This document outlines details of PBS-subsidised anifrolumab for patients with systemic lupus erythematosus (SLE).
For information on how to process a PBS Authority, see Processing Complex Authority Required Listings.
On this page:
Systemic lupus erythematosus (SLE) quick reference
Contraindication to prior therapy for SLE patients
Delayed assessment for SLE patients
Systemic lupus erythematosus (SLE) quick reference
Table 1
Restrictions | Authority level and section | PA assessment | Processing system | Prescriber type | Prescriber self-serve |
Initial PB365 form | Written Electronic S100: anifrolumab | No | OPA | Must be treated by a: - specialist physician experienced in the management of SLE
| Yes - immediate or delayed assessment (delayed if free text field used) |
Continuing or Recommencement (after a break < 12 months) | Telephone Electronic S100: anifrolumab | No | OPA | Must be treated by a: - specialist physician experienced in the management of SLE
| Yes |
Contraindication to prior therapy for SLE patients
Table 2: this table lists the details of contraindication to each of the current systemic treatments according to the relevant Therapeutic Goods Administration (TGA) approved Product Information.
Escalate to a Pharmaceutical Adviser (PA) if not sure.
Prior therapy | Contraindication |
prednisolone (or equivalent) | - Uncontrolled infections
- Known hypersensitivity to prednisone or prednisolone, or any of the excipients
|
hydroxychloroquine | - Pre-existing maculopathy of the eye
- Known hypersensitivity to 4-aminoquinoline compounds
- Long-term therapy in children
- Children under 6 years of age
|
methotrexate | - Hypersensitivity
- Pregnancy
- Breastfeeding
- Severe hepatic impairment
- Severe renal impairment
- Alcoholism or alcoholic liver disease
- Overt or laboratory evidence of immunodeficiency syndromes
- Bone marrow depression or pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or anaemia
- Serious, acute or chronic infections
- Peptic ulcer disease or ulcerative colitis
- Concurrent vaccinations with live vaccines
- Concomitant administration with retinoids such as acitretin
|
azathioprine | - Hypersensitivity to any of the ingredients
- Hypersensitivity to 6-mercaptopurine
- Patients with rheumatoid arthritis previously treated with alkylating agents
- Pregnancy or planning pregnancy
|
mycophenolate | - Hypersensitivity to any of the ingredients
- Pregnancy or planning pregnancy
- Breastfeeding
|
Delayed assessment for SLE patients
Table 3: this table lists the details of what to check for the delayed assessment due to intolerance to prior therapy and common acronyms.
Service Officers to assess that free text is: | Examples | Outcome |
Relevant to the question | Intolerances to prior therapies: - Heart condition
- Worsened renal failure
- Nausea and vomiting
- Elevated or deranged etc., liver function test
- Gastrointestinal toxicity
| Approve |
Random text | - Happy Birthday
- Patient did not want to take
- Ikasditbn
| Reject |
Non-descriptive | - Toxicity (no details)
- Intolerance
- Ineffective
| Reject |
Common acronyms
- LFT - Liver function tests
- GI toxicity - Gastrointestinal
- N+V - Nausea and vomiting
Escalate to a Pharmaceutical Adviser (PA) by phone if not sure of the acronym used.
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