Immunoglobulin is a plasma-derived product used to treat various medical conditions. It can be delivered intravenously or subcutaneously.
The Australian Government and state and territory governments fund the supply of Australian and imported immunoglobulin under the National Blood Agreement.
Immunoglobulin Review Pilot Process
The Immunoglobulin Review Pilot Process (Ig Reviews) looks at how we use government-funded immunoglobulin to treat selected conditions.
It is based on the framework for doing post-market reviews of medicines subsidised via the Pharmaceutical Benefits Scheme (PBS), with modification to suit the Medical Services Advisory Committee (MSAC) process for evaluating evidence.
Why it is important
Demand for immunoglobulin in Australia has been rising over the past 10 years. Internationally, Australia is 1 of the top 3 users of immunoglobulin per person. Immunoglobulin treatment is expensive, and worldwide shortages affect price and supply.
Understanding how effective immunoglobulin treatment is for each medical condition helps us make sure patients receive the most beneficial treatment available.
The Ig Reviews look at medical conditions treated with government-funded immunoglobulin. They assess whether immunoglobulin is safe, effective and cost-effective compared with other treatment options.
This is consistent with how we assess other pharmaceutical and medical technologies for government funding.
The initial Ig Reviews are pilots. We will incorporate feedback during and after the pilot to improve the process for future reviews.
Who we work with
- The National Blood Authority (NBA) provides input to the Ig reviews. The NBA is responsible for governance and supply of immunoglobulin products on behalf of all Australian governments.
- The Ig Review Reference Group supports and guides the PICO process (population, intervention, comparator, outcome – a process that frames and answers a clinical or health care-related question) and the contracted assessment report. The group consists of experts in haematology, immunology, neurology and pharmacy, and includes a health economist and a consumer representative.
- Independent health technology assessment groups assess and analyse the evidence to compare immunoglobulin treatment with other available treatments. They then prepare the contracted assessment report.
- The MSAC provides advice and makes recommendations to the Australian Government and NBA.
The review process for each condition is as follows:
- Referral submission – The NBA submits the referral to the Department of Health. Once accepted, the referral is published on the MSAC website.
- Targeted consultation – Stakeholders, such as sponsors, clinical and consumer groups, are invited to provide feedback on the referral. The reference group considers these submissions when finalising the PICO.
- Development of the PICO – A health technology assessment group develops a draft PICO, guided by the referral and feedback received during targeted consultation. The reference group endorses the finalised PICO, which is then published on the MSAC website.
- Development of the contracted assessment – Guided by the PICO, a health technology research group prepares a draft assessment report. Sponsor companies of Ig are invited to provide information related to the effectiveness, safety and cost-effectiveness of Ig. We share all input with the research group and reference group to include in the assessment report, if appropriate. The reference group provide further input, and gives the final approval for the report to progress to MSAC.
- Public consultation – The MSAC publishes the contracted assessment on its website for comments and submissions.
- Evaluation Sub-Committee advice – The MSAC’s Evaluation Sub-Committee considers all Ig Review documents, including the public submissions. It then advises the MSAC on the quality, validity and relevance of evidence in the contracted assessment report.
- MSAC consideration – The MSAC considers all documents and advice.
- Outcome – The MSAC provides its final recommendations to the NBA, the Jurisdictional Blood Committee and the Australian Government. The MSAC publishes a public summary on its website.
Conditions under review are:
- chronic inflammatory demyelinating polyneuropathy (Condition 1564)
- acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (Condition 1565)
- myasthenia gravis (Condition 1566)
- multifocal motor neuropathy (Condition 1590)
- secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haematopoietic stem cell transplantation (Condition 1591)
- primary immunodeficiency diseases with antibody deficiency (Condition 1592).
To stay up to date with Ig Reviews, sign up to the MSAC email bulletin.