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:

Implementation of new imported immunoglobulin supply arrangements

In December 2020, the National Blood Authority (NBA) finalised a procurement process for new national contracts for the supply of imported immunoglobulin (Ig) products. The procurement resulted in contracts with four companies: CSL Behring and Grifols (which were current suppliers of Ig products), Takeda (which supplies other products to the NBA) and Octapharma (which is a former supplier of products and will re-enter the Australian market).

The new supply arrangements, summarised in the table below, commenced in a progressive transition from 1 January 2021 and will continue for a period of up to five years, with extension options available. Current products such as Gamunex, Flebogamma (Grifols), Privigen and Hizentra (CSL Behring) have been available in supply from 1 January 2021.

Commencement of supply of CUVITRU and Octagam

Under the new supply contracts, the imported immunoglobulin products CUVITRU (SCIg) and Octagam (IVIg) will be available to be supplied to patients on BloodSTAR from 12 April 2021, and AHPs will be able to order these products from Lifeblood from that date.

The NBA has been able to negotiate robust and diverse supply arrangements that introduce an increased number of products and suppliers, thereby improving the security and sustainability of supply arrangements for Australia and achieve better average product prices. The products available under the supply arrangements from 12 April 2021 are as follows:

 

Product name (Supplier)

Imported Intravenous Immunoglobulin

Privigen (CSL Behring)

Flebogamma (Grifols)

Gamunex (Grifols)

Octagam (Octapharma)

Imported Subcutaneous Immunoglobulin

Hizentra (CSL Behring)

CUVITRU (Takeda)

The new supply arrangements also include provision for supply of KIOVIG and HYQVIA (Takeda).  The dates and arrangements for commencement of supply of these two products are yet to be settled.

Supply Allocation

Given the increased number of products in the new arrangements, the NBA will closely monitor and actively manage supply allocation arrangements to maintain the security of supply and manage volumes committed under the new contracts, and to optimise the value for money available under the contracts.

As is currently the case, allocation of domestic or imported products for all patients will be managed within BloodSTAR, based on patients’ specific conditions, according to a pre‑determined allocation matrix which will be regularly adjusted by the NBA.  In some circumstances the product allocation may be set to override pre-set facility preferences in BloodSTAR, or the general preferences of clinicians   Any clinician request to vary the allocated product will require an appropriate clinical justification. Authorisers will specifically consider any request to override the allocation in line with these requirements.

Clinical staff will need to request products in accordance with the allocation arrangements, and AHP dispensers will be required to order and dispense products in line with those requests.  Complying with these requirements will enable the management of supply volumes that will ensure that Australia is able to maintain robust, diverse and affordable supply arrangements for Ig products over time.

In the transition to these new arrangements it is not expected that patients already receiving ongoing treatment with particular Ig products will be required to switch product brands. However, it cannot be ruled out that this may be required in future, depending on the effectiveness for the active management arrangements outlined.

Further information in relation to product allocation is available at https://www.criteria.blood.gov.au/SupportingInformation#Allocation.

Further information on arrangements for the supply of Ig products can be obtained by contacting the National Blood Authority by email at supply.management.plasma@blood.gov.au.

Supply of Clotting Factor Products

The National Blood Authority (NBA) has successfully concluded the tender process for the supply of standard half-life and extended half-life recombinant Factor VIII and IX products. The new arrangements will commence on 1 July 2020 for a period of up to five years.

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

Not all products that were tendered achieved satisfactory outcomes through the tender process and subsequent negotiations. Governments are still considering advice from the NBA in relation to whether a further product, for treatment of haemophilia A patients, should be made available under the national blood arrangements. In the meantime, contracts have been finalised for the products identified below.

 

 

Previous Arrangements

Product name (Supplier)

New Arrangements

Product name (Supplier)

Standard half-life rFVIII

Advate (Shire)

Advate (Shire)

Xyntha (Pfizer)

Xyntha (Pfizer)

Standard half-life rFIX

BeneFIX (Pfizer)

BeneFIX (Pfizer)

Rixubis (Shire)

Not available after a transition period

Extended half-life rFVIII

Adynovate (Shire)*

Adynovate (Shire)

Eloctate (Sanofi)*

Eloctate (Sanofi)

Extended half-life rFIX

Alprolix (Sanofi)*

Alprolix (Sanofi)

* Previously available under limited interim arrangements for EHL products.

Home delivery arrangements will continue to be available for suitable patients under the oversight of the patient’s Haemophilia Treatment Centre. 

The prescription of appropriate treatments for patients with haemophilia is a clinical matter which should be discussed between a patient (or their carer) and a specialist clinician.  The NBA has consulted with the Australian Haemophilia Centre Director’s Organisation (AHCDO), Haemophilia Foundation Australia (HFA) and Australian Haemophilia Nurses Group (AHNG), on transition arrangements where it is considered appropriate for patients to commence using extended half-life products.

As a consequence of COVID-19 restrictions, where it is considered appropriate, patients will be transitioned to extended half-life products according to clinical prioritisation by the local Haemophilia Treatment Centre, based on each centre’s capacity during this time.

The Clinical Advisory Group of AHCDO will be available to provide peer advice to Haemophilia Treatment Centre clinicians considering the transition of appropriate patients to extended half-life products.

The Australian Bleeding Disorder Register (ABDR) and the MyABDR App should be used to record the use of clotting factor products and associated therapies by patients in Australia.  The NBA will utilise data recorded in the ABDR for supply planning purposes, and to monitor utilisation and cost in order to confirm the realisation of the benefits of extended half-life products.

Transition arrangements will take account of the need for appropriate clinical oversight of transitioning patients, and the efficient use of stock already held by Haemophilia Treatment Centres and patients.  The finalisation of arrangements for the ordering of extended half-life products through BloodNet for distribution by the Australian Red Cross Lifeblood (Lifeblood), where this occurs in New South Wales and South Australia, will mean that those arrangements will commence shortly after 1 July 2020 from a date to be advised.

The inclusion of extended half-life products in the new supply arrangements follows the assessment and recommendations by the Medical Services Advisory Committee (see http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1511-public).

The outcome of the tender gives Australian patients optimal access to products through nationally supplied and funded blood arrangements at very competitive prices. The tender outcome is also expected to deliver savings on product costs in the order of $155.8 million across five years, while continuing to ensure a safe and secure supply of these important medicines in Australia.

Further information on the tender process can be obtained by contacting the National Blood Authority by email at supply.management.plasma@blood.gov.au.

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 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 Lifeblood 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 2020 Supplier
rFVIII

ADVATE

ADYNOVATE

Shire Australia
rFVIII ELOCTATE Sanofi-Aventis
rFVIII Xyntha Pfizer Australia
rFIX BeneFIX Pfizer Australia
rFIX ALPROLIX Sanofi-Aventis
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.

The NBA has agreed with CSL Behring to the introduction of a number of product improvements including Berinert IV 1500IU and Berinert SC 2000IU and 3000IU.

The uptake of Berinert SC has been moderated through a clinical management model and implemented through ASCIA clinical guidelines, and supported by a peer review process through a relevant ASCIA subcommittee.

The updated ASCIA guidelines were published in early 2020 to assist clinician’s transition of patients that would benefit from the subcutaneous administration. 
Berinert SC presentations were made available from 1 March 2020 and Berinert IV 1500IU was made available from 1 July 2020.

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