PBAC's latest decision on Carbohydrate formula with minerals: Not recommended (2016). Considered for Proven inborn errors of protein metabolism and proven inborn errors of fat metabolism.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Patients 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.
Therapy area
Metabolic
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Preparation accuracy of glucose polymer-based emergency feeds
Key trials
Gokem-Ozel et al. (2010)
Comparator
ProZero®
Economic model
Cost-minimisation
ICER note
No ICER calculated; minor submission with cost-minimisation approach based on cost per kilojoule comparison.
Why PBAC said no
Reasons cited in the latest PSD: 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