Department of Health

Key messages

  • SCIg is a preparation of human immunoglobulin for subcutaneous use (an injection in which the needle is inserted just under the skin).
  • Under the national blood arrangements SCIg is only approved for specific patients. Health services participating in the national SCIg programs are required to meet specified governance arrangements.
  • In 2023-24, the SCIg Access Program will fund Victorian public health services for patients being treated with self-administered SCIg.

SCIg is a prescription only medication that may be used in an admitted patient or outpatient setting1.

Subcutaneous immunoglobulin (SCIg) is a solution of human plasma proteins and in particular IgG antibodies with a broad spectrum of antibody activity. SCIg is prepared from large pools of human plasma and contains the typical IgG antibodies found in the normal population2.

Approved access conditions for SCIg

SCIg is only approved for patients with a medical condition1:

  1. Where there is support for use cited in the Criteria for the clinical use of immunoglobulin in Australia, namely:

    • primary immunodeficiency diseases with antibody deficiency
    • specific antibody deficiency
    • acquired hypogammaglobulinaemia secondary to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT)
    • secondary hypogammaglobulinaemia unrelated to haematological malignancies, or post-haemopoietic stem cell transplantation (HSCT)
    • chronic inflammatory demyelinating polyneuropathy (CIDP), (including IgG and IgA paraproteinaemic demyelinating neuropathies)*

    * SCIg is approved for use for the treatment of CIDP 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.

  2. Being treated by a clinical specialist within a hospital based SCIg program where the hospital provides access to all resources and takes full accountability for the management and use of the SCIg product, at no additional cost to patients, and
  3. Following a patient-specific SCIg request submitted in BloodSTAR and authorised by the Australian Red Cross Lifeblood (Lifeblood).

Funding arrangements

The Victorian Department of Health has outlined its commitment to funding SCIg in the department's Policy Guide: Policy and Funding Guidelines 2023-24.

The funding covers the ongoing costs associated with SCIg service delivery including:

  • patient training
  • staffing costs
  • consumables
  • pumps
  • dispensing fees.

Administration and supply of SCIg

SCIg is a prescription only medication that may be used in an admitted patient or outpatient setting.

In the admitted patient setting, including day admitted, the medication may be administered by a nurse on the written instruction of a prescriber.

If SCIg is provided to a patient for out of hospital use it must be supplied by a medical practitioner or pharmacist in the lawful practice of their profession.

Any such supply must be labelled in accordance with the provisions of regulation 43 or 58 of the Drugs, Poisons and Controlled Substances Regulations 2017External Link plus Appendix L of the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons StandardExternal Link ) and a record of the supply made.

Public patient charging for SCIg

Under the National Health Reform AgreementExternal Link an eligible person receiving a public hospital service as a public patient will have no charges raised.

Non-admitted patients can be charged for surgical supplies such as syringes, swabs and other sundries the patient requires even though the SCIg is provided free of charge under the national blood arrangements.

National blood arrangements subsidised SCIg products

Imported SCIg products Hizentra® 20% CSL Behring
Cuvitru® 20% Takeda
Xembify® 20%Grifols
Domestic SCIg product Hizentra® AU 20% CSL Behring

Additional resources

The Blood Matters team has a SCIg project nurse to assist in the statewide roll-out of SCIg in Victoria.

The key objective of the SCIg project nurse is to support health services to develop local policies and guidelines aligned with the National Blood Authority guidelines and the Criteria for immunoglobulin use in AustraliaExternal Link .

More information on SCIg can be found at the National Blood Authority and Australian Red Cross Lifeblood websites, (see References on this page).

References

  1. National Blood AuthorityExternal Link
  2. Australian Red Cross LifebloodExternal Link

Reviewed 28 February 2024

Health.vic

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