Condition Name
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Summary of Proposed Changes
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Anti-neutrophil cytoplasmic antibody (ANCA) [Proteinase 3 (PR3) or myeloperoxidase (MPO)]- positive systemic necrotising vasculitis
Condition proforma
 (pdf) (443.28 KB)
 (docx) (65.87 KB)
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- A nephrologist has been added to the list of specialists who can diagnose and review this condition
- Rituximab must have been trialled and failed
- A response is required to be demonstrated to allow access to continued treatment
- Initial treatment is allowed for six months, after which time patients must requalify under a relapse indication
- See the condition proforma for detailed information
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Autoimmune congenital heart block
(formerly Autoimmune congenital heart block (neonatal lupus)
Condition proforma
(pdf) (420.67 KB)
(docx) (56.5 KB)
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- Neonatal lupus has been removed from the name as there are other manifestations of neonatal lupus
- The diagnosis must be made by an obstetrician or clinical immunologist
- Three indications have been added to support three differing qualifying criteria and treatment periods
- Except where previous pregnancies have been affected, heart block and maternal anti-Ro and/or anti-La antibodies must be present to qualify for Ig therapy
- See the condition proforma for detailed information
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Autoimmune retinopathy (formerly Autoimmune uveitis)
Condition proforma
(pdf) (415.38 KB)
(docx) (56.47 KB)
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- Name has been changed to more clearly describe the sub-group of patients who would be eligible for Ig therapy.
- An ophthalmologist is required for diagnosis and to provide ongoing assessment of the eyes, along with another specialist who will manage Ig therapy
- Review is required within first 3 months and annually thereafter
- The tests required for diagnosis and review have been specified by the Royal Australian and New Zealand College of Ophthalmologists
- Requirement for steroids and immunosuppressants to have been trialled and failed, or contraindicated
- See the condition proforma for detailed information
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Catastrophic anti-phospholipid syndrome (CAPS)
Condition proforma
(pdf) (409.49 KB)
(docx) (60.45 KB)
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- The indication has been more clearly defined and acknowledges the role steroids and plasmapheresis in this condition.
- Patients with chronic recurrent thrombosis have been excluded
- The diagnosis must be made by a clinical immunologist or a haematologist
- See the condition proforma for detailed information
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Epidermolysis bullosa acquista (EBA)
Condition proforma
(pdf) (436.44 KB)
(docx) (59.69 KB)
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- Two indications have been developed to provide access for initial therapy, and for continued treatment for worsening disease after a trial off therapy
- The diagnosis must be made by either a dermatologist or a clinical immunologist and review which is required in the first four months and annually thereafter.
- The diagnosis must confirmed by biopsy and immunofluorescence
- Requirement for steroids and immunosuppressants to have been trialled and failed, or contraindicated
- See the condition proforma for detailed information
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Graves Ophthalmopathy
Condition proforma
(pdf) (429.82 KB)
(docx) (61.3 KB)
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- Access is now limited to those with severe disease, and in whom both corticosteroids and immunosuppressants have been trialled and failed, or are contraindicated
- In addition, two alternative treatments (e.g. Cyclosporine, Methotrexate, orbital radiotherapy or orbital decompression surgery), must have also been trialled and failed
- Bartelena Activity Score measures of severity will now be required to assess improvement which must be demonstrated to access continued therapy
- An ophthalmologist or clinical immunologist is required for diagnosis and review which is required within the first three months and six monthly thereafter
- See the condition proforma for detailed information
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HIV in children
Condition proforma
(pdf) (361.9 KB)
(docx) (41.66 KB)
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- It is proposed that this condition will no longer be supported for funded access to immunoglobulin treatment as there are more effective treatments for this condition
- See the condition proforma for detailed information
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Myocarditis in Children
Condition proforma
(pdf) (367.03 KB)
(docx) (43.39 KB)
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- It is proposed that this condition will no longer be supported for funded access to immunoglobulin treatment as there are more effective treatments for this condition
- See the condition proforma for detailed information
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Pyoderma gangrenosum (PG)
Condition proforma
(pdf) (434.92 KB)
(docx) (64.76 KB)
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- Two indications have been defined: one for initial treatment and the other for relapse in responding patients.
- Requirement for severe persistent ulceration and impact on quality of life
- Requirement for other therapies (corticosteroids, immunosuppressant medication and biologic therapy) to be trialled and failed, if not contraindicated
- a dermatologist or clinical immunologist is required for diagnosis and review which is required within the first three months and six monthly thereafter
- A trial off therapy is recommended once disease is controlled
- See the condition proforma for detailed information
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Scleromyxedema
Condition proforma
(pdf) (432.39 KB)
(docx) (58.75 KB)
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- Two indications have been developed to support differing types of disease: skin involvement only and systemic disease
- For patients with disease limited to the skin there is a requirement to have trialled and failed other therapies (corticosteroids, immunosuppressant medication), if not contraindicated.
- To receive Ig as first line therapy, a skin biopsy proving Scleromyxedema and evidence of systemic manifestations is required
- A dermatologist or clinical immunologist is required for diagnosis and review which must occur six monthly
- A trial off Ig therapy is recommended once disease is stable or in remission
- See the condition proforma for detailed information
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Systemic capillary leak syndrome (SCLS)
Condition proforma
(pdf) (407.78 KB)
(docx) (50.07 KB)
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- The symptoms of shock must be described to establish sufficient severity of a life threatening nature including that hospitalisation has been required on more than one occasion
- Clinical immunologist has been added to the list of specialists who can make the diagnosis
- Reviews must be undertaken by a general physician or a clinical immunologist within the first six months and then annually thereafter
- A trial off Ig therapy is recommended once disease is stable or in remission
- See the condition proforma for detailed information
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