Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low Phenylalanine
Recommended MetabolicRestrictedNot applicable line 💬 consumer voice
Dietary management of phenylketonuria. The submission requested listing of a new sachet size (PKU Sphere15) and renaming of the existing product (PKU Sphere to PKU Sphere20).
1
Submissions
2017–17
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2022 Recommended Phenylketonuria
Access path
- Jul 2017Recommended · restricted
vs Camino Pro Bettermilk and PKU Sphere
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the listing of PKU Sphere15® as a Restricted Benefit for the treatment of phenylketonuria on a cost-minimisation basis to Camino Pro Bettermilk® at an equivalent cost per gram of protein equivalent.PSD · Jul 2017
6.2 The PBAC noted that the NPWP supported the listing of PKU Sphere15® on the PBS.PSD · Jul 2017
Consumer comments
5.3 The sponsor claimed that an additional sachet size will allow the product to be used in patients depending on their protein requirement. The sponsor also claimed that an additional pack size will allow for interchangeability with the sponsor’s other listed products including PKU cooler15®, PKU cooler20®, PKU air15®, PKU express15®, PKU express20® which may assist with compliance.PSD · Jul 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC recommended the listing of PKU Sphere15® as a Restricted Benefit for the treatment of phenylketonuria on a cost-minimisation basis to Camino Pro Bettermilk® at an equivalent cost per gram of protein equivalent. PBAC · 2017
Cost-effectiveness accepted
Decision context
PopulationPatients with phenylketonuria requiring dietary management via glycomacropeptide formula.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Recommended · restricted | Camino Pro Bettermilk and PKU Sphere | — | Cost-minimisation · Cost-minimisation |
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
Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low In Phenylalanine89%Glycomacropeptide Formula With Docosahexaenoic Acid And Low Phenylalanine85%Glycomacropeptide And Essential Amino Acids With Vitamins And Minerals84%Glycomacropeptide Formula With Docosahexaenoic Acid With Low Phenylalanine80%Amino Acid Formula Without Phenylalanine77%Glycomacropeptide Formula With Amino Acids, Vitamins, Minerals, Trace Elements, Carbohydrate, Fat And Low Phenylalanine77%Amino Acid Formula With Carbohydrate Without Phenylalanine76%Amino Acid Formula With Vitamins And Minerals, Without Phenylalanine75%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to phenylketonuria patients specifically, while TGA label covers all foods for special medical purposes generally.