High Fat Formula With Vitamins, Minerals And Trace Elements And Low In Protein And Carbohydrate
Recommended MetabolicRestrictedNot applicable line 💬 consumer voice
Management of a ketogenic diet in patients requiring high fat formula with low protein and carbohydrate content supplemented with vitamins, minerals and trace elements.
6
Submissions
4 resub
2015–23
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2023 Recommended Ketogenic diet
- Meeting Jul 2021 Recommended Ketogenic diet
- Meeting Mar 2021 Recommended Ketogenic diet management conditions
- Meeting Mar 2021 Recommended Ketogenic diet
Access path
- Nov 2015Recommended
- Nov 2020Recommended · restricted
Evidence: Other → Single-arm
- Mar 2021Recommended
Comparator changed: KetoCal 4:1, KetoCal 3:1, KetoCal 4:1 LQ → KetoCal 4:1 LQ RTF
- Mar 2021Recommended · restricted
Comparator changed: KetoCal 4:1, KetoCal 3:1, KetoCal 4:1 LQ → KetoCal 4:1 LQ RTF
- Jul 2021Recommended · restricted
Listing: Restricted → Authority Required
- Mar 2023Recommended
Listing: Authority Required → Restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
6.1 The PBAC recommended that new formulations of high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate (KetoVie® 3:1, KetoVie® 4:1, KetoVie® Peptide 4:1) continue to be listed on the PBS under the existing conditions of the current formulations.PSD · Mar 2023
6.2 The PBAC noted and supported the NPWP advice that the new formulations are expected to provide a non-inferior clinical benefit for the management of a ketogenic diet.PSD · Mar 2023
Economic analysis
5.16 The minor submission presented a cost-minimisation analysis of KetoVie 3:1 and 4:1 compared with KetoCal products based on the same price per kilojoule of $0.0042 at the AEMP. The equi-effective doses were estimated as the same number of kilojoules per day and the comparison was based on the estimated requirement of 6280 kilojoules per day.PSD · Nov 2020
5.17 The sponsor requested a '''''''% premium price for KetoVie Peptide 4:1 over KetoCal 4:1 with an AEMP of $''''''''''''' per kJ (further details on the price are provided in Table 6). The sponsor argued that the premium price was based on: 9PSD · Nov 2020
Clinical claim
5.3 The submission claimed non-inferior comparative effectiveness and safety of KetoVie Peptide 4:1 compared with Formulation 1 and Formulation 2. Product cost/patient/year: $'''''''''''''''''PSD · Jul 2021
5.4 The estimated product cost/patient/year would be $''''''''''''''''''' based on 12 prescriptions per year at the AEMP of $''''''''''''. The actual cost will vary due to variations in individual patient needs. Estimated PBS utilisation and financial implicationsPSD · Jul 2021
Consumer comments
• The amount of Vitamin A has been lowered to match the levels in KetoVie 4:1 as previous clinician feedback reported some patients on higher calorie volumes approached upper limits of Vitamin A.PSD · Mar 2023
• The amount of Vitamin A has been lowered in the KetoVie 4:1 flavours reformulation to match the levels in KetoVie 4:1 unflavoured as clinician feedback reported some patients on higher calorie volumes approached upper limits of Vitamin A.PSD · Mar 2023
Cost-effectiveness
No economic evaluation conducted; cost-minimisation submission with no change to pricing.
The submission did not present economic or financial evaluations. PSD · 2023
Cost-effectiveness accepted ×3
Decision context
PopulationPatients requiring management of a ketogenic diet with high fat formula, low in protein and carbohydrate, supplemented with vitamins, minerals and trace elements.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2023 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Jul 2021 | Recommended · restricted | KetoCal 4:1; modular amino acid-based formulations (Formulation 1 and Formulation 2) | — | Cost-minimisation · Cost-minimisation |
| Mar 2021 | Recommended | KetoCal 4:1 LQ RTF | — | Cost-minimisation · Cost-minimisation |
| Mar 2021 | Recommended · restricted | — | — | Cost-minimisation |
| Nov 2020 | Recommended · restricted | KetoCal 4:1, KetoCal 3:1, KetoCal 4:1 LQ | — | Single-arm · Seizure frequency |
| Nov 2015 | Recommended | — | — | Other |
Consumer voice
No consumer comments were received for this submission.
The PBAC noted that this item received no consumer comments. Consumer comments · PSD
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