It is the responsibility of the NBA to manage the national blood supply to ensure that healthcare providers have sustainable, reliable and efficient access to blood and blood products needed for patient care. The NBA ensures blood supply security by working with states and territories to determine and manage an annual supply plan and budget, and by negotiating and managing blood supply contracts and arrangements with domestic and overseas suppliers.

National Supply Plan and Budget

A key element of the NBA's role in ensuring security of supply is to develop, coordinate and monitor the annual National Supply Plan and Budget (NSP&B), including obtaining annual approval from Health Ministers.

This is achieved by:

• developing a national estimate of product demand
• liaising with states and territories to refine the estimated demand for products
• collecting and distributing data on product issued and reporting variations to jurisdictions on the approved supply plan
• intensively managing products if they are in short supply.

Performance against the 2019-20 NSP&B

Throughout 2019-20 products were supplied to meet clinical demand and supply risks were effectively managed. The approved budget for 2019-20 covering the supply and management of blood and blood products and services under contract was $1,289.60 million. This comprised $656.08 million for fresh blood products and plasma collection and $614.47 million for plasma and recombinant products. There is also an additional $19.05 million included for items such as support for the publication of PBM Guidelines, maintenance of the Australian Haemophilia Centre Directors' Organisation (AHCDO), administration of the Australian Bleeding Disorders Registry (ABDR), BloodSafe eLearning, Blood Sector ICT Systems and the operations of the NBA. Table 2.8 identifies the NBA's expenditure for the supply of products in each product category by supplier in 2019-20 and prior years.

Fresh blood products

The list of fresh blood products supplied in 2019-20 is at Appendix 2 Fresh blood components supplied under contract by Lifeblood in 2019-20. The four main products were:

1. red blood cells
2. platelets
3. clinical fresh frozen plasma
4. plasma for fractionation.

As summarised in Table 2.9, the increase in fresh blood expenditure has moderated during the last ten years, primarily as a result of improved efficiencies in Lifeblood operations together with a significant reduction in demand for some fresh blood products due to improved appropriate use and reduced wastage.

Fresh blood expenditure in 2019-20 decreased by 2.5 per cent compared to 2018-19. Key factors that have influenced this include:

• an increased emphasis on the collection of plasma for fractionation, which increased from 736 tonnes to 803 tonnes at no increased cost
• annual price indexation of 1.95 per cent
• moderation in demand for some fresh products as a result of improved appropriate use and reduced wastage.

For each of the last five years, the NBA has seen funds returned to governments as highlighted in Figure 2.1. In 2019-20, $35.2 million was returned including $31.7 million for the Lifeblood operating surplus and a saving from the decrease in red blood cell demand of 1.8 per cent against the budget.

FIGURE 2.1 Returns to government 2015-16 to 2019-20

Red blood cells

Red blood cells comprise approximately 20.5 per cent of total blood and blood product expenditure and are the second largest item of cost in fresh products behind plasma for fractionation. Figure 2.2 illustrates that there was no change in issues of red blood cells compared to 2018-19, with continuation of the steady decline in issues per 1,000 head of population nationally from 26.9 in 2015-16 to 24.7 in 2019-20. In the last five years, demand for red cells has declined by 6.5 per cent, realising a saving to governments of more than $38.7 million. The decline in red cell demand is the result of the ongoing success of programs to improve appropriate use and reduce wastage. These programs encompass a range of health provider and clinical engagement activities, development of best practice guidelines and tools, improved data collection and analysis and improved education and training arrangements. The publication and implementation of the Patient Blood Management Guidelines underpins much of the success in improving appropriate use of fresh blood products.

FIGURE 2.2 Red Cells issued by Lifeblood 2015-16 to 2019-20 per '000 population

Platelets

Platelets comprise 4.6 per cent of total blood and blood product expenditure. Figure 2.3 illustrates that there was a 1.3 per cent increase in issues of platelets from 2018-19. Platelets are either derived from an apheresis collection or a whole blood collection. In 2019-20 platelets issued were 64 per cent whole blood pooled (66 per cent in 2018-19) and 36 per cent apheresis (34 per cent in 2018-19).

