Latest online version of the Criteria
During the BloodSTAR transition period (July to December 2016), 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. The Criteria (Second Edition) for states not yet transitioned to BloodSTAR.
- Access to intravenous immunoglobulin (IVIg) in Australia
- Access to subcutaneous immunoglobulin (SCIg) in Australia
- Access to normal human immunoglobulin (NHIg) in Australia
There are two main ways intravenous immunoglobulin (IVIg) is available in Australia:
- Supply under national blood supply arrangements
- Direct order and other 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.
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.
Sometimes doctors may want to prescribe immunoglobulin for medical conditions that are not funded under the Criteria for the clinical use of intravenous immunoglobulin in Australia (Criteria). In this case, the doctor can seek funding for immunoglobulin through their local arrangements (e.g. local hospital therapeutics committee). These local arrangements vary between hospitals and jurisdictions.
Only imported immunoglobulin is available for indications that are not listed in the Criteria. This is because all immunoglobulin made from Australian plasma is used to treat the indications listed in the Criteria. Imported immunoglobulin is available to Approved Recipients. The Jurisdictional Direct Order (JDO) arrangements operate as follows:
- Approved Recipients are entities such as hospitals that wish to purchase imported immunoglobulin. Each state and territory health department will have nominated these entities to suppliers.
- If an entity is unsure whether it is an Approved Recipient, it should contact the relevant state or territory health department to clarify this and ensure it is nominated as an Approved Recipient to each supplier.
- Approved Recipients place orders for imported immunoglobulin directly with the supplier.
- Purchases are paid for in full by the Approved Recipient.
- Upon placement of the order, a contract is established directly between the supplier and the Approved Recipient for the supply of the immunoglobulin product.
Imported immunoglobulin can be accessed directly from the supplier at the same price negotiated by the NBA for governments. In circumstances where immunoglobulin cannot be accessed under the Criteria or JDO arrangements, clinicians can choose to access imported immunoglobulin directly from suppliers at the patient’s cost.
Products that can be supplied under direct order arrangements are listed on the following document.
- Immunoglobulin products available under JDO (pdf) (218.18 KB)
- Immunoglobulin products available under JDO (docx) (50.3 KB)
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.