Objective 1. Secure the supply of blood and blood products
It is the responsibility of the National Blood Authority (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. NBA ensures blood supply security by working with states and territories to determine and manage an annual supply plan and budget and negotiating and managing blood supply contracts and arrangements with local 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 2014–15 NSP&B
Throughout 2014–15, products were supplied to meet clinical demand and supply risks were effectively managed. The approved budget for 2014–15 covering the supply and management of blood and blood products and services under contract was $1,164.26 million, comprising $613.0 million for fresh blood products and plasma collection (see Fresh blood products on p.24) and $531.43 million for plasma and recombinant products (see Plasma and recombinant products on p.27). The remaining $19.82 million included items such as support for the publication of PBM Guidelines, maintenance of the Australian Haemophilia Centre Directors' Organisation (AHCDO) and administration of the Australian Bleeding Disorders Registry (ABDR). Table 2.1 identifies the NBA's expenditure in 2014-15 and earlier years by supplier for the supply of products in each product category.
Supplier | Products Purchased | 2010‑11 ($M) |
2011‑12 ($M) |
2012‑13 ($M) |
2013‑14 ($M) |
2014‑15 ($M) |
---|---|---|---|---|---|---|
CSL Behring (Australia) Pty Ltd |
Plasma Products
Diagnostic Reagent Products
Imported Plasma and Recombinant Products
|
215.15 |
228.22 |
222.02 |
210.10 |
245.19 |
Australian Red |
Fresh Blood Products
|
496.57 |
526.35 |
549.31 |
583.13 |
547.10 |
Baxalta Australia |
Imported Plasma and Recombinant Products
|
96.93 |
45.95 |
6.301 |
8.25 |
29.11 |
Imported IVIg |
Nil |
7.37 |
26.76 |
29.20 |
40.30 |
|
Bayer Australia Limited |
Imported Plasma and Recombinant Products
|
Nil |
11.30 |
34.96 |
35.14 |
9.00 |
Pfizer Australia Pty Ltd |
Imported Plasma and Recombinant Products
|
57.03 |
66.55 |
93.28 |
93.05 |
54.66 |
Novo Nordisk Pharmaceuticals Pty Ltd |
Imported Plasma and Recombinant Products
|
27.37 |
24.55 |
33.60 |
27.20 |
32.81 |
Octapharma Pty Ltd |
Imported IVIg |
8.95 |
23.38 |
49.10 |
46.00 |
70.02 |
Grifols Australia |
Imported IVIg Diagnostic Reagent Products
|
24.50 0.60 |
22.51 Nil |
0.28 Nil |
Nil 0.32 |
Nil 0.41 |
Ortho-Clinical Diagnostics (Johnson & Johnson Medical Pty Ltd) |
Diagnostic Reagent Products
|
0.38 |
0.45 |
0.44 |
0.43 |
0.44 |
Bio-Rad Laboratories Pty Ltd |
Diagnostic Reagent Products
|
Nil |
0.13 |
0.63 |
0.57 |
0.52 |
Abacus ALS Pty Ltd |
Diagnostic Reagent Products
|
0.03 |
0.05 |
0.04 |
0.04 |
0.00 |
Total Purchases of Blood and Blood Products |
927.51 |
956.81 |
1016.72 |
1033.43 |
1029.56 |
1 In the 2012-13 annual report, Baxter Healthcare Pty Ltd imported Plasma and Recombinant Products figure of 33.06 included 6.30 Imported IVIg which has a category in subsequent reports. Care should be taken in making comparisons with previous reports.
2 With effect from 1 April 2015, all NBA contracts with Baxter Healthcare Pty Ltd were novated to Baxalta Australia Pty Ltd. Throughout this report, references are made to Baxalta Australia Pty Ltd.
Fresh blood Products
The list of fresh blood products supplied in 2014-15 is at Appendix 2 Fresh blood components supplied under contract by the Blood Service. The four main products were:
- red blood cells
- platelets
- clinical fresh frozen plasma
- plasma for fractionation.
