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Amino Acid Synthetic Formula Supplemented With Long Chain Polyunsaturated Fatty Acids

Recommended MetabolicAuthority RequiredNot applicable line

Treatment of cows' milk anaphylaxis, severe cows' milk protein enteropathy with failure to thrive, combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae, cows' milk protein enteropathy, proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein, and severe intestinal malabsorption including short bowel syndrome.

1
Submissions
1 resub
2023–23
On the record
—
ICER range
Not modelled
Cost basis

Decisions on record

4 decisions
  • Meeting Mar 2023 Recommended 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; severe intestinal malabsorption inc
  • Meeting Mar 2020 Recommended Cow’s milk allergy, multiple food intolerance and other medical conditions where an amino acid- based formula is recommended
  • Meeting Nov 2011 Recommended Medicinal food no PSD
  • Meeting Nov 2008 Recommended Medicinal food no PSD

Access path

1 submission · public record
  1. Mar 2023
    Recommended
  2. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended that EleCare LCP continue to be listed on the PBS under the same conditions as the current listing.PSD · Mar 2023
6.2 The PBAC agreed with NPWP advice that the new source of DHA-B is safe and appropriate and that the change in source of DHA is unlikely to change the clinical effectiveness or safety profile of the product.PSD · Mar 2023

Cost-effectiveness

Category 3 submission; no economic analysis required or provided. Formulation change only (DHA source).

Decision context

PopulationInfants and children requiring amino acid-based formula due to cows' milk protein allergy, severe enteropathy, or severe intestinal malabsorption.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2023 Recommended — — Other

Similar precedents

By decision profile
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