Amino Acid Formula With Fat, Carbohydrate, Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids Without Phenylalanine And Supplemented With Docosahexaenoic Acid
Recommended · restricted MetabolicRestrictedNot applicable line
Phenylketonuria (PKU) in infants requiring oral nutritional support.
1
Submissions
1 resub
2016–16
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Mar 2016Recommended · restricted
vs PKU Anamix Infant
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended listing amino acid formula with fat, carbohydrate, vitamins, minerals and long chain fatty acids without phenylalanine and supplemented with docosahexaeonic acid Oral liquid 500 mL, 20 (PKU Baby) as a Restricted Benefit for phenylketonuria on a cost-minimisation basis against amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine, Oral powder 400 g (PKU Anamix Infant) at an …PSD · Mar 2016
6.2 The PBAC noted the advice of the NPWP that supported the listing of PKU Baby® on the PBS, following its consideration of additional information received from the sponsor post-submission.PSD · Mar 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated as the product is listed at an equivalent price per gram of protein to the comparator.
The PBAC noted additional clinical data provided post-submission to support this claim of a price premium over the comparator product, but agreed with the NPWP that the level of evidence provided did not justify the claim that this product provided improved clinical outcomes when compared to the currently listed alternatives. PBAC · 2016
Cost-effectiveness accepted
Decision context
PopulationInfants with phenylketonuria requiring oral amino acid formula nutrition.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2016 | Recommended · restricted | PKU Anamix Infant | — | Single-arm · Time to achieve desired blood phenylalanine level |
Similar precedents
Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids Without Phenylalanine93%Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids, Without Phenylalanine88%Amino Acid Formula With Vitamins And Minerals, Low Phenylalanine And Supplemented With Docosahexaenoic Acid And Arachidonic Acid84%Amino Acid Formula With Carbohydrate, Vitamins, Minerals And Trace Elements Without Phenylalanine82%Amino Acid Formula With Fat, Carbohydrate, Vitamins And Minerals Without Phenylalanine81%Amino Acid Formula With Carbohydrate Without Phenylalanine81%Amino Acid Formula Without Phenylalanine80%Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low In Phenylalanine79%