Protein formula with carbohydrate, fat, fibre, vitamins and minerals
Brand: Nutrini Low Energy Multi Fibre
PBAC's latest decision on Protein formula with carbohydrate, fat, fibre, vitamins and minerals: Not recommended (2015). Considered for Dietary management of conditions requiring a low energy enteral tube feed in children with reduced mobility.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Children aged 1–12 years with cerebral palsy who have low energy requirements due to reduced mobility and are receiving enteral tube feed nutrition.
Therapy area
Metabolic
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Growth and body composition
Pivotal trial size
14 patients
Key trials
Vernon-Roberts et al. (feasibility study), Grogan et al. (tolerance study)
Comparator
combination of diluted standard energy enteral tube feed formula (Nutrini Multi Fibre), Paediatric Seravit, and skim milk powder
Economic model
Cost-minimisation
ICER note
No formal economic analysis was provided; submission presented cost-comparison only.
Why PBAC said no
Reasons cited in the latest PSD: uncertain definition of patient group likely to benefit, uncertain clinical need, low quality evidence with small sample size (n=8 with follow-up), lack of comparative evidence, risk that estimated use may underestimate actual patient population with potential use in non-cerebral palsy patients, uncertainty about clinical place for product, participants were not overweight despite submission claiming main benefit in overweight patients