FIGURE 2.3 Platelets issued by Lifeblood 2015-16 to 2019-20 per '000 population

Plasma for fractionation

Lifeblood collects plasma for fractionation to supply to CSL Behring (Australia) Pty Ltd for the manufacture of plasma derived products. In 2019-20 the target quantity agreed by governments of plasma to be collected by Lifeblood was 730.5 tonnes, noting that Lifeblood could collect up to 802.6 tonnes at no additional cost to governments. Lifeblood achieved the maximum collection of 802.6 tonnes or 72.1 tonnes over the target. The growth in apheresis plasma collection by Lifeblood over the last five years is shown in Figure 2.4.

In 2015-16 the ratio of whole blood to apheresis plasma for fractionation was 29:71 and in 2019-20, 22:78. This is in part due to the decline in red blood cell demand.

FIGURE 2.4 Whole blood and apheresis plasma for fractionation 2015-16 to 2019-20

Plasma and recombinant products

The cost of plasma derived and recombinant blood products issued under NBA arrangements in 2019-20 totalled $601.6 million, an increase of $33.5 million (5.9 per cent) from 2018-19. A decline in demand growth for Immunoglobulin (Ig) resulted in a $26.4 million or 7.0 per cent overall cost reduction against the NSP&B. Lower demand for Prothrombinex ($2.25 million) and plasma derived clotting factors ($4.38 million) offset increases in demand of recombinant Factor IX and recombinant Factor VIIa resulting in an increase of $7.11 million over the NSP&B. In addition, the demand for C1 Esterase Inhibitor increased by 5.8 million IUs or $4.0 million over the NSP&B.

In the 15 years to 2019-20, expenditure on plasma and recombinant products issued under the national blood arrangements has increased from $205.2 million to $611.1 million. Key drivers of this increase are:

• $441.7 million from increased demand
• $51.8 million to fund recombinant clotting factor products (rFVIII and rFIX).

The combined effect of demand and price drivers on expenditure can be seen in Figure 2.5. It is of note that significant improvements in price have driven a large increase in savings that has reduced the impact of increases in demand.

FIGURE 2.5 Plasma derived and overseas product expenditure: cumulative increases on 2003-04 base year

Issues of clotting factors

In 2019-20 clotting factors comprised 14.5 per cent of total blood and blood product expenditure.
Figure 2.6 indicates that the demand for Factor VIII products increased by 0.4 per cent when compared to 2018-19. The demand for recombinant Factor VIII increased by 1.2 per cent in 2019-20. Demand for plasma derived Factor VIII decreased by 5.2 per cent.

FIGURE 2.6 Issues of Factor VIII products 2015-16 to 2019-20 per '000 population

The demand for Factor IX products in 2019-20 increased by 1.0 per cent compared to 2018-19 (Figure2.7). Plasma derived Factor IX demand decreased by 3.9 per cent in 2019-20 due to a reduction in specific patient requirements. Demand for recombinant Factor IX decreased by 1.1 per cent in 2019-20. Continuation of limited interim arrangements to provide temporary access to Extended Half Life recombinant Factor IX clotting factor products under the national supply arrangements contributed to the variability of year-to-year growth for these products.

FIGURE 2.7 Issues of Factor IX products 2015-16 to 2019-20 per '000 population

The 2019-20 level of demand for recombinant Factor VIIa increased by 2.4 per cent and Factor VIII Anti-Inhibitor (FEIBA) decreased by 23.5 percent compared to 2018-19.

FIGURE 2.8 Issues of Factor VIIa products 2015-16 to 2019-20 per '000 population

Demand for recombinant Factor VIIa and FEIBA can change significantly from year to year as a result of the variable needs of a small number of patients. These products have also been variable due to ongoing clinical trials of new products for haemophilia therapies.

FIGURE 2.9 Issues of FEIBA, 2015-16 to 2019-20 per '000 population

Issues of immunoglobulin (Ig)

Demand for Ig was growing at a consistent annual rate of more than 10 per cent up to and including 2017-18. This rate of growth has slowed to 6.7 per cent in 2019-20 compared to 7.2 per cent in 2018-19. This is the lowest annual rate of increase since 2004-05 when Australia first secured supply sufficiency through national importation of Ig by the NBA. The National Fractionation Agreement for Australia (NaFAA) with CSL Behring commenced on 1 January 2018 for the continued manufacture and supply of fractionated blood plasma products and delivered savings in 2019-20 of $4.26 million for domestic immunoglobulin.