As demonstrated in Table 2.2, the increase in fresh blood expenditure has progressively moderated over the last 10 years primarily as a result of improved efficiencies in Blood Service operations, and in the last three years, a significant reduction in the demand for some fresh blood products due to improved appropriate use and reduced wastage.
Year | Amount ($M) | Growth (%) |
---|---|---|
2005-06 |
297.7 |
7.5 |
2006-07 |
327.1 |
9.9 |
2007-08 |
369.1 |
12.8 |
2008-09 |
417.2 |
13.0 |
2009-10 |
456.1 |
9.3 |
2010-11 |
496.6 |
8.9 |
2011-12 |
526.3 |
6.0 |
2012-13 |
549.3 |
4.4 |
2013-14 |
583.1 |
6.2 |
2014-15 |
547.1 |
-6.2 |
Total |
4,569.6 |
7.2 (average) |
Fresh blood expenditure in 2014-15 compared to 2013-14 has decreased by 6.2%. Key factors that have influenced the changes include the following:
- an increase in the quantity of collected plasma for fractionation from 545 tonnes to 572 tonnes
- restrained annual price indexation to 2.95 per cent
- reduction in demand for some fresh products as a result of improved appropriate use and reduced wastage.
Since the implementation of the Output Based Funding Model (OBFM) in 2010-11 where governments paid for the actual costs of producing fresh blood products supplied by the Blood Service rather than a grant based funding model, we have seen an increase in returns to government year on year as highlighted in Figure 2.1. In 2014-15 $66.2 million was returned including $28.5 million in Blood Service operating surplus and a saving from the decrease in red blood cell demand of 5 per cent. This compared to $95.4 million in 2013-14 (which included $40.4 million operating surplus and 8 per cent reduction in red blood cell demand).
Red blood cells
Red blood cells comprise approximately 25 per cent of total blood and blood product expenditure and are the largest single item of cost in fresh products. Figure 2.2 illustrates that there was a decline in issues of red blood cells (5 per cent) compared to 2013-14, with continuation of the steady decline in issues per 1,000 head of population. In the last three years, demand for red cells has declined by over 18 per cent, realising a saving in excess of $78 million. The decline in red cell demand is the result of the ongoing success of programmes to improve appropriate use and reduce wastage. These programmes encompass a range of health provider and clinical engagement activities, development of best practice guidelines and tools (see Best practice tools section on p.49), improved data collection and analysis and improved education and training arrangements. The publication and implementation of the PBM Guidelines underpins much of the success in improving appropriate use of fresh blood products (see Reference Development on p.47).
Platelets
Platelets comprise 5 per cent of total blood and blood product expenditure. Figure 2.3 illustrates that there was a decline in issues of platelets (1.6 per cent) from 2013-14 and a continued decline in issues per 1,000 head of population. As with red cells, the decline is the result of the ongoing success of programmes to improve appropriate use and reduce wastage. Platelets are either derived from an apheresis collection or a whole blood collection. In 2014-15, platelets issued were 64.2 per cent whole blood pooled (61.3 per cent in 2013-14) and 35.8 per cent apheresis (38.7 per cent in 2013-14).
Plasma for fractionation
The Blood Service collects plasma for fractionation to supply to CSL Behring (Australia) Pty Ltd for the manufacture of plasma derived products. In 2014-15, the target for the quantity of plasma to be collected by the Blood Service was 572 tonnes, which the Blood Service successfully achieved. The growth in apheresis plasma collection by the Blood Service over the last five years is shown in figure 2.4 below. In 2010-11 the ratio of whole blood to apheresis plasma for fractionation was 50:50 and in 2014-15 32:68. This is in part due to the decline in red blood cells.
The growth in plasma collection for 2014-15 is consistent with governments' target of 5 per cent per annum.
