Introduction

• National Blood Agreement
• Governance arrangements for the supply and management of blood products in Australia
• Availability of intravenous immunoglobulin in Australia
• Intravenous Immunoglobulin Standing Offer

Intravenous immunoglobulin (IVIg) is a fractionated blood product made from pooled human plasma. IVIg is increasingly important in replacement therapy and as an immunomodulatory agent in autoimmune disease. It is the market driver for the plasma industry in the developed world with an increasing demand internationally. The continued growth in IVIg demand in Australia makes its supply and management a high priority in both the government and clinical settings alike. Governments will continue to develop and refine mechanisms for monitoring the use of IVIg.

National Blood Agreement

The National Blood Agreement ¹ sets out the primary and secondary policy objectives of all Australian governments in relation to the Australian blood sector. The Australian Government, and state and territory governments, signed the agreement in 2003 and, in so doing, agreed to implement a coordinated national approach to policy setting, governance and management of the Australian blood sector, including administrative and financial arrangements.

Under the agreement, blood products are provided at no direct cost to patients. The blood sector is funded by the Australian Government (63%) and by the states and territories (37%), with the funding provided by each state and territory determined by the quantity of product provided to each particular state and territory.

The National Blood Agreement’s primary policy objectives are:

1. to provide an adequate, safe, secure and affordable supply of blood products, blood-related products and blood-related services in Australia; and
2. to promote safe, high-quality management and use of blood products, blood-related products and blood-related services in Australia.

A supporting principle is that blood and blood-related products can be accessed by patients at no direct cost, provided such use is in accordance with clinical need and appropriate clinical practice.

In December 2007, Australian Health Ministers agreed to fund the conditions identified in Chapter 5, Chapter 6 and Chapter 7 of the Criteria under the National Blood Agreement, as outlined in the Funding Policy Statement (Appendix A). IVIg funded under the National Blood Agreement is not available for use to treat conditions identified in Chapter 8. This funding policy was confirmed during the approval of this second edition.

For conditions not described in Chapter 5, Chapter 6 or Chapter 7, Approved Recipients may obtain IVIg via the Jurisdictional Direct Order component of the IVIg Standing Offer arrangements (see page 22).

Governance arrangements for the supply and management of blood products in Australia

SCoH and AHMAC

The Standing Council on Health (SCoH) formerly the Australian Health Ministers’ Conference (AHMC) is the ultimate decision-maker responsible for the oversight and management of the Australian blood sector. AHMC’s responsibilities include national policy and financial decisions in relation to the supply of blood and blood products, and the determination of which products and services can be bought with public funds. It has oversight of the implementation of the National Blood Agreement and is supported in its roles by the Australian Health Ministers’ Advisory Council (AHMAC). In November 2010, AHMC endorsed the Statement on national stewardship expectations for the supply of blood and blood products. The statement was developed to address the lack of specific accountability obligations, other than general safety and quality issues mandated by other agencies, on health providers such as laboratories and clinics and other institutions that receive blood and blood products for dispensing to patients.

The Statement contains a concise description of responsible, sustainable and appropriate use of blood and blood products relevant to handling, storage, administration, usage and capacity to report inventory and can be found at Appendix B.

Clinical, Technical and Ethical Principal Committee

The role of the Clinical, Technical and Ethical Principal Committee (CTEPC) is to provide advice to AHMAC on clinical, technical and medico-legal issues that affect the formulation of health care policy or delivery of health care services across multiple jurisdictions. Among other things, CTEPC provides advice on options for the ongoing coordination of clinical and technical services that are managed on a national basis.

Jurisdictional Blood Committee

The Jurisdictional Blood Committee (JBC) is a sub-committee of CTEPC established to implement a coordinated national approach to policy setting and management of the blood sector. The JBC has representation from the Australian Government, and each state and territory government. It provides recommendations to the AHMC on policy relating to the blood sector.

National Blood Authority

The National Blood Authority (NBA) was established in 2003. It manages contracts with suppliers of blood and blood products to ensure that the supply of products meets the needs of the Australian public. Together, the National Blood Authority Act 2003 and the National Blood Agreement form the foundations of the current arrangements within the blood sector and underpin the functions of the NBA.

Therapeutic Goods Administration

All blood, blood components and plasma derivatives supplied in Australia are regulated under the Therapeutics Goods Act 1989 by the Therapeutic Goods Administration (TGA). The TGA is responsible for enforcing standards within the blood sector to ensure blood products meet appropriate safety, quality and efficacy requirements. It also registers individual products for specific indications.

