Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids, Without Phenylalanine
Recommended MetabolicRestrictedNot applicable line
Dietary management of phenylketonuria (PKU) in infants.
1
Submissions
1 resub
2018–18
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Mar 2024 Recommended Phenylketonuria (PKU)
Access path
- Jul 2018Recommended · restricted
vs PKU Anamix Infant
- 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
Cost-minimisation analysis; no ICER calculated. Submission requested listing on cost-minimisation basis per gram of protein of PKU Anamix Infant.
The submission proposed that PKU Start be cost-minimised to PKU Anamix Infant at an equivalent price per gram of protein equivalent (PE) as PKU Anamix Infant. PSD · 2018
Decision context
PopulationInfants with phenylketonuria (PKU) requiring dietary management with amino acid formula.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2018 | Recommended · restricted | PKU Anamix Infant | — | Cost-minimisation · Cost-minimisation |
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to infants with PKU requiring dietary management, whereas TGA label covers all foods for special medical purposes.