Subcutaneous immunoglobulin (SCIg) access program

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 and reporting arrangements

The Victorian Department of Health has outlined its commitment to funding SCIg in the department's Policy and Funding Guidelines for health services.

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

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

Funding and reporting arrangements for Victorian public health services subcutaneous immunoglobulin (SCIg) infusion therapy administered in the home environment by the patient or carer.

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 2017 plus Appendix L of the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard) and a record of the supply made.

Public patient charging for SCIg

Under the National Health Reform Agreement 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

Additional resources

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

The key objective of the Nurse Consultant is to support health services to develop local policies and guidelines aligned with the National Blood Authority guidelines and the criteria for the clinical use of immunoglobulin use in Australia.

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 Authority
2. Australian Red Cross Lifeblood