1566 - Myasthenia Gravis

Page last updated: 21 November 2019

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 Myasthenia Gravis.

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 (the Criteria). Immunoglobulin is used as immunomodulation therapy in Myasthenia Gravis.

Description of Medical Condition

Myasthenia Gravis is an autoimmune condition that causes problems with the transmission of signals from the nerves to the muscles. Clinical features are characterised by fluctuating weakness and fatigability of voluntary muscles, namely levator palpebrae, extraocular, bulbar, limb and respiratory muscles. Patients usually present with unilateral or bilateral drooping of eyelid (ptosis), double vision (diplopia), difficulty in swallowing (dysphagia) and proximal muscle weakness. Weakness of respiratory muscles can result in respiratory failure in severe cases or in acute severe exacerbations (myasthenic crisis) (the Criteria). Over a longer term, the symptoms of Myasthenia Gravis usually progress, reaching a maximum or near-maximum severity within one to three years of onset in most people (Muscular Dystrophy Foundation Australia 2012).

Myasthenia Gravis affects two to seven out of every 10,000 people in Western countries. It occurs about one and half times more in women than in men.

Reason for Application

Health Technology Assessment

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

PICO Confirmation

PICO confirmation (PDF 1147 KB)
PICO confirmation (Word 448 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 1566 assessment report (PDF 4077 KB)
Public consultation 1566 assessment report (Word 2078 KB)

Guidance document and cover sheet for 1566 assessment report (PDF 617 KB)
Guidance document and cover sheet for 1566 assessment report (Word 70 KB)

Public Summary Document

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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

MSAC

2-3 April 2020