Amino Acid Formula Without Phenylalanine
Recommended MetabolicRestrictedNot applicable line
Treatment of phenylketonuria (PKU) in adult patients. The submission requested an increase in maximum quantities to better meet the monthly protein requirements of adult PKU patients.
2
Submissions
1 resub
2015–16
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Nov 2013 Recommended Phlexy-10® Nutricia Australia Pty Ltd Minor submission Medicinal food To advise the PBAC and NPWP of a minor change to the nutritional information of Phlexy-10 tablets. Noting that there was no change to the current PBS listing for Phlexy-10 tablets, and the Nutritional Products Working Party advice no PSD
- Meeting Sep 2001 Recommended A food supplement for inborn errors of metabolism no PSD
Access path
- Nov 2015Recommended · restricted
vs Phlexy-10®
- Nov 2016Recommended
Comparator changed: Phlexy-10® → PKU Air, PKU Squeezie, PKU Express, PKU Anamix…
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended the proposed increase to the maximum quantities of PKU Easy®, PKU Easy Shake & Go®, and PKU Easy Microtabs® for the treatment of phenylketonuria.PSD · Nov 2016
6.2 The PBAC noted the advice of the Nutritional Products Working Party (NPWP) that supported the changes to the listing of PKU Easy®, PKU Easy Shake & Go®, and PKU Easy Microtabs®.PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis; no numeric ICER calculated. The sponsor estimated nil financial cost to PBS as all products are listed at the same price per gram of protein equivalent as their comparators.
The NPWP supported the listing of PKU Easy Microtabs® as a Restricted Benefit for phenylketonuria on a cost-minimisation basis against Phlexy-10® at an equivalent price per gram of protein. PSD · 2015
Cost-effectiveness accepted ×2
Decision context
PopulationAdult patients with phenylketonuria (PKU) requiring supplemented protein formulas.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended | PKU Air, PKU Squeezie, PKU Express, PKU Anamix, Phlexy-10, PKU Cooler 15, PKU Express-15 | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended · restricted | Phlexy-10® | — | RCT · Surrogate |
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to phenylketonuria treatment in adults; TGA label covers all medical-purpose foods under the standard.