Vitamins, Minerals And Trace Elements With Carbohydrate
Recommended · restricted MetabolicRestrictedNot applicable line
Dietary management of conditions requiring a highly restrictive therapeutic diet in infants and young children.
3
Submissions
2014–20
On the record
—
ICER range
Not modelled
Cost basis
Access path
- Jul 2014Recommended · restricted
vs Paediatric Seravit
- Nov 2016Not recommended
product contained less than half the iron of the nominated comparator Paediatric Seravit®, iron levels at 56% of the…
- ↻ resubmittedJul 2020Recommended · restricted
Evidence: Cost-minimisation → Other
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended continuing the Restricted Benefit listing of vitamins, minerals and trace elements with carbohydrate, Paediatric Seravit, for the dietary management of conditions requiring a highly restrictive therapeutic diet in infants and young children following its reformulation due to changes in European compositional standards.PSD · Jul 2020
6.2 The PBAC noted that the NPWP considered that although the manganese levels were lower than the Australian adequate intake (AI) levels, this was not a concern as drinking water, vegetables and cereals were the main dietary sources for manganese.PSD · Jul 2020
Cost-effectiveness
Not modelled — formulation change submission with no economic evaluation required.
The PBAC considered that this was appropriate. PBAC · 2014
Cost-effectiveness accepted
Decision context
PopulationInfants and young children requiring dietary management of conditions requiring a highly restrictive therapeutic diet.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2020 | Recommended · restricted | — | — | Other |
| Nov 2016 | Not recommended | Paediatric Seravit® | — | Cost-minimisation |
| Jul 2014 | Recommended · restricted | Paediatric Seravit | — | Cost-minimisation · Cost-minimisation |
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to infants and young children with highly restrictive dietary conditions; TGA label covers all FSMP uses under Food Standards Code.