Glycomacropeptide Formula With Docosahexaenoic Acid With Low Phenylalanine
Treatment of phenylketonuria (PKU) in patients aged 3 years or older.
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
From the public summary
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
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
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
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.
Listed in law
PBS listings commencing 1 Dec 2019 were made by these 3 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.
| Determination | Made | Status | |
|---|---|---|---|
| PB 92 of 2019 | 27 Nov 2019 | Repealed | PDF ↗ |
| PB 94 of 2019 | 27 Nov 2019 | Repealed | PDF ↗ |
| PB 94 of 2019 | 27 Nov 2019 | Repealed | PDF ↗ |