← The record

Glycomacropeptide And Essential Amino Acids With Vitamins And Minerals

Recommended MetabolicRestrictedNot applicable line 💬 consumer voice

Dietary management of phenylketonuria (PKU).

14
Submissions
6 resub
2015–24
On the record
ICER range
Cost-min
Cost basis

Decisions on record

4 decisions
  • Meeting Nov 2024 Recommended Phenylketonuria
  • Meeting Mar 2023 Recommended Tyrosinaemia
  • Meeting Mar 2023 Recommended Phenylketonuria
  • Meeting Mar 2023 Recommended Phenylketonuria

Access path

14 submissions · public record
  1. Mar 2015
    Recommended

    vs Camino Pro Bettermilk

  2. Jul 2015
    Recommended · restricted

    Comparator changed: Camino Pro Bettermilk → TYR Cooler® 20 and TYR Cooler® 15

  3. Nov 2015
    Recommended
  4. Jul 2016
    Recommended · restricted
  5. Nov 2016
    Recommended · restricted
  6. Nov 2017
    Recommended

    Comparator changed: Camino Pro® Bettermilk → Camino Pro Bettermilk and PKU Bettermilk Lite

  7. Nov 2017
    Recommended · restricted

    Comparator changed: Camino Pro® Bettermilk → Camino Pro Bettermilk and PKU Bettermilk Lite

  8. Nov 2018
    Recommended · restricted

    Comparator changed: Tylactin RTD → PKU Glytactin RTD 15

  9. Jul 2019
    Recommended · restricted

    Comparator changed: PKU Glytactin RTD 15 → Tylactin RTD and Tylactin Complete

  10. Nov 2019
    Recommended · restricted

    Comparator changed: Tylactin RTD and Tylactin Complete → Camino Pro Bettermilk and Camino…

  11. Jul 2020
    Recommended · restricted

    Comparator changed: Camino Pro Bettermilk and Camino Pro Bettermilk Lite → Tylactin RTD…

  12. Mar 2023
    Recommended

    Comparator changed: Tylactin RTD 15 (lowest cost alternative GMP formula on PBS) → Camino…

  13. Mar 2023
    Recommended

    Comparator changed: Tylactin RTD 15 (lowest cost alternative GMP formula on PBS) → Camino…

  14. Nov 2024
    Recommended · restricted

    Evidence: Other → Cost-minimisation

  15. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
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
Economic analysis
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
Consumer comments
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
Price cut / RSA needed ×2Cost-effectiveness accepted ×11

Decision context

PopulationPatients with phenylketonuria (PKU) requiring dietary management.

Submission history

14 entries
DecidedOutcomeComparatorICEREvidence
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

Trials cited in the PSDs · ClinicalTrials.gov
TrialPhaseNPrimary outcomeStatus
NCT01428258 NA 32 Change in the Plasma Phenylalanine Concentration of PKU Subjects Fed the Glycomacropeptide… completed

Consumer voice

Nov 2024

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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