In 2019-20 the NBA achieved a range of objectives to improve blood sector performance and risk management, particularly in the areas of immunoglobulin governance, evaluation of new products, ICT developments, data availability and analysis, risk management and knowledge management.

Ig Governance

Work on the NBA Immunoglobulin (Ig) Governance Program throughout 2019-20 continued to improve the governance and management of publicly funded Ig. This program aims to ensure:

• Ig product use and management reflects appropriate clinical practice and represents efficient, effective and ethical expenditure of government funds, in accordance with relevant national safety and quality standards for health care
• access to Ig products is consistent with the Criteria for access determined by governments
• improved capture of information on the need for, use of, and outcomes of treatment with Ig products (including adverse events) to inform future changes to the Criteria.

In 2018-19 the NBA published a Performance Improvement Strategy (the Strategy) to strengthen Ig governance, drive improvement in the prescription, use and management of Ig products and support the Ig Governance Program to continue to deliver against agreed objectives. During 2019-20 the NBA progressed activities listed in the Strategy. The key activities undertaken under the five pathways identified in the Strategy facilitate improvement in each of the key performance management areas. These activities have supported a decrease in the rate of growth of Ig use to the lowest level since 2004-05.

The five key performance management areas which set the objectives for the strategy are:

• provision of Ig reflects appropriate clinical practice
• uniform compliance with the National Policy
• local Ig governance arrangements are robust and align with relevant standards, guidelines and legislative requirements
• service delivery provided to support appropriate management and use of Ig (by the NBA and agencies contracted by the NBA) is efficient and effective
• collection of data supports future work.

The pathways that will drive improvement across the performance areas listed above are:

• Education and Support
• Communications and Relationships
• Program Assurance and Policy Compliance
• Knowledge Development
• Enhancement of Policy and Access Arrangements.

Education and Support

The NBA is working collaboratively with educational designers to develop tools and resources to enhance understanding of Ig governance arrangements in Australia and to promote compliance with the National Policy.

BloodSafe eLearning Australia is developing a suite of courses about the National Policy. There are five courses planned in total of which three are close to finalisation and are expected to be released in 2020-21. The courses will complement the NPS Medicinewise courses. The courses are:

• Introduction to Immunoglobulin
• Accessing Immunoglobulin
• Prescribing Immunoglobulin
• Administering Immunoglobulin
• Adverse Events.

The NBA is also working with the Commonwealth Department of Health to administer a grant to NPS Medicinewise under the Value in Prescribing (ViP) Program which aims to deliver improvements in the prescription and use of immunoglobulin, in line with the objectives of the Ig Governance Program. In 2019-20 NPS Medicinewise consulted with a wide range of stakeholders to identify the knowledge gaps, scoped a suite of behavioural interventions, tools and activities such as fact sheets, webinars, and educational videos targeted towards an audience of clinicians, consumers, nurses, dispensers and other relevant health professions. They also commenced development of the first tranche of these interventions.

Communications and Relationships

In 2019-20 the NBA continued to work with the Ig Governance Program's network of committees to deliver program activities. In December 2018, the NBA began a process of refreshing the membership of National Immunoglobulin Governance Advisory Committee (NIGAC) and the Specialist Working Groups (SWGs) in Neurology, Immunology, Haematology and Transplant Medicine. The first stage of the refresh was undertaken in March 2020 with half the membership for both NIGAC and SWGs completed. The complete list of SWG members is available on the NBA website https://www.blood.gov.au/Ig-committees.

NIGAC met twice during 2019-20 to provide advice to the NBA on particular aspects of the Ig Governance Program and to oversee the work of SWGs. Key projects that involved NIGAC and SWGs in 2019-20 included ongoing review of the Criteria and performance improvement activities.

The Health Department Liaison Group has been refreshed as a Jurisdictional Ig Performance Improvement Group to provide further support for various performance improvement activities.

Program Assurance and Policy Compliance

The NBA is supporting the Commonwealth Department of Health in undertaking Health Technology Assessment (HTA) reviews of Ig use for specific medical conditions. The reviews are based on evidence of clinical safety, effectiveness and cost-effectiveness, consistent with how other pharmaceutical and medical technologies are assessed for government funding. The outcomes of the reviews will inform the ongoing activities within the Ig Governance Program.

