Carbohydrate, Fat, Vitamins, Minerals And Trace Elements
Recommended · restricted MetabolicRestrictedNot applicable line
Proven inborn errors of protein metabolism.
1
Submissions
2020–20
On the record
—
ICER range
Not modelled
Cost basis
Access path
- Jul 2020Recommended · restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended continuing the Restricted Benefit listing of carbohydrate, fat, vitamins, minerals and trace elements formula, Energivit, following its reformulation due to changes in European compositional standards.PSD · Jul 2020
6.2 The PBAC noted that the NPWP was not concerned that the levels of folate were relatively low for the 7-12 months age group due to the high fruit and vegetable intake of the patient group.PSD · Jul 2020
Consumer comments
5.2 The NPWP noted that the levels of folate were relatively low for the 7-12 months age group (69% RDI), however it considered that this would not be an issue in practice due to the high fruit and vegetable intake of the patient group.PSD · Jul 2020
5.5 The NPWP had no concerns that the changes to formulation would pose a risk to the health and safety of patients and accepted the request to change the formulation. For more detail on PBAC’s view, see section 6 PBAC outcome.PSD · Jul 2020
Cost-effectiveness
Not applicable; this is a formulation change submission with no economic evaluation.
Decision context
PopulationPatients with proven inborn errors of protein metabolism.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | — | — | Other |
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to 'proven' inborn errors of protein metabolism, excluding unconfirmed or suspected cases covered by the TGA label.