ANIFROLUMAB
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Saphnelo®
- Form and strength:
-
- Solution for subcutaneous injection 120 mg in 0.8 mL
- Submission sponsor:
- ASTRAZENECA PTY LTD
- Condition/indication:
(therapeutic use) -
- Systemic lupus erythematosus (SLE)
- Listing requested:
- To request listing of a new subcutaneous form of anifrolumab for use as add-on treatment for adult patients with severe SLE with persistent disease activity (supported by a SLE Disease Activity Index 2000 score of at least 10 points) despite standard of care with hydroxychloroquine, immunosuppressant medication and prednisolone (or equivalent).
- Funding program:
- PBS General Schedule
- Request authority level:
- Authority Required (Written)
- PBAC Submission type:
- New PBS listing (Category 3)
- Comment:
- --
- Other PBAC consideration:
- --
Progress Details
-
Submission received for: - July 2026 PBAC meeting
-
Opportunity for consumer comment: - Open 25/03/2026 and close 20/05/2026 (see PBS Website)
-
PBAC meeting: - Held on 08/07/2026
-
PBAC outcome published: - Recommended (see PBAC Outcomes)
-
Notice of intent submitted:
- Awaiting lodgement from pharmaceutical company
-
5Lodgement of required documentation:
-
6Agreement to listing arrangements:
- Has not yet commenced
-
7Government processes:
- Has not yet commenced
-
8Medicine listed on the PBS:
- Has not yet occurred
PBAC Outcome
The PBAC recommended the Section 85 Authority Required listing for anifrolumab pre-filled pen auto-injector for subcutaneous injection (referred to as anifrolumab SC) for the treatment of adults with severe systemic lupus erythematosus (SLE) and high disease activity despite the standard of care. The PBAC recommended the listing on a cost-minimisation basis to the currently Section 100-listed anifrolumab for intravenous administration (anifrolumab IV).
The PBAC advised the equi-effective doses to be anifrolumab 120 mg SC weekly as equivalent to the 300 mg IV infusion given every 4 weeks, so that four pre-filled 120 mg pens (i.e., total dose 480 mg) are equivalent to the 300 mg infusion over a 28-day period.