Amino Acid Formula With Fat, Carbohydrate, Vitamins And Minerals Without Phenylalanine
Recommended MetabolicRestrictedNot applicable line
Dietary management of phenylketonuria (PKU) in children aged 3 years and older, and adults with PKU requiring amino acid supplementation.
1
Submissions
2024–24
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2024 Recommended Phenylketonuria (PKU)
Access path
- Nov 2024Recommended · restricted
vs PKU Easy Microtabs
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended a General Schedule Restricted Benefit listing of amino acid formula with fat, carbohydrate, vitamins and minerals without phenylalanine tablets (modified release), 54 g protein per 100 g, 100 g, pack of 6 (PKU Easy Microtabs Plus) for the dietary management of phenylketonuria (PKU), under the same circumstances as the current PBS listing for PKU Easy Microtabs.PSD · Nov 2024
7.2 The PBAC considered that PKU Easy Microtabs Plus should be cost-minimised to the lowest cost comparator accepted by the NPWP (i.e., PKU Easy Microtabs, Phlexy 10, and PKU Easy Tablet) at an equivalent price per gram of protein equivalent.PSD · Nov 2024
Economic analysis
5.8 The submission presented a cost-minimisation analysis of PKU Easy Microtabs Plus compared to PKU Easy Microtabs, based on the same cost per gram of PE. The proposed approved ex-manufacturer price (AEMP) and dispensed price for maximum quantity (DPMQ) for PKU Easy Microtabs Plus are provided in Table 3.PSD · Nov 2024
5.9 The protein equivalent contents and prices of PKU Easy Microtabs Plus and alternative therapies accepted by the Nutritional Products Working Party (NPWP) are provided in the table below.PSD · Nov 2024
Clinical claim
5.7 The submission claimed that PKU Easy Microtabs Plus provides non-inferior effectiveness and safety compared to PKU Easy Microtabs.PSD · Nov 2024
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered that PKU Easy Microtabs Plus should be cost-minimised to the lowest cost comparator accepted by the NPWP (i.e., PKU Easy Microtabs, Phlexy 10, and PKU Easy Tablet) at an equivalent price per gram of protein equivalent. PBAC · 2024
Price cut / RSA needed
Decision context
PopulationChildren aged 3 years and older, and adults with phenylketonuria (PKU) requiring amino acid supplementation.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | PKU Easy Microtabs | — | Cost-minimisation · Cost-minimisation |
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to children aged ≥3 years and adults requiring amino acid supplementation; TGA label covers all PKU dietary management without age or supplementation restriction.