Immunoglobulin is a plasma-derived product used as a treatment for a range of medical conditions. It may be infused intravenously or subcutaneously. Access to government-funded immunoglobulin is through the national blood arrangements and determined by the National Blood Authority’s (NBA) National Policy: access to government-funded immunoglobulin products in Australia and the Criteria for the clinical use of immunoglobulin in Australia (the Criteria).
All Australian Governments, through the Jurisdictional Blood Committee (JBC), have agreed to conduct robust Health Technology Assessments (HTAs) of immunoglobulin use (Ig Reviews) funded under the National Blood Agreement. The Ig Reviews will consider immunoglobulin use in the context of both intravenous and subcutaneous infusion where relevant. Outcomes of Ig Reviews will ensure government-funded use within Australia for specific medical conditions based on evidence of clinical safety, effectiveness and cost-effectiveness. This is consistent with how other pharmaceutical and medical technologies are assessed for government funding.
The Ig Reviews will complement the NBA Immunoglobulin Governance Program. The process for conducting the Ig Reviews has been based on the framework for conducting Post Market Reviews of medicines subsidised via the Pharmaceutical Benefits Scheme, with modification to allow evaluation of the evidence for each immunoglobulin indication by the Medical Services Advisory Committee (MSAC). The initial Ig Reviews are considered a pilot. Feedback during and after the pilot will be incorporated to improve the process and formalise a framework for future reviews.
For further information regarding the review process please see the outline provided on the Department of Health website at https://www1.health.gov.au/internet/main/publishing.nsf/Content/ig-review-pilot-process.
The following links will direct you to the MSAC webpage where the Ig Review documents are available:
Current Conditions under review
- MSAC – 1564 – Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- MSAC - 1566 - Myasthenia Gravis
- MSAC – 1590 – Multifocal motor neuropathy (MMN)
- MSAC – 1591 – Secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haematopoietic stem cell transplantation (HSCT)
- MSAC – 1592 – Primary Immunodeficiency diseases (PID) with antibody deficiency
- MSAC - 1565 - Acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation
To receive news alerts and information related to the Ig Review from the MSAC Website, you can sign up to the MSAC home page under the heading MSAC email bulletin - MSAC - Subscribe. You may also email any queries to the MSAC Ig Review Secretariat: MSACIg_Secretariat@health.gov.au.