Immunoglobulin Governance Program Updates

This page is updated quarterly to provide medical specialists, nurses, dispensers, consumers and other stakeholders a snapshot of the NBA’s current work program and priorities in the Immunoglobulin (Ig) space. Links to further information are provided as applicable.

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November 2021 Update

 

Impact of the Immunoglobulin (Ig) Governance Program. An external evaluation of the Ig Governance Program has found that the Program is effective in helping ensure that Ig products are available to the right patients.

Ig products are used to treat a range of immune deficiencies and autoimmune conditions. They can substantially improve the quality of people’s lives and can be life-saving. However, as they are made from thousands of donations of human plasma, they are a precious and finite resource.

Before the introduction of the Ig Governance Program (Program) in 2014, Ig usage in Australia was increasing unsustainably, with annual increases in use of 10-12%. The Program was set up to ensure that Ig products are available to patients in an equitable, clinically-appropriate manner nationally, with efficient, effective and ethical expenditure of government funds.

The external 2021 evaluation of the Program (by PricewaterhouseCoopers Consulting) concluded that the Program has been effective in reducing the growth in demand for Ig, with effectiveness linked to the key program elements:

  • the National Policy on Access to Government-funded Immunoglobulin Products in Australia (National Policy), which defines the roles and responsibilities of all professionals involved in the prescription, management and use of Ig
  • the Criteria for the Clinical Use of Immunoglobulin in Australia (Criteria), which defines patient eligibility
  • BloodSTAR - the Blood System for Tracking Authorisations and Reviews, the national online management system that facilitates clinical requests for patient access to Ig products in line with the National Policy and Criteria.

Prior to the introduction of the Program (July 2009-December 2013), the evaluation found that Ig usage per 1,000 population was growing at 8% annually. This dropped to 7.3% during the Program’s implementation (January 2014-October 2019), and fell further, to 5.1%, once the program was fully implemented. Critically, this has been achieved without major changes in the most commonly treated medical conditions.

The reduced growth in demand, driven by the Ig governance arrangements, has delivered an estimated savings of almost $90 million in product expenditure since 2018-19, with predictions of $2.2 billion savings by 2030-31 (compared to estimated costs without the program).

Review of the National Subcutaneous Immunoglobulin (SCIg) Program. The NBA will shortly be seeking quotes from suitable providers to conduct and evaluation of the effectiveness of the National SCIg Program and identify options that can overcome current barriers to optimal program update and inform the Program’s future direction.

Changes to the Criteria for the Clinical Use of Immunoglobulin in Australia. As previously reported, changes were made to the Criteria in April to include the temporary addition of Vaccine-Induced Thrombotic Thrombocytopenia (VITT), and minor changes to Kawaski disease. Although the decision to use alternative vaccines to protect against COVID-19 moving forward will see the incidence of VITT decrease, monitoring will continue, with the condition to be reviewed in 12 months.

Details are available here: https://www.criteria.blood.gov.au/MedicalCondition/View/2669, with access through BloodSTAR, in line with usual procedures.

Ig health technology assessment (HTA) reviews by the Medical Services Advisory Committee (MSAC). In 2018, the NBA and Department of Health commenced a series of six pilot HTA reviews of Ig use currently funded under the National Blood Agreement. Each of the six medical conditions that were selected for the pilot have now been reviewed. The public summary documents (PSDs) are available on the MSAC website (link is external). The conditions included were: Acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (AHG); Myasthenia gravis (MG); Multifocal motor neuropathy (MMN); Primary immunodeficiency disease (PID), and; Secondary hypogammaglobulinaemia (SHG) unrelated to haematological malignancies or haemopoietic stem cell transplantation, and Chronic inflammatory demyelinating polyneuropathy (CIDP).

Work will continue, in accordance with the NBA’s statutory responsibilities, to manage access and use of Ig funded under the national blood arrangements. This will include considering the feasibility and relative value of actions arising from the MSAC advice. Some of the MSAC advice is relevant to more than one condition. Relevant SWGs are working to prioritise potential action items. Any material uplift to current NBA activities and systems will require a commensurate increase in funding.

Ig authorisation management through BloodSTAR. The last changes to the BloodSTAR sector systems (BSS) were implemented in July (a summary is available in the July Ig Program Updates), with the next BSS release (BloodSTAR 3.7) planned for early December 2021.

