Application Detail
Review of Immunoglobulin use in Australia
Demand for immunoglobulin in Australia has increased around 11% per year since 2009-10. Internationally, Australia is in the top three users of immunoglobulin, along with the US and Canada.All Australian Governments, through the Jurisdictional Blood Committee (JBC), have agreed to conduct a robust Health Technology Assessment review to ensure government-funded immunoglobulin use within Australia is based on strong evidence of clinical and cost effectiveness. This is consistent with how other pharmaceutical and medical technologies are assessed for government funding.
The review is to ensure treatment with immunoglobulin, funded by Governments, is both clinically and cost effective compared to other treatment options
The review complements the National Blood Authority Immunoglobulin Governance Program, which aims to strengthen clinical governance and authorisation of government-funded immunoglobulin in Australia.
The review is being conducted through the Medical services Advisory Committee (MSAC) assessment process supported by a bespoke reference group. The MSAC Immunoglobulin Review Reference Group will oversee all immunoglobulin HTA review applications.
Initially, the review will assess three immunoglobulin indications considered to have strong evidence and usage data. This includes Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Description of Medical Service
Immunoglobulin is a plasma-derived product manufactured to treat a range of medical conditions. Access to government-funded immunoglobulin is through the national blood arrangements and is determined by the National Blood Authority’s Criteria for Clinical Use of Immunoglobulin in Australia. Immunoglobulin is used as immunomodulation therapy in CIDP.Description of Medical Condition
CIDP is an acquired sensorimotor polyneuropathy characterised by a progressive or relapsing/remitting course developing over at least two months with evidence of demyelination on electrophysiological or pathological studies and response to immunomodulating therapies.CIDP is caused by the body’s immune system inappropriately reacting against and damaging myelin. Myelin surrounds the peripheral nerves and acts like an insulator so that the nerves can conduct impulses properly. It can occur at any age and in both sexes, but is more common in men than women.
Symptoms include tingling, numbness or altered feeling which often begins in the feet and hands, weakness of the arms and legs, fatigue and aching pain in the muscles.
Reason for Application
Health Technology AssessmentMedical Service Type
TherapeuticPrevious Application Number
Not ApplicableAssociated Documentation
PICO Confirmation
PICO confirmation (PDF 1209 KB)PICO confirmation (Word 187 KB)
Assessment Report
Public consultation on the draft assessment report will be open until 0900 AEST, 16 December 2019.Please refer to the below guidance document and provide the completed cover sheet with your submission.
Public consultation 1564 assessment report (PDF 3911 KB)
Public consultation 1564 assessment report (Word 1040 KB)
Guidance document and cover sheet for 1564 assessment report (PDF 617 KB)
Guidance document and cover sheet for 1564 assessment report (Word 70 KB)
Public Summary Document
-Meetings for this Application
Immunoglobulin Review Reference Group
21 November 20187 February 2019
24 July 2019
9 October 2019