Data and reporting activities remain a focus for the Ig Governance Program. BloodSTAR is exclusively utilised to manage Ig authorisations. Through BloodSTAR, the NBA has the ability to capture better quality data to inform future planning and policy development, and provide those responsible for supporting Ig governance compliance with information that will identify:

• differences in treatment between conditions, hospitals, clinicians and jurisdictions
• accurate stock level requirements
• consistency of Ig use across conditions, hospitals, clinicians and jurisdictions.

The development of enhanced reporting capability is necessary to maximise the benefits of this improved data and ensure nationwide transparency. In 2019-20 the NBA published two National Reports on the Issue and Usage of Immunoglobulin. The reports covered Australia’s issue and use of Ig for 2016-17 and 2017-18.

The NBA publishes a selected set of Ig usage data on a regular basis on the NBA website at https://www.blood.gov.au/ig-usage-data-and-statistics.

An initial tranche of reports on Ig use was also developed during 2019-20 to provide jurisdictions with information to draw out factors from each of the key performance areas. They will inform future reporting, promote discussion, and highlight areas for improvement, both for the NBA and external stakeholders.

Further work to define stakeholder performance indicators and benchmarks under the Ig Governance Performance Improvement Strategy has been progressed and a dashboard for key performance measures is being developed to support external reporting. Other key activities currently underway are:

• developing the 2018-19 National Report on the Issue and Use of Immunoglobulin
• scoping and developing audit tools to measure and address local governance and inventory management issues.

Knowledge Development

Knowledge development activities support policy development, promoting a sustainable Ig Governance Program and enabling the program to be responsive to change, including in response to new advances in research. Identifying and closing knowledge gaps are key activities within the performance improvement strategy.

During 2019-20 the NBA continued to fund research through the National Blood Sector Research and Development Program which is one mechanism to actively close identified knowledge gaps.

Publication of Version 3 of the National Policy

The National Policy: Access to Government Funded Immunoglobulin Products in Australia (National Policy) was first published in November 2014 and revised in July 2016 to include the implementation of BloodSTAR. The National Policy sets out the process, rules and requirements that must be complied with to ensure appropriate access to government-funded Ig products in Australia.

The National Policy was updated in 2018-19 and Version 3 was published in July 2019. Version 3 takes into account the release of Version 3 of the Criteria and the completion of the BloodSTAR rollout. Feedback received from stakeholders about the National Policy was carefully considered as part of the ongoing monitoring and review activities.

The National Policy comprises the following information:

Evolution of the Criteria

The Criteria identifies the conditions and circumstances for which the use of Ig is clinically appropriate and accessible to patients under the National Blood Agreement and within the National Policy.

Version 1 of the Criteria was published in 2007 and was updated to Version 2 in 2012. The development and implementation of Version 3 of the Criteria in BloodSTAR was a major project spanning four years and involved wide public consultation to allow community consideration of proposed revisions.

Version 3 of the Criteria was published in 2018 and the transition of patients from Criteria Version 2 to Criteria Version 3 was completed in December 2019. Updates to the Criteria are now implemented through a continuous review cycle to ensure the qualifying, exclusion and review criteria and indicative dosages for each condition remain appropriate and in keeping with an evidence-based approach. Two mechanisms for updating the Criteria have been developed: progressive change; and programmed changes.

Programmed changes will provide for a formal periodic review of a condition in relation to the Criteria while progressive changes address clarifications, minor corrections and implement administrative improvements.

Progressive changes to the Criteria were published in August 2019, October 2019 and March 2020. Where clinical advice was needed to develop the appropriate change to the Criteria it was obtained from the relevant Specialist Working Group and was approved by JBC. In August 2019 access to subcutaneous Ig for chronic inflammatory demyelinating polyneuropathy (CIDP) was approved pending the outcomes of the HTA assessment which is evaluating the use of Ig in the treatment of CIDP.