Plasma and recombinant products
The cost of plasma derived and recombinant blood products issued under NBA arrangements in 2014–15 decreased to $477.19 million, a reduction of $10.93 million (2.2 per cent) from 2013–14. The largest proportion of this decrease was the reduction in cost of some recombinant products resulting from significantly lower prices realised through a highly successful tender process undertaken in early 2014. The cost of most other products increased by less than 2 per cent. The average unit price for domestically produced IVIg increased by only 1.3 per cent due to the favourable price structure under the CSL Australian Fractionation Agreement (CAFA).
In the 10 years to 2014-15, expenditure on plasma and recombinant products issued under NBA arrangements has increased from $205.2 million to $477.19 million. Key drivers of this increase are as follows:
- $274.8 million from increased demand
- $51.8 million due to the safety based government policy decision to introduce full funding to allow access to 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 changes in price have driven a large increase in savings.
Issues of clotting factors
Clotting factors comprise 14.1 per cent of total blood and blood product expenditure. Figure 2.6 indicates that the demand for Factor VIII products increased marginally by 3.9 per cent when compared to 2013–14. The relative proportion of recombinant versus plasma derived product remains reasonably stable. Plasma derived Factor VIII remains an important alternative for immune tolerisation therapy and von Willeband disease (vWD). The demand for recombinant Factor VIII increased by 5.3 per cent compared to the demand for 2013-14. Conversely plasma derived Factor VIII demand decreased 7.0 per cent.
Figure 2.7 indicates that demand for Factor IX products in 2014–15 decreased by 8.9 per cent compared to 2013-14. Plasma derived Factor IX decreased by 44.7 per cent due to reduction in specific patient requirements. Recombinant Factor IX decreased 3.7 per cent after an increase in 2013-14 which was driven by an increase in surgeries.
Patients commencing or ceasing participation in company clinical trials also contributed to the variability of year-to-year growth rates for both Factor VIII and Factor IX products.
The demand for Recombinant Factor VIIa and Factor VIII inhibitor bypass agent (FEIBA) may vary significantly from year to year as a result of the impact of a small number of patients experiencing very high needs from time to time. Figures 2.8 and 2.9 depict demand for the last five years. The 2014-15 level of demand for Recombinant Factor VIIa increased by 17.7 per cent due to an increase in inhibitor and acquired haemophilia A patients. FEIBA demand increased with demand in 2014-15 exhibiting a 37.7 per cent increase compared to 2013-14.
Issues of immunoglobulin: Ig and Normal Immunoglobulin (NIg)
As shown below demand for Ig continues to grow at a consistent annual rate of more than 10 per cent.
2010-11 | 2011-12 | 2012-13 | 2013-14 | 2014-15 |
---|---|---|---|---|
11.1% | 10.9% | 10.7% | 11.0% | 10.2% |
In 2014–15, a total of 4.43 million grams of Ig was issued, representing a cost of $484.1 million nationally (including the cost of plasma collections). Of this amount, 60 per cent was Ig produced in Australia and 40 per cent was imported. Figure 2.10 highlights that the relative proportion of imported Ig compared to domestic Ig is growing at a rate of approximately 8 per cent per year. This reflects the shortfall between the annual growth of domestic demand (approximately 11 per cent) and the annual growth of domestic plasma collection used to manufacture Ig (approximately 5 per cent).
Excluding Ig issued under direct orders, a total of 14,983 patients (compared with 13,981 in 2013-14) nationally were issued Ig during 140,855 treatment episodes (122,791 in 2013-14). Approximately 1.35 per cent of the issued Ig was subcutaneous Ig SCIg. SCIg was added to the National Supply List in September 2013.
An analysis of Ig use indicates that there are still considerable variations in the grams issued per treatment episode across jurisdictions for some conditions. Neurology remains the discipline using the greatest amount of Ig and demand is still increasing. Haematology is the next largest user of Ig but growth has slowed. A similar decline in growth has been observed in Immunology, the third largest user of Ig. The top three indications for Ig use are chronic inflammatory demyelinating polyneuropathy, common variable immunodeficiency disease and myasthenia gravis.