Usage data, statistics and evaluation. Data collection and analysis is an important part of the NBA Ig Governance Program, and the NBA’s performance improvement strategy. Activities under this strategy are focussed on ensuring that precious Ig product is used for those who gain the most benefit from it.

Recent data on Ig usage is revealing an encouraging trend: the last two years’ statistics show that Ig usage is currently increasing at a rate of approximately 7% per annum. This is a substantial decrease in Ig’s rate of growth over the preceding decade and more; until 2018-19, Ig use had been rising at a rate of 10-12% per year. This finding has recently been confirmed through an external evaluation by PricewaterhouseCoopers Consulting – summarised here.

See the latest Ig use statistics here. NBA’s annual reports on the issue and use of immunoglobulin are available here. For more information on the Ig Governance Program’s performance improvement initiatives see: National Immunoglobulin Governance Program Performance Improvement Strategy, 2019-2022.

Education and training resources BloodSafe eLearning Australia (link is external) (BEA) recently released the 5th and final Immunoglobulin eLearning course in late June 2021. Developed in collaboration with the NBA, with expertise provided by a multidisciplinary group of clinicians, the 5 courses are aimed at health care staff involved in the prescription, ordering, administration and reporting of Ig product, for both intravenous and subcutaneous Ig products use.

Users must register for the courses, but access to all the courses is free. At the time of writing, there have been approximately 1300 course completions across all 5 courses.

Further information on each of the courses is available at Ig Resources, or on the BEA website (link above).

Value in Prescribing (ViP) Immunoglobulin Program. The NBA has been working in partnership with the Department of Health (DoH) and NPS Medicinewise to deliver the ViP Immunoglobulin Program. Funded through a DoH grant, this three-year initiative will deliver a range of educational resources for both medical professionals and consumers, supporting the NBA’s Ig governance work with the key objective of ensuring that Australia can provide Ig treatment equitably and affordably to those who need it most. A number of resources have already been released, but timeframes for program delivery have recently been extended, with many more resources now expected in late 2021 or early 2022.  

More information is available at the NPS MedicineWise website (link is external). Links are also included on the NBA Ig Resources page.

Committee and stakeholder meetings

 

National Immunoglobulin Governance Advisory Committee (NIGAC). The NIGAC met in August. Discussions included: progressing outcomes of the immunoglobulin health technology assessment (HTA) reviews by the Medical Services Advisory Committee (MSAC); educational resource development work progressing through the Value in Prescribing Immunoglobulin Program; and revised Criteria for the use of intravenous immunoglobulin for treatment of Vaccine Induced Immune Thrombotic Thrombocytopenia (VITT) (information on  the Criteria update process can be found here). The next meeting of the NIGAC is scheduled for early December 2021.

See key issues summary for further information on individual items.

Immunoglobulin Specialist Working Groups (SWGs). All four SWGs – Immunology, Haematology, Neurology and Transplant – met in October/November 2021. Key issues discussed at these meetings, and progressed out-of-session, include: HTA reviews by MSAC* and the public summary document on immunoglobulin use for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as well as the analysis of MSAC Ig reviews advice; information available through the Myeloma and Related Diseases Registry (MRDR) and the Lymphoma and Related Diseases Registry (LaRDR) and how this could be used to inform the work of the Haematology SWG; potential changes to the Criteria; refinement of SWG work plans; feedback on the NBA’s Ig usage data and reporting and how this can be used to better inform the work of the SWGs and BloodSTAR systems related feedback and suggestions for system enhancement.

*See key issues summary for further information.

Previous Ig Program Updates

Keep up to date

Ig Program Updates provides a snapshot of the NBA’s current work program and priorities in the immunoglobulin space. It is updated quarterly.

To receive the latest Immunoglobulin Governance Program Updates by email, join the Ig Updates and National Immunoglobulin Interest Group (NIIG) subscription list: email Iggovernance@blood.gov.au with the words SUBSCRIBE Ig Program Updates and NIIG in the subject line.

In the body of the email, please indicate your interest (e.g. Healthcare Professional/ Patient/ Government, etc.) and include your signature block.

Subscribers receive notification of the quarterly Ig Program Updates, and may also be invited to informally discuss and comment on individual Ig-related issues as they arise (participation is optional).

For more information on NIIG, see: www.blood.gov.au/Ig-committees.

For further information

 

Please contact the National Blood Authority on 13 000 BLOOD (13 000 25 663)  or email IgGovernance@blood.gov.au.