Protein Formula With Carbohydrate, Fat, Fibre, Vitamins And Minerals
Not recommended MetabolicRestrictedNot applicable line
Dietary management of conditions requiring a low energy enteral tube feed in children with reduced mobility.
1
Submissions
2015–15
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
PBAC outcome
7.1 The PBAC did not recommend the listing of Nutrini Low Energy Multi Fibre on the PBS for children with cerebral palsy aged 1-12 years due to an uncertain definition of the patient group likely to benefit from this product and an uncertain clinical need.PSD · Nov 2015
7.2 The PBAC noted and agreed with the advice of the Nutritional Products Working Party (NPWP) that did not support the listing of Nutrini Low Energy Multi Fibre on the PBS, including: uncertainty about the clinical place for this product; that the comparator is currently available to patients through subsidised schemes in state and territory hospitals, and thus the patient is unlikely to be paying the whole cost of the medicine; the quality of the …PSD · Nov 2015
Economic analysis
6.16 The submission did not provide a formal economic analysis. Instead, the submission presented a cost-comparison of Nutrini Low Energy Multi Fibre to the comparator to derive a suitable price.PSD · Nov 2015
Clinical claim
6.14 The submission claimed that children who used Nutrini Low Energy Multi Fibre continued to grow normally without a disproportionate increase in body fat. The 5PSD · Nov 2015
The results of the tolerance study are not sufficiently robust to substantiate a claim for improvement in bowel habits in terms of less reliance on laxative use to relieve constipation. The NPWP and the ESC considered that there was insufficient information available in order to support the clinical claim.PSD · Nov 2015
Cost-effectiveness
No formal economic analysis was provided; submission presented cost-comparison only.
The PBAC considered that the clinical evidence presented to support the proposed listing was inadequate due to the small number of patients with follow up results in the feasibility study (n=8) and the lack of comparative evidence to demonstrate the extent of benefits in terms of improved body composition. PBAC · 2015
No head-to-head trial
Decision context
PopulationChildren aged 1–12 years with cerebral palsy who have low energy requirements due to reduced mobility and are receiving enteral tube feed nutrition.
Why it was knocked back
- 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
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Not recommended | combination of diluted standard energy enteral tube feed formula (Nutrini Multi Fibre), Paediatric Seravit, and skim mil | — | Single-arm · Growth and body composition |
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