Glycomacropeptide Formula With Amino Acids And Low Phenylalanine
Recommended · restricted MetabolicRestrictedNot applicable line 💬 consumer voice
Treatment of phenylketonuria (PKU) in children from 3 years of age, and adults.
1
Submissions
2022–22
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Mar 2022Recommended · restricted
vs PKU Restore (main comparator); also Phlexy-10, PKU Easy…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the General Schedule Restricted Benefit listing of glycomacropeptide formula with amino acids and low phenylalanine (PKU GMPro MIX-IN®) for the treatment of phenylketonuria.PSD · Mar 2022
7.2 The PBAC noted and agreed with the NPWP advice detailed in Section 6 NPWP consideration.PSD · Mar 2022
Consumer comments
5.2 The PBAC noted and welcomed the input from an individual via the Consumer Comments facility on the Pharmaceutical Benefits Scheme (PBS) website. The comments described a range of benefits of treatment with PKU GMPro MIX-IN including fewer side effects and overall better treatment of a chronic condition such as PKU. 2PSD · Mar 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Same price per gram protein equivalent ($0.795) as main comparator PKU Restore.
The PBAC considered the cost-minimisation analysis of PKU GMPro MIX-IN compared with the main comparator PKU Restore® appropriate, based on the same price per gram protein equivalent (PE) of $0.795. PBAC · 2022
Cost-effectiveness accepted
Decision context
PopulationChildren from 3 years of age, and adults with phenylketonuria (PKU).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2022 | Recommended · restricted | PKU Restore (main comparator); also Phlexy-10, PKU Easy Tablet, PKU Easy Microtabs | — | Cost-minimisation · Cost-minimisation |
Consumer voice
An individual submitted consumer input describing benefits of PKU GMPro MIX-IN treatment, including fewer side effects and better overall management of the chronic condition PKU.
The comments described a range of benefits of treatment with PKU GMPro MIX-IN including fewer side effects and overall better treatment of a chronic condition such as PKU. Consumer comments · PSD
side effectstreatment efficacychronic disease managementquality of life
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to phenylketonuria (PKU) specifically; TGA label is broad food-for-medical-purposes category.