The NBA produced an annual report of Ig usage in 2013–14, to document trends in Ig use and provide insights into the drivers of use at the micro level.
The Report on the Issue and Use of IVIg 2013-14 can be found on the NBA website at http://www.blood.gov.au/data-analysis-reporting.
Normal Ig
As shown in Figure 2.11, demand for normal Ig NIg has declined over recent years largely as a result of implementation of the NIg policy outlining the national position on access and use under the national blood arrangements and the introduction of SCIg. Since 2011-12, the demand for NIg has reduced by 76.9 per cent.
Contract Management
Maintaining security of supply requires the NBA to manage contracts with suppliers of blood and blood products. 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 Australian National Audit Office (ANAO) on Developing and Managing Contracts.
In 2014-15 the NBA managed 18 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 CSL Australian Fractionation Agreement (CAFA)
- contracts for the provision of imported IVIg, imported recombinant factors VIIa, VIII, IX, and XIII, and other imported plasma and recombinant products
- red cell diagnostic reagents product procurement.
Deed of Agreement with the Red Cross
The Deed of Agreement with the Red Cross for the supply of fresh blood products by the Blood Service is one of the most important contracts managed by the NBA. The Blood Service 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 programme with the Blood Service to improve contract performance and accountability under the Deed.
Funding provided to the Blood Service is based on an OBFM arrangement. Funding provided to the Blood Service through the Deed was $547.1 million in 2014–15, a decrease of $36 million over the $583.1 million provided in 2013–14.
Performance
The performance of the Blood Service is a key element in meeting blood sector objectives. Governments expect the Blood Service to deliver effective services at optimum value for money. Governments outline their expectations of the Blood Service in relation to performance through the Deed of Agreement and the Blood Service Statement of Expectations. Blood Service performance against selected indicators is outlined in Table 2.3.
Domain | Indicator | 2013-14 result* | 2014-15 Blood Service target | 2014-15 result* | |
---|---|---|---|---|---|
Donor management | First time donors | Whole Blood | 94,080 | 95,779 | 88,834 |
Apheresis Plasma | 33,173 | 33,887 | 31,336 | ||
Supply chain management | Number of days within inventory bands (note: bands set by the Blood Service) | 315 | N/A | 330 | |
Red cell yield (proportion of collections covered to supply) | 89.5% | 89.0% | 90.1% | ||
Age of red cells at issue (days) | 8.31 | 8.00 | 6.80 | ||
Order fulfilment | 98% | 97.5% | 96.8% | ||
Quality and level of service |
Health provider satisfaction with Blood Service (mean score out of 10) | 8.7 | 8.8 | 9.1 | |
Finance | Main operating programme financial result | $44.9 million surplus | >0 | $33.5 million surplus |
* As measured by the Blood Service.
Implementing improvements to current arrangements
The NBA worked with the Blood Service to deliver a range of contract improvements in 2014-15, including the following:
- completion of a review of capital funding arrangements
- implementation of Phase 1 of the National Service Requirements and Standards that set out the Blood Service's relationships with health providers and the NBA. This includes business rules and standards for ordering, delivery, and receipt of products
- commencement of implementation of the National Inventory Management Framework (NIMF) project for red blood cells, including proof of concept and pilots
- extension of the current Deed by mutual agreement until 15 December 2015.
Blood Service research and development
Through a grant specified in the Deed of Agreement, the Blood Service received grant funding of approximately $8.6 million for its research and development programme. The Blood Service has four research programmes:
- donor and community
- applied and developmental
- transfusion science
- clinical.
Research projects in 2014-15 included work on the development of frozen blood products. The Blood Service also conducted research on the extension of the shelf-life of platelets from five days to seven days and this is currently with the Therapeutic Goods Administration (TGA) for review. The Blood Service is reviewing the Research and Development Framework as part of the business improvement process within the Blood Service.
