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 Australian Fractionation Agreement for Australia

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 National Australian Fractionation Agreement for Australia (NaFAA).

The NaFAA came into force on 1 January 2018 and, after a contract term review in 2022, will continue until 31 December 2026.  It provides for manufacture of a comprehensive range of blood products from Australian plasma provided by the Australian Red Cross Blood Service.

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

  • A term of 5 plus 4 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.

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.

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

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

Limited Interim Arrangements for Extended Half-Life Clotting Factor Products

At the request of Australian Governments, the NBA has entered into limited interim arrangements with two companies, Bioverativ and Shire, to provide temporary access to extended half-life (EHL) clotting factor products under NBA supply arrangements for a limited number of haemophilia A and B patients with high priority needs.

These arrangements will be in place pending the outcomes of an evaluation by the Medical Services Advisory Committee to support government decisions about whether extended half-life clotting factor products should be available under publicly funded supply arrangements managed by the NBA on an ongoing basis.

Only a limited number of patients are can be covered under these interim arrangements:

  • the Bioverativ product Eloctate (recombinant Factor VIII) will be available for around 40 patients
  • the Bioverativ product Alprolix (recombinant Factor IX) will be available for around 60 patients, and
  • the Shire product Adynovate (recombinant Factor VIII) will be available for around 100 patients.

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

Patients who wish to find out more about these limited interim arrangements should contact their specialist Haemophilia Treatment Centre clinician.

These limited interim arrangements have been put in place following consultations undertaken within 2017.  More detail on these consultations can be found at https://www.blood.gov.au/2017-closed-public-consultations.