Glycomacropeptide And Essential Amino Acids
Recommended MetabolicRestrictedNot applicable line
Treatment of phenylketonuria (PKU).
1
Submissions
2016–16
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Nov 2016Recommended
vs Camino Pro Restore®
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the listing of PKU Restore® for the treatment of phenylketonuria on a cost-minimisation basis against Camino Pro Restore® at an equivalent cost per gram of protein.PSD · Nov 2016
6.2 The PBAC noted the advice of the Nutritional Products Working Party (NPWP) that supported the decision to list PKU Restore® on the PBS.PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Product assessed on equivalent cost per gram of protein against comparator.
The PBAC recommended the listing of PKU Restore® for the treatment of phenylketonuria on a cost-minimisation basis against Camino Pro Restore® at an equivalent cost per gram of protein. PBAC · 2016
Cost-effectiveness accepted
Decision context
PopulationChildren aged 2 years or older with phenylketonuria requiring nutritional management with glycomacropeptide-based medical foods.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended | Camino Pro Restore® | — | RCT · Other |
Similar precedents
Glycomacropeptide Formula With Docosahexaenoic Acid With Low Phenylalanine85%Glycomacropeptide Formula With Amino Acids And Low Phenylalanine84%Glycomacropeptide Formula With Docosahexaenoic Acid And Low Phenylalanine84%Glycomacropeptide Formula With Amino Acids, Vitamins, Minerals, Trace Elements, Carbohydrate, Fat And Low Phenylalanine82%Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low In Phenylalanine81%Glycomacropeptide And Essential Amino Acids With Vitamins And Minerals81%Amino Acid Formula With Carbohydrate, Vitamins, Minerals And Trace Elements Without Phenylalanine77%Amino Acid Formula Without Phenylalanine76%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to PKU in children ≥2 years requiring glycomacropeptide-based medical foods; TGA label covers all foods meeting Standard 2.9.5.