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Amino Acid Formula With Carbohydrate, Vitamins, Minerals And Trace Elements Without Phenylalanine

Recommended MetabolicRestrictedNot applicable line

Phenylketonuria. The product is an amino acid formula designed for dietary management of PKU across the age range of 6 months to 10 years.

1
Submissions
1 resub
2016–16
On the record
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. Mar 2016
    Recommended

    vs PKU Gel and PKU Anamix Junior

  2. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended listing amino acid formula with vitamins carbohydrate, vitamins, and minerals and trace elements without phenylalanine, sachets containing oral powder 20 g, 30 (PKU Go) as a Restricted Benefit for phenylketonuria on a cost-minimisation basis against amino acid formula with vitamins and minerals without phenylalanine, sachets containing oral powder 24 g, 30 (PKU Gel) at an equivalent price per gram of protein.PSD · Mar 2016
6.2 The PBAC noted the advice of the NPWP that supported the listing of PKU Go® on 3PSD · Mar 2016

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated. Submission was on a cost-minimisation basis against PKU Gel at equivalent price per gram of protein.

The NPWP supported the listing of PKU Go® as a Restricted Benefit for phenylketonuria on a cost-minimisation basis against PKU Gel® at an equivalent price per gram of protein. PSD · 2016
Cost-effectiveness accepted

Decision context

PopulationPatients with phenylketonuria, suitable for use across the age range of 6 months to 10 years.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2016 Recommended PKU Gel and PKU Anamix Junior Cost-minimisation · Cost-minimisation

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to ages 6 months to 10 years; TGA label (food standard) has no specified age restriction.