Public Consultation

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.

Proposed Changes to the Criteria for the Clinical Use of Immunoglobulin in Australia

Public Consultation – open until 9 June 2017.

The Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia (the Criteria) have been developed by governments using expert Specialist Working Groups of clinicians to identify the medical conditions and circumstances for which immunoglobulin product is supplied and funded by governments under the national blood arrangements.  The NBA is currently seeking feedback on further proposed changes to the Criteria. These changes, which aim to more clearly articulate and standardise the diagnostic, qualifying and review criteria, are required to assist with managing the growth in demand for this precious, human-derived product by ensuring it is only used for clinically appropriate purposes.

With the exception of NSW, all states and territories in Australia access Ig through the NBA’s new online system called BloodSTAR. The access criteria in BloodSTAR are aligned with those published in The Criteria for the Clinical Use of Immunoglobulin in Australia (Second Edition) 2012 (the Criteria).  The BloodSTAR criteria are referred to as ‘Version 2.1 Criteria’ or ‘v2.1’.  

Over the past three years the NBA’s Specialist Working Groups (SWGs) in Haematology, Neurology, Immunology and Transplantation have been reviewing the Criteria.  In 2015, public consultation was conducted on the SWG’s proposed changes to conditions listed in Chapters 5 and 6, where Ig has an Established and Emerging therapeutic role respectively. The revised criteria for Established and Emerging therapeutic role, called ‘Version 3 Criteria’ or ‘v3.0’, were subsequently endorsed by the National Immunoglobulin Governance Advisory Governance Committee and approved by the Jurisdictional Blood Committee. 

Version 3 criteria will be included in BloodSTAR once all conditions (across Established therapeutic role, Emerging therapeutic role and Chapter 7 - Exceptional circumstances only) have all been updated to v3.0.  

The current 2017 public consultation relates to:

  • the proposed v3.0 changes to all conditions in Exceptional circumstances only    
  • a small number of conditions listed in Emerging therapeutic role where further proposed changes have been recommended since approval in 2015, and
  • the list of indications which are explicitly listed as ‘not supported’ under the national blood arrangements.

The 2016-17 review process has involved:

  • SWG assessment of the literature in the context of the role of Ig therapy, the pathogenesis of disease and in light of the availability of alternative therapies, the burden of disease and historic Ig usage
  • review of the policy positions of other countries including Canada and the United Kingdom
  • consultation with sub-specialists and expert groups, specialist colleges and societies as required
  • many SWG teleconferences to achieve SWG consensus on the revised Criteria, and
  • endorsement by the National Immunoglobulin Governance Advisory Committee for public consultation.

The above process has resulted in:

  • review of the ‘Level of Evidence’ and strengthening of bibliographies
  • consideration of the appropriate category of use for each condition
  • drafting of new information for sections where v2.1 Criteria was not previously drafted such as all the following sections for all conditions listed in the Exceptional circumstances only category:
    • Description and diagnostic criteria
    • Justification for evidence level
    • Indications for use
    • Qualifying criteria with supporting evidence items
    • Review  periods and review criteria with supporting evidence items
    • Dosing regimen and treatment periods
  • renaming of some conditions where evidence has changed since initial publication in 2007
  • moving conditions to incorporate them under a different, more appropriate condition, and
  • moving conditions to the ‘not supported’ category.

Each condition proforma contains data on the number of patients and Ig usage over the past four years. To maintain privacy, where there were less than five patients, the actual number of patients has been replaced by <5, the grams usage has been rounded up to the nearest 500grams and the percentage of total Ig grams has been rounded up to the nearest 0.01%.

Each condition has a separate ‘condition pro forma’. They are available in both MS Word and PDF formats to support accessibility.

Please note that feedback must be submitted on the feedback form provided and received by 9 June, 2017:

email:IgGovernance [at] blood.gov.au
mail:IgGovernance – National Blood Authority, Locked Bag 8430, Canberra ACT 2601.

Specialist Working Groups will consider all submissions and make revisions where appropriate.  Specialist Working Group recommendations will be considered by the National Immunoglobulin Governance Advisory Committee before submission by the National Blood Authority to governments through the Jurisdictional Blood Committee. In addition to appropriate clinical use, there will be a strong focus on the cost effectiveness and affordability of this high-cost blood product. Revisions to condition pro forma may be made at all steps of this process.

Once the changes have been approved, an extensive analysis of each condition to enable its adaptation for inclusion in the BloodSTAR system will be undertaken. This will be accompanied by the development of detailed transition and communication plans to support patient management during the transition process to Version 3.0.

Condition Proforma

There is one Condition Proforma for each condition which has been made available in both MS Word and PDF formats.  These are available beside the ‘Summary of the proposed changes’ below.

The Condition Proforma are presented in alphabetical order and are grouped by speciality.