CSL Australian Fractionation Agreement (CAFA)
Most plasma derived products used in Australia are manufactured by CSL Behring (Australia) Pty Ltd under the CAFA from plasma collected by the Blood Service. CSL Behring (Australia) Pty Ltd is the sole manufacturer of plasma derived blood products in Australia and the NBA is responsible for negotiating and managing the CAFA.
In 2014-15, 571.9 tonnes of Australian plasma was pooled for fractionation under the CAFA, and expenditure on CAFA products was $240.4 million.
Performance
The 2014-15 performance by CSL Behring (Australia) Pty Ltd against the CSL Australian Fractionation Agreement (CAFA) Key Performance Indicators (KPIs) is shown in Table 2.4. This table reports actual performance. Sufficient supply of all products was maintained at all times. The performance of CSL Behring (Australia) Pty Ltd was within defined tolerances for each of the KPIs with a few minor exceptions. Some approvals for KPI deviations were given by the NBA where known issues were beyond the control of CSL Behring (Australia) Pty Ltd, including changes in the level of Ig in plasma, and the dynamics of supply, demand and production for some products, which affected CSL Behring (Australia) Pty Ltd's ability to meet KPI standards.
Description of performance measure |
Results 2014-15 Q1 |
Results 2014-15 Q2 |
Results 2014-15 Q3 |
Results 2014-15 Q4 |
Results 2014-15 Annual |
|
---|---|---|---|---|---|---|
KPI1 | Plasma stewardship | Achieved | Substantially Achieved* | Substantially Achieved* | Achieved | Substantially Achieved* |
KPI2* | Production yield | 4.94g/kg | 5.07g/kg | 5.14g/kg | 4.95g/kg | 5.03g/kg |
KPI3 | Management of required inventory levels | |||||
Minimum starting plasma inventory | Not active in 2014-15 | |||||
Products in CSL Behring (Australia) Pty Ltd inventory | 94% Achieved |
96% Achieved |
96% Achieved |
100% Achieved | 96% Achieved |
|
Products in national CSL Behring (Australia) Pty Ltd reserve | 100% Achieved |
100% Achieved | 100% Achieved | 100% Achieved | 100% Achieved | |
KPI4 | Fulfilment of orders | |||||
Orders by distributor (Blood Service) | 98% Achieved |
100% Achieved | 98% Achieved |
100% Achieved | 99% Achieved |
|
Orders by non-distributor |
100% Achieved |
100% Achieved | 100% Achieved | 100% Achieved | 100% Achieved | |
KPI5** | Shelf life of national reserve products | 100% Achieved |
100% Achieved | 100% Achieved | 100% Achieved | 100% Achieved |
Note:
* In these instances, the performance of the relevant supplier departed from the contracted requirement at some periods during the year. Such instances were managed in discussions of supplier performance at regular contract management meetings.
** The NBA and CSL Behring (Australia) Pty Ltd are considering the effects of changes in plasma collection practices on CAFA contractual provisions relating to IVIg yield.
Imported Ig
Ig is imported to meet a shortfall in domestic Ig production against clinical demand in Australia. In addition to supply under the national blood arrangements, the NBA also supports the purchasing of small amounts of imported Ig using jurisdictional direct orders.
Two contracts are in place for supply of imported Ig under the national blood arrangements. The contracts commenced on 1 January 2012 and expire on 31 December 2015. The suppliers are Baxalta Australia Pty Ltd and Octapharma Australia Pty Ltd. In 2014-15, the NBA spent $110.32 million for both contracts.
In 2014-15, the NBA successfully concluded a tender process for new contracts for the national supply of imported Ig to replace the current contracts which expire on 31 December 2015. The new contracts were awarded to CSL Behring Pty Ltd and Grifols Australia Pty Ltd and are projected to achieve annual savings in the order of $30 million per year.
Performance
The 2014-15 performance of both suppliers against the contractual KPIs is shown in Table 2.5. Sufficient supply of products was maintained at all times in accordance with contractual requirements and was not affected by transient or administrative KPI deviations.
