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Whey Protein Formula Supplemented With Amino Acids, Vitamins And Minerals, And Low In Protein, Phosphate, Potassium And Lactose

Recommended · restricted MetabolicRestrictedNot applicable line

Dietary management of chronic renal failure in infants and young children.

1
Submissions
2020–20
On the record
ICER range
Not modelled
Cost basis

Access path

1 submission · public record
  1. Jul 2020
    Recommended · restricted
  2. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended continuing the Restricted Benefit listing of whey protein formula supplemented with amino acids, vitamins and minerals, and low in protein, phosphate, potassium and lactose, Kindergen®, for the dietary management of chronic renal failure in infants and young children following its reformulation due to changes in European compositional standards.PSD · Jul 2020
6.2 The PBAC noted the NPWP had no concerns that the changes in formulation would pose a risk to the health and safety of patients.PSD · Jul 2020
Consumer comments
4.4 There are changes in the guidance of Kindergen usage according to age range in the new formulation. The new formulation of Kindergen is suitable as a sole source of nutrition for infants and as a supplementary feed for children over 1 year of age, instead of a complete nutritional support or supplementary feeding for both infants & children in the old formulation of Kindergen.PSD · Jul 2020

Cost-effectiveness

Not applicable; minor submission for formulation change with no economic evaluation.

Decision context

PopulationInfants and young children with chronic renal failure.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2020 Recommended · restricted Other

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to chronic renal failure in infants and young children; TGA label permits general nutrition for all infants and supplementary nutrition for all children over 1 year.