Glycomacropeptide And Essential Amino Acids With Vitamins And Minerals
Dietary management of phenylketonuria (PKU).
Decisions on record
- Meeting Nov 2024 Recommended Phenylketonuria
- Meeting Mar 2023 Recommended Tyrosinaemia
- Meeting Mar 2023 Recommended Phenylketonuria
- Meeting Mar 2023 Recommended Phenylketonuria
Access path
- Mar 2015Recommended
vs Camino Pro Bettermilk
- Jul 2015Recommended · restricted
Comparator changed: Camino Pro Bettermilk → TYR Cooler® 20 and TYR Cooler® 15
- Nov 2015Recommended
- Jul 2016Recommended · restricted
- Nov 2016Recommended · restricted
- Nov 2017Recommended
Comparator changed: Camino Pro® Bettermilk → Camino Pro Bettermilk and PKU Bettermilk Lite
- Nov 2017Recommended · restricted
Comparator changed: Camino Pro® Bettermilk → Camino Pro Bettermilk and PKU Bettermilk Lite
- Nov 2018Recommended · restricted
Comparator changed: Tylactin RTD → PKU Glytactin RTD 15
- Jul 2019Recommended · restricted
Comparator changed: PKU Glytactin RTD 15 → Tylactin RTD and Tylactin Complete
- Nov 2019Recommended · restricted
Comparator changed: Tylactin RTD and Tylactin Complete → Camino Pro Bettermilk and Camino…
- Jul 2020Recommended · restricted
Comparator changed: Camino Pro Bettermilk and Camino Pro Bettermilk Lite → Tylactin RTD…
- Mar 2023Recommended
Comparator changed: Tylactin RTD 15 (lowest cost alternative GMP formula on PBS) → Camino…
- Mar 2023Recommended
Comparator changed: Tylactin RTD 15 (lowest cost alternative GMP formula on PBS) → Camino…
- Nov 2024Recommended · restricted
Evidence: Other → Cost-minimisation
- PBS listing · Restricted
From the public summary
7.1 The PBAC recommended a General Schedule Restricted Benefit listing of a 30-pack of glycomacropeptide and essential amino acids with vitamins and minerals sachets containing 15 g of oral powder (PKU Build 10) under the same conditions as the currently listed 60-pack size of PKU Build 10, except for the maximum quantity, for the dietary management of phenylketonuria (PKU).PSD · Nov 2024
7.2 The PBAC considered that the new 30-pack of PKU Build 10 should be cost-minimised to the lowest cost comparator accepted by the NPWP (60-pack PKU Build 10, PKU Build 20, Camino Pro Bettermilk, PKU Restore, and PKU Glytactin RTD 15) at an equivalent price per gram of protein equivalent.PSD · Nov 2024
5.4 The submission did not present an economic analysis. The submission requested the same DPMQ of $1,075.35 as the currently PBS-listed 60-pack size.PSD · Nov 2024
5.5 PKU Build 10 was recommended on a cost-minimisation basis against the nominated comparators Camino Pro® Bettermilk and PKU Bettermilk Lite® at an equivalent price per gram of protein equivalent (paragraph 6.1, PKU Build, PSD, November 2017 PBAC meeting). PKU Bettermilk Lite was delisted from the PBS on 1 February 2023.PSD · Nov 2024
5.2 The PBAC noted that there was no consumer comment for this submission.PSD · Nov 2018
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission requested same DPMQ as currently PBS-listed 60-pack size.
The PBAC considered that the new 30-pack of PKU Build 10 should be cost-minimised to the lowest cost comparator accepted by the NPWP (60-pack PKU Build 10, PKU Build 20, Camino Pro Bettermilk, PKU Restore, and PKU Glytactin RTD 15) at an equivalent price per gram of protein equivalent. PBAC · 2024
Decision context
PopulationPatients with phenylketonuria (PKU) requiring dietary management.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2024 | Recommended · restricted | 60-pack PKU Build 10 (currently listed), PKU Build 20, Camino Pro Bettermilk, PKU Restore, PKU Glytactin RTD 15 | — | Cost-minimisation · Cost-minimisation |
| Mar 2023 | Recommended | Camino Pro Bettermilk (current 49 g form); PKU Glytactin RTD 15; PKU Build | — | Cost-minimisation · Cost-minimisation |
| Mar 2023 | Recommended | — | — | Other · Other |
| Jul 2020 | Recommended · restricted | Tylactin RTD 15 (lowest cost alternative GMP formula on PBS) | — | Cost-minimisation · Cost-minimisation |
| Nov 2019 | Recommended · restricted | Camino Pro Bettermilk and Camino Pro Bettermilk Lite | — | Cost-minimisation · Cost-minimisation |
| Jul 2019 | Recommended · restricted | Tylactin RTD and Tylactin Complete | — | Cost-minimisation · Cost-minimisation |
| Nov 2018 | Recommended · restricted | PKU Glytactin RTD 15 | — | Cost-minimisation · Cost-minimisation |
| Nov 2017 | Recommended | Camino Pro Bettermilk and PKU Bettermilk Lite | — | Meta-analysis · Cost-minimisation |
| Nov 2017 | Recommended · restricted | Tylactin RTD | — | Cost-minimisation · Cost-minimisation |
| Nov 2016 | Recommended · restricted | Camino Pro® Bettermilk | — | Cost-minimisation · Cost-minimisation |
| Jul 2016 | Recommended · restricted | Camino Pro® Bettermilk | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2015 | Recommended · restricted | TYR Cooler® 20 and TYR Cooler® 15 | — | Cost-minimisation · Cost-minimisation |
| Mar 2015 | Recommended | Camino Pro Bettermilk | — | Cost-minimisation · Cost-minimisation |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT01428258 | NA | 32 | Change in the Plasma Phenylalanine Concentration of PKU Subjects Fed the Glycomacropeptide… | completed |
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