1565 - Acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation

Page last updated: 30 May 2019

Application Detail

Status

Open

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 not about whether treatment with immunoglobulin should be funded by governments, rather on ensuring treatment with immunoglobulin is clinical 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 acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation.

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 Acquired hypogammaglobulinaemia.

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 (HSCT), MM, Non‐Hodgkin lymphoma (NHL) and other Haematological malignancy.

Reason for Application

Health Technology Assessment

Medical Service Type

Therapeutic

Previous Application Number

Not Applicable

Associated Documentation

Application Form

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Consultation Survey

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PICO Confirmation

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

Assessment Report

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Public Summary Document

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Meetings for this Application

Immunoglobulin Review Reference Group

21 November 2018

ESC

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MSAC

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