Factsheets

Contract Arrangements for the Supply of IMPORTED Intravenous Immunoglobulin (IVIg) including Direct Orders (DO) in Australia from 1 January 2010

IVIg is a critical plasma derived blood product used to treat an increasing number of indications.  The two principal ways IVIg can be accessed in Australia are as follows:

 

D = Domestic, I = Imported

This Fact Sheet addresses the contractual arrangements for the supply of IMPORTED IVIg products to meet any shortfalls in the availability of domestically produced IVIg (Intragam®P). To guarantee an adequate, safe and secure supply of this important blood product, the National Blood Authority (NBA) has established contracts for the supply of two imported IVIg products, Octagam® and Flebogamma 5% DIF.

Under the NBS arrangements, indications which meet the Criteria are covered by shared funding arrangements between the Australian Government and the State or Territory Governments.  Intragam® P, the domestically produced product, and Octagam®, an imported product, are available under the NBS arrangements through the ARCBS Transfusion Medicine Services.

Under the DO arrangements, approval for funding for indications which do not meet the Criteria may be given by the individual State or Territory.  An Approved DO Recipient is a health provider authorised by the State or Territory to order and receive IVIg product.  The DO arrangements provide for the direct supply of Octagam® and Flebogamma 5% DIF to Approved DO Recipients.

In circumstances where IVIg cannot be accessed under NBS or DO arrangements, clinicians can choose to access imported IVIg product direct from suppliers at the patient’s cost.

Octapharma Australia Contract

The NBA has contracted with Octapharma Australia for the supply of Octagam® for both the NBS and DO.  This contract commenced on 1 December 2007.
Octapharma was one of the suppliers under the previous contractual arrangements and has demonstrated a strong commitment to the Australian market through the provision of high quality blood products and associated services.

Lateral Grifols Contract

The NBA has entered into contractual arrangements with Lateral Grifols Pty Ltd for the supply of Flebogamma 5% DIF for DO arrangements only.  This contract commenced on 1 January 2010.  

Contract Arrangements for Imported IVIg Products (including DO arrangements)

The contracts, combined, satisfy all Jurisdictional Blood Committee (JBC) mandated parameters and offer Governments exceptional value for money and a range of significant improvements, including:

• a highly competitive price compared to current and forecast global prices.  See below for price details;
• a choice of two imported products for DO;
• the transfer of the overhead and risk for NBS inventory management from the NBA to the supplier;
• the maintenance of a three month in-country reserve for NBS at the supplier’s cost;
• delivery of critically urgent orders of Octagam® to any Approved NBS Recipient in a capital city within 12 hours or to other locations within 24 hours;
• delivery of urgent orders of Octagam® to any Approved NBS or DO Recipient anywhere in Australia within 24 hours;
• delivery of urgent orders of Flebogamma 5% DIF to any Approved DO Recipient anywhere in Australia within 24 hours;
• delivery of non-urgent orders of Octagam® made to any Approved NBS or DO Recipient anywhere in Australia by 5pm in the place where the Recipient is located, by the second business day after receipt of the order;  and
• delivery of non-urgent orders of Flebogamma 5% DIF made by any Approved DO Recipient anywhere in Australia by no more than 48 hours of receipt of the order, or where the Order is placed on a Friday then the next Business Day in the place where the Recipient is located unless the person making the order has requested a later date.

Price details for Imported IVIg Products (including DO)

Octapharma Australia - Octagam® – NBS and DO

Lateral Grifols - Flebogamma 5% DIF – DO only

Ordering Imported IVIg

NBS Arrangements

Requests for IVIg for treating conditions listed in the Criteria (that is NBS supplies) are made to the local Transfusion Medical Service in the ARCBS.  In consultation with the clinician, the Transfusion Medicine Services will determine whether the request meets the Criteria and, if so, whether Intragam® P or Octagam® is appropriate.  The ARCBS will then supply the product, except in the case of the ACT, whereby Octapharma supplies direct under a standing order to the Canberra Hospital.

Supplier’s Contact Details for Placing Orders for Imported IVIg under NBS arrangements

Direct Order Arrangements

Approved DO Recipients can order DO supplies of Octagam® and Flebogamma 5% DIF directly from Octapharma or Lateral Grifols.

Suppliers’ Contact Details for Placing Orders for Imported IVIg under JDO arrangements

Details of the contractual ordering and delivery arrangements are set out below:

Contracted Ordering and Delivery Arrangements for Imported IVIg

Ordering

• An order is effective when the Supplier receives an order for imported IVIg Product from an Approved NBS Recipient or an Approved DO Recipient.   Supplier contact details for orders are listed above
• The Supplier must not accept an order unless it can substantiate:
• the name of the Approved Recipient;
• whether it is an order under the National Blood Supply component or under the Direct Order component;
• if required, the valid NBA approval information for an order under the National Blood Supply component;
• the date of order;
• the timeframe for delivery;
• if the Order is specified as being an urgent order that there are reasonable grounds for the urgency;
• the name of the Product to be delivered by the Supplier;
• if appropriate, the Item Number of the Product to be delivered by the Supplier;
• the quantity of Product to be delivered by the Supplier;
• the vial sizes required by the Approved Recipient;  and
• shipping address details.
• Suppliers must be able to receive orders for the Product by phone (with confirmation to be provided in writing), facsimile or email.
• Suppliers must be able to accept orders 24 hours a day 7 days a week (including public holidays).

Delivery

The Supplier must ensure that the remaining shelf-life of the IVIg Product is no less that 12 months (in the case of Octagam®) and 16 months (in the case of Flebogamma 5% DIF) from the date it is received by an Approved Recipient.

1. An Order is filled when the Product, as ordered, is:
   • delivered to the Approved Recipient at the address specified in the order;  and
   • the delivery docket/receipt has been signed.
2. The delivery docket/receipt must show the name and quantity of Product delivered.
3. The Supplier must provide a unique identifier to each order to enable linkage to invoice breakdown details.
4. The Supplier must be able to meet the delivery arrangements specified in the Order, including date and time of delivery and location.
5. The Supplier must establish and maintain procedures to track and record all instances where Products are not able to be delivered in accordance with Orders under the Deed.
6. The Supplier must comply with the return of Products when the NBA or an Approved Recipient considers on reasonable grounds that the Product is faulty or damaged on delivery and notifies the Supplier within 2 business days after delivery;  The Supplier agrees to:
   • take reasonable steps to facilitate and accept the return of the Product(s);  and
   • replace the Product(s) within 2 business days of notification by the NBA or Approved Recipient.
7. The Supplier must provide Product Information Sheets in the packaging of each item.

For further information on ordering IVIg email supply.management.plasma@nba.gov.au or to download/order a copy of the Criteria for the Clinical Use of IVIg in Australia.

 

Related Document

Imported IVIg Fact Sheet (131KB)

 

Agreement Ensures Continuation of Blood Plasma Supplies

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Imported IVIg Stakeholder Discussion Paper

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Imported IVIg Suppliers Request for Information

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Criteria for the Clinical Use of Intravenous Immunoglobulin (IVIg)

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