Updates were made to the following conditions in 2019-20:

• Acquired hypogammaglobulinaemia secondary to haematological malignancies or post-haemopoeitic stem cell transplant (HCST)
• Acute disseminated encephalomyelitis (ADEM)
• Autoimmune congenital heart block
• Autoimmune encephalitis mediated by antibodies targeting cell-surface antigens (AMAE)
• Childhood epileptic encephalopathy
• Chronic inflammatory demyelinating polyneuropathy (CIDP) (including IgG and IgA paraproteinaemic demyelinating neuropathies)
• Guillain-Barré Syndrome (GBS)
• Haemolytic disease of the fetus (HDF)
• Inflammatory myopathies: polymyositis (PM), dermatomyositis (DM) and necrotising autoimmune myopathy (NAM)
• Neonatal haemochromatosis (NH)
• Paediatric autoimmune neuropsychiatric disorder associated with streptococcal infections (PANDAS) or paediatric acute neuropsychiatric disorders (PANS)
• Primary immunodeficiency diseases (PID) with antibody deficiency
• Pyoderma Gangrenosum
• Secondary hypogammaglobulinaemia unrelated to haematological malignancy or haemopoeitic stem cell transplant (HCST)
• Specific antibody deficiency
• Susac syndrome.

The revised Criteria will undergo regular review to ensure the qualifying, exclusion and review criteria and indicative dosages for each condition remain appropriate and in keeping with an evidence-based approach. While some changes meant that many patients could transition seamlessly from Version 2 to Version 3, others required additional information and assessments in order to be able to continue to receive product.

BloodSTAR

The BloodSTAR system was developed by the NBA on behalf of governments to support health providers in managing their Ig governance obligations as set out in the National Policy. The system standardises and manages access to the supply of Ig products by enabling authorisation requests to be submitted electronically and work-flowed to an authoriser for assessment and approval. The NBA has continued to enhance BloodSTAR so that functionality supports the Criteria and the Ig Governance Program objectives in general, as well as improving system usability. Updates were released in October 2019 and March 2020 and further enhancement work is underway.

Evalution of new products

Applications for new blood and blood related products to be listed on the National Product Price List (NPPL) are received by the NBA for evaluation, to be undertaken under Schedule 4 of the National Blood Agreement. Evaluations are not exclusive to new products, and may include existing products for an additional or new indication.

In 2019–20:

• MSAC conducted a cycle 2 assessment of emicizumab for routine prophylaxis in patients with congenital haemophilia A with Factor VIII inhibitors
• the NBA completed a cycle 1 assessment of Obizur for treatment of bleeding in acquired haemophilia A
• the NBA commenced a cycle 1 assessment of RiaSTAP for treatment of acquired fibrinogen deficiency.

Data developments

In 2019-20 the NBA continued to build its data capture and analysis capabilities across all aspects of the supply chain, in particular through system and reporting enhancements to BloodNet and BloodSTAR. Enhancing data quality and completeness is a key strategy to improve the overall efficiency and sustainability of the sector by providing a measurement for improvement.

A significant amount of data and information exists within the blood sector. The extent to which this data is currently available to those who need it, the quality of the data, and the capacity of the systems that hold it, varies widely. During 2019-20 the NBA progressed the following activities:

• commenced the Data Improvement Program, with the objectives of:
  • implementing common data standards across NBA systems
  • improving data accuracy, timeliness, consistency, availability, reliability, and relevance through new system capabilities
  • developing a strategic view of how data can support strategic corporate and program objectives
  • implementing new system capabilities for data reporting, analysis, analytics, and visualisation (data warehouse, visualisation tools) to support strategic corporate and program objectives
• refined existing and implemented additional monthly and quarterly issue reports for stakeholders
• collected, analysed and distributed discard data from BloodNet to support the establishment of revised targets for discard rates
• for Haemovigilance:
  • provided secretariat for the Haemovigilance Advisory Committee and the working groups
  • developed and published the annual National Haemovigilance Reports for 2016-17 and 2017-18 with data collected by states and territories, including donor vigilance data collected from Lifeblood
  • undertook activities as part of the work plan to support implementation of the Strategic Framework for the National Haemovigilance Program approved in 2014-15 and drafted a revised work plan and Strategic Framework for 2019-22
  • established working groups to continue to develop haemovigilance tools
  • reviewed the Australian Haemovigilance Minimum Data Set for haemovigilance reporting
• continued to implement the National Blood Product Management Improvement Strategy 2018-22 (Improvement Strategy)
• for Australian Bleeding Disorders Registry (ABDR):
  • refined and added to the ABDR Annual Report for 2018-19
  • continued to develop the set of data standards as part of the data integrity process for the ABDR for review by AHCDO Executive and the Data Managers
  • provided the 2018-19 ABDR Benchmarking Report to AHCDO
• initiated the development of the Ig Annual Report for 2018-19 from BloodSTAR and STARS
• provided BloodSTAR reporting to jurisdictions
• responded to 73 data requests from internal and external stakeholders.

