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Inborn Errors of Immunity (Primary Immunodeficiencies) Clinical Care Standard

This document has been developed by ASCIA, the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand. ASCIA information is based on published literature and expert review, is not influenced by commercial organisations and is not intended to replace medical advice.        

For patient or carer support contact AusPIPS, IDFA, or IDFNZ.

This Clinical Care Standard aims to improve the diagnosis and management of children and adults in Australia and New Zealand with inborn errors of immunity (IEI), include primary immune deficiencies (PID), except for Hereditary Angioedema (HAE), as a separate Standard will be developed for HAE.

pdfASCIA HP IEI PID CCS 2025211.81 KB

GUIDING PRINCIPLES

Inborn errors of immunity (IEI) include primary immune deficiencies (PID) and are a group of more than 550 potentially serious chronic medical conditions. They are caused by defects in genes that control the immune system and can lead to frequent or severe infections and other chronic immunological conditions, including autoimmune problems.

This standard does not include secondary or acquired immune deficiencies.

High-Quality, Team-Based Care

People with IEI, including those in regional, rural and remote areas, should have access to healthcare services that are equitable, accessible, timely, efficient, integrated, safe, effective and culturally appropriate. Management should include the following:

  • Primary clinical team comprising of a clinical immunologist, immunology nurse, general practitioner and in some cases a local or regional paediatrician or physician.
  • Multidisciplinary team aligned with the patient’s evolving needs, such as other medical specialists, dietitians, pharmacists, dentists, physiotherapists, occupational therapists, child life therapists, exercise physiologists/scientists, psychologists, social workers, genetics counsellors and transition services, working along with the patient’s primary clinical team.
  • Medical and allied health approach aligned with the patient’s physical, emotional, mental, cultural and social needs and wellbeing.

Effective Communication

To facilitate and integrate care, the primary clinical and multidisciplinary teams that care for people with IEI should use effective communication to share information, knowledge and expertise with each other and the patient.

Self-Management

People with IEI should be supported by their medical team to learn about their condition, self-administration of therapies and effective self-care strategies, so that they are empowered to take an active role in managing their condition.

Shared Decision-Making

People with IEI should have the information, support and resources they need to make decisions together with expert advice and guidance from their medical team, through effective communication and shared decision-making processes.

QUALITY STATEMENTS

The following quality statements focus on 8 specific areas of care where improvements should lead to better health outcomes and an improved quality of life for people with IEI:

1. Time to first immunology appointment

When there is a high clinical suspicion of IEI (e.g. when a patient is assessed by a paediatrician or GP), they should be discussed with a clinical immunologist. When referral is made, an appointment with a clinical immunologist for review should occur within 4 weeks of referral:

  • Early recognition of symptoms enables early diagnosis and treatment which can lead to better long-term clinical outcomes and a better quality of life.
  • Starting appropriate treatment early can reduce the risk of infections and complications.

2. Newborn screening

Immunology services should have a clinical and diagnostic pathway in place to urgently respond to infants identified by newborn screening, including those in regional, rural and remote areas.

Early diagnosis of severe combined immunodeficiency (SCID) and other severe IEI enables timely access to curative therapies which include:

  • Haematopoietic stem cell transplantation (HSCT).
  • Gene therapy.

3. Diagnostic (including functional and genomic) testing

People with IEI should have equitable and timely access to appropriate, funded and accredited genomic and functional immune testing. This requires:

  • Funded diagnostic genomic testing performed by accredited diagnostic laboratories. Genomic testing should only be ordered by health professionals with appropriate knowledge and expertise, supported by genomic medicine and genetic counselling expertise.
  • Adequate staffing and resourcing of laboratories to ensure timely provision of functional and genomic test results.
  • Funded and accessible highly complex specialised functional immune testing for patients with suspected IEI.

