2010/2011 IVIg Criteria Review

The Criteria for the clinical use of intravenous immunoglobulin (IVIg) in Australia (the Criteria) was implemented in 2008. The Criteria was developed utilising an evidence framework following a systematic literature review and extensive consultations with clinicians and other stakeholders.

In order to ensure that access to IVIg funded under the National Blood Arrangements remains consistent with evidence of demonstrable benefit in patients, for whom there are no alternative safe, effective, and cost-effective treatments, Australian governments agreed to review the Criteria on a three-yearly basis. The review process commences two years after the release of each edition to allow adequate time for consultation and drafting. The 2010/2011 review has recently been completed.

The 2010/2011 review was based on the following principles:

Safe, effective and affordable alternative therapies are preferable to IVIg
The lowest dose of IVIg for the shortest period should be prescribed to achieve the desired clinical outcome
Measurable clinical outcomes must be achieved for IVIg therapy to continue.

The 2010/2011 review:

Limited its focus to proposals for the following:
- Chapter reassignment of existing indications

Modifications to existing indications
Removal of existing indications
Inclusion of new indications.

Required proponents of changes to existing indications to submit new evidence (published from June 2006) and other new information in support of their proposed changes
Required submissions for new indications to provide all available evidence
In the absence of evidence, required submissions to include documented evidence of clinical support from the relevant College or Society
Required submissions to demonstrate international parity.

National IVIg Criteria Review Working Group (NICRWG)

A National IVIg Criteria Review Working Group (NICRWG) was established to oversee the Criteria review process. The NICRWG comprises representatives from both the clinical and government sectors.

Membership:

Ms Joan Bedford – Jurisdictional Blood Committee representative
Dr Marija Borosak – Blood Service representative
Dr Philip Crispin – Haematology Society of Australia and New Zealand representative
Ms Carolyn Duck – Jurisdictional Blood Committee representative
Professor Henry Ekert – Commonwealth Department of Health and Ageing representative
Dr Chris Hogan – National Blood Authority representative
Associate Professor Lynette Kiers – Australian and New Zealand Association of Neurologists representative
Dr Jane Peake – Australasian Society of Clinical Immunology and Allergy representative

Individual Experts:

The clinicians who chaired the discipline specific sub-groups during the development of the initial Criteria were invited to participate as individual experts on the NICRWG. The experts are:

Associate Professor Andrew Kornberg - neurology
Associate Professor John Gibson – haematology
Associate Professor Sean Riminton – clinical immunology

Chair:

JBC appointed Ms Joan Bedford as the chair of the NICRWG for the duration of the review.

Formal Submissions

In order to commence the review process, the NICRWG invited formal submissions from the clinical community in December 2009. Individuals, organisations and representative bodies which had indicated they would make a submission, and those who had previously sought clarification were notified directly of the formal submission process. Members of IVIg User Groups and clinicians ordering IVIg also were informed of the submission process.

Twenty-eight formal submissions were received. The NICRWG determined the process for reviewing the submissions.

A systematic review was conducted by an expert reviewer contracted by the NBA and the results were considered by the NICRWG. A consensus process to agree on outcomes was conducted where evidence was insufficient to determine an evidence-based recommendation.

Public Consultation

Following the completion of the 2010/2011 review, the NBA called for submissions from interested individuals and organisations on the proposed revisions to the Criteria. Public consultation was advertised in The Australian on Saturday 25 June 2011. Notification via direct email was also sent to all relevant colleges and societies and to all stakeholders who previously requested via the NBA website to be advised when public consultation commenced. Public consultation concluded on Friday 19 August 2011.

The submissions will now be forwarded to the NICRWG for consideration. Once the NICRWG has reviewed the submissions and made any necessary changes to the Criteria, a recommendation will be put through to health ministers via government committees. Ministerial approval is required because the Criteria determines the indications for which IVIg is funded by governments. It is expected that the amendments to the Criteria will be presented to health ministers in the first half of 2012.

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