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Amino Acid Formula With Fat, Carbohydrate, Vitamins, Minerals, Trace Elements And Medium Chain Triglycerides

Recommended MetabolicAuthority RequiredNot applicable line 💬 consumer voice

Amino acid formula for children with 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 and soy protein, eosinophilic oesophagitis, cows' milk anaphylaxis, and severe intestinal malabsorption including short bowel syndrome.

3
Submissions
2 resub
2017–24
On the record
ICER range
Cost-min
Cost basis

Decision on record

1 decision
  • Meeting Nov 2024 Recommended Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae; severe intestinal malabsorption including short bowel syndrome; eosinophilic oesophagitis; cows' milk protein enteropathy; severe cows' milk protein enteropathy with failure to thrive; proven IgE-mediated aller

Access path

3 submissions · public record
  1. Mar 2017
    Recommended · restricted

    vs Alfamino Junior®

  2. Mar 2021
    Recommended · restricted

    Comparator changed: Alfamino Junior® → Neocate Junior

  3. Nov 2024
    Recommended · restricted

    Comparator changed: Neocate Junior → Essential Care Jr 800 g (primary); also Neocate…

  4. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended a General Schedule Authority Required (Telephone/Online) listing of a 400 g pouch of amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides oral powder (Essential Care Jr) with a new formulation, for the same indications as the current PBS listings for the 800 g pouch of Essential Care Jr.PSD · Nov 2024
7.2 The PBAC considered that the new 400 g pack size of Essential Care Jr with the new formulation should be cost-minimised to the lowest cost comparator accepted by the NPWP (the current 800 g pack of Essential Care Jr, Neocate Junior, and Alfamino Junior) at an equivalent cost per kilojoule.PSD · Nov 2024
Economic analysis
5.7 The submission did not present an economic analysis. The submission requested the same dispensed price for maximum quantity (DPMQ) of $336.55 as the currently PBS- listed Essential Care Jr 800 g.PSD · Nov 2024
5.8 In March 2021, the PBAC recommended Essential Care Jr 800 g on a cost-minimisation basis compared with Neocate Junior and Alfamino Junior at an equivalent cost per kilojoule at the March 2021 PBAC meeting (paragraph 7.01, Essential Care Jr, PSD, March 2021 PBAC meeting). The energy content and proposed price of Essential Care Jr 400 g in comparison to these products is presented in Table 2.PSD · Nov 2024
Clinical claim
5.16 The PBAC noted the submission described Essential Care Jr as non-inferior in terms of both effectiveness and safety to Neocate Junior. The PBAC considered this was reasonable, on the basis that Essential Care Jr provides the same amount of energy in comparison to Neocate Junior.PSD · Mar 2021
Consumer comments
5.2 The PBAC noted and welcomed the input from ausEE Inc. via the Consumer Comments facility on the PBS website. The comment supported the continuous supply and availability of Essential Care Jr and emphasized the importance of having a variety of amino acid formula options for children with Eosinophilic Oesophagitis and other PBS- listed indications. Nutritional profilePSD · Nov 2024
5.5 The sponsor provided comparisons of the new nutritional profile against the Australia New Zealand Food Standards Code Standard 2.9.1 Schedule 2 requirements and the Standard 2.9.5 Schedule 2 requirements as well as adequate intake (AI) and recommended daily intake (RDI) requirements.PSD · Nov 2024

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated as submission was on cost-minimisation basis at equivalent cost per kilojoule

The PBAC considered that the new 400 g pack size of Essential Care Jr with the new formulation should be cost-minimised to the lowest cost comparator accepted by the NPWP (the current 800 g pack of Essential Care Jr, Neocate Junior, and Alfamino Junior) at an equivalent cost per kilojoule. PBAC · 2024
Cost-effectiveness accepted ×2

Decision context

PopulationChildren 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/protein hydrolysate formulae, proven IgE-mediated allergy to cows' milk and soy protein, eosinophilic oesophagitis, cows' milk anaphylaxis, or severe intestinal malabsorption including short bowel syndrome, under specialist allergist, clinical immunologist, or specialist paediatric gastroenterologist and hepatologist management.

Submission history

3 entries
DecidedOutcomeComparatorICEREvidence
Nov 2024 Recommended · restricted Essential Care Jr 800 g (primary); also Neocate Junior and Alfamino Junior Cost-minimisation · Cost-minimisation
Mar 2021 Recommended · restricted Neocate Junior Cost-minimisation · Cost-minimisation
Mar 2017 Recommended · restricted Alfamino Junior® Cost-minimisation · Cost-minimisation

Consumer voice

Nov 2024

ausEE Inc. supported the continuous supply and availability of Essential Care Jr and emphasized the importance of having a variety of amino acid formula options for children with Eosinophilic Oesophagitis and other PBS-listed indications.

The comment supported the continuous supply and availability of Essential Care Jr and emphasized the importance of having a variety of amino acid formula options for children with Eosinophilic Oesophagitis and other PBS-listed indications. Consumer comments · PSD
product availabilitytreatment optionsunmet need

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