The National Blood Authority (NBA) periodically undertakes public consultations. The NBA welcomes comments from individuals or groups on topics in the required formats and timeframes.
Imported Plasma and Recombinant Product – Supply Contracts
Submissions Close 10.00am Wednesday 22 July 2015
Under the national blood arrangements administered by the National Blood Authority (NBA), Australia imports a range of plasma derived and recombinant products, to supplement domestic supply and obtain products that are not manufactured in Australia.
Contracts for a number of imported plasma and recombinant products expire on 30 June 2016. The NBA is conducting a Request for Information and Stakeholder Consultation to decide whether to go to tender, negotiate outside the tendering arrangement or to undertake a combination of these actions.
The NBA is interested in seeking feedback from all stakeholders, including clinicians, nurses scientists and suppliers to achieve the best possible outcome from the tender process.
- Supply of Imported Plasma & Recombinant Products: Stakeholder Consultation (pdf) (2.72 MB)
- Supply of Imported Plasma & Recombinant Products: Stakeholder Consultation (docx) (363.15 KB)
- Supply of Imported Plasma & Recombinant Products: Request For Information (pdf) (3.81 MB)
- Supply of Imported Plasma & Recombinant Products: Request For Information (pdf) (297.7 KB)
Public consultation on proposed changes to the Criteria for the clinical use of immunoglobulin in Australia
Submissions Close 5:00pm Monday 27 July 2015
The National Blood Authority is conducting public consultation on proposed changes to the Criteria for the Clinical use of Intravenous Immunoglobulin in Australia (the Criteria) 2012. The Criteria determines patient eligibility to receive access to immunoglobulin therapy funded by all Australian governments.
Intravenous (IV) immunoglobulin (Ig) represents over one third of the national blood budget. In 2013-14, a total of 4.02 million grams of IVIg was issued at a cost of $427.1 million nationally (including costs for plasma collections). Australia is one of the highest per capita users of IVIg globally. The average annual increase in IVIg demand and costs has been 11.4% and 14% respectively since 2003. This rate of growth is unsustainable. Further, there is high variability between practitioners and states and territories for the same indications. Governments and experts believe that the variability and high rate of growth can be stemmed through improvements to the systems used for product authorisation and management.
In 2007, governments, in consultation with representatives from clinical and consumer bodies, published the Criteria to ensure that government funded immunoglobulin products are directed to patients who are most likely to benefit. Despite an update to the Criteria in 2012, there remains considerable prescribing variation and demand has continued to increase. As a result, the National Blood Authority is undertaking a review of the Criteria to improve their clarity. In the first phase, conditions with indications that are already funded are under review. Specialist Working Groups were appointed in the disciplines of Haematology, Immunology, Neurology and Transplant Medicine to consider the relevant conditions and make recommendations for changes. Where appropriate, feedback was also sought from experts in Dermatology and Rheumatology. The aim of these changes is to ensure that Ig is used in situations where it is clearly efficacious, at appropriate doses and for appropriate periods of time. The requirement for objective data documenting efficacy is in line with the requirement for other restricted PBS funded therapies such as biologics. This has resulted in a range of recommended changes.
The purpose of the most recent changes, which are the subject of this public consultation, is to more clearly articulate and standardise the diagnostic, qualifying and review criteria for indications included in Chapters 5 and 6 of the Criteria. The focus has been to provide greater consistency across conditions and to more clearly define the requirements for eligibility at qualification and where patients require continuing treatment, to demonstrate the effectiveness of Ig therapy at patient review.
The revised ‘criteria’ will be included in a newly developed information system, BloodSTAR, which will underpin improved governance arrangements. The changes will be applied from the launch of the new BloodSTAR system, which is due to go-live in the first quarter of 2016. A process to transition existing patients currently receiving Ig therapy will be developed prior to the implementation of the new system.
We invite interested individuals, groups and organisations to comment on the proposed changes. We encourage you to advise your colleagues of the availability for public comment.
The Specialist Working Groups will consider your feedback and revise the Criteria as necessary before submission to the National Immunoglobulin Governance Advisory Committee and the Jurisdictional Blood Committee.
The proposed changes to the Criteria can be viewed online at https://test.blood.gov.au/UAT/IgPublicConsultation/ or to access word or pdf versions of the documents click here:
Please email your submissions to IgGovernance [at] blood.gov.au by 5:00pm Monday 27 July 2015. If you are unable to email your submission, you can mail or fax a hard copy to:
National Blood Authority
Locked Bag 8430
CANBERRA ACT 2601
Fax: +61 2 6151 5300
To view outcomes from previous consultations visit Closed Public Consultations.