Amino Acid Formula With Vitamins And Minerals Without Methionine And 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 methionine and supplemented with arachidonic acid (ARA) and docosahexaenoic acid (DHA) (HCU explore5) for the dietary management of pyridoxine non-responsive homocystinuria (HCU) under the same circumstances as HCU 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 HCU explore5 should be cost-minimised to the lowest cost comparator accepted by the NPWP (HCU gel, HCU Anamix infant or HCU Anamix Junior) at an equivalent price per gram of PE.PSD · Mar 2023

5.9 The submission presented a cost-minimisation analysis of HCU explore5 compared with HCU gel and HCU cooler 10, based on the same price per gram of PE of $1.33 at the approved ex-manufacturer price (AEMP) (Table 2). 5PSD · Mar 2023

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

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