Glycomacropeptide Formula With Long Chain Polyunsaturated Fatty Acids And Docosahexaenoic Acid And Low In Phenylalanine

7.1 The PBAC recommended a General Schedule Restricted Benefit listing of glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine (PKU GMPro Delight®) sachets containing oral powder 40 g for the dietary management of phenylketonuria (PKU) under the same circumstances as glycomacropeptide formula with long chain polyunsaturated fatty acids and docosahexaenoic acid and low in phenylalanine (PKU …PSD · Mar 2026

7.2 The PBAC considered that PKU GMPro Delight should be cost-minimised to PKU Sphere20, the comparator accepted by the NPWP at an equivalent price per gram of PE.PSD · Mar 2026

5.12 The submission presented a cost-minimisation approach of PKU Sphere Liquid compared with PKU Sphere20 Powder, based on the same price per gram PE of $0.76 at the approved ex-manufacturer price (AEMP).PSD · Nov 2022

5.13 The proposed AEMP per maximum quantity PE ($1,827.68) is the same as the main comparator PKU Sphere20 Powder. The PBAC considered this to be appropriate as PKU Sphere Liquid contains the same PE as PKU Sphere20 Powder.PSD · Nov 2022

5.5 The submission claimed the nutritional composition of PKU GMPro Delight is therapeutically equivalent to PKU Sphere20 and is expected to deliver comparable clinical outcomes. The submission provided a comparison of the nutritional profile of PKU GMPro Delight with PKU Sphere20 (Table 2).PSD · Mar 2026

5.6 The submission stated one 160 ml serving (40 g powder in 140 ml water) PKU GMPro Delight provides 519 kJ/ 122 kcal, 20 g protein equivalent (PE); 36 mg phenylalanine (PHE), and 100 mg docosahexaenoic acid (DHA).PSD · Mar 2026

5.8 The submission stated PKU Sphere Liquid is less concentrated in PE than PKU Sphere20 Powder. The submission considered patients who switch to PKU Sphere Liquid will require more formulation volume per day of PKU Sphere Liquid to maintain the same level of metabolic control as PKU Sphere20 Powder. The submission considered the extra volume of formulation will not introduce additional calories.PSD · Nov 2022

5.9 The submission stated PKU Sphere Liquid has higher concentration of PE than PKU GMPro LQ and considered patients will require less formulation volume of PKU Sphere Liquid per day to maintain the same level of metabolic control as PKU GMPro LQ. The submission argued PKU Sphere Liquid may improve dietary compliance for patients struggling to consume the large volume. The submission also stated PKU Sphere Liquid contains fewer calories than PKU GMPro LQ.PSD · Nov 2022