Glycomacropeptide Formula With Docosahexaenoic Acid With Low Phenylalanine
Noted MetabolicRestrictedNot applicable line
Treatment of phenylketonuria (PKU) in patients aged 3 years or older.
1
Submissions
2018–18
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Jul 2022 Noted Phenylketonuria no PSD
- Meeting Jul 2019 Recommended Phenylketonuria (PKU)
- Meeting Nov 2018 Recommended Phenylketonuria (PKU)
Access path
- Nov 2018Recommended · restricted
vs PKU Glytactin RTD 10
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the Restricted Benefit listing of a new form of glycomacropeptide formula with docosahexaenoic acid with low phenylalanine (PKU GMPro®) on a cost-minimisation basis to the comparator PKU Glytactin RTD 10 for the treatment of phenylketonuria (PKU) at an equivalent cost per gram of protein equivalent (PE).PSD · Nov 2018
7.2 The PBAC noted that the Nutritional Product Working Party (NPWP) supported the decision to list PKU GMPro® on the PBS.PSD · Nov 2018
Consumer comments
5.2 The PBAC noted that there was no consumer comment for this submission.PSD · Nov 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Listed on equivalent cost per gram of protein equivalent (PE) as the comparator.
The PBAC recommended the Restricted Benefit listing of a new form of glycomacropeptide formula with docosahexaenoic acid with low phenylalanine (PKU GMPro®) on a cost-minimisation basis to the comparator PKU Glytactin RTD 10 for the treatment of phenylketonuria (PKU) at an equivalent cost per gram of protein equivalent (PE). PBAC · 2018
Cost-effectiveness accepted
Decision context
PopulationPatients aged 3 years or older with phenylketonuria (PKU).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2018 | Recommended · restricted | PKU Glytactin RTD 10 | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Glycomacropeptide Formula With Docosahexaenoic Acid And Low Phenylalanine96%Glycomacropeptide Formula With Amino Acids And Low Phenylalanine90%Glycomacropeptide Formula With Amino Acids, Vitamins, Minerals, Trace Elements, Carbohydrate, Fat And Low Phenylalanine89%Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low In Phenylalanine88%Glycomacropeptide And Essential Amino Acids85%Glycomacropeptide And Essential Amino Acids With Vitamins And Minerals84%Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low Phenylalanine80%Amino Acid Formula Without Phenylalanine79%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients aged 3 years or older, while TGA label covers food for medical purposes without age specification.