← The record

Amino Acid Synthetic Formula Supplemented With Long Chain Polyunsaturated Fatty Acids And Medium Chain Triglycerides

Recommended · restricted GastroenterologyAuthority RequiredNot applicable line

Eosinophilic oesophagitis and severe intestinal malabsorption including short bowel syndrome (Alfamino®); eosinophilic oesophagitis (Alfamino® Junior).

1
Submissions
1 resub
2015–15
On the record
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. Nov 2015
    Recommended · restricted

    vs Neocate® Gold (Alfamino®); Neocate® Advance (Alfamino®…

  2. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended the listing of Alfamino® as an Authority Required Benefit for patients with eosinophilic oesophagitis and patients with severe intestinal malabsorption, with no changes to current pricing arrangements.PSD · Nov 2015
6.2 The PBAC recommended the listing of and Alfamino® Junior as an Authority Required Benefit for patients with eosinophilic oesophagitis, with no changes to current pricing arrangements.PSD · Nov 2015

Cost-effectiveness

Cost-minimisation analysis; no economic model provided for this minor submission.

No changes to current pricing arrangements were requested, and the submission was therefore considered to be cost neutral to the PBS. PSD · 2015
Cost-effectiveness accepted

Decision context

PopulationPatients with eosinophilic oesophagitis or severe intestinal malabsorption including short bowel syndrome requiring amino acid based formula as part of dietary elimination program; age 18 years or less for eosinophilic oesophagitis indication.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Nov 2015 Recommended · restricted Neocate® Gold (Alfamino®); Neocate® Advance (Alfamino® Junior) Cost-minimisation · Cost-minimisation

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to specific medical conditions (eosinophilic oesophagitis, severe intestinal malabsorption) and age ≤18 years; TGA label covers all foods for special medical purposes.