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Amino Acid Formula With Vitamins And Minerals Without Valine, Leucine, Isoleucine, Supplemented With Arachidonic Acid And Docosahexaenoic Acid

Recommended · restricted MetabolicRestricted 💬 consumer voice

Dietary management of maple syrup urine disease (MSUD) in infants and young children from 6 months to 5 years of age.

1
Submissions
1 resub
2023–23
On the record
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. Mar 2023
    Recommended · restricted

    vs MSUD gel (primary comparator); MSUD cooler10 and MSUD…

  2. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the General Schedule Restricted Benefit listing of amino acid formula with vitamins and minerals without valine, leucine, isoleucine and supplemented with arachidonic acid and docosahexaenoic acid (MSUD explore5) for the dietary management of maple syrup urine disease (MSUD) under the same circumstances as MSUD gel, except with a maximum quantity of 8 cartons rather than 4 cartons to provide the same number of grams of PE.PSD · Mar 2023
7.2 The PBAC considered that MSUD explore5 should be cost-minimised to the lowest cost comparator accepted by the NPWP (MSUD gel, MSUD Anamix Junior or MSUD Anamix Junior LQ) at an equivalent price per gram of PE.PSD · Mar 2023
Economic analysis
5.10 The submission presented a cost-minimisation approach of MSUD explore5 compared with MSUD gel and MSUD cooler10, based on the same price per gram PE of $1.33 at the approved ex-manufacturer price (AEMP) (Table 3). 6PSD · Mar 2023
This has been updated here to $1598.52. a DPMQ as at 17 October 2022PSD · Mar 2023
Clinical claim
5.7 The submission claimed non-inferior comparative effectiveness and non-inferior comparative safety of MSUD explore5 compared with MSUD gel. The submission provided a comparison of the nutritional profile of MSUD explore5 with MSUD gel presented as Table 2. 4PSD · Mar 2023
5.8 The PBAC advised MSUD explore5 is expected to provide a non-inferior clinical benefit for the management of MSUD compared to the comparators identified.PSD · Mar 2023

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated. MSUD explore5 was cost-minimised to comparators at equivalent price per gram of protein equivalent ($1.33 per gram PE).

The PBAC considered that MSUD explore5 should be cost-minimised to the lowest cost comparator accepted by the NPWP (MSUD gel, MSUD Anamix Junior or MSUD Anamix Junior LQ) at an equivalent price per gram of PE. PBAC · 2023
Cost-effectiveness accepted

Decision context

PopulationInfants and young children aged 6 months to 5 years with maple syrup urine disease (MSUD) requiring dietary management.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2023 Recommended · restricted MSUD gel (primary comparator); MSUD cooler10 and MSUD Anamix Junior/MSUD Anamix Junior LQ (secondary comparators) Cost-minimisation · Cost-minimisation

Consumer voice

Mar 2023

No consumer comments were received for this item.

The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD

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