Amino Acid Formula With Vitamins And Minerals, Without Phenylalanine And Tyrosine, Supplemented With Arachidonic Acid And Docosahexaenoic Acid

7.1 The PBAC recommended the General Schedule Restricted Benefit listing of amino acid formula with vitamins and minerals, without phenylalanine and tyrosine and supplemented with arachidonic acid and docosahexaenoic acid (TYR explore5), for the dietary management of tyrosinaemia (TYR) under the same circumstances as TYR gel, except with a maximum quantity of 8 cartons rather than 4 cartons to provide the same number of grams of PE.PSD · Mar 2023

7.2 The PBAC considered that TYR explore5 should be cost-minimised to the lowest cost comparator accepted by the NPWP (TYR gel, TYR Anamix infant or TYR Anamix Junior), at an equivalent price per gram of PE.PSD · Mar 2023

5.9 The submission presented a cost-minimisation analysis of TYR explore5 compared with TYR gel, based on the same price per gram of PE of $1.33 at the approved ex- manufacturer price (AEMP) (Table 2).PSD · Mar 2023

5.6 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of TYR explore5 compared with TYR gel. The submission provided a comparison of the nutritional profile of TYR explore5 with TYR gel presented as Table 1.PSD · Mar 2023

5.7 The PBAC advised TYR explore5 is expected to provide a non-inferior clinical benefit for the management of TYR compared to the comparators identified.PSD · Mar 2023