4. Management

People with IEI should start appropriate treatment as soon as feasible after diagnosis, which should not be delayed:

  • When immunoglobulin therapy is indicated, it should be started as soon as it is clinically indicated, ideally within 4 weeks. The person with IEI (and their carer/s or family members if applicable) requires information about intravenous immunoglobulin (IVIg) therapy and subcutaneous immunoglobulin (SCIg) therapy. This includes benefits and possible risks of treatment to facilitate informed decision-making regarding choice of therapy.
  • When SCID is diagnosed by newborn screening, curative therapy should be initiated by 3.5 months of age.
  • Many people with IEI require ongoing appropriate antimicrobial therapy to reduce complications from recurrent and/or severe infections. This should be adequately funded and readily accessible.
  • Some people with IEI require immunomodulatory therapy to reduce complications from infections, autoimmune disease and/or other inflammatory conditions. This should be adequately funded and readily accessible.
  • People with IEI should be regularly reviewed by their immunology team, ideally in-person at least once a year. In some cases they should have regular follow-up with their local or regional paediatrician or physician.
  • People with IEI should have access to funded clinical monitoring and disease surveillance, including lung function testing, diagnostic imaging and pathology testing.
  • People with IEI should have access to funded, additional vaccines. Vaccination status, and the need for further vaccinations based on each patient’s needs, should be regularly assessed, ideally at least once a year.

5. Access to home-based therapies and training

People with IEI should have access to home-based therapies, including SCIg when indicated, depending on their suitability and preference:

  • Immunology clinics should have adequate specialised nurses, appropriate space and equipment to support training and regular assessment (ideally at least once a year) of people receiving SCIg.
  • It is recommended that nurses follow ASCIA training competency checklists before instructing people receiving SCIg on how to self-administer, including those in regional, rural and remote areas.
  • People receiving SCIg should be provided with information and documents that support their training on SCIg, which may include a current SCIg equipment checklist, SCIg infusion checklist and SCIg treatment plan.
  • Access to telehealth services is required for people receiving SCIg and other home therapies, including those in regional, rural and remote areas.
  • Equitable access to SCIg should be enabled through funding (e.g. Activity based funding in Australia as detailed on the Independent Health and Aged Care Pricing Authority website

6. Infection prevention and control 

People with IEI are at increased risk of complications from infections and therefore require special consideration in healthcare settings (inpatient and outpatient), including the following infection control measures:

  • Some people will need isolation from potentially infectious patients in waiting areas, emergency departments, clinics and wards.
  • Adherence to local infection control procedures and additional measures to mitigate risk of any respiratory infections, not limited to influenza, COVID and tuberculosis.

Additional measures are required for infants with SCID.

7. Access to support and advice

People with IEI should be empowered by their clinical and allied health teams to make use of the information, educational resources and support services available through professional and patient/carer organisations:

  • The patient’s clinical and multidisciplinary team members should empower, educate and support people with IEI (and carer/s or family members if applicable) to appropriately engage in managing their condition to optimise health outcomes.
  • Clinical and multidisciplinary teams should direct people with IEI to well-established professional and patient/carer organisations in Australia and New Zealand. These organisations can provide advocacy, information, educational resources and support services to help people manage the practical, physical and psychological challenges of living with their condition.
  • People with IEI should be provided with a management plan such as the ASCIA SCIg treatment plan and/or ASCIA treatment summary for immunoglobulin therapy (previously known as a transfer care plan), that includes information on who to contact when unwell.
  • The immunology team should be adequately resourced and available to be contacted by other clinicians in a timely manner for specialist advice.
  • Healthcare providers who manage people with suspected or confirmed IEI are encouraged to discuss diagnostic and management issues with the immunology team, as well as the rest of the multidisciplinary team, where relevant.
  • Physical, emotional, mental, cultural and social needs and wellbeing should be regularly assessed, and timely supportive services provided when required.

8. Transition from paediatric to adult medical services

Young people with IEI should understand their condition and learn how to look after their health independently to facilitate transition from paediatric to adult medical services:

  • Young people with IEI should be supported by their clinical team and their carers to learn about their condition, self-administer therapies and self-care strategies, to be empowered and take an active role in managing their condition.
  • The process should start when developmentally ready, ideally from 12 years of age.
  • Genetic counselling tailored to the young person is recommended to discuss reproductive risk, even if there has been previous genetic counselling at the time of diagnosis.
  • Young people should be transitioned to a corresponding adult specialist for all specialties involved in their care.

