Factsheets

Contract Arrangements for the Supply of IMPORTED Intravenous Immunoglobulin (IVIg) including Jurisdictional Direct Orders (JDO) in Australia from 1 December 2007

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:

Type of arrangement	What products are available?	Who pays for the product?	How are products accessed?	What indications are funded?
National Blood Supply (NBS) Arrangement	Intragram® P (D) Octagam® P (I)	Cost is shared between the Commonwealth and the jurisdiction	Except in the ACT, through ARCBS Transfusion Medicine Services	Indications included in the Criteria for the Clinical Use of IVIg in Australia (the Criteria)
Jurisdictional Direct Order (JDO) Arrangement	Octagam® P (I) Sandoglobulin® NF Liquid (I)	Individual jurisdiction bears full cost	Local arrangements for approval and ordering vary - usually via hospital therapeutics committee	For indications that are not included under the Criteria

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 Sandoglobulin® NF Liquid.

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

In circumstances where IVIg cannot be accessed under NBS or JDO 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 JDO.  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.

CSL Bioplasma Contract

The NBA has contracted with CSL Bioplasma for the supply of Sandoglobulin® NF Liquid for JDO arrangements only.  This contract commenced on 1 January 2008. CSL Bioplasma was also a supplier under previous standing offer arrangements and has a long record of commitment to Australia and the domestic manufacture and delivery of high quality blood products (including Intragam®P)  and associated services.

Contract Arrangements for Imported IVIg Products (including JDO 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 JDO;
• 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 JDO Recipient anywhere in Australia within 24 hours;
• delivery of urgent orders of Sandoglobulin® NF Liquid to any Approved JDO Recipient anywhere in Australia within 24 hours;
• delivery of non-urgent orders of Octagam® made to any Approved NBS or JDO 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 Sandoglobulin® NF Liquid made by any Approved JDO 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 JDO)

Octapharma Australia - Octagam® – NBS and JDO

Product	Price per vial (GST inclusive)
Octagam® normal immunoglobulin (human) 2.5g/50ml injection vial	$218.35
Octagam® normal immunoglobulin (human) 5g/100ml injection vial	$436.70
Octagam® normal immunoglobulin (human) 10g/200ml injection vial	$873.40

CSL Bioplasma - Sandoglobulin® NF Liquid – JDO only

Product	Price per vial (GST inclusive)
Sandoglobulin® NF Liquid immunoglobulin (human) 6g/50ml injection vial	$514.80
Sandoglobulin® NF Liquid immunoglobulin (human)12g/100ml injection vial	$1,029.60

Ordering Imported IVIg
Except for the ACT, 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.  In the ACT, approval for access to and ordering of Octagam® is provided by ACT Health.  Approved JDO Recipients can order JDO supplies of Octagam® and Sandoglobulin®NF Liquid directly from Octapharma or CSL Bioplasma.

Supplier's Contact Details for Placing Orders for Imported IVIg

SUPPLIER	TELEPHONE	FACSIMILE	EMAIL
Octapharma Australia	1300 720274	02 95844374	sales@CH2.net.au
CSL Bioplasma	1800 063892	03 92465342	bioplasma.customerservice@csl.com.au

 

Details of the contractual ordering and delivery arrangements are set out below:
Contracted Ordering and Delivery Arrangements for Imported IVIg
Ordering

1. An order is effective when the Supplier receives an order for imported IVIg Product from an Approved NBS Recipient or an Approved JDO Recipient.   Supplier contact details for orders are listed above
2. 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 Jurisdictional 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.
3. Suppliers must be able to receive orders for the Product by phone (with confirmation to be provided in writing), facsimile or email.
4. Suppliers must be able to accept orders 24 hours a day 7 days a week (including public holidays).

Delivery

1. The Supplier must ensure that the remaining shelf-life of the IVIg Product is no less that 12 months from the date it is received by an Approved Recipient.
2. An Order is filled when the Product, as ordered, is:
1. delivered to the Approved Recipient at the address specified in the order;  and
2. the delivery docket/receipt has been signed.
3. The delivery docket/receipt must show the name and quantity of Product delivered.
4. The Supplier must provide a unique identifier to each order to enable linkage to invoice breakdown details.
5. The Supplier must be able to meet the delivery arrangements specified in the Order, including date and time of delivery and location.
6. 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.
7. 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:
1. take reasonable steps to facilitate and accept the return of the Product(s);  and
2. replace the Product(s) within 2 business days of notification by the NBA or Approved Recipient.
8. The Supplier must provide Product Information Sheets in the packaging of each item.

 

For further information on ordering IVIg email ivig@nba.gov.au or to download/order a copy of the Criteria for the Clinical Use of IVIg in Australia visit http://www.nba.gov.au/ivig/index.html

 

Related Document

Imported IVIg Products - Contract Arrangements (200KB)

 

National Blood Supply Contingency Plan (NBSCP)
Australia's Response to Blood Shortages

---

National Blood Sector Conference 08
Conference Proceedings

---

Annual Report for 2007-08

---

Procurement

- Provision of Internal Audit Services