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IVIg is a critical plasma-derived blood product used to treat a range of neurological, immunological, haematological and other conditions.
Australia’s requirements for IVIg are largely met through products made from Australian blood donations and manufactured in Australia by CSL Limited. In addition, the NBA also contracts for the supply of imported IVIg products because the amount of IVIg which is manufactured in Australia does not meet all requirements.
Supply of IVIg is funded under the National Blood Supply (NBS) cost shared arrangements (63% Commonwealth Government, 37% state/territory governments) for conditions which meet qualifying criteria described in The Criteria for the Clinical Use of IVIg in Australia (the Criteria). The Australian Red Cross Blood Service is contracted by the NBA to manage the authorisation, allocation and distribution process for NBS supply of IVIg.
Because there are some conditions which do not qualify for NBS funding under the Criteria but where IVIg may still be used, the NBA has also established Jurisdictional Direct Order (JDO) arrangements which can be accessed to provide a cost-effective way for IVIg to be ordered for these conditions directly from commercial suppliers. In this case the supply of the product is not funded under the NBS arrangements, and the cost must be met in some other way.
IVIg produced in Australia (Intragam P) is only available under the NBs arrangements.
Some changes in supply arrangements for IVIg which will occur in October 2011 and January 2012 are outlined below. Further information can be found in the following documents:
| RTF Document 
Reintroduction of Octagam 5% into NBS supply arrangements from 24 October 2011
The Therapeutic Goods Administration has recently approved variations to the registration of Octagam 5% and the product will be available for supply again under the NBS arrangements from 24 October 2011.
Flebogamma 5% DIF will remain available to be ordered for continuing or new patients under the NBS arrangements until 31 December 2011. After that date, Flebogamma 5% DIF will be able to ordered under NBS arrangements on a limited basis only, to allow for transition of continuing patients to another imported IVIg product within January and February 2012.
Reintroduction of Octagam 5% and continued availability of Flebogamma 5% DIF
From September 2010, the primary imported IVIg product under the NBS arrangements, Octagam 5%, was subject to a voluntary withdrawal by the supplier Octapharma. During the period of the recall imported IVIg requirements under the NBS arrangements have been met by Flebogamma 5% DIF supplied by Grifols Australia Pty Ltd.
On 4 August 2011 the Therapeutic Goods Administration approved a variation in the registration of Octagam 5%. More information on the voluntary recall and subsequent actions taken by Octapharma can be obtained at www.octapharma.com or at http://tga.gov.au/safety/alerts-medicine-octagam-110826.htm.
The NBA has arranged with the Blood Service for Octagam 5% to be available for ordering under the NBS arrangements from 24 October 2011.
Flebogamma 5% DIF will remain available to be ordered for continuing or new patients under the NBS arrangements until 31 December 2011. After that date, Flebogamma 5% DIF will be able to ordered under NBS arrangements on a limited basis only, to allow for transition of continuing patients to another imported IVIg product within January and February 2012.
Outcomes of IVIg tender
The NBA recently conducted a tender process to establish new supply arrangements for imported IVIg to commence from 1 January 2012. This tender provided for an increase in the number of imported IVIg products available under the NBS arrangements.
Two imported IVIg products will be supplied and funded under the NBS arrangements from 1 January 2012:
Kiovog and Octagam will also be available under JDO arrangements. Flebogamma 5% DIF will continue to be available under JDO arrangements from 1 January 2012. The current JDO contract with Grifols Australia expires on 31 December 2012 and the NBA has an option to extend up to a further year.
The new supply arrangements established by the imported IVIg tender will apply from 1 January 2012 to 31 December 2014, and may be extended for a further year.
Distribution and allocation of products
The Blood Service will continue to authorise and distribute domestic and imported IVIg under the NBS arrangements. The process for allocating orders for IVIg to either the domestically produced product (Intragam P) or to an imported IVIg product will also remain unchanged.
From the date of reintroduction of Octagam 5% on 24 October 2011, where an order is allocated to imported IVIg under the NBS arrangements, the ordering clinician will now have the choice of which available IVIg product will be supplied (operating within any relevant jurisdictional or hospital policy that may apply). The Blood Service will provide the clinician with information about the available products including relevant precautions, but will not provide any advice or recommendation on the choice of a particular imported IVIg product.
Subcutaneous Administration
At present this product is only funded and supplied under NBS arrangements for intravenous use, even where the Product Information approved by the Therapeutic Goods Administration for a particular product includes subcutaneous administration for certain conditions. This funding policy has not changed as a result of the recent tender.
Further queries on the national supply arrangements for IVIg can be directed to supply.management.plasma@nba.gov.au.
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This page last modified on December 21, 2011
