BIRCH TRITERPENES
Information current as at: 1 September 2026
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 (Category 1)
- 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: - Not Recommended (see PBAC Outcomes)
-
Lodgement of required documentation: - Not applicable
-
Agreement to listing arrangements: - Not applicable
-
Government processes: - Not applicable
-
Medicine listed on the PBS: - Not applicable
PBAC Outcome
The PBAC did not recommend birch triterpenes topical gel for listing on the PBS for the treatment of partial thickness wounds associated with dystrophic or junctional epidermolysis bullosa.
The PBAC welcomed the input from health care professionals and organisations highlighting the high clinical need for effective therapies for this debilitating disease. The PBAC noted the input supported listing birch triterpenes topical gel on the PBS and described the lengthy and often extremely painful process of dressing changes and wound management, and the effect of the disease on quality of life. The PBAC acknowledged there is a high need for an effective treatment option.
Based on the clinical evidence in the submission, the PBAC accepted that for some patients with dystrophic or junctional epidermolysis bullosa, some wounds treated with birch triterpenes gel would close faster compared to current treatment (standard of care) involving wound management, pain/itch control and monitoring and management of complications, and acknowledged that this would be of value to the patients who obtained benefit. However, the PBAC considered the benefit was modest noting that not all patients responded to the gel and longer term data from the trial suggested no difference in wound closure between patients treated with birch triterpenes gel and patients managed with current treatment. The PBAC did not accept that birch triterpenes gel was as safe as standard of care because wound-complication adverse events (including wound re-opening) occurred more often in patients treated with birch triterpenes gel compared to control gel in the key clinical trial. Overall, the PBAC considered that PBS listing of birch triterpenes gel was not adequately supported .
The PBAC considered that the sponsor’s approach to justify its requested price, which relied on estimates of long-term benefits was unreliable. The PBAC considered that it was not possible to determine the value of any long-term benefits from the data presented.
Sponsor’s Comment:
The sponsor had no comment.