Review of Immunoglobulin in AustraliaDemand 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 (see MSAC applications 1564, 1565 and 1566). Phase 2 of the review will assess an additional three immunoglobulin indications, including multifocal motor neuropathy (MMN).
Description of Medical ServiceImmunoglobulin 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 MMN.
Description of Medical ConditionMMN is a neurological condition characterised by a slowly progressive, asymmetric limb weakness without sensory impairment. It usually starts in the arms and can mimic motor neurone disease due to the combination of weakness, wasting, cramps and involuntary muscle twitch. However, clinical examination may demonstrate that the pattern of weakness follows the distribution of individual nerves rather than a spinal segmental pattern.
Investigations typically show conduction block on nerve conduction studies and conduction block can be persistent for prolonged periods, months or years. IgM anti-GM-1 antibodies have been reported in a large number of patients with MMN and provide confirmatory evidence but are not essential for diagnosis.
Remission in MMN is very uncommon, even on treatment. The prolonged periods of disability caused by MMN can ultimately result in severe wasting. The aim of treatment is to reduce the motor deficit, reverse or improve the motor conduction block and limit axonal degeneration which leads to irreversible functional impairment.
Reason for ApplicationHealth Technology Assessment
Medical Service TypeTherapeutic
Previous Application Number/sNot Applicable
Application FormDraft Referral (Word 356 KB)
Draft Referral (PDF 1004 KB)
Consultation SurveyTemplate for targeted consultation (Word 76 KB)
Template for targeted consultation (PDF 628 KB)
PICO ConfirmationPICO Confirmation (PDF 1280 KB)
PICO Confirmation (Word 450 KB)
Assessment ReportPublic consultation on the draft assessment report will be open until 0900 AEST, 20 May 2020.
Please refer to the below guidance document and provide the completed cover sheet with your submission.
Public consultation 1590 assessment report (PDF 4080 KB)
Public consultation 1590 assessment report (Word 1797 KB)
Guidance document and cover sheet for 1590 assessment report (PDF 765 KB)
Guidance document and cover sheet for 1590 assessment report (Word 70 KB)
Public Summary Document-
Meetings for this Application
Immunoglobulin Review Reference Group24 July 2019
9 October 2019
25 March 2020