Essential Amino Acids Formula With Vitamins And Minerals
Recommended MetabolicRestrictedNot applicable line
Urea cycle disorders (UCDs) and gyrate atrophy of the choroid and retina.
1
Submissions
2021–21
On the record
—
ICER range
Not modelled
Cost basis
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
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
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
Consumer comments
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
Cost-effectiveness accepted
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
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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.