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 six 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 disease characterised by a progressive or relapsing/remitting course. The condition develops over at least two months, with evidence of demyelination in 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 Assessment

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

PICO Confirmation

PICO Confirmation (PDF 1277 KB)
PICO Confirmation (Word 187 KB)

Assessment Report

Public consultation on the 1564 CIDP re-submission assessment report (post-April 2020 MSAC meeting) closed on 0900 AEST, 14 May 2021.
The resubmission assessment report and guidance report are provided below for reference.

Updated Public consultation 1564 re-submission assessment report (PDF 4531 KB)
Updated Public consultation 1564 re-submission assessment report (Word 3375 KB)

Guidance document and cover sheet for 1564 re-submission assessment report (PDF 767 KB)
Guidance document and cover sheet for 1564 re-submission assessment report (Word 75 KB)

Public consultation on the original MSAC 1564 assessment report closed on 0900 AEST, 16 December 2019.
The original report and guidance document are provided below for reference.

Public consultation 1564 assessment report (superseded) (PDF 3911 KB)
Public consultation 1564 assessment report (superseded) (Word 1040 KB)

Guidance document and cover sheet for 1564 assessment report (superseded) (PDF 617 KB)
Guidance document and cover sheet for 1564 assessment report (superseded) (Word 70 KB)

Public Summary Document

April 2020 MSAC Outcome
After considering the strength of the available evidence in relation to the safety, clinical effectiveness and cost-effectiveness of immunoglobulin (Ig) therapy for CIDP, MSAC deferred giving advice on the clinical and cost-effectiveness of immunoglobulin in the treatment of chronic inflammatory demyelinating polyneuropathy because of the substantial uncertainties in the submission – the validity of the criteria for initiation and continuation to identify those patients with the greatest benefit and in whom Ig was cost effective, apparent discrepancy between epidemiological data on prevalence and usage (four times higher than expected), and an economic evaluation that did not appear to have a robust model structure. Further targeted analysis was required to address the areas that were insufficiently covered in the submission.

Public Summary Document - July 2021 (PDF 662 KB)
Public Summary Document - July 2021 (Word 358 KB)

Meetings for this Application

Immunoglobulin Review Reference Group

21 November 2018
7 February 2019
24 July 2019
9 October 2019

ESC

13-14 February 2020
10-11 June 2021

MSAC

2-3 April 2020
29-30 July 2021

Stakeholder Meeting

Tuesday, 2 November 2021, members of MSAC, clinicians with experience and expertise in neurology medicine, representatives of immunoglobulin sponsor companies; a representative of Lifeblood; a representative from a consumer organisation; representatives of the National Blood Authority, and the Department of Health met to discuss immunoglobulin use for Chronic Inflammatory Demyelinating Polyneuropathy. This was not an MSAC decision forum, but a meeting that would inform the issues considered by MSAC, following its July 2021 consideration of application 1564. The final minutes of this meeting are below.

Final Stakeholder Meeting Minutes (PDF 268 KB)
Final Stakeholder Meeting Minutes (Word 66 KB)