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.
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. Immunoglobulin products supplied and funded under these arrangements are listed on the National Product Price List, and include:
- Intravenous Immunoglobulin (IVIg)
- Subcutaneous Immunoglobulin (SCIg)
- Normal Human Immunoglobulin (NHIg)
Purpose of the program
Following the Review of the authorisation and clinical governance of intravenous immunoglobulin in 2012 the Jurisdictional Blood Committee (JBC) endorsed the National Blood Authority Immunoglobulin Governance Program which aims to develop and implement a number of improvement projects to address the findings and recommendations of the Review and to further strengthen the governance and authorisation for the management and use of Ig in Australia.
The program aims to improve the governance and management of publicly funded Ig to ensure that:
- product use and management reflects appropriate clinical practice and
- represents efficient, effective and ethical expenditure of government funds
- in accordance with relevant national safety and quality standards for health care.
Outcomes of the program
Program measures include:
Development and maintenance of policies and procedures for access to Ig products – The National Policy: Access to Government-Funded Immunoglobulin Products in Australia describes the roles and responsibilities of key participants in the governance and management framework for immunoglobulin products. This includes integration of NHIg into IVIg arrangements, introduction of consent forms and centralised ordering.
Establishment and support of a national network of committees – An integrated network of National Immunoglobulin Governance Committees has been established, including the National Immunoglobulin Governance Advisory Committee and specialist working groups. The advice and recommendations of this committee network fundamentally informs the development, implementation and ongoing operation of the other governance program measures.
Evolving the criteria for access - The Criteria for the clinical use of intravenous immunoglobulin in Australia (Criteria) were first published in 2007 and updated in 2012, and have been successful in defining the eligibility for access to product funded under the national blood arrangements. Note: In 2016, Version 2 criteria has been adapted for use in the new online ordering and outcomes database BloodSTAR.
Development and implementation of a national ordering and outcomes database – BloodSTAR has been developed to support prescribers, nurses, dispenser and health facilities, manage supply and order Ig products and assist them in meeting their obligations set out in the National Policy. BloodSTAR is expected to facilitate a consistent and equitable approach to the application of the national policy and the Criteria, as well as improve transparency for governments and others to help inform supply and demand of immunoglobulin products.
Development and implementation of a performance improvement program – Under the guidance of the national committee network; and utilising the Criteria and National policy, and the outcomes and ordering database, a program will be developed to monitor, assess and improve the performance of the governance system and identify improvements to systems and processes.
Facilitate knowledge development – The knowledge development program will identify priorities for development of better knowledge to allow for better decision making. This will be at both the clinician and system level and will looking at things like value of investment in research, education and training.
If you would like to be involved in informing the development of the Ig Governance Program, you can contact the National Blood Authority on 13 000 IGGOV (13 000 44468) or email IgGovernance [at] blood.gov.au