Access to Subcutaneous immunoglobulin (SCIg) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

From 1 August 2019, CIDP has been added to the list of conditions  for which SCIg is able to be accessed under the national blood arrangements, pending the outcome of a current Health Technology Assessment (HTA) review evaluating the use of immunoglobulin in the treatment of CIDP. 

Immunoglobulin (Ig) products are provided under the national blood arrangements when the prescription, use and management accords with principles as described in the National Policy: Access to Government-Funded Ig Product in Australia (National Policy). In addition to these principles, access to SCIg products is provided through an assurance framework for the appropriate use of the product. Details of this framework are described in the National Policy and on the NBA website at https://www.blood.gov.au/SCIg  

Key elements of the arrangements are as follows:

  • BloodSTAR will allow SCIg to be requested for authorisation for suitable CIDP patients following stabilisation with IVIg from 1 August 2019.  Access will be dependent on:
    • oversight by an appropriate specialist clinician, as specified in the Criteria for the clinical use of immunoglobulin in Australia, in order to confirm patient suitability;
    • approval of a patient-specific SCIg authorisation request having been submitted and authorised within BloodSTAR;
    • clinical suitability of subcutaneous administration for individual patients; and
    • capacity and readiness of the treating hospitals participating in the National SCIg Program to support patient access to SCIg products for CIDP patients.
  • The arrangements will remain in place until decisions on more permanent arrangements are made by the Jurisdictional Blood Committee once the outcomes of the specific purpose Health Technology Assessment review currently underway for Ig use in CIDP are known.​
  • SCIg products Evogam and Hizentra are currently available under the National Blood Arrangements for the treatment of CIDP.

The arrangements agreed by the NBA with CSL Behring to implement access to SCIg for CIDPl include dissemination of appropriate communications and support materials to stakeholders including the Australian Red Cross Lifeblood, Approved Health Providers and clinicians.

Frequently Asked Questions:

1. When will access to subcutaneous immunoglobulin (SCIg) for the treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) commence?

Clinicians will be able to order SCIg for CIDP patients through BloodSTAR from 1 August 2019. A Health Technology Assessment (HTA) review is currently underway to consider the use of immunoglobulin in the treatment of CIDP. The arrangements for CIDP patients to access SCIg will remain in place pending consideration of the outcome of the HTA review.The review is progressing and further advice will be provided when available.

Further information on the HTA review can be found at http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1564-public .

2. Which patients can receive access to SCIg for CIDP?

Australian governments have agreed to provide Immunoglobulin (Ig) under national blood arrangements when the prescription, use and management of Ig accords with the principles described in the in the National Policy: Access to Government-Funded Ig Product in Australia (National Policy). In addition to these principles, access to SCIg products is provided through an assurance framework for the appropriate use of the product.  Patients must be treated by a clinical specialist within a hospital participating in the National SCIg program.  Further details of the framework are described in the National Policy and on the NBA website at https://www.blood.gov.au/SCIg  

Patient access to SCIg for CIDP will be dependent on initial stabilisation with intravenous immunoglobulin (IVIg) and the following:

  • oversight by an appropriate specialist clinician, as specified in the Criteria for the clinical use of immunoglobulin in Australia, in order to confirm patient suitability;
  • approval of a patient-specific SCIg authorisation request having been submitted and authorised within BloodSTAR;
  • clinical suitability of subcutaneous administration for individual patients; and
  • capacity and readiness of the treating hospitals participating in the National SCIg Program to support patient  access to SCIg products for CIDP patients.

3. What SCIg products will be available for CIDP patients?

The NBA has arrangements in place for the supply of SCIg products. There are both domestic and imported SCIg products available. All immunoglobulin products available under the national blood arrangements are listed on the NBA website at https://www.blood.gov.au/national-product-list.  Please note the imported Ig products may change from time to time as the result of the outcomes of procurement activities that are typically undertaken every three to five years. 

4. How do I request SCIg for my patient in BloodSTAR? 

For authorisations approved prior to 1 August 2019, Medical Officers may request SCIg by submitting a   Request for Continuing Treatment. 
For authorisations approved after 1 August 2019, Medical Officers may request SCIg by submitting a Dose Change Request.

For further questions or advice, please contact the Blood Operations Centre on
13 000 BLOOD (13 000 25663) or support@blood.gov.au

Keep up to date

 

Ig Program Updates provides a snapshot of the NBA’s current work program and priorities in the immunoglobulin space.

To keep up to date with the latest Immunoglobulin Governance Program activities and accomplishments, join the informal subscription-based group: the National Immunoglobulin Interest Group (NIIG). Members of the NIIG receive the NBA’s quarterly Ig Program Updates. They may also be invited to informally contribute to immunoglobulin-related discussions or projects. (Participation is optional.) For more information, see NIIG, or to subscribe, create a BloodPortal account and from the home page click on ‘My Subscriptions’ and ‘Subscribe’ to Ig Program Updates and the National Ig Interest Group (NIIG).

For further information

Please contact the National Blood Authority on 13 000 BLOOD (13 000 25 663)  or email IgGovernance@blood.gov.au.

Updated:  1 August 2019