← The record

Glycomacropeptide Formula With Amino Acids, Vitamins, Minerals, Trace Elements, Carbohydrate, Fat And Low Phenylalanine

Recommended MetabolicRestrictedNot applicable line 💬 consumer voice

Treatment of phenylketonuria (PKU) in children and adults.

1
Submissions
2022–22
On the record
ICER range
Cost-min
Cost basis

Decision on record

1 decision
  • Meeting Mar 2022 Recommended Phenylketonuria

Access path

1 submission · public record
  1. Mar 2022
    Recommended · restricted

    vs PKU Bettermilk Lite, PKU Build 20

  2. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the General Schedule Restricted Benefit listing of glycomacropeptide formula with amino acids, vitamins, minerals, trace elements, carbohydrate, fat and low phenylalanine (PKU GMPro ULTRA®) for the treatment of phenylketonuria.PSD · Mar 2022
7.2 The PBAC noted and agreed with the NPWP advice detailed in Section 6 NPWP consideration.PSD · Mar 2022

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated by design.

The PBAC considered the cost-minimisation analysis appropriate noting the AEMP of PKU GMPro ULTRA compared with the main comparators PKU Bettermilk Lite® and PKU Build 20® was based on the same price of protein equivalent (PE) per gram of $0.8016. PBAC · 2022
Cost-effectiveness accepted

Decision context

PopulationChildren from 3 years of age and adults with phenylketonuria.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2022 Recommended · restricted PKU Bettermilk Lite, PKU Build 20 Cost-minimisation · Cost-minimisation

Consumer voice

Mar 2022

No consumer comments were received for this item.

The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to children ≥3 years and adults; TGA label covers all ages eligible as medical food.