Introduction

This quick reference guide (QRG) is an abbreviated version of the Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia Second Edition (the Criteria second edition) approved by all Australian Health Ministers in June 2012.

The second editions of both the Criteria and QRG have been produced to assist clinicians and transfusion medicine professionals identify the conditions and circumstances for which the use of intravenous immunoglobulin (IVIg) can be accessed under the National Blood Arrangements. The complete Criteria second edition should be referred to in the first instance.

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

  • Where safe, effective and affordable alternative therapies exist, these are considered preferable to IVIg.
  • When IVIg is used, the lowest dose for the shortest duration required to achieve the desired outcome should be chosen.
  • For ongoing therapy, the achievement of measurable clinical outcomes is a requirement and IVIg should not be continued in patients with no demonstrable clinical benefit.

IVIg is a precious biological product for which demand continues to grow. This growth prompted action by Australian governments to ensure it is reserved for use in those patients with the greatest need. 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 conditions listed in the Criteria second edition are categorised according to the evidence identified through systematic reviews of the literature and the advice of clinical experts (see Level of Evidence Categories table on page 3). Governments have agreed to provide funded IVIg for the indications described in the Criteria second edition in chapter 5 (established therapeutic role), chapter 6 (emerging therapeutic role) and chapter 7 (exceptional circumstances only). IVIg is not funded under the National Blood Agreement to treat conditions listed in Chapter 8.

This publication was prepared under the auspices of the Jurisdictional Blood Committee (JBC) for and on behalf of the Standing Council on Health (formerly the Australian Health Ministers’ Conference).

The Jurisdictional Blood Committee would like to acknowledge and thank those who contributed to the compilation of the Criteria including the members of the National IVIg Criteria Review Working Group:

Associate Professor Andrew Kornberg – neurology expert

Associate Professor John gibson - haematology expert

Associate Professor Sean riminton - clinical immunology expert

Dr Jane Peake - Australasian Society of Clinical Immunology and Allergy representative

Dr Marija Borosak - Australian red Cross Blood Service (Blood Service) representative

Associate Professor Lyn Kiers - Australian and New Zealand Association of Neurologists

Dr Philip Crispin - Haematology Society of Australia and New Zealand representative

Ms Joan Bedford and Ms Carolyn Duck - JBC representatives

Dr Chris Hogan - National Blood Authority Principal Medical Officer (to January 2012)

Professor Henry Ekert - Department of Health and Ageing (DoHA) Clinical representative

The following colleges and societies provided additional expert advice

Australasian College of Dermatologists

Australian & New Zealand Intensive Care Society

Bone Marrow Transplant Society of Australia and New Zealand

National Asthma Council Australia

Perinatal Society of Australia and New Zealand

Thoracic Society of Australia and New Zealand

Many other clinical experts gave generously of their time and expertise. All contributions are gratefully acknowledged.

Governments recognise the need for the Criteria to be regularly reviewed to take account of the evolving processes of disease diagnosis, treatment and outcome evaluation.

This QRG and its updates will be available on the National Blood Authority website (http://www.nba.gov.au/).

Disclaimer: Important information about this document

This document is not a clinical practice guideline. It intends only to provide information about criteria for accessing intravenous immunoglobulin funded under the National Blood Arrangements. Any advice relating to other forms of treatment relevant to the conditions in The Criteria for the clinical use of intravenous immunoglobulin in Australia (the Criteria) have not been subject to a systematic review and should not be relied upon to guide treatment.

Patients and doctors should not use this document as a substitute for expert medical guidance and advice. The relevance and appropriateness of information in this document depends, amongst other things, on an accurate diagnosis, the severity of the condition being properly ascertained, the individual response to diagnostic tests and therapies, and other relevant circumstances in each case.

The Criteria was first published in 2007 after a systematic review that was completed in mid-2006. Another systematic review, of a limited number of indications, was then undertaken in 2010-11 to update the Criteria. This review resulted in the addition of a small number of indications, removal of a small number of indications and a rewording of a limited number of indications.

Inclusion of indications in the Criteria is based where possible upon systematic review of the evidence. In the absence of published evidence, information and access criteria are based on clinical advice provided to the development group by clinical colleges, clinical societies and individual experts.

Each person involved in developing this document, and their employer where they are involved as an employee, or the organisation they represent where they are involved in a representative capacity, expressly disclaims and accepts no responsibility for any consequences arising from relying upon the information or recommendations contained herein.


ISBN 978-0-9872519-0-9

© Commonwealth of Australia, National Blood Authority 2012

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