Latest online version of the Criteria
During the BloodSTAR transition period, the addition of ‘new’ Criteria ‘evidence items’ fields does not change the basis for approval of authorisation of Ig product. Authorisers will evaluate authorisation requests with the same approach that applies to authorisation based on the use of previous paper forms.
National Immunoglobulin Governance Advisory Committee
The National Immunoglobulin Governance Advisory Committee (NIGAC) is the peak committee in a national network of existing jurisdictional and specialist working groups that have been established under the National Immunoglobulin Governance Program.
As a subcommittee of the Jurisdictional Blood Committee, NIGAC’s main purpose is to provide advice and make recommendations to inform governments in the development and implementation of measures to further strengthen Ig product use and governance arrangements including:
- evolving the Criteria to include expected clinical outcomes for continuing access to Ig for all diagnoses
- knowledge management and development program
- performance improvement framework
- consideration of conditions for automatic approval within the national database for a subset of diagnoses
- consideration of streamlining the distribution path for Ig products
- In addition, NIGAC plays a critical leadership role to ‘champion’ for the program performance improvement supporting more cost effective and appropriate clinical practice and better governance, management and use of Ig products.
The four medical specialist representatives on NIGAC each Chair a Specialist Working Group, providing established links and working relationships to be able to make recommendations and receive advice regarding prescribing practice within specialities and related to eligibility for access and reforms to the Criteria for example.
NIGAC Membership and Terms of Reference
- NIGAC Terms of Reference (pdf) (342.31 KB)
- NIGAC Terms of Reference (docx) (56.04 KB)
- NIGAC membership (pdf) (257.88 KB)
- NIGAC membership (docx) (53.08 KB)
Immunoglobulin Specialist Working Groups
Four immunoglobulin specialist working groups have been established as the national functional autonomous structures to provide expert medical advice and clinical considerations for the Ig Governance program in each of the areas of Haematology, Immunology, Neurology and Transplantation. Representation is sought from additional specialty areas (e.g. Rheumatology, Dermatology) as required.
The composition of the SWGs includes medical specialists with clinical expertise and appropriate qualifications to consider the clinical appropriateness, safety and cost effectiveness of Ig, including comparative outcomes of different therapies. The SWGs:
- Provide specialist clinical advice, feedback and make recommendations regarding changes to the Criteria for the clinical use of Intravenous immunoglobulin in Australia (the Criteria)
- Provide specialist insight and advice on the development and commissioning of clinical treatment guidelines, research projects, consensus statements or other knowledge development in areas where prescribing variations exist with the potential for inappropriate use or regarding emerging areas of clinical practice
- Define the relative prioritisation of each indication for eligibility during times of product shortage
- Identify and recommend improvements to education and training regarding Immunoglobulin (Ig) and its use and provide education of clinicians regarding the Ig Program, as required
- Provide advice and feedback regarding system values and modifications to the Immunoglobulin authorisation and outcomes database (BloodSTAR System)
- Provide advice and contribute to Performance Improvement activities including the review of data and reports and identify, make recommendations and take action regarding opportunities for continuous improvement.
- Contribute to the national body of knowledge and the broader Ig Governance Program including liaising as part of the national network of committees (including with NIGAC, other SWGs, and jurisdictional Ig advisory groups) as required.
- Participate in specialist networks that may provide approval for use in specific conditions as required
- Receive advice from jurisdictional clinical stakeholders regarding the Criteria.
SWG Membership and Terms of Reference
- Specialist Working Group Membership List (pdf) (192.12 KB)
- Specialist Working Group Membership List (docx) (38.2 KB)
- Ig Governance SWG Terms of Reference (pdf) (397.51 KB)
- Ig Governance SWG Terms of Reference (docx) (61.51 KB)
Ig Governance Program Structure