Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids Without Phenylalanine
Recommended MetabolicRestrictedNot applicable line 💬 consumer voice
Dietary management of phenylketonuria (PKU) in infants.
2
Submissions
1 resub
2015–24
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2024 Recommended Phenylketonuria (PKU)
Access path
- Nov 2015Deferred
vs PKU Anamix Infant
- Mar 2024Recommended
Evidence: Single-arm → Cost-minimisation
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the new formulation of amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine (PKU Start™) continue to be listed on the PBS for the dietary management of PKU under the existing conditions of the current formulation.PSD · Mar 2024
7.2 The PBAC agreed with the NPWP advice that the new formulation is expected to provide a non-inferior clinical benefit for the management of PKU.PSD · Mar 2024
Consumer comments
2.3 The NPWP supported the Restricted Benefit listing of PKU Start®, on the basis of a similar level of iron in the listed comparator, but remained concerned at the insufficient level of iron in both PKU Start® and PKU Baby®. The NPWP advised that the Department should write to the relevant professional organisation (i.e.PSD · Jul 2018
Cost-effectiveness
Not modelled. This is a minor submission for a formulation change with no economic evaluation requested or provided.
The submission did not present economic or financial evaluations. PSD · 2024
Decision context
PopulationInfants requiring dietary management of phenylketonuria (PKU).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended | PKU Anamix Infant | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Deferred | PKU Anamix Infant | — | Single-arm · Time to reach desired blood phenylalanine level |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids, Without Phenylalanine97%Amino Acid Formula With Fat, Carbohydrate, Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids Without Phenylalanine And Supplemented With Docosahexaenoic Acid93%Amino Acid Formula With Vitamins And Minerals, Low Phenylalanine And Supplemented With Docosahexaenoic Acid And Arachidonic Acid86%Amino Acid Formula With Carbohydrate, Vitamins, Minerals And Trace Elements Without Phenylalanine85%Amino Acid Formula With Carbohydrate Without Phenylalanine84%Amino Acid Formula With Fat, Carbohydrate, Vitamins And Minerals Without Phenylalanine83%Amino Acid Formula Without Phenylalanine83%Amino Acid Formula With Vitamins And Minerals, Without Phenylalanine82%