Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid

PBAC's latest decision on Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid: Recommended with restriction (2016). Considered for Phenylketonuria (PKU) in infants requiring oral nutritional support.

Eligible population

Infants with phenylketonuria requiring oral amino acid formula nutrition.

Therapy area

Metabolic

Line of therapy

Not applicable

Evidence base

Single-arm

Primary endpoint

Time to achieve desired blood phenylalanine level

Pivotal trial size

207 patients

Comparator

PKU Anamix Infant

Economic model

Cost-minimisation

ICER note

Cost-minimisation analysis; no ICER calculated as the product is listed at an equivalent price per gram of protein to the comparator.

Similar precedents

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