BIRCH TRITERPENES

Information current as at: 1 June 2026

PBAC meeting date: July 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

Submission Details

Brand name:: Filsuvez®
Form and strength:: Gel containing 100 mg per 1 g, 23.4 g
Submission sponsor:: CHIESI AUSTRALIA PTY LTD
Condition/indication: (therapeutic use): Dystrophic or junctional epidermolysis bullosa (EB)
Listing requested:: To request listing of birch triterpenes for the treatment of patients aged 6 months and older with partial thickness skin wounds caused by dystrophic or junctional EB. Authority Required (Written) for initial treatment Authority Required (Telephone/Online) for continuing treatment
Funding program:: PBS General Schedule
Request authority level:: Authority Required (Written) for initial treatment Authority Required (Telephone/Online) for continuing treatment
PBAC Submission type:: New PBS listing (–)
Comment:: --
Other PBAC consideration:: BIRCH TRITERPENES

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 Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

1255

Page last updated

31 May 2026

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