PEGCETACOPLAN
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- Empaveli®
- Form and strength:
-
- Solution for subcutaneous infusion 1,080 mg in 20 mL
- Submission sponsor:
- SWEDISH ORPHAN BIOVITRUM PTY LTD
- Condition/indication:
(therapeutic use) -
- Complement 3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN)
- Listing requested:
- Resubmission to request listing of pegcetacoplan for the treatment of patients aged 12 years and older with C3G or primary IC-MPGN.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required (Written)
- PBAC Submission type:
- Change to existing listing (Early Re-entry Pathway)
- 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
-
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 expanding PBS subsidy for pegcetacoplan to include treatment of complement 3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The PBAC considered that there is a high clinical need for treatments for C3G and primary IC-MPGN, which are rare conditions that impact predominantly young people and cause decline in kidney function.
The PBAC recalled it previously accepted that pegcetacoplan may slow progression to end-stage kidney disease for some patients. The clinical evidence also showed that pegcetacoplan was less safe than standard of care, as it increased risk of infection.
The PBAC noted the resubmission presented a cost-per-responder analysis with a reduced cost for pegcetacoplan and provided revised financial models to address the Committee’s previous concerns that the cost of pegcetacoplan was not commensurate with the benefits estimated. The PBAC considered the cost-effectiveness of pegcetacoplan would be acceptable with a further reduction to the price consistent with comparable conditions in patient populations of a similar size.
The PBAC noted that the revised financial impact for pegcetacoplan had increased substantially compared with the previous submission and advised that amendments to the proposed Risk Sharing Arrangement were required to manage the risk of use in a larger population than expected, or for longer than expected.