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Amino Acid Formula With Vitamins And Minerals, Low Phenylalanine And Supplemented With Docosahexaenoic Acid And Arachidonic Acid

Recommended MetabolicRestrictedNot applicable line

Dietary management of phenylketonuria (PKU) in older infants and young children.

2
Submissions
2017–19
On the record
—
ICER range
Cost-min
Cost basis

Access path

2 submissions · public record
  1. Mar 2017
    Recommended · restricted

    vs PKU Gel

  2. Jul 2019
    Recommended

    Comparator changed: PKU Gel → PKU Anamix First Spoon

  3. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the listings for two new forms of amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachiodonic acid (PKU Explore 5 and PKU Explore 10) for the dietary management of phenylketonuria (PKU) on a cost minimisation basis to PKU Anamix First Spoon at an equivalent cost per gram of protein equivalent (PE). 4PSD · Jul 2019
7.2 The PBAC noted that the NPWP supported the proposed listing of the products as they provide an alternative treatment for some patients as part of their dietary management of PKU.PSD · Jul 2019

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated by design.

The PBAC accepted that this substitution would be cost neutral to the PBS as PKU Explore and PKU Anamix First Spoon have an equivalent cost per gram PE. PBAC · 2019
Cost-effectiveness accepted ×2

Decision context

PopulationInfants and young children aged from weaning-age to 5 years with phenylketonuria (PKU) diagnosed by newborn screening.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Jul 2019 Recommended PKU Anamix First Spoon — Single-arm · Acceptability and tolerance
Mar 2017 Recommended · restricted PKU Gel — Cost-minimisation · Cost-minimisation

Similar precedents

By decision profile
Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids Without Phenylalanine86%Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids, Without Phenylalanine85%Amino Acid Formula With Fat, Carbohydrate, Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids Without Phenylalanine And Supplemented With Docosahexaenoic Acid84%Amino Acid Formula With Carbohydrate, Vitamins, Minerals And Trace Elements Without Phenylalanine82%Amino Acid Formula Without Phenylalanine78%Amino Acid Formula With Vitamins And Minerals Without Phenylalanine78%Amino Acid Formula With Vitamins And Minerals, Without Phenylalanine78%Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low In Phenylalanine78%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to PKU management in weaning-age to 5 years; TGA label covers all foods for special medical purposes.

Listed in law

Federal Register of Legislation

PBS listings commencing 1 Dec 2019 were made by these 3 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.

DeterminationMadeStatus
PB 92 of 2019 27 Nov 2019 Repealed PDF ↗
PB 94 of 2019 27 Nov 2019 Repealed PDF ↗
PB 94 of 2019 27 Nov 2019 Repealed PDF ↗