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Amino Acid Formula (Multiple Formulations For Pku, Tyrosinaemia, Ga1, Mma/Pa, Hcu, Msud)

Not recommended MetabolicRestrictedNot applicable line

Dietary management of proven inborn errors of amino acid metabolism: Phenylketonuria (PKU), Tyrosinaemia (TYR), Glutaric Aciduria Type 1 (GA1), Methylmalonic acidaemia and Propionic acidaemia (MMA/PA), Pyridoxine non-responsive homocystinuria (HCU), and Maple syrup urine disease (MSUD) in infants from birth to 12 months and as supplementary feed up to 3 years of age.

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

Decisions on record

19 decisions
  • Meeting Nov 2017 Not recommended Phenylketonuria
  • Meeting Jul 2017 Recommended Cows' milk protein enteropathy Severe cows' milk protein enteropathy with failure to thrive Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae Cows' milk anaphylaxis Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein Se
  • Meeting Jul 2017 Recommended Phenylketonuria
  • Meeting Jul 2017 Deferred Phenylketonuria
  • Meeting Nov 2016 Recommended Phenylketonuria
  • Meeting Mar 2016 Recommended Medicinal food
  • Meeting Mar 2016 Recommended Medicinal food
  • Meeting Nov 2015 Recommended Proven glutaric aciduria type 1
11 earlier decisions
  • Nov 2015 Recommended Medicinal food
  • Nov 2015 Recommended Medicinal food
  • Nov 2015 Recommended Medicinal food
  • Nov 2015 Recommended Medicinal food
  • Nov 2015 Recommended Medicinal food
  • Nov 2015 Deferred Medicinal food
  • Nov 2015 Deferred Medicinal food
  • Jul 2014 Recommended oral liquid, 30 x 125 mL cans PKU Lophlex LQ 10® & PKU Lophlex LQ 20® Nutricia Australia Pty Ltd Change to listing (Minor submission) Medicinal food To inform the Nutritional Products Working Party and the PBAC of additional flavour variants and minor nutritional upgrades within the currently listed
  • Nov 2008 Recommended Medicinal food no PSD
  • Nov 2008 Recommended Medicinal food no PSD
  • Jul 2004 Not recommended A food for inborn errors of metabolism no PSD

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 listings of: PKU Anamix Infant® for the dietary management of Phenylketonuria; TYR Anamix Infant® for the dietary management of Tyrosinaemia; GA1 Anamix Infant® for the dietary management of proven Glutaric Aciduria Type 1; MMA/PA Anamix Infant® for the dietary management of proven Methylmalonic acidaemia and Propionic acidaemia; HCU Anamix Infant ®for the dietary management of proven Pyridoxine …PSD · Jul 2020
6.2 The PBAC noted that the NPWP was not concerned with the manganese levels being lower than the Australian AI levels, as adequate levels could be reached with the consumption of drinking water, vegetables and cereals.PSD · Jul 2020

Cost-effectiveness

Not modelled; Committee Secretariat formulation change submission with no new economic evaluation

Decision context

PopulationInfants aged birth to 12 months with proven phenylketonuria, tyrosinaemia, glutaric aciduria type 1, methylmalonic acidaemia, propionic acidaemia, or maple syrup urine disease; use as supplementary feed up to 3 years of age.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2020 Recommended · restricted — — Cost-minimisation

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