There are several publications on transitioning from paediatric to adult medical services, including the following open access published articles:

https://www.jaci-inpractice.org/article/S2213-2198(23)00464-6/fulltext

https://www.frontiersin.org/journals/immunology/articles/10.3389/fimmu.2023.1211524/full 

RESOURCES

ASCIA website - health professionals

https://www.allergy.org.au/hp/papers/immunodeficiency

https://immunodeficiency.ascia.org.au/

ASCIA website – patients and carers

https://www.allergy.org.au/patients/immunodeficiencies

Patient and Carer support organisations

Lifeblood Australia

www.lifeblood.com.au/health-professionals/products/fractionated-plasma-products/immunoglobulins/SCIg

New Zealand Blood Service

https://www.nzblood.co.nz/healthcare-professionals/transfusion-medicine/health-professionals-medicine-datasheets/immunoglobulins/

National Blood Authority

https://www.blood.gov.au/immunoglobulin-videos-clinicians-and-patients

BloodSafe elearning Australia 

https://bloodsafelearning.org.au/

International Patient Organisation for PIDs (IPOPI) educational videos

https://ipopi.org/pids/what-are-pids/  

© ASCIA 2025

Content developed August 2024, updated May 2025 

For more information go to www.allergy.org.au/hp/papers/immunodeficiency

To support allergy and immunology research go to www.allergyimmunology.org.au/donate

Treatment Summary for Patients on Immunoglobulin Therapy

The ASCIA Treatment Summary for Patients of Immunoglobulin Therapy is medical document that has been developed for completion by an completed by an immunology or nurse specialist, to improve and support continuity of medical care. This document replaces the prveious ASCIA Transfer Care Plan, and can be used:

  • As documentation for health professionals within an immunology department, or
  • To give to a new clinical immunology/allergy specialist and/or immunology nurse, 

pdfASCIA Treatment Summary Immunoglobulin Therapy 2024118.04 KB

ASCIA Treatment Summary Immunoglobulin Therapy 2024

Content updated May 2025

Travel Plan for patients on SCIg (subcutaneous immunoglobulin) therapy

This plan has been developed as a medical document to be completed by an immunology or nurse specialist.

Information about travelling with SCIg is available on the National Blood Authority (NBA) website:

https://www.blood.gov.au/patient-information/travelling-blood-products-or-outside-australia

TGA export permits can no longer be applied for online. Forms must be emailed to This email address is being protected from spambots. You need JavaScript enabled to view it.

pdfASCIA Travel Plan SCIG 2024115.42 KB

ASCIA Travel Plan SCIG 2024 

Content updated May 2025

Position Statement - Immunoglobulin Replacement Therapy (IRT) for Primary Immunodeficiency (PID)

This document has been developed by ASCIA, the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand. ASCIA information is based on published literature and expert review, is not influenced by commercial organisations and is not intended to replace medical advice. 
For patient or carer support contact AusPIPS, HAE Australasia, IDFA, or IDFNZ.

The aim of this document is to improve health outcomes for people with inborn errors of immunity (IEI), including primary immunodeficiencies (PID), by:

  • Assisting GPs, paediatricians and other medical specialists to recognise the early signs of PID and refer patients to a clinical immunologist to confirm diagnosis and initiate treatment, including immunoglobulin replacement therapy (IRT) if required.
  • Increasing awareness of IRT options for patients with PID, which is given as intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg), and the pros and cons of IVIg versus SCIg.

pdfASCIA HP Position Statement IRT for PID 2025347.36 KB

Contents

  1. Overview of PID       
  2. Early recognition and referral of patients with PID
  3. Warning signs of PID
  4. IRT for PID
  5. IVIg or SCIg
  6. Resources 

This document is based on expert opinion, consensus and publications, and reviewed by the ASCIA IRT/PID Working Party. This document is a source for ASCIA IRT e-training for health professionals which is available at https://traininghp.ascia.org.au.