Risk Management

The events of 2019 and 2020, including bushfires across Australia and the COVID-19 pandemic, have reinforced the importance of a focus on risk management processes within the NBA. The NBA recognises that risk is a critical and integral part of its business, and that issues faced by the NBA could directly impact on the core responsibility of ‘Saving and improving Australian lives through a world-class blood supply’. Ongoing work continues across the risk management framework, ensuring the NBA is well placed to deal with present and future events.

National Blood Supply Contingency Plan (NBSCP)

The NBSCP is the specific risk plan covering a potential interruption to supply of blood and blood related products within Australia. Starting in late 2019, a detailed review of the NBSCP took place, conducted by an expert consultant, to assess the currency and viability of the NBSCP and internal NBA procedures. A report was provided in January 2020 which in part concluded that: ‘The NBSCP provides a detailed, documented approach to responding to nationally significant disruptions to Australia’s blood supply. The plan is designed to promote a joined-up approach to managing disruptions within the blood sector’. Building on the report’s findings, the NBA will form a working group with jurisdictional representatives as well as participants from relevant Commonwealth agencies and key suppliers to develop and design a test plan or program including simulation exercises, to further strengthen the NBSCP during 2020-21.

Business Continuity Plan (BCP)

The BCP Framework outlines continuity requirements and obligations for the NBA’s efficient management of an event that has the potential to impact on the ability to deliver on key objectives during a business disruption. The BCP Framework was updated significantly in 2019-20 with:

• a new BCP Policy
• updated Business Recovery Plans - providing guidance for prioritising the re-establishment of the NBA’s Critical Business Processes
• updated Resource Planning - outlining the resourcing requirements (ICT, people and facilities) needed to recover from a business disruption
• updated standard operating procedures (SOPs) and ongoing maintenance and improvement process for the BCP Framework.

Supply risk mitigation for plasma derived and recombinant products

Specific risk management strategies have been developed and implemented for individual plasma and recombinant products. The plasma and recombinant supply risk assessment is updated annually. The NBA completed the update for 2019-20. The update included the validation of existing stock and contractual supply reserves.

Preparation to refresh arrangements for some products in 2019-20 such as Intravenous Immunoglobulin (IVIg) has allowed the NBA to ensure a framework of risk mitigation arrangements is in place, including:

• notification and reporting processes to identify impending risks
• intensive product management mechanisms for products that may be in short supply
• commitments from suppliers to accord preferred customer status to supply for Australia
• intensive product management mechanisms for products that may be in short supply as well as required levels of in-country reserves.

As part of the management of the National Fractionation Agreement for Australia, an annual risk management workshop between CSL Behring and the NBA is held to take into account the present variety of potential risk issues when developing risk management plans for supply arrangements. The most recent workshop took place in November 2019 and provided opportunities to strengthen the NBA’s overall risk management framework for plasma derived and recombinant products.

2019-20 sector monitoring

In 2019-20 the NBA continued its horizon scanning of international experience that may influence the management of blood and blood products in Australia. This monitoring activity informs the provision of current and proactive analysis to governments to enable the NBA to fulfil its functions under the National Blood Agreement.

The focus of this activity is on:

• new product developments and applications
• global regulatory and blood practice trends
• scientific and clinical research with implications for supply or demand in the sector
• business events that may have an impact on global supply, demand and pricing, such as changes in company structure, financial outlook, production capacity, organisation, ownership, and marketing and contractual arrangements
• diseases or pandemics that may affect supply or risk
• developments in testing methods, vaccines and disease control strategies that could potentially mitigate risks to supply
• any other emerging risks that could potentially put financial or other pressures on the Australian sector.

