Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid
Brand: PKU Explore
PBAC's latest decision on Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid: Recommended (2019). Considered for Dietary management of phenylketonuria (PKU) in older infants and young children.
PBAC outcome
Recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2017
Submissions
2
2017 → 2019
Eligible population
Infants and young children aged from weaning-age to 5 years with phenylketonuria (PKU) diagnosed by newborn screening.
Therapy area
Metabolic
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Acceptability and tolerance
Pivotal trial size
19 patients
Comparator
PKU Anamix First Spoon
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design.
Submission history
Mar 2017: Recommended with restriction · Restricted