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Vitamins, Minerals And Trace Elements Formula

Recommended · restricted MetabolicRestrictedNot applicable line

Dietary management of conditions requiring a highly restrictive therapeutic diet, particularly in patients aged 3 years and older following a ketogenic diet for refractory epilepsy or with inborn errors of metabolism.

1
Submissions
2017–17
On the record
—
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. Jul 2017
    Recommended · restricted

    vs FruitiVits

  2. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
6.1 The PBAC recommended the Restricted Benefit listing of Phlexy-Vits® for the dietary management of conditions requiring a highly restrictive therapeutic diet, on a cost- minimisation basis against FruitiVits® at an equivalent cost per sachet.PSD · Jul 2017
6.2 The PBAC agreed with the NPWP’s advice that the product is unsuitable for patients between the ages of 1-3 years. The PBAC noted that the sponsor indicated in their pre-PBAC response that they no longer intended to pursue a request to list Phlexy Vits® for that particular age group (1-3 years).PSD · Jul 2017
Consumer comments
5.3 The minor submission claimed that Phlexy-Vits® meets an unmet clinical need for patients aged 1-3 years and over 10 years of age following a ketogenic diet. The minor submission claimed that the main comparator, FruitiVits® is not suitable for this population, and that there are currently no listed products for this patient population.PSD · Jul 2017

Cost-effectiveness

Cost-minimisation basis; no ICER calculated as this is a minor submission for a nutritional product.

Cost-effectiveness accepted

Decision context

PopulationPatients aged 3 years or older with insufficient vitamin and mineral intake due to a specific diagnosis requiring a highly restrictive therapeutic diet, who are unable to adequately meet vitamin, mineral and trace element needs with other proprietary vitamin and mineral preparations.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2017 Recommended · restricted FruitiVits — Cost-minimisation · Cost-minimisation

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Regulatory · TGA

Label narrower than PBS population — PBAC restricts to age ≥3 years with specific diagnoses (refractory epilepsy, inborn errors of metabolism) requiring highly restrictive diets; TGA label covers all medical purposes foods.