Imported Plasma & Recombinant Product Tender Outcomes (Request for Tender 02/2013)

The National Blood Authority (NBA), on behalf of Australian governments has successfully concluded the tender process for the national supply of recombinant Factor VIII and IX products, to replace the contracts for these products which will commence from 1 July 2014.

These products are critical for the treatment of Australian patients with bleeding disorders, such as haemophilia. Australia imports these products as they are not made in Australia.

The outcome of the tender gives Australian patients funded access to products equivalent to that available in other parts of the world at a very competitive price and has been highly successful at ensuring a secure supply of essential products for haemophilia patients.  The effect on the implementation of these arrangements is expected to provide savings on product costs in the order of $50 million per year, while continuing to ensure a safe and secure supply of these important medicines in Australia.

As a result of the tender process, there will be a change in brand for rFVIII and for the first time there is a new market entrant for rFIX enhancing supply security and clinical choice.

The details of the new supply arrangements for these products compared to the previous arrangement are within the table below.


Imported Product

New Arrangements

Trade Name (Supplier)

Previous Arrangements

Trade Name (Supplier)



National preferred rFVIII product

ADVATE (Baxter)



Xyntha (Pfizer)

Xyntha (Pfizer)

Kogenate FS*(Bayer)

Not available after a transition period

Kogenate FS (Bayer)


BeneFIX (Pfizer)

BeneFIX (Pfizer)

RIXUBIS** (Baxter)


* For patients on active immune tolerance therapy using Kogenate FS as at the time of the tender announcement, exceptional arrangements will be available for continuation of this product for a longer period where this is clinically necessary.

**At the time of implementation of the new arrangements from 1 July 2014, the registered indications for RIXUBIS will include routine prophylaxis, treatment and prevention of bleeding episodes, and perioperative management in adults (18 years and older) in haemophilia B, but will not include registered indications for paediatric patients.

The NBA has consulted with the Australian Haemophilia Centre Director’s Organisation (AHCDO), Haemophilia Foundation Australia (HFA), Australian Haemophilia Nurses Group (AHNG), state and territory health departments and product suppliers to develop detailed implementation arrangements.

A set of Transition Principles has been agreed to guide the process.

These arrangements will guide the transitioning of all relevant patients at the earliest convenient and clinically appropriate time, with clinical oversight and the appropriate and efficient use of existing Kogenate FS stock.

Further information on how the outcomes of the tender affects you can be found in the Frequently Asked Question for patients and Information for health professionals.