Amino Acid Formula With Carbohydrate, Vitamins, Minerals And Trace Elements Without Phenylalanine, Supplemented With Docosahexaenoic Acid

8.1 The PBAC did not recommend the listing of PKU Synergy for the dietary management of phenylketonuria (PKU) or hyperphenylalaninaemia in children from 10 years of age.PSD · Jul 2020

The PBAC maintained its previous view that there were other products with better nutritional profiles for this patient population and that there was no clinical need for this product.PSD · Jul 2020

5.6 The sponsor claimed that the study demonstrated that reintroducing a low volume, nutrient enriched protein substitute (PKU Synergy) at 1 sachet 33 g per day, delivered favourable nutritional results and potential mood benefits in non-compliant PKU patients. The sponsor also claimed that the study demonstrated no deficiencies in copper, phosphorous, vitamin B6, folate, biotin and niacin.PSD · Jul 2020

5.7 The sponsor maintained that PKU Synergy will enable patients who are non-compliant in their dietary therapy and patients with a higher tolerance to phenylalanine, to meet micronutrient requirements in a smaller volume of product, which may result in less wastage of current protein substitute (prescriptions), savings to the PBS and potentially better patient compliance. Pricing considerationsPSD · Jul 2020

5.5 The sponsor noted that the study reported at days 1-3 of the study, natural protein intake and estimated Phenylalanine were high with low intakes of calcium, magnesium, iron, zinc, iodine and Vitamin D. The sponsor noted that after intervention (day 29-31) with PKU Synergy, the following results were reported: 3PSD · Jul 2020