SEBELIPASE ALFA
Information current as at: 1 June 2026
PBAC meeting date: July 2026
Submission Details
- Brand name:
-
- Kanuma®
- Form and strength:
-
- Solution for injection 20 mg in 10 mL vial
- Submission sponsor:
- ALEXION PHARMACEUTICALS PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Late-onset lysosomal acid lipase deficiency (LAL-D)
- Listing requested:
- To request listing of sebelipase alfa (as a long-term enzyme replacement therapy) for the treatment of children and adults with late-onset LAL-D who are receiving, or enrolled to receive, professional nutritional support including dietetic and weight management advice.
- Funding program:
- PBS Section 100 (Highly Specialised Drugs Program)
- Request authority level:
- Authority Required (Written)
- PBAC Submission type:
- New PBS listing (–)
- 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)
-
3PBAC meeting:
- Has not yet occurred
-
4PBAC outcome published:
- Pending PBAC outcome (see PBAC Outcomes)
-
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
Case ID
1240
Page last updated
31 May 2026
v.9.19