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Amino Acids – Synthetic, Formula

Recommended MetabolicAuthority RequiredNot applicable line

Nutritional supplement formulation for patients requiring a therapeutic elimination diet, particularly those with food allergies or intolerances.

1
Submissions
2018–18
On the record
—
ICER range
Not modelled
Cost basis

Decisions on record

7 decisions
  • Meeting Nov 2018 Recommended Cow’s milk allergy, multiple protein food intolerance and other medical conditions where an elemental diet is required no PSD
  • Meeting Nov 2007 Recommended Cows’ milk protein allergy (CMPA) no PSD
  • Meeting Jul 2007 Recommended Food no PSD
  • Meeting Nov 2006 Recommended Nutritional supplement no PSD
  • Meeting Nov 2006 Recommended Nutritional supplement no PSD
  • Meeting Nov 2006 Deferred Nutritional Supplement no PSD
  • Meeting Dec 2001 Recommended A food for inborn error of metabolism no PSD

Access path

1 submission · public record
  1. Nov 2018
    Recommended · restricted
  2. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
4.1 The PBAC agreed with the change to the formulation processed by the Secretariat and specifically noted the following matters raised in the sponsor’s pre-PBAC response:  The sponsor acknowledged the error in the submission which claimed prebiotic fibre was a new ingredient and noted the prebiotic fibre content had not changed from the old formulation; and  The sponsor agreed to notify all relevant healthcare professionals and consumers of the change …PSD · Nov 2018

Cost-effectiveness

Not modelled — minor formulation change submission with no economic evaluation.

Decision context

PopulationPatients requiring a therapeutic elimination diet, including those with food allergies or intolerances, supported by a highly restricted diet that may be low in fibre.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2018 Recommended · restricted — — Other

Similar precedents

By decision profile
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