Key points

  • Inborn errors of immunity (IEI), including PID are a diverse group of more than 550 potentially serious, chronic illnesses due to inherited absence or dysregulation of parts of the immune system.
  • Due to their rarity, delay in the diagnosis of PID is common, increasing the risk of further complications and reduced survival rates. As well as the recognition of warning signs, improved access to specialist clinical and diagnostic laboratory services is required to improve the early diagnosis and treatment of PID.
  • Early and correct diagnosis of PID leads to appropriate treatment, including IRT, which improves quality and length of life. The aim of this treatment is to replace immunoglobulin to maintain normal Immunoglobulin G (IgG) levels, with the dose used individualised for each patient.
  • IRT is the standard of care for patients with antibody deficiency due to a PID disease. It should be readily available to these patients while under the active care of a clinical immunology/allergy specialist with support from specialist medical, nursing and allied health professionals.
  • IRT can be given as IVIg or SCIg and pharmacokinetics differ according to administration route. The choice of route (IVIg or SCIg) is dependent on multiple factors, including patient preference, medical conditions and lifestyle. The preferred route may vary at different times during a patient’s life.

1. Overview of PID

Inborn errors of immunity (IEI), including primary immunodeficiencies (PID), are a diverse group of more than 550 potentially serious, chronic illnesses due to inherited absence or dysregulation of parts of the immune system. Symptoms often appear in childhood, but many can first occur in adult life.

PID can lead to reduced quality of life and life expectancy due to recurrent, chronic or severe infections, swellings, autoimmune and inflammatory problems, and are a significant health burden.

PID are different from acquired immunodeficiencies (also known as secondary immunodeficiencies), which may be due to malignancy, cancer treatments, immunosuppressive medications, autoimmune diseases, or infections such as the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS).

There are six main types of  primary immunodeficiencies that affect the immune system in different ways:

  1. Predominantly antibody deficiencies e.g. common variable immunodeficiency (CVID)
  2. Combined immunodeficiencies e.g. severe combined immunodeficiency (SCID)
  3. Phagocytic cell deficiencies e.g. chronic granulomatous disease (CGD)
  4. Immune dysregulation e.g. autoimmune lymphoproliferative syndrome (ALPS)
  5. Autoinflammatory disorders e.g. familial Mediterranean fever (FMF)
  6. Complement deficiencies e.g. hereditary angioedema (HAE)

Note: A published classification of IEI has been developed by the International Union of Immunological Societies (IUIS), which is regularly modified.

Research and advances in therapies have resulted in improved health and a longer life for people with PID. There are currently six main types of treatment options depending on the type of PID:

  1. Antibiotics
  2. IRT - SCIg or IVIg
  3. Immunomodulation – including biologics
  4. HAE Treatments
  5. Haematopoietic Stem Cell Transplantation (HSCT)
  6. Gene Therapy

The focus of this document is IRT (SCIg or IVIg) for patients with PID.

For further information about the types of PID and treatments refer to Appendices A and B in the ASCIA Immunodeficiency Strategy for Australia and New Zealand 

2. Early recognition and referral of patients with PID

Due to their rarity, delay in diagnosis of PID is common, increasing the risk of further complications and reduced survival rates:

  • For infants and very young children with severe PID, diagnostic delay leads to severe complications due to infections and early death.
  • Early diagnosis is vital for severe PID, to allow curative treatment such as urgent HSCT, also known as bone marrow transplant.
  • For older children and adults with PID where curative treatment is not currently possible, delay in diagnosis can be associated with:
    • Infections, resulting in possible organ damage.
    • Increased morbidity.
    • Reduced life expectancy.

Early and correct diagnosis will lead to appropriate treatment, including IRT, which improves quality and length of life. This requires support from expert multi-disciplinary teams comprising of specialist medical, nursing and allied health professionals.

As well as the recognition of warning signs listed in this document, access to specialist clinical and diagnostic laboratory services is required to improve early diagnosis and treatment.

With targeted resources, patients with PID can be spared unnecessary interventions, and instead utilise available medical treatments to maximise their opportunities to lead productive and healthy lives.

