Plasma and Recombinant Product Procurement

To implement the annual National Supply Plan, the National Blood Authority (NBA) has supply contracts with various suppliers of blood products which it manages closely to ensure that demand for product is always met.

In addition to the information below, a printable factsheet on the supply arrangements for plasma and recombinant products is also available for download:

CSL Australian Fractionation Agreement

Most plasma derived products used in Australia are manufactured by CSL Behring from plasma collected by the Australian Red Cross Blood Service (Blood Service) under the CSL Australian Fractionation Agreement (CAFA).

The CAFA came into force on 1 January 2010 and, after a mid-term review in 2014, will continue until 31 December 2017.  It provides for manufacture of a comprehensive range of blood products from Australian plasma provided by the Australian Red Cross Blood Service.

The CAFA was negotiated to provide the following key benefits for the supply of blood products under the national blood arrangements:

  • A term of 5 plus 3 years on the basis of a review of continued performance against all required elements of the contract, price and value for money, and no change to government policy.
  • Minimal price rises and a pricing structure that provides increasing value for money for governments as volumes increase.
  • Key performance indicators to assist in maximising CSL Behring’s performance in key areas, including manufacturing yield, loss or wastage of plasma or of finished products, shelf-life on delivery, and fulfilment of orders, supported by improved reporting by CSL Behring.
  • Improvements in product range to increase supply efficiency and reduce wastage.
  • Security of supply through increased supply security inventory reserves at CSL Behring’s cost. Supported by performance guarantees and alternative supply arrangements which may be invoked in a serious risk scenario.

 An edited version of the CAFA is available for download:

Change to Supply Arrangements for Domestic Intravenous Immunoglobulin

CSL Behring has commenced manufacture of Australia’s domestically produced intravenous immunoglobulin (IVIg) product Intragam 10 to replace the current IVIg product Intragam P.  As a result of recent higher than expected demand for INTRAGAM P, the second phase of the transition will commence earlier than anticipated.  Phase 2 of the transition will commence Wednesday 22 March 2017.

Phase 2 Transition arrangements

1.    In all states and territories except NSW:

On Wednesday 22 March 2017, all patients who have a current authorisation to receive INTRAGAM P in BloodSTAR will automatically be changed to INTRAGAM 10. 

Intragam P can still be dispensed to deplete existing inventory at health care facilities.  A dispense discrepancy will not be recorded in BloodNet.

2.    In NSW only:

All patients who have a current authorisation to receive INTRAGAM P will be transitioned to INTRAGAM 10 when national inventories of INTRAGAM P are depleted. It is currently anticipated that this is likely to occur within four weeks of commencement of Phase 2 of the transition. The Blood Service will use existing processes to manage the transition for these patients. 

Detailed information regarding the transition are available for download:

Imported plasma and recombinant product supply contracts

Australia is reliant on an imported supply of plasma derived Factors XI and XIII, Anti-inhibitor Coagulant Complex Concentrates, Protein C, a plasma-derived Rh(D) immunoglobulin products, Fibrinogen Concentrate and C1 Esterase Inhibitor Concentrate, which are not manufactured in Australia. A number of recombinant clotting factor products are also imported.  These products are not manufactured in Australia.

TABLE: Current contracts for imported plasma and recombinant products

Product Type Brands Supplied from 1 July 2017 Supplier
rFVIII ADVATE Baxalta Australia
rFVIII Xyntha Pfizer Australia
rFIX RIXUBIS Baxalta Australia
rFIX BeneFIX Pfizer Australia
rFXIII NovoThirteen Novo Nordisk
APCC FEIBA Baxalta Australia
rFVIIa NovoSeven Novo Nordisk
Anti-Rh(D) Rhophylac CSL Behring
Protein C Ceprotin Baxalta Australia
pdFXI BPL Factor XI CSL Behring
pdFXIII Fibrogammin

CSL Behring

Fibrinogen Concentrate RiaSTAP CSL Behring
C1 Esterase Inhibitor Concentrate Berinert CSL Behring

Access to Fibrinogen Concentrate

Fibrinogen Concentrate is available for patients with congenital fibrinogen deficiency and is funded and supplied under the national blood arrangements, subject to certain management requirements.

Details of these requirements are available for download in the management model for fibrinogen concentrate:

Access to C1 Esterase Inhibitor Concentrate

In December 2015 Governments approved the addition of C1 Esterase Inhibitor Concentrate to the national blood arrangements for supply and funding of blood products administered by the National Blood Authority (NBA).
Governments will fund C1 Esterase Inhibitor Concentrate for the following indications for Type I or II hereditary angioedema:

  • treatment of acute attacks  
  • pre-procedural (short term) prophylaxis for high risk procedures such as dental work, head or neck surgery, or surgery requiring intubation
  • second line as routine (long term) prophylaxis for patients who experience the equivalent of eight or more acute attacks per month.

The NBA has a Deed in place with CSL Behring for supply of Berinert for the indications listed above.  Authorisation of an order confirms that the product is being ordered for the indications funded by the NBA and is in accordance with the Australasian Society of Clinical Immunology and Allergy (ASCIA) clinical guidance for funded access.  

For further information on how to order the funded product please contact CSL Behring.

Imported immunoglobulin product supply contracts

Intravenous immunoglobulin (IVIg) and subcutaneous immunoglobulin (SCIg) products are imported under NBA contracts to supplement domestic supply in order to meet clinical demand.

Availability of IVIg under the national blood arrangements is provided through a managed authorisation and allocation process based on eligibility under a defined set of IVIg Criteria for Use endorsed by all Australian governments.

TABLE: Current contracts for imported immunoglobulin products

Supply Arrangement

Products Supplied


National blood supply and direct orders

Flebogamma 5% DIF

Grifols Australia 

National blood supply and direct orders

Flebogamma 10% DIF

Grifols Australia

National blood supply and direct orders

Privigen 10%

CSL Behring

National blood supply and direct orders


CSL Behring