This section provides information on how the National Blood Authority (NBA) ensures that Australians have an adequate, safe, secure and affordable supply of blood and blood-related products. The NBA does this through several measures, including the annual development of a National Supply Plan and Budget (NSP&B) and the negotiation and implementation of Blood Supply Contracts.
National blood products supply arrangements
The national blood supply is a national scheme for the subsidised supply of blood products into the Australian health sector. As such, it is similar to other national health subsidy schemes such as Medicare, the Pharmaceutical Benefits Scheme, the Aged Care Scheme, the Hearing Services Program, and the National Diabetes Services Scheme. The blood supply chain in Australia from donors to patients is outlined in the image below (click here to enlarge image).
OVERSEAS
FIGURE: The Australian blood products supply chain
Key aspects which distinguish the national blood supply from other national subsidy schemes include:
- policy aims and objectives agreed by all governments under the National Blood Agreement
- shared funding framework established under the National Blood Agreement, in which costs are essentially shared on a 63%:37% basis between the Australian Government and state/territory governments
- method for the delivery of the subsidy, through centralised supply contracts agreed and administered by the NBA, operating within the Australian Government procurement and financial accountability framework.
The national blood supply is wholly government funded (no co-payment mechanisms apply), with nine governments providing $1,204.1 million in 2017/18 to the NBA for the management and purchase of blood and blood products. Under the scheme, blood and blood products are ultimately provided free of charge to patients in Australia.
Supply planning
Under the National Blood Agreement, the NBA is responsible for undertaking annual supply and production planning and budgeting, in consultation with funding jurisdictions and suppliers, and for the approval of all health ministers through the Council of Australian Governments (COAG) Health Council (visit Governance Arrangements and Key Stakeholders for more information on NBA stakeholders).
Each year the NBA prepares a National Product Price List and National Supply Plan and Budget (NSP&B) for blood and blood products. This annual development is a critically important function for the blood sector as a whole and underpins much of the NBA’s work. The NBA is also responsible for collecting data on products issued, reporting to jurisdictions against the approved supply plan, and for making improvements to the national supply planning process. Each year, the NBA has introduced more sophisticated demand modelling processes as it improves its knowledge and understanding of the products and clinical environment.
In supply planning process each year, the NBA analyses volumes issued, combined with information/intelligence from suppliers, IT systems (e.g. BloodNet) and states and territories to inform the volume forecast for the next financial year. These volumes are costed and submitted to the Jurisdictional Blood Committee for approval. The NSP&B is then submitted to health ministers who have final approval of the NSP&B.
In January and February a mid-year review is undertaken. This process looks at how the current financial year is tracking compared with the full year budget (NSP&B). This provides jurisdictions with a view of where the year-end figures may be and allows for adjustments in planning for commercial suppliers and the Australian Red Cross Lifeblood.
Once the financial year is complete the NBA undertakes a full reconciliation process to ensure jurisdictions only pay for the products that they have been issued, rather than forecast demand.
Supply management
Under the National Blood Agreement, the NBA is also required to;
“use best endeavours to manage the national blood supply to provide a sufficient level of supply to meet the demand in all states and territories and to ensure that patients continue to access the blood and blood related products their clinicians determine will best meet their clinical needs do are as practicable in accordance with national best practice….”
To fulfil this function, the NBA monitors the balance between supply and demand throughout the year and is responsible for the intensive management of products in short supply. For example, intravenous immunoglobulin (IVIg) and Biostate (a CSL plasma derived FVIII product for treating haemophilia) and cytomegalovirus immunoglobulin (CMV) have been under intensive product management at various stages since the NBA commenced.
Monitoring product use
The NBA conducts utilisation reviews to understand usage patterns of products listed on the National Product Price List (NPPL). Utilisation reviews examine key aspects of product use including prescribing, ordering, dispensing and administration. This help ensure that products are appropriately used in view of pre-determined criteria such as approved funding indications.
C1-esterase inhibitor concentrate utilisation review
C1-esterase inhibitor concentrate (C1-INH) is one of the available treatment options for hereditary angioedema (HAE), a rare genetic condition caused by insufficient or partially inactive C1-esterase inhibitor. HAE causes swellings, or attacks, that can cause death and severely impact on patients’ ability to participate in the community without appropriate treatment due to their unpredictability.
C1-INH was added to the NPPL in 2016 as a second line treatment for acute HAE attacks, for long term prophylaxis in patients experiencing eight or more attacks per month, and for short term prophylaxis prior to undergoing high risk head and neck surgery. The NBA supplies the C1-INH product Berinert (CSL Behring) under the national blood arrangements.
In 2021, the NBA conducted a preliminary utilisation review of C1-INH which identified an unanticipated increase in C1-INH use. In 2023, a full independent utilisation review (the C1-INH review) was subsequently conducted with the aim of identifying factors driving increased demand and determining whether increased demand is appropriate in the context of funded access.
The C1-INH review found that increased demand for C1-INH was influenced by the withdrawal of the first line prophylactic treatment from the Australian market, followed by the introduction of a new subcutaneous form of C1-INH that was considered by clinicians and patients to be a superior product.
To address the issues identified in the review, it was recommended that the NBA:
- review the system of governance for ordering and recording the supply of NBA funded C1‑INH; and
- review the guidelines for accessing NBA funded C1-INH.
Actions to address the recommendations from the C1-INH review are underway.
The Executive Summary of the C1-INH utilisation review can be found here.
Eptacog alfa (NovoSeven) utilisation review
Eptacog alfa (recombinant coagulation Factor VIIa - NovoSeven) is one of the available treatment options for some patients with haemophilia A or B inhibitors, congenital Factor VII deficiency and Glanzmann’s thromasthenia. It is funded under the national blood arrangements for the control of bleeding and prophylaxis in patients.
A review into the utilisation of Factor VIIa was conducted by the NBA in 2022 to determine whether its use is consistent with the criteria for NBA funded access. Findings of the review include that the volume of Factor VIIa distributed between 2015-2021 is steady and predictable, and the volume issued to patients is consistent with a stable patient population. Overall, the review found that Factor VIIa is being used appropriately for the treatment of bleeding disorders.
The Eptacog alfa utilisation review can be found here.
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