The role of GPs, paediatricians and physicians in identifiying and managing patients with PID

GPs, paediatricians and adult medicine physicians, particularly respiratory medicine physicians and gastroenterologists, have an important role in identifying and managing patients with PID including:

  • Recognition of early symptoms and signs of PID.
  • Appropriate investigation and interpretation of test results.
  • Appropriate and timely referral to a clinical immunologist.
  • Appropriate follow up care in conjunction with a clinical immunologist.
  • Management of general health issues, particularly assessment of growth and development in children in patients with PID.

When should patients be referred to a clinical immunologist?

Patients with suspected PID should be referred to a clinical immunologist when:

  • They have early warning signs of PID.
  • Results of initial testing suggests PID.
  • Results of initial testing are confusing and diagnosis is unclear.
  • Results do not confirm PID but there remains a high clinical suspicion for PID.

3. Warning signs of PID

Early diagnosis of other PID is important, since delayed treatment results in complications that can be chronic or life threatening.

Warning signs of PID are listed below. However, there is a broader range of symptoms and signs as some PID patients may not present with recurrent and severe infection but develop other features such as autoimmunity, autoinflammation or neoplasiaIf clinical concern exists patients should be referred to a clinical immunologist for further assessment.

CHILDREN

ADULTS

Four or more ear infections within one year

Two or more ear infections (otitis media) within one year

Two or more serious sinus infections within one year

Two or more sinus infections in one year in the absence of allergies

Two or more pneumonias within one year

Recurrent pneumonia

Recurrent, deep skin or organ abscesses

Recurrent, deep skin or organ abscesses

Two or more deep seated infections such as sepsis, meningitis or cellulitis

Infection with normally harmless tuberculosis-like bacteria

Persistent thrush in the mouth, skin or elsewhere after age one

Persistent thrush or fungal infection on skin or elsewhere

Two or more months on antibiotics with little effect

Persistent or recurrent viral infections (warts, herpes, EBV)

Need for intravenous antibiotics to clear infections

Need for intravenous antibiotics to clear infections

Failure to gain weight, grow at a normal rate, or chronic diarrhea

  

Family history of PID

Family history of PID

This table is adapted from the ten warning signs developed by the Jeffrey Modell Foundation www.info4pi.org

4. IRT for PID

In people who have primary antibody (immunoglobin) deficiencies, immunoglobulin replacement therapy (IRT):

  • Is the standard of care.
  • Is used to maintain Immunoglobulin G (IgG) levels.
  • Greatly improves health and quality of life.
  • Is often required lifelong, to prevent organ damage due to recurrent infections, which can be life saving.

IRT should be given under the supervision of a medical specialist trained in the care of patients with primary antibody deficiencies.

Access to IRT is guided by clear prescribing criteria to ensure clinically appropriate and economical use of immunoglobulin products.

All immunoglobulin products approved for use in Australia and New Zealand:

  • Are made from pooled plasma from many healthy human donors, which is screened for hepatitis B, hepatitis C and HIV.
  • Are treated with additional viral inactivation steps such as heat treatment, enzyme treatment, detergent treatment and nanofiltration.
  • Contain 97-98% IgG specific antibodies against a broad spectrum of bacterial and viral pathogens, with traces of IgM and IgA.
  • Are plasma derived products and therefore a limited resource. Prescribing a dose that uses a partial vial results in unnecessary wastage so prescribers must ensure that doses are rounded to the full vial size. Vial sizes vary between products and this must be taken into account.
  • Are available to patients meeting the prescribing criteria under the active care and follow up of a clinical immunology/allergy specialist.

Immunoglobulin replacement therapy (IRT) can be given as IVIg or SCIg and pharmacokinetics differ according to administration route.

Both IVIg and SCIg:

  • Are effective at reducing infections and hospitalisations.
  • Preserve organ function and reduce long term damage from recurrent infections.
  • Are associated with significant benefits to patient quality of life.
  • Improve the lifespan of patients with PID.
  • Have advantages and disadvantages, and the preferred route may vary during a patient’s life.

Multiple brands of IRT products are available through the National Blood Authority (NBA) and the New Zealand Blood Service (NZBS). Rates of administration may vary for different products.

