Amino Acid Formula Supplemented With Prebiotics, Probiotics And Long Chain Polyunsaturated Fatty Acids
Treatment of cows' milk protein enteropathy, severe cows' milk protein enteropathy with failure to thrive, combined intolerance to cows' milk protein/soy protein/protein hydrolysate formulae, IgE-mediated allergy to cows' milk protein and soy protein, cows' milk anaphylaxis, severe intestinal malabsorption including short bowel syndrome, and eosinophilic oesophagitis.
Decision on record
- Meeting Mar 2024 Recommended Cows' milk protein enteropathy; severe cows' milk protein enteropathy with failure to thrive
Access path
- Jul 2017Recommended · restricted
vs Neocate Gold
- Mar 2024Recommended
Evidence: Single-arm → Cost-minimisation
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the new formulation of amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids (Neocate® Syneo) continue to be listed on the PBS under the existing conditions of the current formulation. 4PSD · Mar 2024
6.2 The PBAC noted and supported the NPWP advice that the new formulation is expected to provide a non-inferior clinical benefit for the management of cows' milk protein intolerance, cows’ milk allergy, EoE and the other indicated conditions.PSD · Mar 2024
4.2 The PBAC noted and welcomed the input from health care professionals (1), medical organisations (2) and consumer groups (1) via the Consumer Comments facility on the PBS website. The PBAC noted submissions from the Australasian Society of Clinical Immunology and Allergy, ausEE Inc and a joint submission from the National Allergy Council and Allergy & Anaphylaxis Australia.PSD · Mar 2024
Cost-effectiveness
No economic or financial analyses presented; cost-minimisation submission with no ICER calculated.
The PBAC considered the new formulation is not expected to have impacts on current utilisation of the product or the current costs to Government. PBAC · 2024
Decision context
PopulationInfants and children with cows' milk protein intolerance, cows' milk allergy, eosinophilic oesophagitis, severe intestinal malabsorption, or combined protein intolerances requiring amino acid-based formula.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2024 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2017 | Recommended · restricted | Neocate Gold | — | Single-arm · Other |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| NCT00664768 | NA | 126 | The primary endpoint is attained growth (i.e. incremental gains in weight) over the study … | completed |
Consumer voice
Consumer input from healthcare professionals, medical organisations and consumer groups highlighted the benefits of Neocate Syneo's probiotic and prebiotic formula for gut health and improved compliance, while raising concerns about supply chain issues and the shrinking range of nutritional products available in Australia for managing cow's milk allergy and related conditions.
the probiotic and prebiotic formula supports gut health in infants and children Consumer comments · PSD