Amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine, supplemented with docosahexaenoic acid
Brand: PKU Synergy®
PBAC's latest decision on Amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine, supplemented with docosahexaenoic acid: Not recommended (2020). Considered for Dietary management of phenylketonuria (PKU) or hyperphenylalaninaemia in children from 10 years of age or adults.
PBAC outcome
Not recommended
Not applicable
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2017
Submissions
2
2017 → 2020
Eligible population
Children from 10 years of age and adults with phenylketonuria (PKU) or hyperphenylalaninaemia, particularly those non-compliant with dietary therapy or with higher tolerance to phenylalanine.
Therapy area
Metabolic
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Eating behaviour, nutrient intake, mood
Pivotal trial size
12 patients
Key trials
Green et al. (Benjamin Green et al., 2019)
Comparator
PKU Express 20®, PKU Lophlex®
Economic model
BIA only
Eligible patients/year
44
ICER note
Not modelled; this is a nutritional product submission without economic evaluation of cost-effectiveness.
Why PBAC said no
Reasons cited in the latest PSD: No clinical need for the product; other products with better nutritional profiles available; product does not provide adequate copper and phosphorus for patients on a relaxed diet; insufficient evidence of additional benefits compared to PBS-listed alternatives; recommended dosing (one sachet per day) may be confusing to patients; inadequate clinical evidence from single small study of short duration