Carbohydrate Formula With Minerals
Not recommended MetabolicRestrictedNot applicable line
Proven inborn errors of protein metabolism and proven inborn errors of fat metabolism.
1
Submissions
2016–16
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2016 Not recommended Dietary management of proven inborn errors of protein or fat metabolism
From the public summary
PBAC outcome
6.1 The PBAC did not recommend the listing of carbohydrate formula with minerals for the treatment of proven inborn errors of protein metabolism and proven inborn errors of fat metabolism. The decision was based on the potential of product wastage and a lack of clarity surrounding the indications. The PBAC considered there was a high risk of use outside the restriction, based on the current wording.PSD · Nov 2016
6.2 The PBAC noted the advice of the Nutritional Products Working Party (NPWP) that supported the decision to not recommend listing the SOS® products on the PBS.PSD · Nov 2016
Cost-effectiveness
No ICER calculated; minor submission with cost-minimisation approach based on cost per kilojoule comparison.
The PBAC did not recommend the listing of carbohydrate formula with minerals for the treatment of proven inborn errors of protein metabolism and proven inborn errors of fat metabolism. The decision was based on the potential of product wastage and a lack of clarity surrounding the indications. PBAC · 2016
Economic model disputed
Decision context
PopulationPatients with proven inborn errors of protein metabolism or proven inborn errors of fat metabolism who are unable to meet their energy requirements with permitted food and formulae.
Why it was knocked back
- High risk of product wastage due to short shelf life and sporadic patient use, lack of clarity surrounding the indications leading to risk of use outside restrictions, inappropriate comparator (ProZero® contains fats while SOS® products do not), lack of clinical data supporting the new indication of proven inborn errors of fat metabolism
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Not recommended | ProZero® | — | Single-arm · Preparation accuracy of glucose polymer-based emergency feeds |
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to proven inborn errors of protein/fat metabolism unable to meet energy needs; TGA label is broader foods for special medical purposes.