Implementation of new imported immunoglobulin supply arrangements

In December 2020, the National Blood Authority (NBA) finalised a procurement process for new national contracts for the supply of imported immunoglobulin (Ig) products. The procurement resulted in contracts with four companies: CSL Behring and Grifols (which were current suppliers of Ig products), Takeda (which supplies other products to the NBA) and Octapharma (which is a former supplier of products and will re-enter the Australian market).

The new supply arrangements, summarised in the table below, commenced in a progressive transition from 1 January 2021 and will continue for a period of up to five years, with extension options available. Current products such as Gamunex, Flebogamma (Grifols), Privigen and Hizentra (CSL Behring) have been available in supply from 1 January 2021.

Commencement of supply of CUVITRU and Octagam

Under the new supply contracts, the imported immunoglobulin products CUVITRU (SCIg) and Octagam (IVIg) will be available to be supplied to patients on BloodSTAR from 12 April 2021, and AHPs will be able to order these products from Lifeblood from that date.

The NBA has been able to negotiate robust and diverse supply arrangements that introduce an increased number of products and suppliers, thereby improving the security and sustainability of supply arrangements for Australia and achieve better average product prices. The products available under the supply arrangements from 12 April 2021 are as follows:

The new supply arrangements also include provision for supply of KIOVIG and HYQVIA (Takeda). The dates and arrangements for commencement of supply of these two products are yet to be settled.

Supply Allocation

Given the increased number of products in the new arrangements, the NBA will closely monitor and actively manage supply allocation arrangements to maintain the security of supply and manage volumes committed under the new contracts, and to optimise the value for money available under the contracts.

As is currently the case, allocation of domestic or imported products for all patients will be managed within BloodSTAR, based on patients’ specific conditions, according to a pre-determined allocation matrix which will be regularly adjusted by the NBA. In some circumstances the product allocation may be set to override pre-set facility preferences in BloodSTAR, or the general preferences of clinicians Any clinician request to vary the allocated product will require an appropriate clinical justification. Authorisers will specifically consider any request to override the allocation in line with these requirements.

Clinical staff will need to request products in accordance with the allocation arrangements, and AHP dispensers will be required to order and dispense products in line with those requests. Complying with these requirements will enable the management of supply volumes that will ensure that Australia is able to maintain robust, diverse and affordable supply arrangements for Ig products over time.

In the transition to these new arrangements it is not expected that patients already receiving ongoing treatment with particular Ig products will be required to switch product brands. However, it cannot be ruled out that this may be required in future, depending on the effectiveness for the active management. arrangements outlined

Further information in relation to product allocation is available at https://www.criteria.blood.gov.au/SupportingInformation#Allocation(Opens in a new tab/window).