Amino Acid Synthetic Formula Supplemented With Long Chain Polyunsaturated Fatty Acids, Medium Chain Triglycerides, 2'-Fucosyllactose And Lacto-N-Neotetraose
Treatment of cows' milk protein enteropathy, severe cows' milk protein enteropathy with failure to thrive, combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae, cows' milk anaphylaxis, proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein, severe intestinal malabsorption including short bowel syndrome, and eosinophilic oesophagitis.
Decision on record
- Meeting Nov 2022 Recommended Cows' milk protein enteropathy and related conditions
Access path
- Nov 2022Recommended · restricted
vs Alfamino (amino acid synthetic formula without HMO)
- PBS listing · Authority Required
From the public summary
The PBAC recommended the General Schedule Authority Required listing of amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids, medium chain triglycerides, 2’-fucosyllactose and lacto-n-neotetraose (Alfamino®) for the treatment of cows' milk protein enteropathy, severe cows' milk protein enteropathy with failure to thrive, combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae, cows' milk …PSD · Nov 2022
The PBAC recommended that Alfamino HMO (13.3 g of protein per 100 g) be listed at the same price per gram of protein as Alfamino (13.3 g of protein per 100 g).PSD · Nov 2022
The submission claimed Alfamino HMO provides superior efficacy by reducing the risk of infections (e.g. respiratory tract infection, otitis media) measured at up to 12 months due to the addition of HMOs. The PBAC considered this claim was not adequately supported by the evidence in the submission.PSD · Nov 2022
The submission also claimed non-inferior efficacy in terms of growth and development (mean weight gain per day at month 4) and non-inferior safety of Alfamino HMO compared with the comparator, Alfamino. The PBAC considered this was reasonable.PSD · Nov 2022
The PBAC noted and welcomed the input from ausEE Inc. via the Consumer Comments facility on the PBS website. The comments described the benefits of having an 2PSD · Nov 2022
Cost-effectiveness
Cost-minimisation analysis conducted; no ICER calculated. PBAC recommendation on cost-minimisation basis at same price as comparator Alfamino.
Decision context
PopulationInfants up to 24 months of age with cows' milk protein enteropathy, severe cows' milk protein enteropathy with failure to thrive, combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae, cows' milk anaphylaxis, proven combined IgE mediated allergy to cows' milk protein and soy protein, severe intestinal malabsorption including short bowel syndrome, or eosinophilic oesophagitis.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2022 | Recommended · restricted | Alfamino (amino acid synthetic formula without HMO) | — | RCT · Non-inferiority of weight gain |
Consumer voice
Consumer input from ausEE Inc. highlighted that having additional amino acid formula options on the PBS for children with eosinophilic esophagitis (EoE) allows patients to find suitable formulas in terms of taste, tolerance, and availability, leading to improved treatment adherence and better health outcomes, especially when formula is a sole or main source of nutrition.
The comments described the benefits of having an additional amino acid formula available on the PBS for children with EoE, highlighting that an increase in treatment options with amino acid formulae allows a patient to find a suitable formula in terms of taste, tolerance, and availability leading to improved treatment adherence and better health outcomes, especially when a patient is reliant on a formula as a sole source or main source of nutrition. Consumer comments · PSD