The Condition Proforma have three sections as follows:

Section 1 Provides information about the condition name and any proposed name changes, the categorisation of the condition and any proposed changes (i.e.’ Established therapeutic role’, Emerging therapeutic role, Exceptional circumstances only’ or ‘Not supported’), a summary of the key changes and the rationale for these changes, and a brief description of the role of Ig therapy .

Section 2 presents the actual changes and the rationale for these changes. For all conditions listed under Exceptional circumstances only, the proposed wording for v3.0 is presented alongside the information currently held in BloodSTAR v2.1. The wording in BoodSTAR v2.1 is the same as in the Criteria Edition 2 (2012). For conditions presented previously to public consultation in 2015 from the Emerging therapeutic role category, v3.0 is compared to the information presented previously for public consultation. Note that this is different to the wording in BloodSTAR for this small number of indications.

Section 3 presents information about any anticipated impacts. These include how the changes might impact on doctors and patients.  Respondents are  asked to advise of any additional impacts through this public consultation process.

Summary of Proposed Changes

The four tables below present the summary of the key proposed changes and the Condition Proforma. Note that for chapter 7, the information relating to Diagnosis, Qualifying Criteria, Review Criteria and Dosing is all NEW information.  Also note that not all changes have been included in the summary and you should read the Condition Proforma to be fully informed.

Conditions Not supported

Immunology

The following conditions will continue to be listed as ‘not supported’.

  • Acute rheumatic fever
  • Adrenoleukodystrophy
  • Antiphospholipid syndrome (non-obstetric)
  • Asthma
  • Atopic dermatitis/eczema — adult
  • Behçet’s disease
  • Congestive cardiac failure
  • Crohn’s disease
  • Female infertility
  • Henoch–Schonlein purpura
  • HIV/AIDS — adult
  • Idiopathic dilated cardiomyopathy
  • Polyneuropathy of critical illness
  • Recurrent fetal loss (with or without antiphospholipid syndrome)
  • Rheumatoid arthritis
  • Sepsis
  • Systemic lupus erythematosus (SLE)
  • Ulcerative colitis
  • Linear IgA disease

The following conditions will no longer be supported for funding under the national blood arrangements.

  • HIV in children (see Condition Pro-forma above for rationale)
  • Myocarditis in children (see Condition Pro-forma above for rationale)

Haematology

The following conditions will continue to be listed as ‘not supported’.

  • Amegakaryocytic thrombocytopenia
  • Aplastic anaemia/pancytopenia
  • Autologous Haemopoietic stem cell transplantation
  • Diamond Blackfan syndrome

The following conditions will no longer be supported for funding under the national blood arrangements.

  • Pure white cell aplasia (see condition Pro-forma above for rationale)

The following condition has been removed from ‘not supported’

  • Sickle Cell Disease:  While Sickle Cell Disease remains ‘not supported’, there is a sub-set of patients with Sickle Cell Disease who may qualify for Ig therapy under the reviewed condition of “Haemolytic transfusion reaction – not associated with red cell antibodies” previously known as “haemolytic transfusion reaction”.  These patients may qualify for funded Ig therapy if they meet the specific qualifying criteria for this condition (ie a hyperhaemolysis episode post transfusion). As such, a proposal has been made to remove Sickle cell disease from Not supported to avoid confusion.

Neurology

The following conditions will continue to be listed as ‘not supported’.

  • Acute Optic Neuritis
  • Autism
  • Lupus cerebritis
  • Motor neuron disease/amyotrophic lateral sclerosis
  • Myalgic encephalomyelitis
  • Narcolepsy/cataplexy
  • Obsessive compulsive disorders

The following conditions will no longer be supported for funding under the national blood arrangements.

  • Diabetic Amytrophy (see Condition Pro-forma above for rationale)
  • Paraneoplastic subnacute sensory neuropathy (see Condition Pro-forma above for rationale)

Transplantation

The following conditions will continue to be listed as ‘not supported’.

  • Glomerulonephritis — IgA nephritis
  • Haemolytic uraemic syndrome
  • Nephrotic syndrome
  • Lupus nephritis

Supply of Imported Plasma and Recombinant Products – Future Arrangements

Under the national blood arrangements administered by the NBA, Australia imports a range of plasma derived and recombinant products.  The NBA last tendered for a range of imported plasma derived and recombinant products (IPRP) products in 2014. The initial term of some of these Products expire during the next few years.

The NBA is currently conducting consultations with suppliers and stakeholders via a Request for Information (RFI) and stakeholder consultation paper to inform forward decision making.

Stakeholder Consultation Paper

The NBA is seeking information from stakeholders on a range of issues relevant to the IPRP Products.

Request for Information

The NBA is also seeking information from industry to inform decisions to extend current IPRP contracts or conduct a Request for Tender.

To view outcomes from previous consultations visit Closed Public Consultations.