5. IVIg or SCIg

Intravenous immunoglobulin (IVIg) replacement therapy:

  • Is usually administered approximately monthly (three to four weekly) in hospital.
  • Leads to a high peak of IgG after infusion.
  • Levels decrease rapidly over a few days then slowly decrease over the next few weeks.
  • Does not require patient training as it is usually hospital based.

Most side effects are mild and self-limiting and include headache, fever, chills, nausea, and fatigue. The frequency of side effects may be linked to the rate of infusion as more side effects are seen with faster infusion rates.

Serious adverse events are rare but include anaphylaxis, aseptic meningitis, renal impairment and thrombosis.

Advantages and disadvantages of IVIg therapy

 

Advantages

Disadvantages

 

IVIg
  • Less frequent infusion (3-4 weekly)
  • Rapid increase in serum IgG
  • Does not require training for patients and carers
  • Usually hospital based
  • IV access required
  • Risk of immediate and systemic adverse effects
  • Adverse effects from high IgG levels in 12-48 hours post infusion
  • Wear off symptoms prior to next infusion. Increasing dose or changing frequency may be required if patients are having significant issues with wear off symptoms

This table is an updated version of the original table that was adapted from APIIEG. 

Subcutaneous immunoglobulin (SCIg) replacement therapy:

  • SCIg injection sitesRequires frequent administration (ranging from 1-3 times per week to once a fortnight) by patients or carers at home.
  • Involves slow diffusion of IgG from subcutaneous tissue.
  • Is associated with more consistent IgG levels due to frequent administration. Is administered at multiple injection sites according to personal preference, usually in the lower abdomen. However, the outer edge of the thigh or back of the upper arm can also be used, as shown in this image.

Systemic reactions to SCIg are much less common compared with IVIg.

Local injection site reactions such as redness, itching, swelling, or discomfort are common, but improve with time.

Advantages and disadvantages of SCIg therapy

 

Advantages

Disadvantages

 

SCIg
  • Home based therapy
  • IV access not needed
  • Few systemic side effects
  • Can be used for people with previous systemic reactions to IVIg or IV access difficulties -SCIg therapy may be the preferred treatment in these people.
  • Faster infusion duration
  • More consistent IgG levels with no wearing off effects related to IgG trough levels
  • Improved quality of life for patients and their families due to the flexibility, independence and empowerment associated with SCIg
  • Reduced hospital costs
  • Reduced people travel time and associated costs and inconveniences (e.g. time off school/ work, parking costs)
  • People can take treatment with them when travelling (e.g. on holiday)
  • Frequent administration (1-3 times per week or up to once a fortnight)
  • Local side effects (swelling, induration, local inflammation, itch), which are usually mild and transient
  • Some people may require battery or spring driven pumps, although some people may use the rapid push method which does not require a pump

This table is an updated version of the original table that was adapted from APIIEG

Several factors affect the choice of IVIg or SCIg therapy

The decision to have immunoglobulin replacement therapy (IRT) administered as intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) depends on each patient’s situation including medical history, response to treatment, compliance with therapy and lifestyle.

Factors that may affect the choice of route for IRT (IVIg or SCIg) include:

  • Patient preference and satisfaction - This plays an important role in treatment decisions, particularly as some peopple with antibody defiencies require lifelong IRT.
  • Availability - There is a small number of conditions where SCIg has been approved for use under the national blood supply arrangements in Australia. Eligibility is dependant on the patient’s specific condition.
  • Resourcing of SCIg products and consumables - All consumables are provided at no cost to patients who are eligible for SCIg under the national blood arrangements. Some patients may prefer to use a pump. The arrangements for provision of pumps is different in each state and territory and there may be a cost involved. Health professionals should familiarise themselves with local policies and procedures to be able to correctly inform their patients.
  • Other medical conditions - SCIg therapy may be contraindicated in some patients with severe thrombocytopenia, bleeding disorders or for patients on anticoagulation therapy and may also be problematic for patients with widespread eczema.
  • Less frequent infusion procedures may be preferred for some young patients.