KPI | Performance | Octapharma Australia | Baxalta Australia Pty Ltd |
---|---|---|---|
KPI1 | In-country reserve | Fully achieved | Substantially achieved* |
KPI2 | Shelf life on products delivered |
Fully achieved | Substantially achieved* |
KPI3 | Delivery performance | Substantially achieved* | Substantially achieved* |
KPI4 | Reporting accuracy and timeliness | Substantially achieved* | Fully achieved |
*In these instances, the performance of the relevant supplier departed from the contracted requirement at some periods during the year, but without material effect on supply performance or supply security. Such instances were managed in discussions of supplier performance at regular contract management meetings.
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 2014-15, the NBA managed the supply contracts for imported plasma and recombinant products with the following five companies:
- Bayer Australia Ltd
- Baxalta Australia Pty Ltd
- CSL Behring (Australia) Pty Ltd
- Novo Nordisk Pharmaceuticals
- Pfizer Australia Pty Ltd.
Following a tender process for new contracts for the national supply of recombinant Factor VIII and IX products, new contracts commenced on 1 July 2014. The new contracts were awarded to Baxalta Australia Pty Ltd and Pfizer Australia Pty Ltd and achieved a saving in 2014-15 of approximately $49 million.
In June 2015, the NBA concluded a limited tender process with Novo Nordisk for the supply of recombinant Factor VIIa to replace the contract which expired on 30 June 2015.
The contracts for the supply of Protein C, Activated Prothrombin Complex Concentrate, Factor XIII, anti-Rh (D) expire on 30 June 2016. The NBA will undertake a structured information gathering process, including a supplier Request For Information (RFI) and written Stakeholder Consultation to inform future procurement decisions for these products.
Expenditure on the above contracts and recombinant Factor VIIa during 2014-15 was $126.6 million.
Performance
The 2014-15 performance of suppliers of imported plasma and recombinant blood products for each performance measure is shown in Table 2.6. All suppliers satisfactorily met required performance levels.
KPI | Performance measure | Baxalta Australia (FEIBA/CEPROTIN) | Baxalta Australia (ADVATE/RIXUBIS) | Bayer Australia | CSL Behring (Australia) Pty Ltd | Novo Nordisk Pharmaceuticals | Pfizer Australia |
---|---|---|---|---|---|---|---|
KPI1 | In-country reserve | Fully achieved | Fully achieved | Achieved* | Fully achieved | Fully achieved | Fully achieved |
KPI2 | Shelf life on products delivered | Fully achieved | Not achieved** | Achieved* | Fully achieved | Achieved* | Fully achieved |
KPI3 | Delivery performance | Achieved* | Not achieved** | Fully Achieved | Fully achieved | Fully achieved | Fully achieved |
KPI4 | Reporting accuracy and timeliness | Achieved* | Achieved | Achieved | Fully achieved | Achieved* | Fully achieved |
*In these instances, the performance of the relevant supplier departed from the contracted requirement at some periods during the year, but without material effect on supply performance or supply security. Such instances are managed through prior approvals from the NBA, and discussion of supplier performance during the year.
** In these instances, the performance of the relevant supplier departed from the contracted requirement at some periods during the year. Performance of the relevant suppliers was nonetheless subject to contractual requirements and was managed through ongoing contract management monitoring. Where appropriate, financial consequences of not meeting contractual Key Performance Indicators were applied.
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 haematology tests.
The NBA has established a standing offer arrangement with the following four suppliers for the period 1 July 2011 to 30 June 2016:
- Bio-RAD Laboratories Pty Ltd
- CSL Behring (Australia) Pty Ltd
- Grifols Australia
- Ortho-Clinical Diagnostics (Johnson & Johnson Medical Pty Ltd).
The standing offer lists more than 150 red cell diagnostic products, which are used in laboratory tests known 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 $4.8 million per year. The NBA manages the cap for all jurisdictions and suppliers.