Access to Intravenous Immunoglobulin (IVIg)

Latest online version of the Criteria

An adaptation of the second edition of the Criteria is applicable in BloodSTAR from its launch in July 2016. The Criteria as they appear in BloodSTAR can be viewed here.

During the BloodSTAR transition period, the addition of ‘new’ Criteria ‘evidence items’ fields does not change the basis for approval of authorisation of Ig product. Authorisers will evaluate authorisation requests with the same approach that applies to authorisation based on the use of previous paper forms.

Access to intravenous immunoglobulin in Australia

There are two main ways intravenous immunoglobulin (IVIg) is available in Australia:

  1. Supply under national blood supply arrangements
  2. Direct order and other supply arrangements

1. Supply under national blood supply arrangements

If the IVIg is ordered to treat a medical condition which is funded under the Criteria for the Clinical Use of IVIg in Australia, then the product is supplied and funded under the national blood supply arrangements.  In this case the cost of the product is shared between the Commonwealth and the relevant state or territory.

Orders for IVIg under the national blood supply arrangements are made to the Australian Red Cross Blood Service (Blood Service), which is contracted by the National Blood Authority (NBA) as the authoriser and distributor of all IVIg funded under these arrangements.  In seeking authorisation, the requesting clinician will be asked to provide information to the Blood Service to establish that the request meets the Criteria for Use.  For ongoing conditions, the Criteria for Use may specify review criteria to be applied in reviewing the patient to determine whether access to funded IVIg will continue.

In the role as authoriser of requests for IVIg, the Blood Service maintains a database of requests, and provides data to the NBA which is used as a basis for reporting on the annual use of IVIg in Australia.

Authorisation Request Forms

Domestic versus imported IVIg under national blood supply arrangements

When the Blood Service receives an order for IVIg under the national blood supply arrangements it first confirms that the order is for a patient authorised under the Criteria and that the dosage ordered is consistent with the Criteria.   Orders are then allocated by the Blood Service to be fulfilled by either the domestic IVIg product or by an imported product. This allocation is based on a plan agreed between the Blood Service and the NBA, which is developed in consultation with IVIg user groups and states and territories. The allocation plan specifies the categories of patients who will receive domestic IVIg and the categories who will receive imported IVIg. In general, the allocation plan seeks as far as possible to allocate domestic IVIg for longer term conditions and imported IVIg for shorter term conditions, and keep the allocation categories as consistent as possible between jurisdictions.

If the request is allocated to imported IVIg, then it will be for the requesting clinician (operating within any relevant jurisdictional or hospital policy that may apply) to choose which imported IVIg product available under NBA contracts will be supplied to fulfil the request. 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.

Where BloodSTAR is in use, then the system will allocate product based on system rules. This product choice can be changed by the requesting clinician or the Blood Service if deemed necessary.

Outcomes of RFT for supply of imported immunoglobulin products (NBA RFT 02/2014)

The NBA has successfully concluded the tender process for the supply of imported intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg), to replace the contracts for these products which expired on 31 December 2015.

Further information on the outcomes of the tender and the transition arrangements is available at http://www.blood.gov.au/Ig-tender-outcomes.

2. Jurisdictional Direct Order (JDO) and other direct supply arrangements

The NBA does not manage individual requests to access immunoglobulin products outside of the conditions funded under the national blood arrangements as described in the Criteria for the clinical use of intravenous immunoglobulin in Australia (Criteria).

For conditions not funded under the national blood arrangements, a medical officer may be able to seek access for immunoglobulin products through a jurisdictional direct order (JDO). The JDO arrangements allow hospitals to purchase the product directly from the supplier at an equivalent price to that negotiated by the NBA.  If approved as per the arrangements in place in the relevant jurisdiction, the cost is borne directly by the Approved Health Provider.

The Jurisdictional Direct Order arrangements operate as follows:

  1. Approved Health Providers can order immunoglobulin.  Approved Health Providers are entities such as hospitals that wish to purchase imported immunoglobulin. Each state and territory health department will have nominated these entities to suppliers. *
  2. If an entity is unsure whether it is an Approved Health Provider, it should contact the relevant state or territory health department to clarify this and ensure it is nominated as an Approved Health Provider to each supplier.
  3. Approved Health Providers place orders for imported immunoglobulin directly with the supplier.
  4. Purchases are paid for in full by the Approved Health Provider.
  5. Upon placement of the order, a contract is established directly between the supplier and the Approved Health Provider for the supply of the immunoglobulin product.   

*Note that some jurisdictions do not require providers to be approved each time to access immunoglobulin via the JDO process. If unsure you should contact the local health department or local hospital Drug and Therapeutics committee to ascertain the jurisdictional arrangements.

In circumstances where immunoglobulin cannot be accessed under the Criteria or JDO arrangements, it may be possible to access imported immunoglobulin directly from relevant suppliers on a commercial basis and at private expense.

Only imported immunoglobulin products are available under JDO arrangements. Domestic immunoglobulin products made from Australian plasma are restricted to treating indications listed within the Criteria under the national blood arrangements.

Products that can be supplied under JDO arrangements are listed on the following document.

For further information, please contact the National Blood Authority on 13 000 IG GOV (13 000 44 468) or email IgGovernance [at] blood.gov.au.