AMINO ACID FORMULA WITH VITAMINS AND MINERALS WITHOUT VALINE, LEUCINE AND ISOLEUCINE
Information current as at: 1 September 2026
Submission Details
- Brand name:
-
- MSUD express 15®
- Form and strength:
-
- Sachets containing oral powder 25 g, 30 (MSUD express 15)
- Submission sponsor:
- VITAFLO AUSTRALIA PTY LIMITED
- Condition/indication:
(therapeutic use) -
- Short-chain Enoyl co-A Hydratase (ECHS1) deficiency and 3-Hydroxyisobutyryl co-A Hydrolase (HIBCH) deficiency
- Listing requested:
- To request listing of MSUD express15 for the dietary management of patients aged 3 years and over with a proven diagnosis of either ECHS1 or HIBCH deficiency.
- Funding program:
- PBS General Schedule
- Request authority level:
- Restricted Benefit
- PBAC Submission type:
- Change to existing 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 General Schedule Restricted Benefit listing of MSUD express 15® for patients aged 3 years of age or older with a proven diagnosis of either Short-chain Enoyl Co-A Hydratase 1 (ECHS1) deficiency and 3-Hydroxyisobutyryl Co-A Hydrolase (HIBCH) deficiency. The PBAC considered that MSUD express 15 should be listed under the same circumstances and price as the current PBS listing of MSUD express15 for the indication of Maple Syrup Urine Disease (MSUD), with the same maximum quantity units and number of repeats. The PBAC noted and supported advice from the Nutritional Products Working Party that MSUD express15 is clinically appropriate for the dietary management of ECHS1 and HIBCH deficiencies. The PBAC considered that only a small patient population in Australia is likely to require dietary management of ECHS1 and HIBCH deficiencies.