The National Blood Authority (NBA) is a statutory agency within the Australian Government Health portfolio that manages and coordinates arrangements for the supply of blood and blood products and services on behalf of the Australian Government and state and territory governments.

The key roles of the NBA are to: provide an adequate, safe, secure and affordable supply of blood products, blood related products and blood related services; promote safe, high quality management and use of blood products, blood related products and blood related services in Australia.

Immunoglobulin (Ig) is a precious biological product derived from donated blood plasma, and as such, its prescription and use should be consistent with the available clinical evidence base, and should be prioritised for the treatment of patients who are most likely to benefit from immunoglobulin therapy, and for whom there are no safe and effective alternative treatments. Patients who meet the requirements specified in the Criteria for the clinical use of Ig in Australia (Criteria) will receive Ig at no direct cost funded by all Australian Governments through the National Blood Arrangements.

The demand for Ig in Australia grows at a consistent annual rate of more than 10%. In 2016-17, a total of 5.54 million grams of Ig was issued, representing a cost of $532.3 million nationally (including the cost of plasma collections). The rate of increase of Ig demand is significantly above the rate of increase of Australian plasma collections by the Australian Red Cross Blood Service, with the result that the proportion of Ig demand that is met by imported Ig products is also increasing each year.

The continual significant annual growth in Ig use, the relatively high cost of Ig products and the potential for supply shortages mean that good governance, assurance and quality improvement are essential to maintain a focus on ensuring that use remains consistent with an evidence-based approach and that Ig is able to be accessed under the National Blood Arrangements for those patients with the greatest clinical need.

The NBA Ig Governance Program was established to develop and implement a number of improvement projects to strengthen the governance and authorisation for the management and use of Ig in Australia.

In 2012, the NBA, on behalf of all Australian governments, commissioned a review of the adequacy of the existing intravenous immunoglobulin (IVIg) authorisation and clinical governance arrangements, with a view to recommending options for improvements to deliver governments’ goals for the management of IVIg. The review also analysed the issues, benefits and risks of potentially including normal human immunoglobulin (NHIg) and subcutaneous immunoglobulin (SCIg) in the IVIg management framework. The review highlighted significant variation in Ig use, management and processes nationally, with a number of inefficiencies being described. Improvements recommended by the review included short term and long terms improvement projects.

The infrastructure and implementation phases of the Ig Governance Program are now complete and the totality of the Program elements now in place provides a robust and sustainable platform from which forward assurance, compliance and quality improvement activities will be driven over coming years, to progressively achieve the assurance, appropriateness, equity, efficiency and sustainability objectives of governments for the supply and funding of Ig as a unique, high cost, scarce biopharmaceutical resource which is critical and beneficial across many acute and patient conditions.

At the end of December 2018, the year to date usage had increased by 10%. The year to date usage at the same time point in the previous year (December 2017) was 11%. This 1% reduction in the increase in Ig usage currently equates to a potential saving of approximately $5 million per annum, but savings may increase as more patients transition to Version 3 of the Criteria, and the benefits of other Program achievements begin to be realised.

The NBA established an integrated network of national Ig governance committees whose advice and recommendations has fundamentally informed the recent and ongoing Ig Governance Program work including the Criteria. The network of committees will inform the development of education and learning material to support health professionals involved in the use and management of Ig to undertake their roles and responsibilities in accordance with the National Policy.

The Ig Governance Program also provides a strong platform for interaction with program work and new initiatives of other health agencies. Performance improvement activities will be undertaken in collaboration with entities responsible for assurance and healthcare quality improvement at a jurisdictional and health service level. The national policy and Criteria under the Ig Governance Program interact with the National Healthcare Quality Standards of the Australian Commission on Safety and Quality in Health Care. The NBA is collaborating closely with the Australian Government Department of Health in two new initiatives, one to undertake health technology assessments of the use of Ig for selected medical conditions through the Medical Services Advisory Committee, and the other to undertake a national program of targeted education of medical specialists on prescribing of selected high cost therapies, including Ig.