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 a transition to Intragam 10 will commence from February 2017

Details of 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 2016 Supplier
rFVIII ADVATE Baxalta Australia
rFVIII Xyntha Pfizer Australia
rFIX RIXUBIS Baxalta Australia
rFIX BeneFIX Pfizer Australia
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

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:

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

Supplier

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

Hizentra

CSL Behring