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Intravenous immunoglobulin (IVIg) is derived from human plasma. IVIg is a life-saving therapy in appropriately selected patients and clinical settings. IVIg can be ordered by specialist clinicians.
The Criteria was developed using the best available information and expertise to ensure IVIg use is consistent and for the treatment of patients who are likely to derive a genuine health benefit.
The Criteria identifies conditions for which polyvalent immunoglobulin such as IVIg may be contemplated as a treatment. Conditions listed in Chapters 5 and 6 of the Criteria include those where IVIg has an established or emerging therapeutic role. Conditions listed in Chapter 7 are those where IVIg might be considered in exceptional circumstances and usually when all other possible treatments have failed. The Criteria provides information on diagnostic, qualifying, exclusion and review criteria and also on dosage regimen.
Australian patients with conditions listed in Chapters 5, 6 and 7 of the Criteria will usually get access to IVIg provided under the National Blood Arrangements.
Specialist clinicians may renew an order for IVIg for patients who demonstrate benefit from the therapy and whose ongoing need for the treatment can be confirmed.
Those with a condition listed in Chapter 8 of the Criteria have access to preferred alternative therapies or have a condition where IVIg has been shown to be of benefit. IVIg is not available under the National Blood Arrangements to treat conditions listed in Chapter 8.
If the treating clinician considers that their patient would benefit from IVIg therapy, the clinician may seek to obtain IVIg through the Direct Order (DO) provision. Under the DO arrangements, approval for funding conditions which do not meet the Criteria may be given by individual State or Territory. Procedures for accessing IVIg DO arrangements vary in each State and Territory.
In circumstances, where IVIg cannot be accessed under the Criteria or DO arrangements, clinicians can choose to access imported IVIg direct form suppliers at the patient’s cost.
In these instances it is important to determine before the IVIg is ordered whether the State/Territory or the patient will incur the cost of the IVIg.
The basis for allocating particular diagnoses and criteria to Chapter 5, 6, 7 and 8 was overall consideration of:
The Criteria was first published in December 2007 and implemented in 2008.
Australian governments recognise the need for the Criteria and the conditions identified in it to be regularly reviewed to take account of the evolving processes of disease diagnosis, treatment and outcome evaluation. Governments agreed that the Criteria will be reviewed three-yearly, with the review process commencing two years after the release of each new version, allowing twelve months for consultation and drafting.
When the Criteria was developed, Australian governments recognised the need for the conditions identified for IVIg therapy and the clinical criteria for IVIg use to be regularly reviewed. This will ensure that IVIg use continues to be consistent with the evidence of demonstrable benefit in patients, for whom there are no alternative safe, effective, and cost-effective treatments. The 2010/2011 review aligns with the government proposal that the Criteria is reviewed every three years.
Proposals for new clinical indications, along with the supporting evidence, should be submitted during the document review period. The review period commences two years after the release of each new version of the Criteria. The commencement of a review will be advised on the National Blood Authority website.
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This page last modified on June 23, 2011
