1565 - Review of immumnoglobulin use for acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation

Page last updated: 06 July 2020

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 focused on on ensuring treatment with immunoglobulin 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. This includes acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation.

Description of Medical Condition

Hypogammaglobulinaemia (low serum levels of IgG and IgA with variable IgM) is a complication associated with haematological malignancy, most commonly in chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). It is present in approximately 25% of patients at diagnosis and up to 85% during the disease course, rendering them susceptible to infections.

One of the most common secondary causes of hypogammaglobulinaemia is medication, especially corticosteroids, some seizure medications and certain biologics such as rituximab (Perez et al 2017). Cancer therapies increase the risk of infections in all specific conditions referred to in this review, however the underlying medical condition may also contribute to this risk in CLL and MM.

Specific conditions as noted in the Criteria include Acute leukaemia, CLL, Memory B cell deficiency secondary to haemopoietic stem cell transplantation, MM, Non‐Hodgkin lymphoma and other Haematological malignancy.

Reason for Application

Health Technology Assessment

Medical Service Type


Previous Application Number

Not Applicable

PICO Confirmation

PICO confirmation (PDF 991 KB)
PICO confirmation (Word 210 KB)

Assessment Report

Public consultation on the draft assessment report will be open until 0900 AEST, 10 September 2019. Please refer to the below guidance document and provide the completed cover sheet with your submission.

Public consultation 1565 assessment report (PDF 4276 KB)
Public consultation 1565 assessment report (Word 3470 KB)

Guidance document and cover sheet for 1565 assessment report (PDF 619 KB)
Guidance document and cover sheet for 1565 assessment report (Word 70 KB)

Public Summary Document

Public Summary Document (PDF 705 KB)
Public Summary Document (Word 367 KB)

Meetings for this Application

Immunoglobulin Review Reference Group

21 November 2018
7 February 2019
24 July 2019


10-11 October 2019


28-29 November 2019