Amino Acid Formula With Vitamins And Minerals (Multiple Formulations)
Not recommended MetabolicRestrictedNot applicable line
Nutritional supplementation for patients from three years of age with disorders of protein metabolism (homocystinuria, phenylketonuria, maple syrup urine disease, and tyrosinaemia).
5
Submissions
2021–21
On the record
—
ICER range
Not modelled
Cost basis
Decision on record
- Meeting Nov 2011 Not recommended Medicinal food no PSD
Access path
- Jul 2021Recommended
- Jul 2021Recommended
- Jul 2021Recommended
- Jul 2021Recommended
- Jul 2021Recommended
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended continuing the Restricted Benefits listings of HCU Express 15, PKU Express 15, PKU Express 20, TYR Express 15 or MSUD Express 15 with new formulation under the existing conditions of the respective product.PSD · Jul 2021
6.2 The PBAC noted these new formulations are safe and will continue to meet the Australian adequate intake levels and recommended dietary intake values of patients eligible for PBS subsidised use. 4PSD · Jul 2021
Consumer comments
4.2 The PBAC noted that this item received no consumer comments. Other relevant mattersPSD · Jul 2021
Intakes in individuals with an IEM, on a restricted protein diet, may be very low, and so the aim is to provide 100% in the form of dietary supplementation. There Vitamin K -30% is no evidence to support a higher requirement of Vitamin K and so a higher intake does not seem warranted.PSD · Jul 2021
Cost-effectiveness
Not modelled — this is a minor submission for formulation changes to existing PBS-listed products with no price changes and no economic evaluation.
The PBAC noted these new formulations are safe and will continue to meet the Australian adequate intake levels and recommended dietary intake values of patients eligible for PBS subsidised use. PBAC · 2021
Decision context
PopulationPatients from three years of age with disorders of protein metabolism (homocystinuria, phenylketonuria, maple syrup urine disease, tyrosinaemia) eligible for PBS subsidy.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2021 | Recommended | — | — | Other |
| Jul 2021 | Recommended | — | — | Other |
| Jul 2021 | Recommended | — | — | Other |
| Jul 2021 | Recommended | — | — | Other |
| Jul 2021 | Recommended | — | — | Other |
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to age ≥3 years and four specific protein metabolism disorders; TGA label permits all disorders of protein metabolism.