The NBA regularly posts to its website a selection of items from this horizon scanning process, illustrating the wide range of factors which may influence industry operations, clinical practice and patient outcomes. This information is available from www.blood.gov.au/monitoring-international-trends-blood-sector.

During 2020, the COVID-19 pandemic has been an overwhelming global concern, and issues have arisen which have been of particular significance for blood and blood products, including the volume and safety of blood donations, the use of convalescent plasma as a treatment, and development, testing and manufacture of the relevant hyperimmune immunoglobulin.

Information Communication Technology (ICT)

The NBA operates a range of Information and Communications Technology systems that directly enable blood and blood product ordering, the management of product authorisations and the clinical management and treatment of patients with bleeding disorders. They are underpinned by infrastructure that has been designed to minimise service interruptions, and maximise system availability and performance.

ICT systems are also a key enabler of data collection and analysis to inform performance improvement, research, policy development, system reporting and governance controls. These systems enable us to provide a safe, secure and affordable blood supply for all Australians.

BloodNet

BloodNet is Australia's online blood and blood products ordering and inventory management system, providing Australian hospitals and laboratories with the ability to order blood and blood products. The NBA continued to support BloodNet, with a number of system and functional enhancements in October 2019 and March 2020.

BloodSTAR

BloodSTAR manages the authorisations to prescribe Ig products funded under the National Blood Agreement and in accordance with Version 3 of the Criteria for the clinical use of immunoglobulin in Australia. It provides full visibility of publicly funded immunoglobulin (Ig) usage across Australia in a sector which costs Australian governments over half a billion dollars annually.

The NBA continued to support BloodSTAR, and enhancements were implemented in October 2019 and March 2020 which included the implementation variable dosing functionality to better support the prescription of subcutaneous immunoglobulin.

BloodNet-Laboratory Information System (LIS) Interface

BloodNet interfaces with a number of Laboratory Information Systems (LIS) in Australian hospital systems, providing near real-time visibility of the national blood supply.

During 2019-20 the NBA continued to work with Laboratory Information System (LIS) vendors to deploy capability allowing BloodNet to interface with LIS. Several LIS vendors have completed, or are nearing completion of, BloodNet LIS vendor certification. Vendor certification allows pathology laboratories to achieve BloodNet-LIS facility certification that can be rapidly released into production environments. In 2019‑20 Launceston General Hospital achieved facility certification.

The BloodNet LIS interface provides real time savings for pathology services and jurisdictions through the automated exchange of data. The interface also provides benefits in improved product management in real-time and the potential to further improve longer term business processes and product management practices through improved data quality and analysis.

Australian Bleeding Disorders Registry

The Australian Bleeding Disorders Registry (ABDR) is a clinical tool used on a daily basis by clinicians in all Australian haemophilia treatment centres to assist in the management and treatment of people with bleeding disorders. The associated patient portal (MyABDR) is used by patients to record and manage data relating to their bleeding disorders. The NBA supported and managed both ABDR and MyABDR in 2019-20.

ABDR and MyABDR will be used to record the use of clotting factor products and associated therapies by patients in Australia for extended half-life arrangements and will be the source of data for future health technology assessment reviews. The NBA can utilise data recorded in the ABDR for supply planning purposes, and to monitor utilisation and cost in order to confirm the realisation of the benefits of extended half-life products.

Canadian Bleeding Disorders Registry

In 2015, the NBA entered into a contract with McMaster University acting on behalf of the Association of Hemophilia Clinic Directors of Canada (AHCDC), to provide the Canadian Bleeding Disorder Registry (CBDR) and associated system support services. The CBDR is a modified form of the ABDR and comprises Bleeding Disorders Registry (BDR) functionality and a patient mobile interface (MyCBDR). This contract continues until 2020.

The NBA is currently engaged in consultations with AHCDC and McMaster University, the Australian Haemophilia Centre Directors’ Organisation (AHCDO), and other stakeholders, in relation to the potential benefits of a continued engagement between the NBA and Australian and Canadian organisations in relation to CBDR, including the possibility of:

• continued NBA support for and further development of BDR-based platforms
• a greater emphasis on more “synergistic” software development between Australian and Canadian requirements
• collaboration to foster research.