In 2019-20 a total of 7.01 million grams of Ig was issued nationally representing a cost of $637.1 million (including the cost of plasma for fractionation) or 51.8 percent of total blood and blood product issues. Of this amount, 46.0 per cent was Ig produced in Australia and 54.0 per cent was imported. Figure 2.10 shows the total growth of Ig per year and the relative proportion of imported Ig compared to domestic Ig.

FIGURE 2.10 Issues of Immunoglobulin products, 2015-16 to 2019-20 per '000 population

Contract Management

The NBA manages contracts with suppliers of blood and blood products to ensure efficient, effective and secure supply. Contracts are developed in accordance with the Commonwealth Procurement Rules, and managed in accordance with Best Practice Guidance for contract management, including the guideline from the Department of Finance on Developing and Managing Contracts.

In 2019-20 the NBA managed 15 blood and blood product supply contracts and arrangements. The contracts managed by the NBA included:

• fresh blood product procurement - Australia's fresh blood component requirements through the Deed of Agreement with the Australian Red Cross Society
• plasma and recombinant product procurement - Australia's plasma product and recombinant product requirements through:
  • the National Fractionation Agreement for Australia (NaFAA) with CSL Behring
  • contracts for the provision of imported IVIg, imported recombinant factors VIIa, VIII, IX, and XIII, and other imported plasma and recombinant products from commercial suppliers
  • red cell diagnostic reagent products.

Deed of Agreement with the Australian Red Cross Society

The Deed of Agreement (Deed) with the Australian Red Cross Society for the supply of fresh blood products and plasma for fractionation by Lifeblood is one of the most important contracts managed by the NBA. Lifeblood is the sole supplier of fresh blood products. The provision of fresh blood products under the Deed is an essential clinical service that saves lives every day. The NBA has an ongoing program with Lifeblood to assure contract performance and accountability under the Deed.

The NBA implemented a nine-year Deed with the Australian Red Cross Society on 1 July 2016, including a three-year funding and services agreement. The current funding and services agreement commenced on 1 July 2019 and runs until 30 June 2022.

Funding provided to Lifeblood is based on an Output Based Funding Model (OBFM) arrangement agreed by governments. Funding in 2019-20 was $651.50 million, a reduction of $16.4 million from 2018-19.

Performance

The performance of Lifeblood is a key element in meeting blood sector objectives. Governments expect Lifeblood to deliver effective services and value for money. Governments outline their expectations of Lifeblood in relation to performance through the Deed and the Lifeblood Statement of Expectations. Lifeblood performance against selected indicators is outlined in Table 2.11.

Implementing improvements to current arrangements

A number of initiatives were progressed under the Deed during 2019-20, including:

• completion of an independent external review of the efficiency of Lifeblood
• consideration of Lifeblood’s Plasma Business Case and recommendations developed for future domestic plasma collection targets
• implementation of a new Lifeblood Statement of Expectations for 2019-22, including updated key performance indicators (KPIs)
• implementation of the second Funding and Services Agreement covering the period 2019-20 to 2021-22
• implementation of the fourth cycle of the OBFM for the period 2019-20 to 2021-22.

The second half of 2019-20 was challenging for all Australians due to the COVID-19 pandemic. Despite these challenges, including periodic transport and supply-chain disruptions, Lifeblood met its annual targets for the supply of blood and plasma, and maintained a strong donor panel.

COVID-19 Convalescent Plasma

In May 2020 with the agreement of governments, Lifeblood commenced collecting convalescent plasma from donors who have recovered from COVID-19 infections. This is for use by CSL Behring for the development of a potentially lifesaving plasma-derived treatment for people with COVID-19. In addition, Lifeblood will also supply convalescent plasma to a number of clinical trials investigating the effectiveness of convalescent plasma as a direct treatment in patients with COVID-19. The NBA is facilitating the work in accordance with existing arrangements under the current Deed of Agreement and the current contract with CSL Behring.

Lifeblood research and development

Lifeblood and the NBA have a Research and Development Framework that was introduced on 1 July 2016. In 2019-20 Lifeblood received funding under the Deed of approximately $9.8 million for its research and development program in the following five strategic research areas:

• donor behaviour
• donor health and wellbeing
• product development and storage
• product safety
• product usage.

