday during the hours of 8.30 am to 4.30 pm.

Blood Unit
Office of the Chief Medical Officer
Level 3, GPO Building
3 Forrest Place
Perth WA 6000
Phone: 6373 2324

Last reviewed: 13-07-2020