Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low In Phenylalanine
Recommended MetabolicRestrictedNot applicable line
Dietary management of phenylketonuria (PKU) in children from 3 years of age and adults.
2
Submissions
2022–26
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2022 Recommended Phenylketonuria
Access path
- Nov 2022Recommended · restricted
vs PKU Sphere20 Powder
- Mar 2026Recommended · restricted
Comparator changed: PKU Sphere20 Powder → PKU Sphere20 (glycomacropeptide formula with…
- 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 long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine, bottle containing oral liquid, 237 mL (PKU Sphere Liquid) for the dietary management of patients with phenylketonuria under the same circumstances as PKU Sphere20 Powder.PSD · Nov 2022
7.2 The PBAC noted and agreed with the NPWP advice detailed in Section 6 NPWP consideration. 6PSD · Nov 2022
Economic analysis
5.12 The submission presented a cost-minimisation approach of PKU Sphere Liquid compared with PKU Sphere20 Powder, based on the same price per gram PE of $0.76 at the approved ex-manufacturer price (AEMP).PSD · Nov 2022
5.13 The proposed AEMP per maximum quantity PE ($1,827.68) is the same as the main comparator PKU Sphere20 Powder. The PBAC considered this to be appropriate as PKU Sphere Liquid contains the same PE as PKU Sphere20 Powder.PSD · Nov 2022
Clinical claim
5.10 The PBAC considered that the claim of noninferior comparative effectiveness was reasonable.PSD · Nov 2022
5.11 The PBAC considered that the claim of noninferior comparative safety was reasonable.PSD · Nov 2022
Consumer comments
5.8 The submission stated PKU Sphere Liquid is less concentrated in PE than PKU Sphere20 Powder. The submission considered patients who switch to PKU Sphere Liquid will require more formulation volume per day of PKU Sphere Liquid to maintain the same level of metabolic control as PKU Sphere20 Powder. The submission considered the extra volume of formulation will not introduce additional calories.PSD · Nov 2022
5.9 The submission stated PKU Sphere Liquid has higher concentration of PE than PKU GMPro LQ and considered patients will require less formulation volume of PKU Sphere Liquid per day to maintain the same level of metabolic control as PKU GMPro LQ. The submission argued PKU Sphere Liquid may improve dietary compliance for patients struggling to consume the large volume. The submission also stated PKU Sphere Liquid contains fewer calories than PKU GMPro LQ.PSD · Nov 2022
Cost-effectiveness
Cost-minimisation submission; no ICER calculated. PBAC recommended cost-minimisation to PKU Sphere20 at equivalent price per gram of protein equivalent, but the requested AEMP for PKU GMPro Delight ($0.825 per gram PE) was higher than PKU Sphere20 ($0.76 per gram PE).
The PBAC considered that PKU GMPro Delight should be cost-minimised to PKU Sphere20, the comparator accepted by the NPWP at an equivalent price per gram of PE. PBAC · 2026
Cost-effectiveness accepted
Decision context
PopulationChildren from 3 years of age and adults with phenylketonuria (PKU) requiring dietary management.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2026 | Recommended · restricted | PKU Sphere20 (glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in | — | Cost-minimisation |
| Nov 2022 | Recommended · restricted | PKU Sphere20 Powder | — | Cost-minimisation · Cost-minimisation |
Similar precedents
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to PKU patients requiring glycomacropeptide-based formula; TGA label covers all food for special medical purposes.