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:

National Fractionation Agreement for Australia

On 6 December 2017, the NBA executed a new national contract with CSL Behring Australia Pty Ltd (CSL Behring) for the manufacture and supply of fractionated blood plasma products.

The National Fractionation Agreement for Australia (NaFAA) replaced the previous agreement with CSL Behring which expired on 31 December 2017.

The new Agreement commenced on 1 January 2018 and continues until 31 December 2026 (nine years), subject to a review in 2022.

The new contract will assure the provision of a safe, secure and affordable supply of plasma products to the Australian community. The contract is valued at $3.4 billion and delivers savings against the existing contract of more than $200 million as a result of improved manufacturing processes and efficiencies.

Plasma products are often life-saving and play a vital role in helping people fight infections, recover from serious injury and maintain quality of life.

CSL Behring will manufacture the comprehensive range of products from Australian plasma provided by the Australian Red Cross Blood Service from voluntary blood donations. The products are manufactured at CSL Behring's facilities at Broadmeadows in Victoria.

The NaFAA can be accessed through the following links:

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 2019 Supplier
rFVIII ADVATE Shire Australia
rFVIII Xyntha Pfizer Australia
rFIX RIXUBIS Shire Australia
rFIX BeneFIX Pfizer Australia
rFXIII NovoThirteen Novo Nordisk
APCC FEIBA Shire Australia
rFVIIa NovoSeven Novo Nordisk
Anti-Rh(D) Rhophylac CSL Behring
Protein C Ceprotin Shire 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

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

The NBA’s contracts with CSL Behring and Grifols Australia for the supply of these products have been extended until 31 December 2020.

Introduction of Gamunex 10%

The NBA has also agreed with Grifols Australia that the IVIg product Gamunex 10% will be available under the national blood arrangements for supply from 1 November 2019. The availability of this additional product will enhance the security of imported immunoglobulin supply arrangements over the remaining period of the contracts.  Implementation arrangements for Gamunex 10% include dissemination of appropriate communications and support materials to stakeholders including the Blood Service, Approved Health Providers, clinicians and patients.

Inclusion of Extended Half-Life Clotting Factor Products in National Blood Arrangements

The Jurisdictional Blood Committee (JBC) recently approved the inclusion of Extended Half-Life (EHL) recombinant Factor VIII and EHL Factor IX products within the national arrangements for funding and supply of blood products managed by the NBA.

The JBC decision was supported by an assessment of EHL recombinant factor VIII and factor IX products undertaken by the Medical Services Advisory Committee (MSAC).  A Public Summary Document summarising the MSAC assessment and recommendations can be found at http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1511-public

On the basis of the JBC approval, the NBA will include EHL Factor VIII and Factor IX products in the next national tender for clotting factors and related products, currently planned for 2019.  Further details of this tender will be provided in due course.

Limited Interim Arrangements for Extended Half-Life Clotting Factor Products

In 2018 the NBA implemented limited interim arrangements to provide temporary access to EHL recombinant factor VIII and factor IX clotting factor products under the national supply arrangements for a limited number of haemophilia A and B patients with high priority needs.

These arrangements provide recombinant factor VIII and factor IX products from the supplier companies Shire and Bioverativ for approximately 200 patients, under the coordination and monitoring of the Australian Haemophilia Centre Directors’ Organisation (AHCDO) by arrangement with the NBA.

These limited initial arrangements will remain in place pending the outcomes of the next national tender for clotting factors and related products referred to above.

Further information about the limited interim arrangements is available in the following documents: