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
- Mar 2017Recommended · restricted
vs PKU Gel
- Jul 2019Recommended
Comparator changed: PKU Gel → PKU Anamix First Spoon
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
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
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Recommended | PKU Anamix First Spoon | — | Single-arm · Acceptability and tolerance |
| Mar 2017 | Recommended · restricted | PKU Gel | — | Cost-minimisation · Cost-minimisation |
Similar precedents
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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.