Lifeblood’s research and development business outcomes were on track with most of the research projects completed in 2019-20 being translated into changed business practices or learnings.

This year, research and development at Lifeblood remained focused on understanding what motivates current and future donors, the safety and quality of blood components, development of sensitive, specific and cost-effective testing capabilities, enhancement of knowledge of transfusible blood components and their interactions with patients, and improvement of practice. A strong emphasis is placed on translational research through close interaction between the research and development and operational arms of the business through all stages of a research project's life cycle.

National Fractionation Agreement for Australia (NaFAA)

Many of the plasma derived products used in Australia are manufactured under the NaFAA by CSL Behring (Australia) Pty Ltd (CSL Behring) from plasma collected by the Lifeblood. CSL Behring is the sole manufacturer of plasma derived blood products in Australia and the NBA is responsible for negotiating and managing the NaFAA.

The NaFAA came into force on 1 January 2018 and will continue until 31 December 2026, subject to a review in 2022.

In 2019-20 802.6 tonnes of Australian plasma was pooled for fractionation under the agreement, and expenditure totalled $273.3 million.

Performance

The 2019-20 performance by CSL Behring against the NaFAA key performance indicators (KPIs) is shown in Table 2.12. Sufficient supply of all products was maintained at all times. The performance of CSL Behring was within defined tolerances for each of the KPIs.

Imported Immunoglobulin (Ig)

Ig is imported to meet the shortfall in domestic Ig production against clinical demand in Australia. In addition, the NBA contracts also support the purchase of small amounts of imported Ig when necessary through direct orders by individual jurisdictions.

Two contracts are in place for the supply of imported Ig under the national blood arrangements. The contracts commenced in September 2015 and the base term expired on 31 December 2018. The NBA exercised the available extension options and the contracts will expire on 31 December 2020. The suppliers are CSL Behring and Grifols Australia Pty Ltd (Grifols). In 2019-20 the NBA expended $179.3 million for both contracts.

Performance

The 2019-20 performance of both CSL Behring and Grifols against the contractual KPIs is shown in Table 2.13. Sufficient supply of products was maintained to meet demand during the year and was not adversely affected by transient or administrative KPI deviations.

In some instances, performance deviated from contracted requirements at some periods during the year and was managed by the NBA.

Imported plasma derived and recombinant blood products

The NBA has contracts with suppliers for the importation of selected plasma derived and recombinant blood products to augment domestic supply where these products are not produced in Australia or domestic production cannot meet demand.

In 2019-20 the NBA managed supply contracts for imported plasma and recombinant products with the following five companies:

• CSL Behring (Australia) Pty Ltd
• Novo Nordisk Pharmaceuticals Pty Ltd
• Pfizer Australia Pty Limited
• Sanofi-aventis Australia Pty Ltd formerly Bioverativ Australia Pty Ltd
• Shire Australia Pty Limited.

Expenditure on the above contracts in 2019-20 amounted to $187.18 million.

Performance

The 2019-20 performance of suppliers of imported plasma and recombinant blood products for each performance measure is shown in Table 2.14. All suppliers satisfactorily met required performance levels.

In some instances, performance deviated from contracted requirements at some periods during the year and was managed by the NBA.

Red Cell diagnostic reagent products

Red cell diagnostic reagents are used for testing to establish the blood group of human red cells, detect red cell antibodies and to control, standardise and validate routine immunohaematology tests.

The NBA established a standing offer arrangement with the following four suppliers for the period 1 July 2016 to 30 June 2019. The NBA has exercised available extension options extending the term of the standing offer arrangements to 30 June 2021.

• Bio-RAD Laboratories Pty Ltd
• Grifols Australia
• Immulab Pty Ltd
• Ortho-Clinical Diagnostics (Johnson & Johnson Medical Pty Ltd).

The standing offer lists more than 100 red cell diagnostic products, which are used in laboratory tests such as blood typing and cross matching. These tests ensure that when a person needs a blood transfusion, they receive blood that is compatible with their own.

Expenditure on diagnostic reagent supply is capped at $4.85 million per year. The NBA administers the cap for suppliers on behalf of jurisdictions.