The role of nurses - educating and supporting people on immunoglobulin replacement therapy (IRT)

Nurses play a vital role in educating and supporting people who are being treated with immunoglobulin products. To assist with this process, ASCIA SCIg Nurse Competency and Patient Training Checklists are available at www.allergy.org.au/hp/papers/ascia-scig-competency-training-checklists

It is important that nurses have evidence-based information on:

  • Access to and supply of immunoglobulin products.
  • Administration of these products including storage and cold chain management.
  • The role of immunoglobulins in treating a range of immunology, haematology and neurology conditions.
  • Recognising and managing side effects or adverse reactions.

The role of medical specialists - prescribing immunoglobulin replacement therapy (IRT)

In addition to complying with approved uses of IRT, medical specialists assess:

  • Which patients are eligible for IRT and are likely to benefit.
  • Response to therapy.
  • When to consider trial off therapy, if appropriate.

Prescribing immunoglobulin replacement therapy (IRT) by medical specialists in Australia

The approved uses for immunoglobulin products are set out in the Criteria for the Clinical Use of Immunoglobulin in Australia https://www.criteria.blood.gov.au/CheckEligibility which are funded through the National Blood Agreement.

To access immunoglobulin under the Agreement, a medical officer is required to submit an application through the National Blood Authority (NBA) national online system BloodSTAR (Blood System for Tracking Authorisations and Reviews).

LifeBlood, via BloodSTAR, manages the authorisation request and review process and ensures that access to Ig products is consistent with the Criteria. Immunoglobulin products are funded by the government and provided to eligible patients at no direct cost.

Some patients who are ineligible to access immunoglobulin products may be able to access them through a Jurisdictional Direct Order, at a cost to the approved health provider, or directly from suppliers, at a personal cost.

Prescribing immunoglobulin replacement therapy (IRT) by medical specialists in New Zealand

In New Zealand individual clinicians are required to seek authorisation from New Zealand Blood Service (NZBS) for the administration of immunoglobulin to individual patients.

Where treatment is managed under the care of a District Health Board (DHB) approval must also be gained from that DHB’s local immunoglobulin authority (e.g. immunoglobulin committee).

For further information go to www.nzblood.co.nz/Clinical-information/Transfusion-medicine/Information-for-Health-Professionals/Request-forms

The role of pharmacists or blood bank – dispensing immunoglobulin replacement therapy (IRT)

Dispensers (blood banks or pharmacists) of immunoglobulin products support the safe use and quality management of these products in health services, by ensuring that the right immunoglobulin products are ordered and dispensed at the right time.

Treatment Summary for Patients on Immunoglobulin Therapy

ASCIA SCIg Transfer Care Plan for patients on IRTThe ASCIA Treatment Summary for patients is available at www.allergy.org.au/hp/papers/ascia-transfer-care-plan-irt

This plan has been developed as a medical document to be completed by an immunology or nurse specialist, when a patient is transitioning from:

  • Paediatric to adult medical care
  • One region to another
  • IVIg to SCIg
  • SCIg to IVIg

6. Resources

Further information is available from:

BloodSafe eLearning https://learn.bloodsafelearning.org.au/categories#immunoglobulin-courses

National Blood Authority www.blood.gov.au/  

ASCIA www.allergy.org.au/immunodeficiency

ASCIA - Patients and carers: www.allergy.org.au/patients/immunodeficiencies

ASCIA - Health professionals: www.allergy.org.au/hp/papers/immunodeficiency

ASCIA – Online training: https://traininghp.ascia.org.au/

Patient support

Australian Primary Immunodeficiency Patient Support (AusPIPS Inc) www.auspips.org.au

Immune Deficiencies Foundation Australia (IDFA) www.idfa.org.au

Immune Deficiencies Foundation New Zealand (IDFNZ)www.idfnz.org.nz

© ASCIA 2025

Content updated May 2025

ASCIA is the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand.

ASCIA resources are based on published literature and expert review, however, they are not intended to replace medical advice. The content of ASCIA resources is not influenced by any commercial organisations.

For more information go to www.allergy.org.au

To donate to immunology/allergy research go to www.allergyimmunology.org.au

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