1591 – Review of immunoglobulin use for secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haemopoietic stem cell transplant

Health Technology Assessment.

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.

Type: Therapeutic

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).

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.

• Immunoglobulin Review Reference Group: 
  • 24 July 2019
  • 9 October 2019
  • 25 March 2020
• ESC meeting: 8 to 9 October 2020
• MSAC meeting: 26 to 27 November 2020