Amino Acid Formula With Vitamins And Minerals Without Phenylalanine
Recommended MetabolicRestrictedNot applicable line 💬 consumer voice
Dietary management of phenylketonuria (PKU), particularly for those requiring a lower-calorie option.
12
Submissions
4 resub
2014–24
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2024 Recommended Phenylketonuria (PKU)
- Meeting Nov 2022 Recommended Phenylketonuria
- Meeting Jul 2021 Recommended Phenylketonuria
- Meeting Jul 2021 Recommended Phenylketonuria
- Meeting Jul 2013 Recommended Medicinal food no PSD
- Meeting Mar 2012 Recommended Medicinal food no PSD
- Meeting Mar 2012 Recommended Medicinal foods no PSD
- Meeting Mar 2012 Recommended Medicinal foods no PSD
8 earlier decisions
- Nov 2010 Recommended Medicinal food no PSD
- Nov 2008 Recommended Medicinal food no PSD
- Jul 2008 Recommended Medical Food no PSD
- Jul 2007 Recommended Food no PSD
- Mar 2007 Recommended Nutrient for inborn error of metabolism no PSD
- Jun 2002 Recommended A food for an inborn error of metabolism no PSD
- Mar 2002 Recommended A food for an inborn error of metabolism no PSD
- Sep 2001 Recommended A food supplement for inborn errors of metabolism no PSD
Access path
- Jul 2014Noted
- Nov 2014Deferred
Evidence: Other → Cost-minimisation
- Nov 2014Deferred
Evidence: Other → Cost-minimisation
- Mar 2015Recommended · restricted
Evidence: Other → Cost-minimisation
- Nov 2015Recommended · restricted
Comparator changed: PKU Cooler → PKU Cooler 15®
- Nov 2015Recommended · restricted
Comparator changed: PKU Cooler → PKU Cooler 15®
- Nov 2015Deferred
Comparator changed: PKU Cooler → PKU Cooler 15®
- Mar 2017Recommended
Comparator changed: PKU Gel and PKU Anamix Junior → PKU Cooler, PKU Lophlex LQ
- Mar 2017Recommended
Comparator changed: PKU Gel and PKU Anamix Junior → PKU Cooler, PKU Lophlex LQ
- Mar 2020Recommended · restricted
Evidence: Cost-minimisation → Other
- Nov 2022Recommended
- Mar 2024Recommended · restricted
Evidence: Other → Cost-minimisation
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended that amino acid formula with vitamins and minerals without phenylalanine (PKU Lophlex Select LQ) be listed on the PBS as a General Schedule Restricted Benefit for the dietary management of phenylketonuria (PKU) under the same circumstances as PKU Lophlex LQ 20.PSD · Mar 2024
7.2 The PBAC considered that PKU Lophlex Select LQ should be cost-minimised to the lowest cost comparator accepted by the NPWP (PKU Lophlex LQ 20, PKU Cooler 20 and PKU Air 20) at an equivalent price per gram of PE.PSD · Mar 2024
Economic analysis
5.6 As a Category 3 submission, the economic analysis has not been independently evaluated.PSD · Mar 2024
5.7 The sponsor a presented a cost-minimisation approach of PKU Lophlex Select LQ compared with PKU Lophlex LQ 20, based on the same price per gram PE of $0.638 as the AEMP for This results in a requested AEMP equivalent to PKU Lophlex LQ 20 of $1,531.08 (Table 2).PSD · Mar 2024
Clinical claim
5.5 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of PKU Lophlex Select LQ compared to PKU Cooler 20 and PKU Lophlex LQ 20.PSD · Mar 2024
Consumer comments
5.1 The Nutritional Products Working Party (NPWP) supported the continued PBS listing of PKU squeezie, with new source of Vitamin A, under the existing conditions.PSD · Nov 2022
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered the nominated main comparator, PKU Lophlex LQ 20, to be reasonable and considered that PKU Cooler 20 and PKU Air 20 are reasonable alternative comparators. PBAC · 2024
Cost-effectiveness accepted ×6
Decision context
PopulationAdults and adolescents with phenylketonuria (PKU), particularly those requiring a lower-calorie dietary management option; can be used from age 4.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended · restricted | PKU Lophlex LQ 20 | — | Cost-minimisation · Cost-minimisation |
| Nov 2022 | Recommended | — | — | Other |
| Mar 2020 | Recommended · restricted | — | — | Other |
| Mar 2017 | Recommended | PKU Cooler, PKU Lophlex LQ | — | Cost-minimisation · Cost-minimisation |
| Mar 2017 | Recommended | PKU Air, PKU Lophlex LQ | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended · restricted | PKU Cooler 15® | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended · restricted | PKU Express-15® | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Deferred | PKU Gel and PKU Anamix Junior | — | Cost-minimisation · Cost-minimisation |
| Mar 2015 | Recommended · restricted | PKU Cooler | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Deferred | PKU Cooler | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Deferred | — | — | Other |
| Jul 2014 | Noted | — | — | Other |
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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