Criteria for the clinical use of Intravenous Immunoglobulin in Australia - Second Edition


This document is to assist clinicians and transfusion medicine professionals identify the conditions and circumstances for which the use of intravenous immunoglobulin (IVIg) is able to be accessed under the National Blood Arrangements. IVIg is a precious biological product and, as such, its use should be consistent with the evidence base and prescribed for the treatment of patients who are likely to benefit from IVIg therapy and for whom there are no safe and effective alternative treatments.

The growth in demand for IVIg prompted action by Australian governments to ensure it is reserved for use in those patients with the greatest need.

There is not an exact alignment between Therapeutic Goods Administration registered indications and the indications listed in the Criteria. Where safe and effective alternative therapies are available, the alternative product should be used in preference to IVIg.

In addition, IVIg is used to treat a growing number of diseases where immunomodulation or immunoglobulin replacement therapy is of benefit but the treatment indication does not have regulatory approval. Some of these uses of IVIg have a foundation in the medical literature and others are supported by clinical consensus but have a less conclusive basis in evidence.

The Criteria is based on evidence identified through systematic reviews of the literature and the opinions of clinical experts. In conjunction with government policy, this publication may be used to identify those conditions and circumstances for which IVIg products can be accessed under the National Blood Agreement (see Appendix A).

The development of the Criteria was based on the following key principles:

Structure of this document

This document provides background information on the supply, manufacture, and use of IVIg in Australia, and criteria for its appropriate use.

Chapter 1 deals with the governance of the Australian blood sector and the roles and responsibilities of the various organisations. It discusses the availability of IVIg and two mechanisms through which it can be accessed by clinicians.

Chapter 2 looks broadly at the safety and quality aspects of production, the role of the Therapeutic Goods Administration (TGA) and the obligations of manufacturers and suppliers.

Chapter 3 describes national and international trends in demand for IVIg.

Chapter 4 outlines the process used to develop this document and establish the Criteria.

Chapters 5 to Chapter 8 list the conditions considered for IVIg therapy during the compilation of this document.

Chapter 5 lists conditions for which IVIg in select patients has a well-established therapeutic role.

Chapter 6 lists conditions for which the therapeutic role of IVIg is emerging. Chapters 5 and Chapter 6 also list the clinical criteria used to identify the subsets of patients who benefit from IVIg therapy.

Chapter 7 lists conditions that rarely, if ever, would require IVIg use.

Chapter 8 lists conditions for which the use of IVIg therapy is not supported at this time, either because there are preferred alternative therapies, or there is evidence of no benefit, or because there is insufficient evidence or clinical support.

Maintaining the currency of this document

Governments recognise the need for the conditions identified and the criteria for the clinical use of IVIg to be regularly reviewed to take account of the evolving processes of disease diagnosis, treatment and outcome evaluation.

In concert with its development, the National Blood Authority (NBA) has been charged by the Jurisdictional Blood Committee (JBC) with the responsibility of developing plans for the implementation of this document. These plans include reviewing the current governance and authorisation arrangements.

This document was prepared with the following assistance.

National IVIg Criteria Review Working Group


JBC Representatives (Ms Joan Bedford and Ms Carolyn Duck)

NBA Representative (Principal Medical Officer — Dr Chris Hogan)

Australian Government Department of Health and Ageing Clinical Representative (Professor Henry Ekert)

Australasian Society of Clinical Immunology and Allergy Representative (Dr Jane Peake)

Australian Red Cross Blood Service (Blood Service) Representative (Dr Marija Borosak)

Australian and New Zealand Association of Neurologists (Associate Professor Lyn Kiers)

Haematology Society of Australia and New Zealand Representative (Dr Philip Crispin)

Individual experts

Associate Professor John Gibson

Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, New South Wales

Associate Professor Andrew Kornberg

Department of Neurology, Royal Children’s Hospital, Parkville, Victoria

Associate Professor Sean Riminton

Department of Immunology and Allergy, Concord Hospital, Concord, New South Wales

Individuals making submissions and many other clinical experts gave generously of their time and expertise. All contributions are gratefully acknowledged.

Further information

For information regarding the Criteria for the clinical use of intravenous immunoglobulin in Australia, please visit or contact:

National Blood Authority
Locked Bag 8430
Canberra ACT 2601