Amino Acid Formula With Carbohydrate Without Phenylalanine
Recommended MetabolicRestrictedNot applicable line 💬 consumer voice
Dietary management of phenylketonuria (PKU).
1
Submissions
2019–19
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2019 Recommended Phenylketonuria (PKU)
Access path
- Nov 2019Recommended
vs Phlexy-10 tablets
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended the Restricted Benefit listing of amino acid formula with carbohydrate without phenylalanine, PKU Easy Tablet®, for the dietary management of phenylketonuria (PKU).PSD · Nov 2019
7.2 The PBAC noted the Nutritional Products Working Party (NPWP) supported the proposed listing as a treatment option for the dietary management of PKU. The PBAC also noted the NPWP advice that PKU Easy does not contain any vitamins, minerals or trace elements, and that patients would therefore have to meet their dietary needs through other sources, which may include use of PBS-subsidised vitamin, mineral and trace element supplements such as Phlexy-vits …PSD · Nov 2019
Consumer comments
5.4 The minor submission stated that an additional source of vitamins, minerals and trace elements would be required for patients using PKU Easy to ensure adequate nutrient intake. 2PSD · Nov 2019
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Pricing based on cost equivalence per gram of protein equivalent to comparator.
On balance, the PBAC considered that PKU Easy was a suitable alternative amino acid formula for some patients and would be acceptably cost-effective if it costs no more per gram of protein than the cheapest alternative amino acid formula currently available for PKU. PBAC · 2019
Price cut / RSA neededCost-effectiveness accepted
Decision context
PopulationPatients with phenylketonuria (PKU) requiring dietary management with an amino acid formula without phenylalanine.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2019 | Recommended | Phlexy-10 tablets | — | Cost-minimisation · Cost-minimisation |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
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