The Criteria for the Clinical Use of Intravenous Immunoglobulin (IVIg) in Australia (the Criteria) has been developed to assist clinicians and transfusion medicine professionals to identify the conditions and circumstances for which the use of intravenous immunoglobulin (IVIg) is appropriate and funded under the National Blood Agreement.
The Criteria supersedes the Australian Health Ministers’ Advisory Council (AHMAC) IVIg Guidelines published in 2000. A six month transition period from March has been allowed for full adoption of the Criteria.
The information and recommendations provided in the Criteria represent informed opinion based, where possible, upon systematic review of the evidence. In the absence of published evidence, recommendations are based on clinical advice provided to the parties involved in developing this document (i.e. the Jurisdictional Blood Committee IVIg Working Party and its clinical advisers and consultants, the Jurisdictional Blood Committee, and the Commonwealth of Australia).
The Criteria groups conditions into four chapters;
In accordance with the funding policy, IVIg is available under the National Blood Arrangements for Australians whose conditions fall within Chapters 5, 6 or 7. The Criteria provides a comprehensive description of the diagnostic, qualifying, exclusion and review criteria to determine patient eligibility for access to this product under the National Blood Arrangements.
Patients who do not fulfil the Criteria will not be eligible to receive IVIg under the National Blood Arrangements. In these circumstances, individual jurisdictions or hospitals may elect to make IVIg available to clinicians and patients through the state-based funding arrangements commonly known as Jurisdictional Direct Orders (JDO).
A small number of patients currently receiving IVIg therapy may no longer qualify for access to ongoing IVIg therapy funded under the National Blood Arrangements following the implementation of the new Criteria. These patients may be able to seek access to IVIg funded under the state system or, alternatively, may need to be transitioned to alternative treatment regimes under the guidance of their treating doctor.
Current state and territory arrangements for authorisation, ordering and recording of IVIg treatment remain the same.
To further assist with the implementation process, a time-limited National IVIg Criteria Reference Group, comprising experts involved in the development of the Criteria, key users and approvers from each jurisdiction, will be established to assist with standardising interpretation of the Criteria.
New process for managing orders for blood and blood products
