Essential Amino Acids Formula With Vitamins And Minerals
Urea cycle disorders (UCDs) and gyrate atrophy of the choroid and retina.
Decisions on record
- Meeting Nov 2021 Recommended Gyrate atrophy of the choroid and retina; Urea cycle disorders
- Meeting Nov 2008 Recommended Medicinal food no PSD
Access path
- Nov 2021Recommended
vs Dialamine
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended the listing of essential amino acids formula with vitamins and minerals (EAA Supplement) with new formulation, pack size and maximum quantity to replace the current PBS listed EAA Supplement.PSD · Nov 2021
7.2 The PBAC agreed with the NPWP advice detailed in Section 6 ‘NPWP consideration’.PSD · Nov 2021
5.2 The PBAC noted that this item received no consumer comments. Other relevant mattersPSD · Nov 2021
5.8 The new EAA Supplement contains more leucine (1.6 g more) and isoleucine (0.97 g) to support an adequate intake of these amino acids as low plasma levels have been observed in patients with UCDs prescribed nitrogen scavenging drugs (Mol Genet Metab. 2010). The submission claimed that this change aligns with the World Health Organisation amino acid requirements.PSD · Nov 2021
Cost-effectiveness
Not modelled. This is a Category 4 minor submission (formulation and pack size change) with no economic evaluation required; financial estimates have not been independently evaluated.
The PBAC noted that its recommendation was based on EAA Supplement with new formulation replacing the current PBS listed EAA Supplement on a cost neutral basis. PBAC · 2021
Decision context
PopulationPatients with urea cycle disorders (UCDs) and gyrate atrophy of the choroid and retina requiring essential amino acids supplementation.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2021 | Recommended | Dialamine | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify the same two conditions (UCDs and gyrate atrophy) with essential amino acids; PBAC adds clinical context but does not restrict patient population.
Listed in law
PBS listings commencing 1 Dec 2023 were made by these 5 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 112 of 2023 | 30 Nov 2023 | Repealed | PDF ↗ |
| PB 112 of 2023 | 30 Nov 2023 | Repealed | PDF ↗ |
| PB 114 of 2023 | 30 Nov 2023 | Repealed | PDF ↗ |
| PB 114 of 2023 | 30 Nov 2023 | Repealed | PDF ↗ |
| PB 122 of 2023 | 30 Nov 2023 | Repealed | PDF ↗ |