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

Withdrawn MetabolicRestrictedNot applicable line 💬 consumer voice

Dietary management of Maple Syrup Urine Disease (MSUD).

4
Submissions
2014–20
On the record
—
ICER range
Cost-min
Cost basis

Decisions on record

2 decisions
  • Meeting Nov 2021 Withdrawn Maple syrup urine disease (MSUD)
  • Meeting Jul 2021 Recommended Maple syrup urine disease

Access path

4 submissions · public record
  1. Jul 2014
    Recommended · restricted

    vs MSUD Aid III

  2. Nov 2014
    Deferred
  3. Nov 2019
    Recommended · restricted
  4. Jul 2020
    Recommended · restricted

    Comparator changed: MSUD Gel → MSUD Express 20, MSUD Cooler 20, MSUD Lophlex LQ 20, MSUD…

  5. PBS listing · Restricted
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC recommended the Restricted Benefit listing of amino acid formula with vitamins and minerals without valine, leucine and isoleucine, MSUD Lophlex, for the management of MSUD on a cost-minimisation basis per gram of protein with the nominated comparators.PSD · Jul 2020
7.2 The PBAC noted that the NPWP accepted that MSUD Express 20, MSUD Cooler 20, MSUD Lophlex LQ 20 and MSUD Maxamum were relevant comparators.PSD · Jul 2020

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated.

The PBAC recommended the Restricted Benefit listing of amino acid formula with vitamins and minerals without valine, leucine and isoleucine, MSUD Lophlex, for the management of MSUD on a cost-minimisation basis per gram of protein with the nominated comparators. PBAC · 2020
Cost-effectiveness accepted ×3

Decision context

PopulationPatients aged 3 years or over with Maple Syrup Urine Disease requiring dietary management.

Submission history

4 entries
DecidedOutcomeComparatorICEREvidence
Jul 2020 Recommended · restricted MSUD Express 20, MSUD Cooler 20, MSUD Lophlex LQ 20, MSUD Maxamum — Cost-minimisation · Cost-minimisation
Nov 2019 Recommended · restricted MSUD Gel — Cost-minimisation · Cost-minimisation
Nov 2014 Deferred — — Cost-minimisation
Jul 2014 Recommended · restricted MSUD Aid III — Cost-minimisation · Cost-minimisation

Consumer voice

Nov 2019

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

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

Similar precedents

By decision profile
Amino Acid Formula With Vitamins And Minerals Without Valine, Leucine, Isoleucine, Supplemented With Arachidonic Acid And Docosahexaenoic Acid92%Amino Acid Formula With Fat, Carbohydrate, Without Valine, Leucine And Isoleucine86%Amino Acid Formula With Vitamins And Minerals (Msud, Tyr, Hcu Coolers)76%Amino Acid Formula With Vitamins And Minerals (Three Formulations: Without Phenylalanine; Without Phenylalanine And Tyrosine; Without Valine, Leucine And Isoleucine)76%Amino Acid Formula (Multiple Formulations For Pku, Tyrosinaemia, Ga1, Mma/Pa, Hcu, Msud)72%Amino Acid Formula With Vitamins And Minerals, Without Phenylalanine70%Amino Acid Formula With Vitamins And Minerals (Multiple Formulations)71%Amino Acid Formula With Vitamins And Minerals, Low Phenylalanine And Supplemented With Docosahexaenoic Acid And Arachidonic Acid69%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to patients aged 3 years or over; TGA label does not specify age limits.

Listed in law

Federal Register of Legislation

PBS listings commencing 1 Mar 2021 were made by these 4 determinations under the National Health Act 1953. A determination covers every listing that commenced that day, so this is the legal instrument in force for the date — not a document naming this medicine. Open it and check.

DeterminationMadeStatus
PB 13 of 2021 24 Feb 2021 Repealed PDF ↗
PB 13 of 2021 24 Feb 2021 Repealed PDF ↗
PB 14 of 2021 24 Feb 2021 Repealed PDF ↗
PB 15 of 2021 24 Feb 2021 Repealed PDF ↗