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 (see MSAC Applications 1564, 1565, 1566). Phase 2 of the review will assess an additional three immunoglobulin indications, including secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT).

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 immunoreplacement therapy in secondary hypogammaglobulinaemia.

Description of Medical Condition

Hypogammaglobulinaemia, marked by an abnormal susceptibility to bacterial infections, is defined as a serum immunoglobulin G (IgG) level <700 mg/dL. It can arise from many causes including protein losing states; malnutrition; thymoma; immunosuppressant therapy; and repeated cycles of B-cell depletion therapy (e.g. rituximab). This patient group includes a wide range of conditions including both paediatric and adult patients.

Successful management of the underlying condition will in many cases reverse hypogammaglobulinaemia. However in some cases, it may persist and be complicated by recurrent or severe bacterial infections. Approximately 15 percent of patients who have received a solid organ (heart, lung, kidney) transplant experience secondary hypogammaglobulinaemia with severe IgG deficiency (<400mg/dL) during the first year after transplantation, resulting in a much greater risk of infection compared to patients with normal IgG levels.

The indications for use of Ig under the Criteria include:
- hypogammaglobulinaemia following solid organ transplantation
- hypogammaglobulinaemia following B cell depletion therapy
- thymoma-associated hypogammaglobulinaemia (Goods syndrome)
- other hypogammaglobulinaemia unrelated to haematological malignancies or HSCT.

Reason for Application

Health Technology Assessment

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Referral (PDF 1522 KB)
Referral (Word 349 KB)

Consultation Survey

Template for targeted consultation (Word 73 KB)
Template for targeted consultation (PDF 628 KB)

PICO Confirmation

PICO Confirmation (PDF 1387 KB)
PICO Confirmation (Word 333 KB)

Assessment Report

Public consultation 1591 assessment report (PDF 3167 KB)
Public consultation 1591 assessment report (Word 1940 KB)

Guidance document and cover sheet for 1591 assessment report (PDF 766 KB)
Guidance document and cover sheet for 1591 assessment report (Word 70 KB)

Public Summary Document

Public Summary Document (PDF 693 KB)
Public Summary Document (Word 639 KB)

Meetings for this Application

Immunoglobulin Review Reference Group

24 July 2019
9 October 2019
25 March 2020

ESC

8–9 October 2020

MSAC

26–27 November 2020