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Protein Formula With Vitamins And Minerals, Low In Potassium, Phosphorus, Calcium, Chloride And Vitamin A

Recommended · restricted MetabolicAuthority RequiredNot applicable line 💬 consumer voice

Treatment of chronic renal failure in children aged 3 to 18 years requiring a low protein, low phosphorus diet, with or without low potassium restriction.

2
Submissions
1 resub
2019–20
On the record
—
ICER range
Cost-min
Cost basis

Access path

2 submissions · public record
  1. Nov 2019
    Recommended · restricted

    vs Renastart (and Kindergen as a pricing comparator)

  2. Jul 2020
    Recommended · restricted

    Comparator changed: Renastart (and Kindergen as a pricing comparator) → Kindergen…

  3. PBS listing · Authority Required
RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
The PBAC recommended the Authority Required (STREAMLINED) listing of protein formula with vitamins and minerals and low in potassium (Renastep®) for the treatment of chronic renal failure for patients aged 3 to 18 years on a cost minimisation basis per calorie of energy equivalent against Kindergen.PSD · Jul 2020
The PBAC agreed with the NPWP that Renastart was an appropriate comparator for Renastep, but considered that Kindergen was also a relevant pricing comparator.PSD · Jul 2020
Economic analysis
The resubmission requested to list Renastep on a cost minimisation basis to Renastart, as outlined in Table 1.PSD · Jul 2020
The proposed dispensed price for maximum quantity (DPMQ) is $1,369.73.PSD · Jul 2020

Cost-effectiveness

Cost-minimisation analysis; no ICER calculated by design.

The PBAC noted that this submission is not eligible for an Independent Review because it received a positive recommendation. PBAC · 2020

Decision context

PopulationChildren aged 3 years or older with chronic renal failure requiring treatment with a low protein, low phosphorus diet, or a low protein, low phosphorus, low potassium diet.

Submission history

2 entries
DecidedOutcomeComparatorICEREvidence
Jul 2020 Recommended · restricted Kindergen (primary pricing comparator); Renastart (therapeutic comparator) — Cost-minimisation · Cost-minimisation
Nov 2019 Recommended · restricted Renastart (and Kindergen as a pricing comparator) — Single-arm · Other

Consumer voice

Nov 2019

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
Whey Protein Formula Supplemented With Amino Acids, Long Chain Polyunsaturated Fatty Acids, Vitamins And Minerals, Low In Protein, Phosphate, Potassium And Lactose80%Whey Protein Formula Supplemented With Amino Acids, Vitamins And Minerals, And Low In Protein, Phosphate, Potassium And Lactose79%Sevelamer Hydrochloride64%Sevelamer62%Sevelamer Carbonate61%Amino Acid Formula With Vitamins, Minerals And Long Chain Polyunsaturated Fatty Acids, Without Phenylalanine62%High Fat Formula With Vitamins, Minerals And Trace Elements And Low In Protein Carbohydrate61%Calcium Carbonate61%

Listed in law

Federal Register of Legislation

PBS listings commencing 1 Dec 2020 were made by these 3 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 111 of 2020 26 Nov 2020 Repealed PDF ↗
PB 112 of 2020 26 Nov 2020 Repealed PDF ↗
PB 113 of 2020 26 Nov 2020 Repealed PDF ↗