The TGA undertakes a comprehensive assessment of the safety, quality and efficacy of all domestic and imported plasma products before they can be registered on the Australian Register of Therapeutic Goods and approved for supply in the Australian market. The TGA licenses (manufacturers in Australia) or certifies (manufacturers located overseas) the facilities where plasma products are manufactured against standards of Good Manufacturing Practice (GMP). Audits are conducted to ensure ongoing compliance with GMP.

Australian Red Cross Blood Service

The Australian Red Cross Blood Service (the Blood Service) is responsible for the collection, processing and distribution of blood and blood components sourced from Australian voluntary non-remunerated donors. All plasma collected by the Blood Service for the manufacture of IVIg is sent to CSL Biotherapies Australia for fractionation. The Blood Service Transfusion Medicine Team currently issues IVIg based on the Criteria.

Availability of intravenous immunoglobulin in Australia

The availability of IVIg in Australia relative to clinical need and demand has been reviewed repeatedly since at least the early 1990s. Three approaches have been used to ensure that IVIg is available for the patients who need it most:

• aligning the use of IVIg with conditions for which there is evidence of benefit;
• increasing the manufacture of IVIg in Australia; and
• importing IVIg from overseas suppliers.

a) Aligning IVIg use with conditions for which there is evidence of benefit

Despite much published clinical research on IVIg, evidence for its efficacy and effectiveness in the treatment of many different conditions remains uncertain. This is due to:

• the difficulty of conducting rigorous evaluative studies of treatments for rare and complex medical conditions that are often accompanied by equally complex co-morbidities;
• the difficulty of evaluating outcomes where IVIg is used as a treatment of last resort (as is sometimes the case) after other therapies have failed; and
• a lack of monitoring data from all parts of the world on the use and outcomes of IVIg therapy.

Given the variable extent and quality of evidence for IVIg use, successive reviews and guidelines since 1992 have recommended that conditions should be categorised according to the quality of the available evidence and whether IVIg treatment was considered beneficial.

b) Increasing the manufacture of IVIg in Australia

Australia has a long-standing commitment to a policy of self-sufficiency in the production and supply of blood and plasma products. This position was endorsed by the 2000 Review of the use and supply of intravenous immunoglobulins in Australia ², the 2001 Review of the Australian Blood Banking and Plasma Product Sector ³ and the 2006 Review of Australia’s Plasma Fractionation Arrangements ⁴.

Domestically produced IVIg is made exclusively by CSL Biotherapies Australia. It is manufactured from plasma collected around Australia from voluntary non-remunerated donors by the Blood Service. The collection of plasma and the manufacture of domestic IVIg have increased in response to increasing demand for plasma products (see Figure 2 and Figure 3).

c) Importing IVIg from overseas suppliers

In 2004, the JBC agreed to supplement the Australian made product with IVIg sourced from overseas.

Intravenous Immunoglobulin Standing Offer

The IVIg Standing Offer is an arrangement for the contingent supply of imported IVIg. Under this arrangement, imported IVIg is used to supplement the domestic IVIg supply. The NBA has Standing Offer arrangements and details are available on the NBA website at www.nba.gov.au.

The IVIg Standing Offer can be accessed through two mechanisms:

• the National Blood Supply component, whereby imported IVIg supplements domestic IVIg for uses under the National Blood Agreement and is supplied at no direct cost to patients; and
• the Jurisdictional Direct Order component, whereby imported IVIg is available to Approved Recipients.

National Blood Supply component

Under the National Blood Supply component, imported IVIg is used to supplement domestically produced IVIg. This is to ensure supply meets demand. To optimise shelf life and continuity of patient care, imported IVIg is issued when there are still reserves of domestically produced product through an allocation model under the management of the Transfusion Medicine Services at the Blood Service.

Jurisdictional Direct Order component

Under the Jurisdictional Direct Order (JDO) component, imported IVIg is available to Approved Recipients. The JDO component operates as follows:

1. Approved Recipients are entities such as hospitals that wish to purchase IVIg. Each state and territory health department will have nominated these entities to suppliers.
2. If an entity is unsure whether it is an Approved Recipient under the JDO component of the Standing Offer it should contact the relevant state or territory health department to clarify this and ensure it is nominated as an Approved Recipient to each supplier.
3. Approved Recipients place orders for imported IVIg directly with the supplier.
4. Purchases from this component of the Standing Offer are paid for in full by the Approved Recipient.
5. Upon placement of the order, a contract is established directly between the supplier and the Approved Recipient for the supply of the IVIg product.

Further details about the IVIg Standing Offer, information on the products available under the Standing Offer, and the contact details of suppliers and each state and territory health department are available on the NBA website at www.nba.gov.au.